The risk of dying from a blood clot after receiving the J&J vaccine is six in 6,800,000 (6.8M). The world population is 7,900,000,000 (7.9B). If everyone on the planet got the J&J vaccine tomorrow, and if it is the cause of the clots, then 6,971 people would die from the vaccine.
Yesterday, Covid19 killed 8,803 people (according to worldometers).
We don't want anyone to die from vaccination, and we don't fully understand what the clotting issue is, so it probably makes sense to pause using J&J as long as the mRNA vaccines (Pfizer, Moderna) have not been implicated (which they haven't). OTOH, if this being in the news causes fewer people to get vaccinated, pausing it may be a mistake that will cause more overall deaths.
Now, your risk of dying either from vaccination or Covid19 depends on various demographic factors not accounted for in my math above. But, nonetheless, the risk of dying from the J&J vaccine is really, really, really tiny.
Like, if I knew there was a 0.00009% chance my car were going to explode every time I got in it and started it, I would not be at all nervous about starting my car everyday for the rest of my life. I'm way more likely, even accounting for my age demographic, to choke to death eating dinner tonight (5,051 deaths from choking in the U.S. in 2015 of which 2,848 were older than 74).
Edit: lifetime risk of car exploding assuming I start it every day for 50 years is about 1.6%. Okay, maybe I wouldn't play that game.
It's not just a "blood clot" or some "rare type of blood clot".
This was what I posted in this post about the European Medicines Agency acknowledging the AstraZeneca vaccine (which I was inoculated with) was linked to something never seen before: https://news.ycombinator.com/item?id=26725232
> "Zero surprises here. Both Norwegian and German research teams identified the /actual specific novel antibody/ that causes this /new previously unclassified syndrome/ that was effectively unheard of before the AstraZeneca COVID-19 vaccine existed. Also, both teams are phenomenally talented for identifying this antibody so quickly. Usually it is on “finding a needle in a haystack” level difficulty. BTW, I am probably going to get downvoted but I am definitely not an antivaxxer and I received the AZ vaccine as innoculation for COVID-19."
Do you have any resources to read more about the research teams and their findings? Most of the articles I'm reading are very hand-wavy about the specifics/science and I'd love to actually learn more about the cause and condition.
The Los Angeles Times wrote an excellent article about the Johnson & Johnson (J&J) vaccine situation, in layman's terms [1]. However, journalists need to stop calling it "blood clots" or "rare blood clots", and instead call it a "rare clotting syndrome" that is "novel (new) and previously unclassified". For the AstraZeneca (AZ) vaccine situation, there has also been other good journalism sources here [2][3]. Pay attention to the subsection on [3] stating "Nothing but the vaccine can explain why".
In both cases, the situation is clinically similar to Heparin-induced thrombocytopenia (HIT), although there are very distinct differences. It should not be used as a comparison.
This is a good peer-reviewed journal article on diagnosis and management [4]. This is another article describing the syndrome [5].
I should emphasize that the treatment that is used for this specific syndrome is extremely expensive: intravenous immunoglobulin. I personally take the same medication (immunoglobulin) subcutaneously (under-the-skin) twice per week, for 2 rare immune-mediated neurological diseases affecting my peripheral nervous system. I will require this medication for life. When I lived in the USA (I live in Croatia now), my medical insurance was paying $278,000/year for the medication, under contract. I am not talking about how much the medication was being billed for, which was way higher. So, you heard me right, my insurance paid $278,000/year for this type of medication.
Sorry, but this is not relevant to this discussion. I refuse to flood this extremely long thread with details that are not relevant to the readers clicking on this thread. Please see my profile and email me instead, for specific answers.
It is relevant to the discussion because the AZ and JJ vaccines are for the "rest of the world", so comparative differences in the cost of IG between US and other healthcare systems is relevant.
I'm not the original poster but I'm from Croatia. I've been living in the US for around 10 years now and have a chronic illness that required constant management: Type 1 Diabetes.
I also have a separate issue, Pectus Excavatum, a chest deformity that required me to undertake a fairly difficult surgery called the Nuss Procedure.
I think these two examples do a good job at demonstrating differences between Croatian an US healthcare payment systems. They are very different medical problems.
Diabetes is a chronic illness that requires constant management. I need to inject insulin multiple times a day and require other supplies such as sugar sensors, lancets, needles, and glucose strips. I have a brother who still lives in Croatia and also has Diabetes Type 1. Our treatment plans are almost identical. We take the same medications and need the same supplies.
Managing Diabetes in the US is fairly annoying and expensive. I'm lucky to work in tech which provides me with good pay and insurance but even then my expenses can go up to $200/mo. It is also difficult, sometimes impossible, to get insurance authorization for better insulins that are widely available in Europe. I am on Humalog, or sometimes Novolog, similar insulins but insurance companies only cover a single one, so you have to switch when you change insurances. Newer insulins such as Fiasp, Apidra, or Tresiba, which are newer, quicker to work, and overall "better" are almost impossible to get in the US. I tried multiple times and the insurance never gave me the authorization to use them.
My brother lives in Zagreb, Croatia. He's been a diabetic all of his life. He's using newer insulins such as Fiasp and Tresiba and he doesn't pay anything for them. Literally 0. It's completely covered by the National Insurance. Same goes for all of the supplies like strips and needles, and glucose sensors (which can be pretty expensive in the US). In total he pays $0.00 on diabetes management.
In addition, Diabetes education is terrible in the US. Doctors here will usually tell me that I can eat whatever I want as long as I cover it with enough insulin. This is just awful advice since people are not computers and will never calculate the correct dosage of insulin they need to cover every meal; resulting in bad sugar management and complications that come with it: blindness, limb amputation, and eventually death.
The ONLY way to properly manage diabetes is to be very careful about eating carbs. Not necessarily eliminate them, but come as close to it as possible. This is the way diabetes education works in Croatia. Fix the diet and then use insulin to fix what you can't fix with diet. The result is way better sugar management, and way cheaper treatments.
Just the other week I had my checkup here in the US and the doctor told me my blood sugars are "too LOW for a diabetic" (my A1c was 5.9% - still higher than the normal 5.5% for a healthy person). I should change my diet and eat more carbs to raise it up. This is just awful, awful advice and I'm sure it's the result of generally terrible diet in the US.
So overall, healthcare treatment and payment for a chronic illness like Diabetes is just immeasurably better in Croatia. It's not even a contest.
Now, on the other hand.
Pectus Excavatum is a bone deformity. In some cases it's small enough to not present any problems but if it's fairly severe it can cause a lot of cardiovascular issues. Nuss procedure involves implanting multiple steel bars (3 in my case) behind the chest wall in order to force the chest bone out. The bars stay in the body for 3 years and are then removed. Surgery is usually successful and after the bars are removed you are considered "cured". There is nothing more to manage and the rate of complications is very low.
This surgery is complicated. It's most often done on children because it becomes much more difficult to perform it in adults. Video if interested: https://www.youtube.com/watch?v=R8SrRzJqbJ8
As an adult, it's almost impossible to get the surgery performed in Europe. I know there's a center in Italy, and another Netherlands that do perform it, but their rate of success is not great. I've seen a lot of people complain about the results.
The place to do it is the United States. Mayo Clinic in Arizona has the absolute world expert on Nuss Procedure and she does surgeries on adult of up to 40ish years of age (I got in at 37, last chance). Her work is absolutely phenomenal and people from all over the world travel to Arizona to do it there. There are also hospitals in Missouri I think and in New Jersey that do it, but I'm less familiar with them.
Now given that there are only a handful of places in the world that perform this surgery on adults, you'd think that the cost of this procedure would be astronomical. In total I paid around $2000 out of pocket. Without insurance it costs around $30k, plus $10k or so for the hospital bed (oh US). Don't get me wrong, it's not cheap, but for something of such difficulty and expertise I expected it to be way more expensive. It's literally impossible to get in most of the world other than the US and it costs less than the price of diabetes supplies for 1 year.
So there you have it. In my opinion the US system is absolutely awful for managing chronic conditions. It's made to exploit you for as much money as possible and even give you bad medical advice that makes sure you're going to need those expensive supplies.
On the other hand, the most difficult procedures in the world are sometimes only available in the US, and the price of those is not nearly as high as you'd expect it to be.
It's great for acute treatable conditions, and absolutely awful for chronic conditions that require constant management.
I’m the OP. I hope you become a US citizen just in case you need it (not just holding a green card). I agree with your assessment. I also have T1D. My neurologists and endocrinologists (I have 2 of each) are pretty sure one of my (very rare) neuro diseases caused the autoimmunity leading to the T1D diagnosis. The disease I have was discovered in the early 2000s at the Mayo Clinic off of NIH research grant funds. Call me crazy, but the only reason I do not renounce my US citizenship is because the US literally saved my life and others around the world via the NIH funded research discovery.
I've been watching this news story today and every 2 hours there was a new top-post from people:
Covid kills X. Vaccine Kills Y. Everyone is stupid.
Programmers (and I'm one of them) are very black/white thinkers. Very few people on here had said ANYTHING that the radio said today: The pause give us the opportunity to train nurses and doctors to immediately identify the blood clot and make correct recommendations based on that. Typical anti-clotting protocols make this worse. The pause helps us get this communication out.
It's all identity politics at this point. Anyone has anything bad to say about a vaccine and suddenly the anti-anti-vaxxers pop up. Now that Trump criticized the pause I'm sure there's going to be a wildly popular support for this pause.
"Now, your risk of dying either from vaccination or Covid19 depends on various demographic factors not accounted for in my math above. But, nonetheless, the risk of dying from the J&J vaccine is really, really, really tiny."
Unless this is a repeat of AstraZeneca, where many were lamenting the interruption of vaccination and calculating the risk for the entire population of people injected with AZ. Meanwhile, in some countries, the risk of dying from the vaccine for young women was higher than the risk of dying from the virus.
After the concerns about AZ turned out to be justified and AZ being banned for certain age groups you'd think that people would get a clue about unconditional vaccine cheerleading.
> the risk of dying from the vaccine for young women was higher than the risk of dying from the virus
Do you have a good source you'd recommend for this? I couldn't find this bit of info from the first few articles I skimmed.
> After the concerns about AZ turned out to be justified and AZ being banned for certain age groups you'd think that people would get a clue about unconditional vaccine cheerleading.
Who is unconditionally cheerleading which vaccines?
Women < 60 years: 10 deaths from covid-19 in total [0]. Four vaccine-related deaths were reported in young, relatively healthy women.
Details on three of the vaccine-related deaths have been published [1]. One of the stories had been made public [2].
The astrazeneca vaccine was put on hold, if not, it's not hard to imagine the number of fatalities surpassing the number of covid-19-related deaths, even when ignoring comorbidities
Where in [1] does it state that 4 died? There seems to be 2 women who died. Patient 3, a man who were discharged and healthy. Patient 4, discharged, healthy. Patient 5, is unclear I think, wether it survived or deceased.
Edit, please correct me if I'm wrong, it's very important that we don't spread false information regarding this.
Yes, it should have been stated explicitly; three fatalities are reported in the study. The forth was reported in the media [0]. Female, 34 years old, no history of chronic disorders.
In australia for example, where there is currently zero community transmission, and AZ was the preferred rollout for most of the population, assuming only women are vulnerable (not true) about 8m women below 50 (the age for which the government instituted the cutoff for alternatives) so at 1:500,000 risk of some injury (edit - originally said death) that’s 16 people who, ceteris paribus, wouldn’t be at any risk
I think your argument can be better if you qualify your assessment of risk for Australian women with the temporal constraint of "for now". Because transmission is low in Australia they may be better off waiting for a safer choice. However eventually travel will return and it is highly likely that the virus will still be around.
6 obvious deaths that we're aware of. The risk of the vaccines is in their novelty and morbidity. An abundance of caution is required in this instance. It would be very bad to discover that there's a vanishingly small chance of blood clots within the first 3 months but a significant chance when paired with other events over the following decade.
So I created a new account for this to avoid linking personal information...
I had blood clots in my lungs last week a few days after getting the J&J vaccine. I'm an otherwise totally healthy man in my 30s, no preconditions. The hospital reported it to the vaccine reporting agency, which I assume is reviewing all this information.
I'm not sure if they considered my case when making this decision. My clots were different type than what these women experienced (pulmonary, not cerebral).
Of course vaccinating the public is extremely important right now. If the risks of clotting really are 1 in a million, it makes sense to re-instate it. I also think that's an obvious conclusion and the people working on this are well aware of the public health trade-off.
I suspect they are working with more information than what's in the press release, and its prudent to give them some time to work through it.
I am so sorry. As somebody who has experienced pulmonary embolism, this is so scary.
Make sure to never forget to take your blood thinning medicine. You absolutely must get the blood clots completely dissolved, and the blood thinner medicine is highly effective at getting rid of it, if you take it.
I agree for the US to pause the rollout is likely based on more data than 6 known cases of clotting. Not trying to be conspiratorial but my two cents is the authorities have more data then what is publicly being shared.
Or they are aware that data reporting is spotty - many deaths could have happened and been attributed to other causes. How many heart attacks or strokes happened in those 6 million people? How many of those might have involved undetected clots?
If we assume that only 5% of cases are being detected and reported correctly, then the numbers look quite different.
Clotting happens much more frequently with or without vaccination. The reported cases are a kind of very rare type of clotting. It's easier to spot something unusual going on when mutiple rare events are observed.
In comparison there have been over 2000 deaths reported (US, all vaccines). But death is not unusual and unless one can find a specific link to vaccination that number alone is not alarming. Sometimes we live with known risk, anaphylactic shocks e.g., because they are unavoidable and benefits outweigh risk. But we do what we can to mitigate such risk.
In summary the current pause is triggered by the particular type of clotting, not just any clotting. But your case should contribute to the overall evaluation of the likely cause and risk.
The PR release tells people to watch for pain in their legs. So I think it’s possible and likely that clots are not only cerebral but arterial and venous.
But, IDK and I’m super skeptical they’re willing to halt vaccine and take this hit for 6 known cases. My guess is 6 deaths they’re willing to acknowledge and a few more cases that will come out.
But again, I know nothing and I would’ve expected their stock price to take a hit today.
Thanks. As I've now learned, almost all of these clots originate in the legs and pelvis and then travel to other parts of the body (lungs, brain).
So I think that's why they're telling people to watch for leg pain. I didn't have any issues with my legs, but it's apparently a common symptom to have pain and swelling there.
I got a little out of breath doing simple tasks like walking briskly or picking up my kids, and I had a pain in my back (actually lung) that gradually got worse over a few days.
Eventually the pain was severe enough that I went to the ER.
Looking back, the shortness of breath was a key indicator. It wasn't that I was struggling to breathe or anything, but I felt like I couldn't take a big deep breath easily and that's not normal.
The pain would also get worse at night when I tried to lie down to go to sleep. I thought I had pulled a muscle in my back at first, but it was quite painful.
ok now I'm worried. I got the JJ vaccine 4 weeks ago. Suffered semi bad flu for few hours that night then after felt great. Now some who now me may consider me a hypochondriac but I've felt a tad "off" since the vaccine but kept it to myself. Maybe only 2-3 tiny lightheadedness episodes while walking the dog (nothing major just more of "what was that"), or some very minor chest tightness and stomach bloating feel.
But last week (would have been 3 weeks after shot) I awoke in the middle of the night with pretty a bad chest pain like you describe. Felt like it was in middle of my chest and was quite painful. I had to physically sit up in my bed for about 5 minutes hoping it would subside. I got up and got some water and hoped it didn't get worse as I started contemplating what I should do if it does.
I was so tired though I just propped myself up with pillows and slept sitting up against the headboard because laying down seemed to make it come back worse. I eventually fell asleep and when I woke for the day I still felt a small amount of pain still. Went about my day normally and it seemed to go away later in the day.
I would think I am out of the window by now after 4 weeks to which I am in any danger from what I'm reading on news sites? I've been the gym since that episode and have done cardio fine. My wife suggests I take some low-dose aspirin for next few days.
If you’re having chest pain that’s severe enough to wake you up at night, I would talk to a doctor. It doesn’t have to have anything to do with the vaccine.
I would also not dismiss the nagging feeling in the back of your head that something doesn’t feel right. You know your body more than anyone.
Not to scare you, but I advise following up with a doctor as soon as possible. My 21 year old brother who was otherwise completely healthy suffered a similar short pattern of pain due to blood clots (not related to vaccine) but with severe neck pain for a short time one night.
It went away after that night, he was fine for 3 weeks with no pain or issues, was working out fine, etc. and thought nothing of it.
Suddenly one night went from perfectly fine sleeping to suffering a major stroke due to a blood clot in his brain within a 10 minute period, unable to do anything himself to get help as he lost all motor skills.
He said in retrospect he wishes he had followed up with a doctor on the thing he thought was no longer an issue 3 weeks before.
There are genetic tests they can run, as well, such as to see if you might have factor V Leiden.
They put me on blood thinners right away to prevent future clots and prevent the clots from getting bigger. I’ll be on them for at least a few months.
They then put me on pain meds and supplemental oxygen for a few days and watched me. The pain went away after a few days (I assume when the inflammation went down).
They didn’t actually treat the clots themselves. The body apparently does that itself over the course of a few weeks and months. There are invasive surgical ways to try to break them up but they felt I wasn’t bad enough to risk it since I could sit up and breathe on my own.
They checked my heart for tissue damage and thankfully didn’t find any. So now they’re doing a slew of tests to find the cause (genetics? Cancer? So far tests show cancer is unlikely).
Recovery has been good to be honest. I’m not really in pain. I do get out of breathe very easily but they say that’s normal and should go away in a few weeks as the clots dissipate. The lung damage should heal, I think.
The real danger from more clots to the brain or damaging the heart are prevented by the blood thinners, which are apparently highly effective. So I think I got lucky and I’m glad I went to the ER when I did.
110+ million vaccinations in the US and holy goddamn, no major issues. 31 million infections and 550,000+ dead, in a year. Millions of long haul COVID cases. Debilitating lung conditions, brain fog, lasting consequences already from the virus, and you wanna crow about long term consequences of the vaccine. What in the actual roasting hell.
I've noticed you, specifically, posting pro-virus misinformation since the very beginning. Half a million people died, man. I wish you would just spare us your trolling, damn it!
>Stop violating people's human rights to make their own individual medical choices.
What are you even referring to? Literally no one has to get a vaccine if they don't want it. Nobody in the comment chain you're replying in had advocated for forced innoculation. This is 100% already a "their body, their choice" situation.
It's worse than that. They are literally rolling out misinformation--lies, really--to try to convince people to not get vaccinated. Comment history on the topic of COVID is littered with trollish behavior and bonkers-bad reasoning fitting a pattern.
I always provide sources for my facts. See above. The parent comment was an opinion. Meanwhile, you don't have access to a long-term study on any Covid treatment, because not enough time has passed. That's not misinformation. That's math.
Blood clots cause strokes. You have no idea if Covid treatment increases your odds of having a stroke in 10 years. I invite you to study the history of various medical treatments that turned out to have unintended consequences on unsuspecting populations. Good luck either way. Stay healthy and stay free.
For example, you can't easily prove that your comment here is not causing me to develop a blood clot if I develop one.
Which is why we try to prove positives: who else has developed a blood clot after reading your comment? Is there any correlation? Anything to suggest there is causation too? What would be the hypothesis.
You are right that vaccines are not proven to be perfectly safe (and to be honest, none of them are even with longer testing time). But you are still muddying the waters by throwing these "prove a negative" statements.
The risk with coronavirus vaccines today is that the risks are not fully known (unlike with other, more established, vaccines for other diseases). Risks of getting coronavirus is also not fully established, though we know it can be pretty severe.
It would be only natural to expect some similar immune response from COVID and vaccines causing similar issues in the body, but that's totally hypothetical until proven to be the case.
Data so far points that it's much less likely for someone to develop issues from a vaccine than from COVID itself (roughly 10000 less likely at least), so it's up to the individual to assess if they are less likely to contract COVID and get serious symptoms, or get serious symptoms out of vaccination.
Also statistically unknowable at this point. But a 34 and under year old already has less than a 1 in 100K chance of dying from Covid. That is to say, an under 34 year old is more likely to die of murder than die of Covid. Anywhere from 4-10x more likely in the U.S. depending on the city.
We never really exposed general population of under 34s to unmitigated coronavirus (perhaps March/April 2020 in USA or Sweden in 2020 is closest we got to it), but even that is uncontrolled for people deciding to reduce exposure to other people on their own.
"10000 less likely" was derived from 1 in 6 million compared to a global death rate of roughly 2%, then allowing for roughly an order of magnitude error: not scientific at all, I agree.
Taking your numbers as undisputable while not acknowledging that they are as uncertain as "the other side" is a bit dishonest in my opinion.
Accepting your stats here, but what about consequences other than death? A friend in their late 30s just had to relearn how to walk and was in a coma for weeks after getting COVID. Months later he still isn't able to work full time.
"The full research, development and approval process can last from 12 to 15 years."
"If the FDA gives the green light, the investigational drug will then enter three phases of clinical trials:
Phase 1: About 20 to 80 healthy volunteers to establish a drug's safety and profile, and takes about 1 year. Safety, metabolism and excretion of the drug are also emphasized.
Phase 2: Roughly 100 to 300 patient volunteers to assess the drug's effectiveness in those with a specific condition or disease. This phase runs about 2 years. Groups of similar patients may receive the actual drug compared to a placebo (inactive pill) or other active drug to determine if the drug has an effect. Safety and side effects are reviewed.
Phase 3: Typically, several thousand patients are monitored in clinics and hospitals to carefully determine effectiveness and identify further side effects. Different types and age ranges of patients are evaluated. The manufacturer may look at different doses as well as the experimental drug in combination with other treatments. This phase runs about about 3 years on average."
Fine, then what issue do you have with my comment? Pressuring or rushing to inject people who have no statistical risk is just adding to the overall risk equation
And when I hear rumblings of vaccine passports and all this nonsense in the news and I see some people's general attitude towards Covid vaccination: you're either for it or you're a flat earthling neophyte.
At any rate, point I'm trying to make:
There's less than 3700 deaths for Under 34 year olds in the United States, from Covid19 [1].
And that number will go down with every year that passes from here on out, because a broader percentage of that demographic already has herd immunity. In fact, there's much more important health problems to focus on for those demographics. Suicide, heart disease, homicide, car accidents, liver disease, diabetes, etc.
Population under 34: 148M
Covid19 deaths under 34 in first year of existence, with no immunity in population: 3710
Flu & pneumonia deaths for pop under 34 in 2018 was 1857 [3].
Odds of dying of Covid19 under 34 in first year of its existence:
.0025%
Odds of long-term consequences from RNA therapy from AZ, J&J, or Pfizer treatment: ???
Unknown. It could increase your odds of having a stroke at in 10 years. No one knows. If it's causing blood clots, that's a distinct possibility.
- these are vaccines, they aren’t gene therapy (ie they aren’t changing cellular DNA)
- saying a portion of the population has herd immunity is non-sensical. Either there’s herd immunity (virus can’t spread bc everyone has antibodies) or there isn’t. It happens at specific thresholds of population exposure/antibody presence that varies based on the R of the virus. It was estimated at ~70% for the ‘original’ virus and with the UK/SA variants now looks to be north of 80%.
- even with exposure, there are case reports of reinfect ion which makes sense in the history of coronaviruses which aren’t considered to provide long term immunity (ie antibody titre falls off and may not provide immunity in some short term horizon, ie 18 months)
- therefore, return to normal relies on elimination of community spread, by herd immunity, which likely will require vaccination; which will hopefully provide longer term immunity than infection with the virus itself (not sure on the evidence on this)
I agree that population that has low statistical risk shouldn’t be pressured into vaccination, and I see the dangers in vaccine passports etc.
To another point you made, regarding long term risks and generally the history of misguided attempts by the medical community to do something that has severe deleterious longer term effects that were unforeseen: I am signicantly less concerned about the risk of ie long term stroke risk being raised in this population, because the emerging evidence points to a HITTs-like antibody mediated condition.
In Heparin induced thrombocytopaenia and thrombosis, removal of trigger removes long term risk and I would think that no further antibody triggering thrombosis should be produced after the acute period in those affected (and indeed in that very large fragment of the population who don’t develop CVTS or vaccine mediated thrombosis, which does seem confined to those who had vaccine via adenovirus vectors), then it should be a non-issue because the autoantibody was never produced in the first place and there are no memory cells there ready to pump it out again at antigen presentation.
Of course, I qualify this with its possible, and you’re free to dismiss my confidence, but we have a plausible mechanism that is relatively well understood so I think the risk of there being long term risks is very low
It's quite true that nobody knows the long-term consequences of these vaccines (which I don't think it is accurate to call gene therapies), but likewise you have no idea what the long-term consequences of COVID exposure are either - it's not a simple die/survive binary as some people have mild symptoms but develop chronic problems.
You obviously have strong feelings about this because you came into the thread with big broad claims, but you seem to be taking disagreement from others very personally.
>Fine, then what issue do you have with my comment?
It's pretty obvious if you read my comment. You said, "Stop violating people's human rights", and I said nobody's rights are being violated. Putting it to you as clearly as possible, your rights are not being violated until you are being strapped into a chair and having a vaccine forced into you, and that's simply not going to happen.
Some regions may adopt a "passport" system for the relative short-term but even then, you still do not have to get a vaccine if you don't want to. You just may have to wait a little bit longer than the vaccinated to get back to participating in certain things, but you would still be exercising your right to not get vaccinated.
It's as simple as that, and has nothing to do with the rambling that followed your question.
I meant the original comment where you levied a personal attack against me. I stated my opinion in earnest. I've been posting on HN for better part of a decade, and you levy a personal assault on me. At any rate, I want you to understand: it's perfectly ok, and perfectly acceptable for there to be people in the world who have different opinions than you, and that does not make them a troll.
The above was my rationalization, with sources that you probably didn't bother to read, for my original comment where you made the personal attack and assaulted my character. At any rate, this conversation is done. Stay healthy and stay free, my friend.
> I meant the original comment where you levied a personal attack against me.
I think you mean me. What I actually wrote was:
> Comment history on the topic of COVID is littered with trollish behavior and bonkers-bad reasoning fitting a pattern.
And I stand by that statement. You've had a long history of rolling out dubious arguments and posting inflammatory misinformation with a deliberate agenda to minimize COVID from the very beginning, the whole damn year. I have no idea why. Your comments on other topics seem reasonable and level-headed, but your COVID trolling is just off the charts. I wish you would just stop it. The world hasn't even processed the trauma of going through millions of deaths, we're finally seeing the light at the end of the tunnel, and we got you out here just making more noises again, with driveby doubt mongering. Every. damn. time. Only with one more zero on the death counts each time. Please, just can it, dude. What are you hoping to accomplish? Talking people out of getting vaccines? You're afraid that you need to take a vaccine, because it's just the sniffles, or something? Fuck off with that already, the world's been on fire for a year. People I know have died. Friends of mine have long COVID. Friends of mine are doctors, nurses, who have seen thousands die. Fuck off with your stupid "gene therapy" fear mongering, on exactly the wrong thing, in exactly the wrong direction, at exactly the wrong time.
It concerns me that you are so keen on citing data in your comments, yet you are unable to notice that my username is not the same username that called you a troll.
My first comment in this thread was where I told you that your rights were not being violated. My second comment was my clarification. This is my third. There have been no personal attacks directed toward you from me - if you feel differently, please highlight where you feel I attacked you.
This is false. MRNA vaccines have no relation to gene therapy. MRNA is not turned into DNA by the body, and is fully gone from the body within a couple days. As such, there are no possible long term effects related to the vaccine being MRNA vs traditional protein based vaccines.
> No one has any clue as to their long term side effects. The under 30 odds of death for Covid-19 are statistically zero percent.
Can't you flip that around? No one has any clue as to the long term side effects of Covid-19. The under 30 odds of death for getting the vaccine are statistically zero percent.
They are vaccines and you should update your knowledge. Herd immunity needs to happen or our economy and health will be suffering for years. The chance of complications is also basically zero. If you want to chicken out and not get one that's fine, but don't spread disinformation. The mRNA vaccine is not gene therapy. Again you are spreading misinformation with that. Stop reading right wing trash sites and read some science sites.
1 death. The other cases are severe blood clotting but still alive by my understanding.
That's literally one-in-6-million chance of death with regards to this blood-clotting issue. A vanishingly smaller chance than the 1-in-40,000 (or 150-in-6-million) a healthy young person has of dying of COVID19.
So 1 death, 5 severe reactions related to blood clotting. Definitely a cause of concern, but lets not overplay the stats here.
This just another "Trolley problem": 150-people (even youngsters) would die from COVID19 vs the 1-person who died from the J&J vaccine.
If we include the general population (instead of focusing on the youngest and healthiest of us): COVID19 mortality rate is 1%ish, or 60,000-people-per-6-million.
You have to multiply the IFR by the odds that the person gets COVID to begin with. In countries where there's no community transmission (Australia) or in countries where it's possible to kill the virus just by vaccinating the at-risk population combined with shut-downs, the multiplier should be pretty small. Even in countries that have handled it badly, it still might be only a 1/3 or 1/2 chance of catching it. So as a young healthy person my chances of dying from COVID are probably less than 1/100000.
I bring this up because I think it misses the actual point. Even if the vaccine had a 1/100000 chance of death or major complications, I would still take it. Because my life is not the only one that matters. Killing the virus is likely (in this country) to require most people who are physically capable (including the young) of taking the vaccine. My taking on a 1/100k risk with the vaccine vs a 1/100k risk without the vaccine is worth it, because for most other adults, the risk is much greater than 1/100k if the population doesn't get vaccinated.
Fortunately, I don't think pausing J&J is necessarily the wrong decision, even given the argument I just made. AFAIK it's the least common of the three vaccines, and so there should not be many "missing" vaccinations that result from the pause. The fact that taking a risk is justified does not mean that pointless risk is justified.
It's not clear to me that the J&J vaccine's supply is large or critical enough that it's going to make that much of a difference (yet). If the supplies of the Moderna and Pfizer vaccines are such that most people with J&J appointments can just get one of the others instead, that's really not that big a deal.
Walk-ins might be affected, though, but I'm not sure what percentage of the total daily vaccinations are walk-ins vs. appointments.
And as a sibling mentions, the general risk of dying from COVID-19 is not 150 in 6M, because the probability of getting (symptomatic) COVID-19 needs to be factored into that figure. I would not be surprised that if that probability drops to under 1 in 6M after accounting for that, though of course the symptomatic infection risk differs based on demographics.
One thing that I am worried about, though, is that this might make people trust all the vaccines less in general. My girlfriend and I had J&J appointments for this Friday; fortunately we were able to get a walk-in Moderna shot today, but the issues with the J&J vaccine did give her a little anxiety even about the Moderna vaccine. I think that (and worse) might be pretty common, and isn't unreasonable.
It takes quite a long time to prove the link between a viral infection and a cancer that develops decades later, so it'll be a while before we know for sure.
I think that given the fact that we've been getting sick from corona-family viruses for years with no suspected link to cancers, this should be of relatively low concern, barring any specific information.
There are other potential longer term side effects that at least seem to have some emerging data to back them up, which seem more concerning to me.
How would we even know? In order to tell if coronaviruses caused cancer, we'd need to be keeping track of which people had ever been infected with one of them and how many of them ended up with cancer, and we're not. It'd just fall into the background level of cancer incidence otherwise. Hell, we haven't even figured out if they're the main cause of Kawasaki disease yet, and that's a fairly spectacular and dangerous condition affecting children. There's some evidence that some common viruses in the family might be really deadly to elderly people, but that doesn't seem to have been researched much either. There's a lot we just don't know.
This isn't actionable information, though. There are no good ways to mitigate all unknown potential risks, because the mitigations have risks themselves.
You mean proteins if you're talking modern/pfizer. It's literally triggered by one protein that matches a protein on the covid membrane. Everything in life is a chance, just stepping out and getting some sun puts you at risk for skin cancer yet still people have been doing it for a couple million years.
Well, consider that a lot of people who aren't applying as much caution to the virus itself just don't think it's that big a deal. Either they think their infection risk is low, or they expect they'll be asymptomatic, or think that even symptomatic infections aren't that bad. Through that lens, it makes sense to be wary of taking a vaccine with possibly-dangerous side effects when they don't believe the virus it protects against is all that bad.
I don't agree with the premise behind this reasoning, but I can see how it'd come about.
I agree but only because about 5% of the vaccines currently distributed are J&J in the USA. The others will more than make up for it I'm sure. I think when we hit the wall and the supply outstrips the demand in the next few weeks as we approach 60-65% vaccinated and qanon and hippy antivaxxers are unwilling, I bet in month there will be so many open spots that they'll start cutting back manufacturing unless Biden convinces Moderna and Pfizer to keep going full speed ahead and we say distribute to Mexico/Central America/South American countries (like we ought to do).
Some experts have said that it's probably an immune reaction to the adenovirus which is used as the delivery mechanism in the vaccine. Wouldn't the side effects therefore be limited to the first weeks after the injection only?
You'd have to compare that to the chances of the long term effects of COVID causing issues down the line, which I'm willing to heavily bet is much more likely given what we've seen so far.
The phase 3 trial for JnJ/Janseen had only ~44k participants whereas here we are talking on the order of ~1 per million (that are reported as of today)
Live harmless vaccines aren't anything new. Some of the TB vaccines from the 60s are of that variety. Live virus vaccines have safely been used for at least the past 5 decades. Stop spreading bullshit.
Ok. Well, perhaps you aren’t actually aware of what the J&J is. I enjoyed the part about spreading bullshit though, good one.
No, there have been no previous live viruses that have been genetically modified to look like other viruses (embedding Covid spike proteins) injected in humans before three months ago in any scale.
We have treated animals with exactly this however, including pigs against piggy rona.
I recommend reading the whole post next time, not just stopping at “live virus”.
This is what worries me. I have had the AZ vaccine. Will I be at risk of this syndrome every time I am exposed to coronavirus? In other words, is the risk cumulative?
I went to the emergency room for earth shattering headaches (no history of headaches like this) after getting the J&J vaccine last week. I mentioned I’d got the vaccine and asked if it was possible the two were linked. The doctor did everything but actually roll his eyes and thought that the headache being caused by the vaccine was ridiculous.
I bet if I went today he wouldn’t be so dismissive.
I did not, thankfully. I went to a follow up appointment and it seems there are several potential causes so I’m working on figuring out proper therapy with my doctor.
>The risk of dying from a blood clot after receiving the J&J vaccine is six in 6,800,000 (6.8M)
that we know of.
I suspect the lack of understanding about what is happening, and what other knock-on effects there might be is what is behind this.
If a wing falls off of one airplane in a million, we still stop and try to figure out what happened because as far as we know, wings are not supposed to fall off any airplanes, so there's something about the system we need to learn more about.
But airplaines are engineered by humans, we know everything about how they are supposed to work until the last bit of physics.
We don't have the same absolute understanding of mechanisms with vaccines. Therefore, I am not sure we can use this metaphore to suggest that it is the right choice in this terrible time to stop vaccinations, causing slowdowns to happen and scepticism to spread in the population that is bombarded by the press which creates an echo chamber repeating over and over superficial news.
I personally don't expect a vaccine, nor any medicine in general, to be supposed to have absolutely zero incidence of possible negative side effects.
We aren't stopping vaccinations. We are stopping this vaccine. For the moment. To gather more information. Which is precisely the kind of responsible behavior that we need, if we want people to be less skeptical of the vetting process for these vaccines.
>We don't have the same absolute understanding of mechanisms with vaccines.
> Especially considering the fact that autoimmune disorders have been on the rise for decades, and we don't know why.
Could it be that we are simply diagnosing them better?
Just throwing it out there as a plausible explanation since autoimmune disorders are commonly diagnosed based on a multitude of symptoms none of which definitely indicates an autoimmune disorder independently; similarly, I find it highly likely the rise in cancer diagnosis to be at least partially linked to better diagnostics too.
I had wondered about this as well - in the pool of people who have gotten the J&J vaccine, how many would we expect to have developed a blood clot under normal circumstances anyway?
That's exactly what they'll be studying to see if it's statistically relevant. They're being super cautious. Some would say over cautious but I think it's fine since J&J is currently only 5-10% of the vaccine supply going out. Which means a slight slow down in vaccine supply but not as big a deal as AZ in Europe since that is their main supply.
Yes, the fact that they are being this cautious is a good thing for public trust. We have other vaccines as well. I rather have this level of transparency then blindly tell people to get JJ and we will figure out edge cases later.
Is it that good? There are places where lots of people are refusing to get the vaccine if they hear it's Astra-Zeneca, because of all the overblown nightmarish news around it. I can tell you for example that in Italy there are examples of regions where 80% of people refuse.
I understand the need for being cautious and for transparency. Actually, I would like to have even more transparency and actual scientific data and numbers from the news. That would help the public understand better why certain decisions are made.
(Maybe my main problem is just with mainstream press, not much with stopping vaccinations per se. I'd just like to know more and be told by politicians: we are listening to scientists, these are the data, this is how numbers compare to the incidence of other side effects for well known medicines and to the numbers of daily deaths and long term problems caused by COVID, and the decisions are taken because X > Y).
> refusing to get the vaccine if they hear it's Astra-Zeneca, because of all the overblown nightmarish news around it
Here is a small problem with this that makes me also consider if I want to take a shot with AZ even if I registered for it months ago waiting for my place:
Before EU started discussing the issue with statistical signifiant number of cases of blood clots in vaccinated population UK Reported 5 cases of blot clots in vaccinated population.
After EU talked second time to suspend vaccination with AZ lo and behold UK discovered that it missed in previous months to report 25 more cases.
Now should I trust any of these agencies that they are telling the truth? I am starting not.
But I had a mild COVID and I am sure after experiencing those symptoms that I really want a vaccine. I am not willing to experience a reinfection.
I was scheduled for JnJ vaccine tomorrow but late in evening I got a text that my appointment is cancelled. I was conflicted all day about whether to keep my appointment or cancel it. I am sort of relieved that someone else made this decision for me and honestly makes me feel good about getting another vaccine. This assures me if there were or are any issues with any other vaccines, our regulators would have paused those vaccines too.
Also I was able to get another appointment for Moderna vaccine next week. So I just have to spend another 4 weeks or so social distancing. It is better than developing blood clots, imo.
It's even worse than that. Many other countries are now following suite and also pausing roll-outs. I'm here in the 3rd world (South Africa) and we really need to get our vaccinations going, so now the government has "paused" their non-existent vaccine program with winter on the way (and after pretty hectic easter celebrations).
Another factor to consider is that COVID is contagious but blood clots are not. The multiplicative (if not exponential) nature of COVID spread makes this a no brainer that the vaccine should be reinstated (and just monitored).
I suspect that what's happening is that these institutions don't think in consequentialist point of view. They are not comfortable with diverting the trolley even if the math checks out.
Also, there is a clot risk for with COVID [1] that's much higher than the vaccine. The clot risk is the reason I've been indoors this whole pandemic, so I'll happily take my these ridiculously better chances with the vaccine.
Per Wikipedia: there are 7.3 deaths per 1 billion km driven in the USA. About 7 million J&J doses have been delivered. One person has died as a result of blood clots thought to be related to the vaccine.
If we assume an average of 32km round trip to get to a vaccination site (~10 miles each way). Statistically speaking at least one person has died driving in their car to get the vaccine. The same number as from the vaccine.
I couldn't find good stats on serious injuries per km driven, but I suspect it's an order of magnitude higher than deaths per km. Your risk of dying on your way to get the vaccine is the same as your risk of dying from the vaccine. You are, almost certainly, far more likely to be seriously injured on your way to get the vaccine than you are from the vaccine.
>> Yesterday, Covid19 killed 8,803 people (according to worldometers).
I'm certainly not denying Covid19, but I do take all the statistics with a grain of salt. It's important to understand that those people died with, not necessarily of Covid19. Also, why are so many positive tested persons without any signs of illness? I wonder what numbers would result in testing every death for other viruses.
The best, maybe only number we can properly compare is the total death rate. In doing so we see that Covid19 causes additional deaths, but it is far from as severe as the media and politics suggest.
The number of excess deaths in the world is quite similar to the number of known COVID deaths. In fact, excess deaths is the higher number. It's very likely that the number of COVID deaths is currently underestimated, as spread of other infectious diseases has been drastically diminished by the lockdowns.
With all due respect to the statistics lessons that usually follows news like this, if you are one of the 6,971 or the 8,803 for that matter, these numbers are not as comforting as you might imagine. It's like the time I was unemployed and I kept hearing from the government about how low the unemployment rate was.
I can avoid getting into my car and running that risk. It’s still there and can happen, but I can opt to not drive my car.
The vaccine is eventually going to be mandated to go back to the office, go places, etc.. That’s a risk that you can’t avoid and will have to take.
I’m all for vaccinations and get them when needed, I’m still not comfortable for vaccines that have not been approved. Right now, they all have emergency approval and not overall approval. According to the cdc, vaccines need at least ten years of data to be considered safe for use. We’re only a little over a year into the development of the vaccine. Not really safe in my eyes.
> if this being in the news causes fewer people to get vaccinated, pausing it may be a mistake that will cause more overall deaths.
Except for that the government covering up the MMR investigation instead of doing it openly is what caused the anti-vaxx movement in the first place. Compare that with the public rallying around J&J after their Tylenol recall.
0.00009% over a 30 year period means you have about a 1% chance of being blown up by starting your car. that's about the odds of catching HIV while having unprotected sex with someone who is HIV positive (depends on a lot of factors though).
> Proclaiming that there could be others is worthless without quantifying what you're willing to accept.
If it can be isolated to certain groups, then those groups could be offered alternatives. The UK did something like that, and it worked well for them. It's not just about an overall number - it's about how effectively this risk can be reduced.
> Just saying to wait is a decision that will kill people.
J&J was a very small proportion of vaccines. There is plenty of extra supply from Moderna and Pfizer in the US, so you'll need a citation that this will kill people.
But you are having conflate for deaths from each of things. Rates in dying are not homogeneous in J&J vax versus corona. J&J vax maybe is received by many younglings who are not risking death so much from Corona for benefit of old. It is not yet being known for if J&J vax is having any greater risk for older people or younger people. So calculus is maybe not so simple. If I are healthy young person maybe it is not a beneficent risk for taking.
This is an excellent point, and exactly the reason why the UK decided to stop administering the AstraZeneca vaccine to people under 30. Not sure why you're being downvoted.
For people under 30, particularly women, the risk of blood clots from AZ is higher, while at the same time the risk from coronavirus infection is lower. When there are alternative vaccines available with no evidence of similar side effects, it makes sense to temporarily stop administering AZ/J&J to those groups to investigate if there are any risk factors we can use to predict and protect those who may be most vulnerable to side effects. (It has been suggested that young women on certain types of birth control are at highest risk of blood clots after AZ.)
That said, as some have pointed out, the risk of blood clots is still thought to be very low, even for women under 30, and anti-vax groups as well as the vaccine hesitant may see this news as a sign that it's not safe for anyone to take any vaccine. However, I don't think we as a society should actively try to conceal news or research about vaccine safety so that people don't worry. In my opinion, people have a right to know, and efforts to conceal concerning information often backfire, producing more public distrust.
Also if you live somewhere like Australia or NZ which is vaccinating but has largely wiped out community COVID. It makes sense to have a bit more caution in such places as long as the mRNA vaccine can still be used. Australia suspended the AstraZeneca vaccine for that reason, but I believe we're using it again now after some analysis.
It's been continued with adequate consultation. I was supposed to have my AZ this morning (however had to postpone) as part of the 1b category. 35 yo male. I'm ok with getting it but i would kind of like the pfizer one coz i'm a nerd and the pfizer vaccine has more science in it.
If airbags kill someone who didn't crash their car, that model of car/airbag should be recalled. If a vaccine kills someone, people should stop taking that vaccine.
The point here is simple. It's worse for someone to die of a vaccine than for someone to die of the coronavirus. How much worse is up for debate, but it's a significant factor and napkin math has to take that into account or it's morally bankrupt.
I think I see your point but the probabilities are an important factor, as well as the freedom to choose based on being well informed. Unfortunately at this stage we don’t have sufficient information to provide solid information to make an informed choice.
If there’s (hypothetical overly high numbers here) a 10% chance of dying from a disease or a 1% chance of dying from the vaccine from that disease, I want the vaccine and would like the freedom to do so. But if a new vaccine is coming out and soon after we see a 1% death rate from it, now I’m gonna want to hold off and take my chances with the disease because that 1% may turn out to be as high as or greater than 10% down the track when more is known.
The main complexity here is just like the early days of coronavirus - until things have played out for a while you can’t have confidence about the extent of the harm and that’s true for both the disease (which we now have over a year of information about) and the vaccines (which we have a month or two of in-the-wild info so far).
Unfortunately, your comments exclusively address a hypothetical scenario. Even if there were solid evidence that "a vaccine will kill people," the likelihood of that occurring currently appears to be orders of magnitude less than the likelihood of having the same occur from actually having COVID. [0]
As someone else pointed out here, you're about as statistically likely to die in a car wreck on your way to get the vaccine than you are to have (not die from) a blood clot from it.
For certain foods, some people die very quickly from immune reactions.
My comment is more or less ridiculous, but I'd like to understand why an effective vaccine that is dangerous to a few people is different than peanuts, which are dangerous to a few people (many of whom discover this by consuming peanuts).
Why is everyone worried about blood clots, and not that the J&J vaccine has a crap-tastic efficiency of 66.3%?
Would you want the chef at your local takeout to be vaccinated to 66.3% efficiency? or 94%?
Why was this vaccine even approved, instead of just having J&J produce the same vaccine Pfizer and Moderna are making, which would be in the best interest of the world? Is this some utterly idiotic capitalism bullshit that prevents J&J from making a 94% vaccine as well?
Why can't we just take $100B out of the $1T military budget, throw it at Pfizer and Moderna to shut up their patent lawyers, and then hand the formula to J&J to become a 3rd factory for a good 94% mRNA vaccine?
And then hand that formula to the rest of the world including Brazil, India, China, and other recent new COVID hotspots so that the virus doesn't boomerang back to the US in an evolved form?
At least that's what I would do if I was president.
This is not full story. 65% efficacy against symptomatic COVID-19 but 100% efficacy against death and hospitalization due to COVID-19. So there is real benefit to it.
This is a leaky vaccine, which is actually a big health risk. You remove selection pressure for lack of virulence, so more fatal strains can spread more easily. Definitely not a good thing.
Would there be anything in particular about the study of that case which would not be valid in humans? I've seen articles/studies from before Covid that suggest this sort of thing could be a concern in humans, but no reported cases of it happening. On the other hand, we don't exactly have a control group, so there's not a good way to tell.
Yes, but 65% efficacy still means that 1/3 of the vaccinated people will continue to be spreaders, which doesn't sound great, especially if that allows the virus to spread and evolve into a harsher variety.
At this stage, getting as many people to near 100% death avoidance and with some immunity is the goal.
We're not at a stage yet when we can play favorites. It'll be a long time before we have the supply to prefer one over the other (except maybe in the US where there will be enough mRNA vaccines to go around).
Not necessarily. Efficacy measures are about protection from hospitalisation or death if you contract COVID. It doesn’t imply loss of viral shedding. There’s a vox video on YouTube that explains this...
> A vaccinated person can have no symptoms of covid and still be spreading
Aren't the efficacy numbers from the phase 3 trials based on giving periodic PCR tests to everyone that was participating in the trials? And not just based on people self-reporting symptoms?
It would be very surprising if there were a new kind of asymptomatic carrier that emerged only for people having taken certain vaccines in which they would never test positive on a PCR test but could still spread covid. The odds that this is how the vaccines work seems very small, relative to the number of times this argument that "we don't know yet" is getting repeated.
It just seems strange to me that so many people are hung up on pointing out that this small possibility is still a possibility. It seems more likely that this will drive more people to skip the vaccine, since they're being told they can't even go back to normal once vaccinated, than anything else.
I don't think the fact that you might be still spreading covid when vaccinated is enough of a reason to continue lockdown. As long we are continually getting people vaccinated, we should be fine for returning to normal.
Depends on the particular trial, but the clinical trial data used to get FDA approval usually measures symptomatic cases, which is a combination of coronavirus symptoms and positive PCR test.
There's some additional data which indicates Pfizer and Moderna are likely to limit transmission, but from my understanding it's not as ironclad as the symptomatic cases data.
Only for a few hours though, not 2 weeks+, and viruses don't mutate on a doorknob. Someone who got vaccine and falls in the ineffective category will likely not die but will be a spreader for a few weeks, with some nonzero probability of mutation, and that times 1/3 of the population that got the vaccine would give the virus a lot of opportunity to mutate.
Lol if the people that don't get it and it's more or less a cold it's not a big deal. If you go to the hospital your chances of dying from it go up astronomically. How can you miss that most basic of points?
If nothing else, the logistics of transporting J&J make it a lot better in a lot of cases. Pfizer in particular needs to be transported super-cold, and Moderna needs to be frozen as well. J&J can be handled much more like a flu shot.
That said, I'm smarting a bit (even though I understand why) that the fully vaccinated guidelines cover 2 weeks after J&J, while it's looking likely the mRNA vaccines give you better protection even 2 weeks after the first shot. (You really do want the second... the 6-month Moderna study shows you get about 10x the antibodies from the second one, which means the protection lasts much longer if nothing else.)
The limits of mRNA vaccine manufacturing are that it's a new process and the technology and supply chain required to produce it are very hard to get right. Derek Lowe does an excellent job of debunking the simplistic "Why don't they share the design" argument here:
Do your research dude. It basically results in essentially 100% non-hospitalization which is the big deal, not whether you get a fever and cough a bit. I can't imagine how anyone would miss that little factoid if they read at all about the J&J vaccine before saying it's useless. Again do a little reading.
> "Why is everyone worried about blood clots, and not that the J&J vaccine has a crap-tastic efficiency of 66.3%?"
The J&J vaccine is marketed as a single-dose vaccine, unlike the others which all require two doses to reach their reported efficacy. Single-dose is a massive advantage which will greatly speed up vaccination progress, especially in developing countries.
> And then hand that formula to the rest of the world including Brazil, India, China, and other recent new COVID hotspots so that the virus doesn't boomerang back to the US in an evolved form?
Such a vaccine would also have two doses and require intense refrigeration which are the primary issues blocking it... additionally many of those jurisdictions might not accept a US vaccine. China, maybe, since they admitted their own vaccines aren't working super well. Russia doesn't have anything wrong with its vaccine but the Kremlin admitted no one is taking it, apparently because they don't believe in covid.
> China, maybe, since they admitted their own vaccines aren't working super well.
Despite what the press has reported, that's not really what happened. In a conference talk on vaccines, the head of China CDC made a general statement about what to do about "low vaccine efficacy." That's been blown up in the Western media into an "admission" that all Chinese vaccines supposedly have low efficacy.
It doesn't even make sense to talk about the efficacy of "Chinese vaccines." Chinese vaccines run the gamut, from inactivated whole virus to protein subunit to adenovirus vectors. There's even a Chinese partner to Biontech, which is going to manufacture the latter's mRNA vaccine.
> Why was this vaccine even approved, instead of just having J&J produce the same vaccine Pfizer and Moderna are making, which would be in the best interest of the world? Is this some utterly idiotic capitalism bullshit that prevents J&J from making a 94% vaccine as well?
Exactly. There should be no place for vaccine profiteering, especially now that we have two extremely good vaccines. But in the interest of pharma profits, instead of cooperatively manufacturing the best vaccines, unburdened by patent hurdles, instead we have massive amounts of public funding going to pharma corps so that they can make profits off this medical crisis. Truly shameless.
"The incidence of cerebral venous thrombosis (CVT) varies between studies, but it is estimated to be between 2 and 5 per million per year. A recent study in the Netherlands with comprehensive ascertainment suggested a much higher incidence."
https://www.ahajournals.org/doi/full/10.1161/STROKEAHA.116.0...
So the six reported cases in 6.8 million vaccinations seems low. Glad I read about all this because I got the J&J vaccine 12 days ago. No noticeable side effects so far. I exercise a lot and did a 5 mile hike four days ago that resulted in a slightly strained a calf muscle. I have been taking it easy the past few days, meaning sitting and reading a lot more than usual. So after learning about the blood clotting, have started exercising the legs frequently. My optimistic thinking is that even if the vaccine does cause an increased risk of CVST that risk can be eliminated via exercise.
It will be most interesting to learn if those six cases involved people at high risk, if they exercise regularly, etc.
If you’re doing the calf exercises to ward off a DVT, (and not to just stretch your strained calf!) you may be barking up the wrong tree.
The preliminary theories (backed by the thrombocytopaenia) are that, if there’s a vaccine induced thrombosis with thrombocytopenia, it is probably immune-mediated (similar to HITT - heparin induced thrombocytopenia and thrombosis).
And then there’s some weird thing that makes them form in your venous sinus.
But there were also reports of more typical blood clots (ie DVTs), the first European Medicines Agency advisory (0) said that this was within the level of noise (im now talking AstraZeneca, so apologies for shifting vaccine as generally they should be considered separately until the evidence catches up, although everyone is quickly drawing parallels between them)
Ps apologies for not referencing around HITTs and theories around antibody-mediation for CVT. Basically it’s all pretty noisy anyway at the moment and so my here-say from the medical tea rooms is as good a gossip as any, as long as everyone is aware that no one really has any definitive idea what may be going on yet
Agreed, I don't think anyone knows clearly what is happening. Some additional points that are related.
Thrombocytopenia has been a known complication of adenovirus vectors that researchers have worked to overcome in recent decades.
These incidents mirror HITT (women are at higher risk for HITT) and seem to be happening in the timeperiod where IgG titers spike post vaccination.
To me this indicates it's not unlikely something with the adenovirus vectored vaccines (J&J, AZ) is causing this issue.
And because this thread seems to have gone to hell, I'll add that I support doing subgroup specific risk calculations and allowing vaccinations to proceed where it makes sense.
Just want to add that this is not a new theory and has been circulating in medical circles for roughly a month [1]. There is also the hope that when it happens it can be diagnosed and treated.
Arterial clots with thrombocytopenia is incredibly rare. Additionally the PF4 activity in these patients is very abnormal and appears to be to immune mediated. Lots of science and focus going into the mechanism around this now. The other recent NEJM articles around clots associated with the other adenovirus COVID vaccines are likely a similar phenomena.
2-5 per m per y is an incidence over the entire year. Assuming a uniform distribution over the 365 days, then the probability of getting it "on that day" becomes a probability of 1-2 per billion.
So the reported cases of are not comparable. They are really, really high.
And while I agree about the relative risk vs covid, again this is not a fair comparison. For many people who are isolating, then a person never leaving the house has a very low risk from covid, both personally and transmitting it. You are not asking people to exchange a very small risk from the vaccine vs a very high risk from covid. You are asking them to exchange a very small but roulette-like risk from the vaccine, versus a presumably equally small if not smaller risk from covid due to their circumstances.
Note, what I am "not" saying is that peoples shouldn't be vaccinated. I'm just saying artificially trivialising the risk further using bad math isn't doing anyone any favours.
"So the six reported cases in 6.8 million vaccinations seems low."
No, because those 6 cases are something more like "1 per day" rather than "per year". Or maybe "per week". But either way, you need to multiply the "per year" base rate by a large number to get the base rate for "coincidentally happened immediately after a particular event", for some definition of "immediately".
It's reports within 3 weeks, so something like 18 per million per year.. The larger danger is any interaction with an automobile to get to the appointment.
My wife says this is not about exercise, while living a healthy lifestyle is good, apparently this specific condition causes clots to form in the brain itself as a result of low platelets.
That’s what I keep saying! People are saying it’s 1 in a million chance, but unless all the people who got the vaccine were women than it’s not. The instance could be far higher but it’s not possible to know without knowing how many were given to men vs women
John Campbell suggested on his video the other day that perhaps this is happening because some injectors are not aspirating. What that means is that when an intramuscular injection is given you want to ensure that it goes into the muscle and not into a vein. So the proper way to do this is for the person doing the injection to first pull out the syringe (after it's been stuck into the arm) a bit to make sure there's no blood coming out. Then if not, the vaccine is pushed in. If blood is seen then a new site has to be chosen. Apparently Denmark has included aspiration in their directions for usage of the AZ vaccine.
Medical professionals are often taught these days that aspiration is not necessary for IM injections, particularly in commonly used sites such as the delts.
From the CDC [1]: Aspiration before injection of vaccines or toxoids (i.e., pulling back on the syringe plunger after needle insertion but before injection) is not necessary because no large blood vessels are present at the recommended injection sites
This lines up exactly with what Dr. Daniel Griffin talked about in the most recent clinical update podcast for TWIV [1]. Apparently aspirating makes the shot more painful, because the needle is in the body longer, and serves no benefit as long as the vaccinator is putting it in the right location.
"no large blood vessels are present at the recommended injection sites"
That's a bold statement. Sure, no large blood vessels may be present at the recommended injection site on an average human, but it's well known there is more divergence in anatomy than they necessarily teach about in primary school, and vaccines are supposed to go in basically everyone.
Your first class may not teach this, but you'd get to it eventually if you kept taking classes. (Then again, your first class may at least mention this sort of thing at some point.) What the "average human" is is not what all humans are. There's all sorts of things like, the stuff in that link, major nerve clusters having additional or missing separations, extra separated or fused bones, major veins and arteries not being quite in the usual location... look close enough and you'll find something on everybody that doesn't match the "standard human anatomy".
That's interesting to know. When I got my Pfizer jab, the lady said "oops, I did it wrong" and blood came out. She didn't jab me again though and I just assumed it was good to go. Should she have done it again at a different site? I was told elsewhere that it doesn't make the vaccine any less effective, but I'm curious what others on here think now...
As I understand it the concern isn't effectiveness so much as potential for side effects. An intramuscular injection is meant to stay pretty much in a small area of muscle tissue. If it goes into the vein the vaccine then travels into tissues all over the body.
That’s not really true, we give lots of drugs IM because the muscle is highly vascular so it generally shoots out all over the body really quickly. Ie want to take down a patient with Ice (crystal meth) induced psychosis? IM. Also, it’s hard to miss most of the time.
If you want something to sit around for a long time, you go for less vascular areas. (Ie insulin for diabetics, subcut abdominal fat)
IM is preferred because of the vascularity which helps in the immune response (ie quick immune response, antigen distributed around the body) as well as any immune reaction confined to the muscle rather than, say the skin.
(0) is a quick and dirty on mechanisms of administration.
To your earlier point about ‘into’ a vein, I’d never heard of Dr Campbell before you mentioned him, he seems to have great credentials, but I can’t easily explain why an accidental IV administration of an IM vaccine would cause CVST, my gut is that it’s a bit of a hand wave but who knows.
Time periods seem off (5-14hrs) in mouse models compared to what’s being seen here though, which seems more like an immune reaction rather than a response to the antigen/delivery system
If this were the case it would be odd that this is happening a.) in a consistent subset of women 18-38
b.) that it would emerge in a 1-shot regimen rather than a 2-shot regimen, because it would seem more likely that any one individual would experience this more frequently with 2 chances for human error rather than 1
The Pfizer & Moderna 2-shot vaccines use mRNA instead of an adenovirus vector. The AZ vaccine is 2 shot, but also uses a similar adenovirus vector - the bloodclot issue has also been seen in the AZ vaccine which has led to some countries in Europe not allowing it for women under 60.
I would assume the guidelines for aspirating would be the same across all of these vaccines, though? If so the original point still stands regardless of adenovirus vs. mRNA
Yes, we know that. But what does adenovirus vs mRNA have to do with aspirating an injection? Does the adenovirus become more dangerous when accidentally placed in a blood vessel?
with only 6 people you can't really say that since it's such a tiny sample size. If it's 6 women then you're starting to get to a pattern worth testing.
Injecting IM solution into a blood vessel is excruciating and you and the provider would notice it immediately if it happened. It is likely to cause an embolism and possibly kill you, but I don't think it would be unnoticeable and then cause a thrombus multiple days later.
There are also not a lot of major vessels near common injection sites, for this reason. It's possible and rather common to nick a surface capillary or something, and those can bleed quite a lot, but a vein or artery would be totally different. Swelling, horrible pain, likely a cough.
Source: inject myself with intramuscular estrogen every week.
hah, I inject myself with estrogen subcutaneously. it gets absorbed quicker which causes peaks and troughs, but I get to use a smaller needle (25g x 5/8") and I don't have to worry so much about bruising or locating the right sites.
Any theory on why this is occurring needs to have a solid explanation for why women under 55 are suffering this effect more than anyone else. Does John Campbell have one?
So this past year the government has been willing to let unemployment, suicides and drug overdoses jump due to isolation and loneliness caused by lockdowns, child abuse to skyrocket and mental health to plumment due to schools being kept closed, all because we needed to stop covid at any cost. Now one person dies out of almost 7 million who received the vaccine, and we need to stop administering the J&J vaccine "out of an abundance of caution"? I'm starting to think more and more that the shitty decisions regarding covid in the past year were because it was an election year.
Besides, in the CDC table, "unintentional injuries" is up by way more than suicides are down. This includes things like car accidents, and is a little suspicious, like suicidal behavior led to a death that wasn't classified as suicide. Also note that the table is "deaths with covid or presumed covid", not "deaths by covid": https://jamanetwork.com/journals/jama/fullarticle/2778234
Government over-reactions to COVID19 have been disastrous. There would have been an economic hit for sure but things would have returned to near normal by August 2020 if they had respected freedom (or if people had disobeyed in mass).
Yeah. The US is apparently already at ~50% antibodies, not counting vaccination. So, there’s a floor on the upside of the vaccine: It did no more than halve deaths. We’re in the middle of a surge, and it looks like most of the remaining 50% will end up catching covid before being vaccinated, so the percentage saved by vaccination will continue to drop.
The ideal strategy without hindsight was conventional wisdom: Protect the vulnerable and stiff upper lip for the rest. That would have more than halved casualties.
With the benefit of hindsight, a 3 month shutdown while hospitals got their acts together (combined with protecting the vulnerable) would have roughly quartered the remaining deaths, but at far lower cost than the full shutdown.
This was predicted by some of the old-guard epidemiologists, which is why they were against the shutdown in the first place.
The cancel culture folks lumped them in with MAGA anti-vaxxers (I blame both sides) and got them censored by the big platforms. Here we are, with 100,000’s unnecessarily dead, trillions squandered, and many careers, businesses and educations ruined.
I suspect roughly zero people have learned a lesson from this. Hopefully I’m overly cynical.
Additionally, you make a few glib statements that don’t really check out - you say give hospitals three weeks to prepare - how? There’s been a lot made of hospitals getting ready, but for the most part, the limiting factor for covid treatment has been how many icu care teams are available. More ventilators don’t help much if there’s nobody to use them. Second, I’m not sure how you protect senior citizens when everyone else, including the people who provide their care, is swimming in a soup of COVID.
Like a while bunch of places did in March and April last year: build emergency capacity during what was supposed to be only a short several-week lockdown. Instead, when the capacity went mostly unused during the lockdown, it was quietly dismantled and lockdowns continued.
Also, we knew by April last year that ventilators were a bad choice: Doctors were jumping to it because of a specific weird symptom (blood oxygen levels impossibly low), but they had to keep turning the ventilators to higher settings to get an effect - to the point it was causing further lung damage. There's a bunch of less damaging ways to get more oxygen into a patient they'd been shifting to: https://www.statnews.com/2020/04/08/doctors-say-ventilators-...
> With the benefit of hindsight, a 3 month shutdown while hospitals got their acts together (combined with protecting the vulnerable) would have roughly quartered the remaining deaths, but at far lower cost than the full shutdown.
Where was this "full shutdown" you speak of? Not anywhere in the US. In Wuhan, and some other Asian countries, sure.
Didn't we kind of have the 3 month shutdown-lite you're referring to? Mid-March through about June for most places were at varying levels of shutdown in the US. But recall things started opening up in June of 2020. And cases started rising again into July.
> The US is apparently already at ~50% antibodies, not counting vaccination.
Citation? That seems like about 3X the most optimistic numbers I've heard from credible sources.
As for shutdown vs shutdown lite: No; the economy didn’t completely reopen in July. The recommendations from March 2020 were for more strict targeted shutdown protocols, but over a shorter duration (Strict reverse quarantines for nursing homes, but only for a few months for example.). The idea was to get less vulnerable groups to herd immunity faster. I’m saying a general, country wide shutdown for three months, concurrently with a strict targeted lockdown for about 5-6 months would have been more effective and cheaper (and, we’d have been done by last August, as the parent of my other post suggested.)
Source for 50%: Wall street journal. We were above 33% (based on random sampling, not confirmed cases) a few months ago.
This one from Feb predicted herd immunity a bit too early. They ran one with updated numbers last week, but I can’t find it:
And then we had excess deaths in NY State because Governor Cuomo FORCED nursing homes to take in infected patients! And then he gave immunity to the whole industry from liability if they didn’t take precautions.
And he became the darling of the media and even won an Emmy.
As someone with a family member working in a hospital who still couldn't get reliable PPE after 3 months, I feel that you live in an entirely different universe than I do. Would that we would have lived in a country where PPE for nurses, physicians, and hospital workers were prioritized in summer 2020. Hah. Hospitals were not in a position to get their own; I saw them jockeying for shipments from China and Korea and it's just ludicrous to expect people to get their PPE in bidding wars that involve calling in favors from the chief cardiologist's wife's uncle who owns a factory in China.
I suspect a lot of folks learned (in the US) is that if you have a president who politicizes a pandemic and shits the bed on leadership, the populous is screwed.
Let's not pretend that rational discourse was ever an option, and the media isn't the place for blame.
I don't know. Seems like a sane, sober, professional, mature, and objective media would go quite far in moderating the overheated partisan rhetoric from politicians.
Putting aside that these claims are presented without any evidence, “most” of 50% of the US population is a minimum of 82M people. ~31M have contracted COVID so far. That we’re going to see almost 3x the number of cases, concentrated in half the population, as we enter summer, and with 3-4M vaccines administered per day, is a pretty bold claim.
> The ideal strategy without hindsight was conventional wisdom: Protect the vulnerable and stiff upper lip for the rest.
China, Vietnam, Australia and New Zealand used strict lockdowns to eliminate community spread, and then largely opened things up again. People in those countries have been able to live much more normal lives than people elsewhere during the pandemic. With hindsight, that was clearly the correct strategy: eliminate the virus, then reopen and keep a hawk eye out for any new cases.
2/4 of those examples are affluent island nations with low population densities.
Another one of those examples has been actively censoring covid information from the start, and thus cannot be trusted.
As for Vietnam, it is an interesting case, and we don't have enough data to rule out cross reactivity or other factors playing a role.
Extrapolating these data points to the entire world with wildly varying sociological, biological, environmental, and countless other factors and saying this is clearly the correct (and implicity achieveable) strategy for all 8 billion people on the earth is at best hypothetical.
> As for Vietnam, it is an interesting case, and we don't have enough data to rule out cross reactivity or other factors playing a role.
They took shit seriously and everyone prepared the minute news reached them of a possible pandemic. A good friend of mine is from VN and he was shipping PPE back home to his parents around August or October of 2019.
I think most Americans don't realize how common pandemics have been in east Asia. To them, it's like preparing for any other natural disaster. It's like comparing the Michiganders response to a blizzard to that of Texans.
This is why we need more data about cross reactivity playing a role in the relatively favorable health outcomes in Asia and Africa compared to the rest of the world.
> 2/4 of those examples are affluent island nations with low population densities.
Australia and NZ have densely populated cities, and what does being an island have to do with anything? Countries can close their borders. In fact, Australian states closed their borders to one another.
> Another one of those examples has been actively censoring covid information from the start, and thus cannot be trusted.
You don't have to trust the government. Just ask people you know in China what's going on there. Things have been mostly open for a year now, with no sign of the virus (outside of a few localized outbreaks, which have been dealt with through local lockdowns and blanket testing of the population). China is not the black box that many people think it is.
> As for Vietnam, it is an interesting case, and we don't have enough data to rule out cross reactivity or other factors playing a role.
Vietnamese people are not somehow immune to SARS-CoV-2. They're susceptible, just like everyone else.
> Extrapolating these data points to the entire world
This is the wrong way to think about this. These aren't data points generated by some semi-random process. They're countries that effectively implemented a strategy that we know should work, based on the basic principles of epidemiology. The virus is spread between people who are in close proximity to one another. If you drastically reduce contacts between people, the virus has far fewer chances to spread, and the epidemic recedes. If you do that long enough, you get down to a small enough number of cases that you can trace every single one and snuff out the virus completely. After that, you have to have strict measures at the border in order to catch imported cases, and you have to do regular testing in the population to make sure you don't miss the beginnings of any new outbreak.
There's nothing to "extrapolate." The strategy works because of very basic principles of how the virus spreads. The only question is whether each county has the organizational capacity and societal will to carry this strategy out.
>question is whether each county has the organizational capacity and societal will to carry this strategy out.
Indeed, that's a critical question to the long term success of the strategy.
If the world is unable to put 8 billion people in solitary confinement (nevermind the disastrous effects that would cause) indefinitely until the virus is eliminated (nevermind the fact that we are incapabale of validating if it was actually completely erradicated), the virus is only going to pop back up.
There is no evidence of such a strategy working at scale across the world.
The scientists on the covid team at the WHO have said as much: lockdowns should only be used as a last resort to buy time to scale up health care resources. Should we listen to those scientists?
It's not indefinite. The longest lockdown in China was 76 days, in Wuhan. Elsewhere, it was significantly shorter. Because they had a strict lockdown early on, they have been living with far fewer restrictions than most of the world for about a year now.
> the virus is only going to pop back up.
It does indeed pop up every once in a while, because the borders can never be 100% sealed. There have been outbreaks in Beijing, Qingdao, border towns in Heilongjiang and Yunnan, and elsewhere. But the government is understandably on high alert, and these outbreaks were caught early enough to be stopped with local lockdowns, coupled with blanket testing of the population (i.e., testing everyone in a city in a few days).
There was a brief "second wave" in China this winter, in which an outbreak managed to spread to several cities, but it was ended with relatively short lockdowns and mass testing. The number of new infections per day peaked around 100.
The basic lesson here is that you can both have near-zero case counts and let people live their lives almost as normal if you first act decisively to bring cases to zero, by using temporary, strict lockdowns, quarantines and mass testing.
> There is no evidence of such a strategy working at scale across the world.
China is the largest country in the world, so I'd call that "at scale." Vietnam is larger than any EU country. We're not talking about San Marino or Monaco here.
> The scientists on the covid team at the WHO have said as much: lockdowns should only be used as a last resort to buy time to scale up health care resources. Should we listen to those scientists?
A lot of recommendations will be reevaluated after the pandemic is over. Nothing like this has happened in 100 years.
The problem is the virus, not the government reaction to it. Personally, I tend to think governments under-reacted in most Western countries. I'm not sure how things would have returned to "normal" if the virus was raging out of control. A good precentage of people would see the deaths and still avoid going out to shop or whatever. I'm assuming you mean by "normal" that people would return to some normal pattern of economic activity - and even if 10 or 20% of people changed their behavior that would still impact the economy.
> A good precentage of people would see the deaths and still avoid going out to shop or whatever.
That seems hard to believe, since significantly more people die every year of all causes than could possibly have died of Covid, even if every single person in the world caught it. Most people probably wouldn’t have noticed anything was different.
> even if 10 or 20% of people changed their behavior that would still impact the economy.
Maybe so, but the economy is not the only or even the most important casualty of our Covid response. The importance of human social gatherings, the freedom to leave one’s home and go wherever one pleases, the education of children, and so on cannot be measured in economic terms.
> The problem is the virus, not the government reaction to it.
Places where there were very few or only brief restrictions, like Serbia, Belarus, or Florida, largely avoided the issues I described above with only a small or in some cases unmeasurable increase in all cause mortality for 2020.
It's not at all hard to believe. All the people in my family, for instance, have changed grocery habits and stopped discretionary shopping in stores essentially entirely. Why? Many are older and have risks yet also have full lives and want to live to play with their grandkids. We prioritized gathering with each other cautiously over spending money shopping and changed habits immediately (I started working from home March 12, before any US guidance).
Sweden is an interesting example. Comparing Sweden and Finland, for instance, older people essentially cloistered themselves in Sweden because they had no trust that they'd be safe in society, and their spending dropped by a higher amount than old people in Finland, who changed their habits less due to the swift and more stringent government response? My old-person family members in Finland were able to keep shopping, going to church, and having birthday parties with many families due to that response (as opposed to in the US where we limited ourselves to gatherings with max 3 households and did everything masked or outdoors due to several people still working on site).
Perhaps you live in a very different place. You certainly interpret statistics quite differently given your example of Florida.
How many dead people would that "normal" have been worth to you?
If, instead, people had behaved responsibly in mass and we had used the time we got from that to establish coherent contact tracing and testing, things would have returned to normal by August as well, only without many the deaths your way would cause.
Or if they just followed the plan for this exact scenario that was handed to them by the last administration, if we're talking about the US, where more than half a million people died preventable deaths.
I'd argue that the "response" at the Federal level was a massive under-reaction. Months of denial didn't seem to work out so well.
6 cases in 7 million doses over 3 months is exactly the rate that CVST would normally be expected at. While that doesn't mean we shouldn't investigate, it does mean there is no reason to be alarmed at this time.
> Cerebral venous sinus thrombosis is rare, with an estimated 3-4 cases per million annual incidence in adults. While it may occur in all age groups, it is most common in the third decade. 75% are female. [0]
The source you mention does not explicitly give a one in 30.000 figure, and it is not something that can be safely concluded from the data in the paper. The authors state that at the time 132,686 people had received their first AZ shot in Norway, of which five had developed thrombosis.
This is definitely not enough data to conclude a 1 in 30,000 figure. And neither does the cited paper conclude this.
5 developed the disease 7 or 8 days after the vaccination. Not sure what you're getting at...sampling error? It's a binomial distribution, right? Back of the fag packet maths, we can easily reject 1 in a million, and put a reasonable upper bound below 1 in 100,000.
There's the question of timing too. It's not clear if the number includes all CVST incidences or only those ocurring in a time window after vaccination. (Update: according to NYT these cases are 1-3 weeks after vaccination, so the background rate is too low to matter here). If there is a strong correlation in timing you can not simply use frequency data to rule out causation.
Of course the cases are shortly after vaccination, the data is symptoms reported shortly after vaccination which might be side effects. You're not going to have anyone who got a clot before the vaccine or long afterwards in the dataset, but those cases still did/will exist. There is no evidence yet of a correlation in timing.
The background rate you quoted are expected to be spread out independent of vaccination. If you pick a two-week window after vaccination you should only expect 1/6 of the cases that are expected in 3 month, which is the number you calculated.
But we're not observing people for 3 months and picking an arbitrary two week window. People do not get added to the population until they have taken the vaccine, and they are all observed for different lengths of time. We did not hypothesize a 2 week period beforehand and compare how many landed within to how many were outside that range, the 2 weeks is just a circle drawn around the datapoints after the fact.
Your logic breaks down at step 2. As a counter example, what are the odds that in the other 7 weeks you would have zero cases? Of course the answer is that this isn't how the data works.
You are not sampling a random, normally distributed event over a fixed interval, you are sampling the spacing between two different events where one of them is systemically linked to how you define the population and the interval.
You are only looking at people a short time after vaccination. Anyone in the population who had a clot prior to being vaccinated or who will get a clot later this year have not been counted.
That is exactly the point. Using the background rate you quoted from Wikipedia within a two week window you are expected to see around one case. So most of the cases can not be explained by the background.
> While that doesn't mean we shouldn't investigate, it does mean there is no reason to be alarmed at this time.
Except to the general public this overcautious behavior and resulting media hype raises vaccine suspicions, and will decrease public trust in J&J (and even vaccines in general) as a result. It’s already happening.
If it's statistically significant, the evidence showing so will emerge quickly and we can decide at that time how the increase in risk compares to that of remaining unvaccinated.
Otherwise, there isn't a whole lot of difference between "not real" and "real but so rare as not to matter."
Yeah, the problem though is that we have a Tragedy of the Commons situation on our hands. There is a non-negligible portion of the population that wants to have its cake and eat it too – reduce the risk that they will suffer health consequences from COVID-19 by letting everyone else get the vaccine, but not getting the vax themselves, therefore putting their risk from vax at zero.
I think part of the thing that makes this more difficult is that some people already have practically no risk of suffering health consequences from COVID-19, and possibly (but also possibly not) do risk suffering health consequences from the vaccination.
It is true; the PDF linked in the GC has to make a number of assumptions and is very obviously made from a point of bias (which does not invalidate its claims but warrants extra scrutiny).
Also it's comparing raw ICU admissions, but there are a number of really nasty adverse reactions that don't throw you in the ICU. The general "second shot syndrome" that something like half of people getting Pfizer/Moderna experience is a great example of that. Yeah it's not bad enough to send them to the ICU, but for many people COVID-19 would be literally asymptomatic or would be minimally symptomatic, whereas the second shot syndrome can be quite brutal.
Why do you believe that? It seems to me that the reputational damage caused by the U of C centre putting out bad slides is going to be stronger than any benefit they might get from being "seen to be a team player" or similar. Skepticism is always good but in this particular case, I do trust that evidence.
> there are a number of really nasty adverse reactions that don't throw you in the ICU
OK, but you can make the same argument for COVID. It seems to me that the slides are at least comparing apples with apples.
> OK, but you can make the same argument for COVID. It seems to me that the slides are at least comparing apples with apples.
If you look at the rates of acute side effects to the vaccines, I forget the exact number but it's at least like 80%. It's insanely high. SARS-2 absolutely does not produce that given the massive proportion of asymptomatic individuals and significant amount of paucisymptomatic individuals
Why do you assume that people who are getting second shot syndrome would be the same people who would have asymptomatic COVID-19? That seems... far-fetched at best.
Second shot syndrome is apparently worse in the young (20's / 30's) due to the stronger immune response. I wasn't assuming that everyone who gets the syndrome would be asymp. but just that many would.
That seems like it'd be easy to fix: the government just needs to say "as soon as you're fully vaccinated, you don't need to social distance or wear a mask in public anymore". Since that isn't their position, there's basically zero incentive for young, healthy people to risk the vaccine side effects.
That is one option. Which is why so many anti-vac people have jumped on the no vaccine passport bandwagon. If there is no way to prove you have been vaccinated, then they can lie about it and take part in non-masked public activity (I'm not sure why they are against the mask).
There are other options. Give everyone who has got the vaccine some money is one I've heard more than once. Maybe someone else has a different idea.
That runs contrary to good public health policy for C19 where even the fully vaccinated should follow many precautions such as masking in public and limiting number of households in close contact.
If you believe good public health policy requires that there be restrictions on gatherings even where everyone is fully vaccinated, then what do you see as the path back to full normality? Or is this just how humanity has to live forever now?
I think the "return to normality" is when the number of new cases reported each day drops to almost nothing and deaths are uncommon. Currently, in the U.S. we're about 70 thousand new cases a day, which is about where we were at the height of the second wave in mid-summer. Deaths are around 750 a day.
I think we'll get to normality eventually, but it may take longer than anyone has patience for, and that will only push it out further as people give up on social distancing and masking.
Time will tell if that's actually enough by itself to get the reproduction number less than 1. If everyone who wants a vaccination has one and yet we still have tens of thousands of new cases per day and hundreds of deaths and no downward trend, then I think continuing with masks and social distancing is going to be necessary.
I'm hoping that as the vaccination numbers go up, we'll eventually start seeing new cases drop off a cliff as the virus runs out of people to infect. (Though I suspect that we'll have problems for awhile with groups of people who hang out together and for whatever reason don't get vaccinated.)
I didn't pick +80% arbitrarily, that's where Israel has been for a bit (age +16 vaxed or recovered) and the stats are impressive. I expect the same in US unless a new more transmissible strain in the face of vaccinations emerges.
The problem for everyone else is that the vaccines aren't 100% effective. Also, we're not vaccinating children yet, and there may be some people who can't get the vaccine for medical reasons.
Another consideration is that if the virus is allowed to continue to spread, there's a real chance that it may mutate into a form that isn't stopped by the vaccine, and then we're right back where we started.
From a public health point of view, I don't see things getting back to ordinary people (and not just the foolhardy) having lunch with coworkers around the same table without masks on unless there isn't any significant amount of community spread going on.
Why does it matter how much of the US is vaccinated? For any given gathering, doesn't it only matter whether the people at that gathering are? Suppose 20,000 people, each from different households, all met at Madison Square Garden, and that they're all vaccinated. Why would that be more dangerous if nobody else in the world was vaccinated vs. if everybody else in the world was?
Look if both households are low risk and everyone has been vaccinated go ahead and meet under one roof without any masks and hug - that's fine under current recommendations. It's even looser than that, like if you unvaccinated low risk children visiting vaccinated grandparents ad so on.
Right now across US being fully vaccinated is only 80% effective against infection. When you have 20k vaxed folks meet when the virus is endemic in the pop, some of those vaxed folks will be infected and some will catch it there.
When more folks are vaxed there will be less of the virus circulating and then that calculation then changes. It's all about how prevalent the virus is in the community to begin with assuming no strains appear that dramatically reduce the effectiveness of the vax.
We've never taken such an attitude for any other endemic respiratory pathogen in existence, and for good reason. It's completely absurd and ignores not only the important health benefits of regular social contact, including direct physical contact, as well as the literal benefits of exchanging pathogens with others.
You and the other commenters arguing your "side" also seem to completely ignore the phenomenom of natural immunity, which I think very obviously has been fallaciously denied by "experts" precisely because they want to convince everyone in the world to get this vaccine. They're already talking about yearly booster shots because most people's mental models are from Flu which has a much greater space of possible genetic configurations, whereas SARS-2 is relatively constrained in how it can evolve and thus should not need a yearly booster if this weren't just about making absurd amounts of money (which it is).
In any case, you should know that there are people like me - very much in the minority - who refuse to submit to such absurdities and will keep fighting. We will continue to be literally as well as metaphorically discriminated against until your "side" stops brainwashing people into a completely disproportionate response to an endemic respiratory virus.
You can stay inside with a mask on while vaccinated all you want. Be my guest. But please stop advocating for and/or supporting mandates and restrictions on the rest of us who have not caught your specific strain of agoraphobia, germaphobia, OCD and misanthropy.
Sure we will get natural immunity, the difference between other diseases respiratory or otherwise is its effectiveness in killing people combined with its transmission. It is in the Goldilocks zone for deadliness and transmission , highly deadly diseases like Nipha or Ebola are easier to keep from being an pandemic precisely because they are so deadly. They still require a strong and immediate response to keep it in control and local.
The annual flu shot is not just for you, it is also to prevent you transmitting what is probably harmless to you but deadly to immuno-compromised like the elderly, they don't have ability to get natural immunity. Pneumonia is significant cause of death amongst senior citizens.
If 600,000 people dying U.S alone in the last year, does not convince you to stay masked and safe and follow some simple instructions for few more months until everyone is vaccinated even if you don't believe in them personally, nothing is going to.
It is more dangerous because people who are vaccinated will take more risks and do less social distancing etc which in turn will harm others.
There is no definitive answer whether vaccine will reduce transmission. Those 20,000 people will definitely meet un-vaccinated people in next 10-12 days, and then may pass the disease to them.
Many people cannot get the vaccine, because it is not open yet to them, or have other conditions. So it is selfish for vaccinated people to behave as though the rest of the population does not exist.
There is also the worry that longer the disease lingers anywhere in the world, there can be mutations which are immune to current vaccines, such an mutation could be disastrous as people will loose trust in the vaccine and a second vaccine even when available will have lesser adoption than now . It could become a vicious cycle where there is third mutation, and this then becomes like the flu shots ( but lot more deadlier)
Young people shouldn't be getting the vaccine period. There is no reason to give every single person who will have children in the future an experimental vaccine for a virus they are at no serious risk from. The long tail risk on that is absolutely insane.
Not exactly sure what procreation has to do with anything.
Also pretty sure risk of death outweighs literally any possible long-tail risk, so still seems sensible for the young to get the vax. Also don't think the long-tail risk of an mRNA vaccine can be worse then COVID's long-tail risk.
Total COVID deaths for people aged 0-17 in the USA are 246 so far.
That's not that many. Despite my wife and I getting vaccinated, I'm not completely sure what the correct answer is for our kids.
To put those numbers into perspective, more kids die from the flu in any given year (despite vaccination!). And far more kids die from car related accidents, and cars are a daily fact of life here.
I'm also interested in the other longer term effects of COVID on kids, but there doesn't seem to be a lot of information out there about it.
You talk as if it's a clear cut answer. Given the numbers involved I don't see how it can be.
(Not the one you responded to) I know what an mRNA vaccine is and the only clearcut answer is that "yes, obviously the long-tail risks of mRNA vaccines could outpace the long-tail risk of COVID-19". The statement is also true when you say "...COVID-19 could outpace...mRNA vaccines" as well, if that's not clear.
BTW the "long tail" of COVID-19 in children is totally unproven and the whole "long haulers" phenomenom is likely (a) a small part normal post-viral fatigue which we see with basically any virus, and (b) mostly psychosomatic/psychogenic illness.
That uncertainty is exactly the point. It's possible that the cure could be worse than the disease, but we have every reason to believe that it won't be in the long-term, and that in fact the long-term prospects from COVID-19 are probably much worse than any of the vaccines. And in the short-term the question is decided quite clearly.
So when faced with the choice of vaccine or virus, it should be a foregone conclusion.
> Also don't think the long-tail risk of an mRNA vaccine can be worse then COVID's long-tail risk.
It absolutely could, and that should be self-evident.
> Also pretty sure risk of death outweighs literally any possible long-tail risk, so still seems sensible for the young to get the vax.
This is just not true. The risk of death in children from COVID-19 is so low you literally should not ever worry about it. If you want to compare numbers in an academic sense go ahead, but the fact that actual adults are wasting valuable cognitive and emotional energy worrying about their kids is a great tragedy.
The recorded COVID-19 deaths in children are, by the way, using the absurd definition of a COVID-19 case/death that most of the western world is using; a definition where having PCR-confirmed SARS-2 infection means that ANY death is classified as a COVID death. This is not how this is supposed to work; there is supposed to be a distinction between the virus and the disease, but we define the disease as merely having the virus! It's completely absurd. Indeed I'm writing an article about this concept (pathological vs physiological) right now
Yes we do? The mRNA vaccines cause your body to produce the coronavirus spike protein. That is the beauty of an mRNA vaccine – the cure literally cannot be worse than the disease, because the cure is just a subset of the disease. Anything these mRNA vaccines do to your gametes would also be done (and worse) by COVID-19 itself, so... definitely get vaxxed with an mRNA vaccine if you're worried about long-tail risk. Also this is the J&J vaccine which is viral vector, not mRNA (Moderna/Pfizer).
We don't know that it has no other effect. We don't know all of the circumstances where reverse transcription can happen in the human body. This kind of epistemic arrogance is dangerous and is how we ended up with thalidomide causing mass birth defects and other such disasters.
This is not, in any way, similar to thalidomide. Thalidomide was an issue because it is enantiomeric and different effects were caused by each enantiomer, only one of which was noticed. That is not an issue here, as we are talking about proteins. The primary difference though is that there was no treatment imperative with thalidomide, but there is with this.
Again, we are talking about introducing something that is guaranteed to be in your body anyway if you contract COVID-19. SARS-CoV-2 is viral to the point where, without perpetual lockdowns/mask-wearing/vaccinations, you will get it. So it is still definitely better to get vaccinated, at least with an mRNA vaccine – please stop spreading FUD. Your concerns could be more warranted for vaccines like J&J which use modified viral vectors, but again, exceedingly unlikely that this could be any worse than the virus itself.
You're talking what we learned after the fact about thalidomide. And I'm obviously not saying thalidomide and the mRNA vaccines are similar in their actions in any way. I'm just saying we don't know what injecting a bunch of synthetic spike protein mRNA (a huge percent of which has errors) into your body might do. The same way we didn't know what thalidomide might do, we don't know what this might do. We are not at the level of knowledge about the human body where we can rule out unexpected effects. That is why we have a very stringent drug and vaccine testing regime.
I think the point parent is making is slightly different. Let me try to re-phrase it negatively: What we don't know about mRNA vaccines we don't know about SARS-CoV-2 either. Our state of knowledge of the effects of SARS-Cov-2 will soon be eclipsed by our knowledge of the effects of mRNA vaccines. SARS-Cov-2 is only 6 months older than the mRNA vaccines. There will always be unknown unknowns for both mRNA vaccines and SARS-Cov-2.
We’ve given the mRNA vaccines to enough people to be highly confident that your fears are ungrounded. The mRNA doesn’t linger more than a few hours. People received the vaccine a year ago.
The US has administered 250 million shots, of which 7 million were J&J. These numbers, and the fact that the mRNA started trials earlier makes me proportionately less worried about surprise side effects for the mRNA shots.
Probably none, the tricky part is how it affects an embryo because that's an known unknown of a lot of this molecular biology/medicine things. It's already counter-indicated for pregnant women though.
I'm not qualified to comment on whether or not that is a valid concern, but the vaccine we're discussing here (J&J) uses a modified viral vector, as do the AstraZeneca and Gamaleya vaccines.
Correct. I meant the mRNA vaccines. The AZ & J&J vaccines don't have that same concern, but I'd still worry about an untested vaccine. There is really no good reason for the young and healthy to get the vaccine yet or any time soon.
At the moment we're shitting on the younger generation even harder than usual, by denying them the opportunity to go out, meet people and generally enjoy their youth. Doing that for a year was maybe justified, but it is just totally unfair to carry on for an extended period.
To open up again we need to bring the demand on healthcare services down and we need to do it sustainably, i.e. in a way which prevents another exponential spike. If we can achieve that aim without mass vaccination of healthy young people then great, of course, let's do that. But: if the only way to squash this thing and return everyone to a somewhat normal life turns out to be to keep vaccinating until we get right down to the twenty year olds, shouldn't we do so -- for their sake as much as everyone else's?
In my neck of the woods, kids are in school and going to wrestling tournaments and before that hockey tournaments that got to be superspreader events. We're certainly not denying kids sports where I am, or the opportunity to infect their older family members (yay!).
False dichotomy. If the 20 year olds all get covid, almost nothing bad will happen. So just let them catch it. If the at-risk people are all vaccinated, then it's not a big deal.
Almost nothing bad will happen—with the current variants. Uncontrolled spread in a sub population will almost certainly lead to new variants emerging. Given the reduced effectiveness of current vaccines against certain variants, this is reckless.
Very true! But that is no different than flu and cold mutations year to year. The only reason we are worried about covid is the high death rate for some populations. Otherwise, we would not have done any lock downs or mask mandates.
Continuous mutation of common viruses is the background risk that human beings have evolved over three billion years to withstand as a species. That is different than a completely novel man-made intervention.
This sounds like special pleading to me. We have two new possible things that could be introduced to your body - a vaccine or the virus.
In neither case is it possible to know what hidden long-term effects they could have on you. But the virus is known to kill and maim people in the short-term at a much higher rate than the vaccine, which is known to protect you from the virus.
I don't think it's a special pleading. Covid is a nasty coronavirus but it is ultimately an incremental change in a very widespread kind of virus that humans have coexisted with forever. Human beings have evolved to survive this kind of thing as a species. This is the kind of risk that a species has to be equipped to survive to have made it this far. Which is not to say that a virus can't come around and wipe us all out, but it would be a truly extraordinary event.
For all we know, mRNA vaccines can alter your gametes. We don't know because this is the first time we ever use them. They aren't like viruses or weakened viruses. They are just a massive injection of genetic material (much of it deformed) that encodes a single foreign protein. No human being has ever had such a thing done to them until very recently. mRNA vaccines are not part of any natural process that modern humans or our ancestors have had to withstand to get to the present day.
Viruses are like super mRNA vaccines. They commandeer your cells not to just create a single protein, but to create a bunch of proteins in order to form new viruses. And unlike mRNA, they reproduce and can stay in your body for months or years. I don't see the huge new risk.
I don't know why you have this special concern about the gametes. In any case, if there's a significant bump in miscarriages / infertility from the vaccine, we'll probably know very soon, now that lots of younger people are being vaccinated.
The fact that the vaccines create just a single spike protein and the real virus creates much more is actually one of the issues.
First: does the rate at which the cells are made to artificially produce spike protein follow a different curve than the rate at which SARS-2 would? i.e. could mRNA vaccination cause a much more aggressive "inflammatory cliff", thus the huge percentage of "mild" adverse reactions (mild meaning, you feel like death for a day but end up fine with no detectable long-term issues)? It's possible.
And switching to efficacy, while personally I think resistance to the spike protein alone will be sufficient, because SARS-2 does not have the same ability to mutate/evolve the way Influenza does (for example, I can't imagine SARS-2 evolving away from the spike protein), it's very possible that the diverse epitopes produced by real SARS-2 infection give a much more robust and enduring immunity.
Your point about efficacy is not currently born out by the data, AFAIK. Seems like re-infection after COVID is much higher than infection after vaccine.
I have special concern about gametes because it’s one thing to risk the health of currently living people, but it’s another to risk the gene pool going forward into eternity.
> Difference is that I know person that got COVID in November and now has issues with memory.
> I don't know a single person that has that after flue and cold - and those are with us much longer.
Look into ME/CFS, whose existence is still contested (or rather I should say, whether it's a physical or psychogenic illness is disputed). I know you're just speaking anecdotally but just wanted to mention that post-viral issues (fatigue, memory, etc) absolutely does happen.
> As for viruses mutations etc. do we for sure know that this one is not man made?
At most SARS-2 is the result of extensive gain of function research on https://en.wikipedia.org/wiki/RaTG13. I don't know any credible individual that thinks it's fully artificial / manmade (and to be clear, my definition of "credible" is not the "anyone who agrees with the WHO/CDC and nobody else" definition that the establishment relies on).
Personally I think it's more likely that SARS-2 was GoF'd into existence rather than was a purely natural zoonotic leap, whereas I think the probability that it was fully artificial is almost zero.
If we pick the 25-29 year olds and an estimated infection fatality rate of 0.01% [1] it's still 13.5M x 0.01% = 1,350 deaths. It's not a lot by any means, but it's not 'almost nothing' either.
This is the worst case scenario of cause, sibling comment has already mentioned long Covid, where we don't know prevalence precisely.
I'm aware I've picked the 'worse half' of the 20 year olds, 20-24 will fare better obviously.
No, and no one had any reason to think that thalidomide would cause mass birth defects. This is why we have such long testing periods for vaccines and drugs in general. We also go through extra testing before approving things for pregnant women. We don't know what we don't know. Modern medicine is impressive, but we must maintain epistemic humility.
(A) vaccination means less social distancing sooner. Lots of people are interested that.
(B) covid-19 might very well become endemic. Like how the common cold is always around. It's not so bad if we're vaccinated. But for those that don't get vaccinated hurd immunity might not cover them.
In practice: I think we just need to be honest about the risk of vaccines. And say that taking it is the patriotic thing to do :)
> vaccination means less social distancing sooner.
i guess you can put it like that.
from my understanding the vaccines do reduce the transmissibility of the virus, but they do not lower it to zero [0]. you can still get the virus, but with the vaccine your chances of needing hospitalisation drop to zero [1].
i guess this is why you still need to wear a mask, and still need to socially distance even if you are vaccinated [2].
> from my understanding the vaccines do reduce the transmissibility of the virus
Yeah, but once vaccinated you can start to worry less. And surely we'll see things open up to those who are vaccinated.
The fact that it's possibly still transmissible by vaccinated people is probably the reason why we all need to get vaccinated, and there is no hurd immunity to be gained :/
No vaccine ever reduces transmissibility to zero. Vaccines prime your immune system to fight off the invader as quickly as possible, but they are not a magic shield that prevents the invader from ever entering your system. And if it is in your system, it is of course possible to transmit it.
Both the AstraZeneca and J&J vaccines use an adenovirus to deliver DNA instead of mRNA wrapped in lipid (like Moderna & Pfizer).
Everywhere I read about the J&J vaccine, I see something like "the DNA vaccine doesn't alter your DNA". Can somebody please clear this up?
As far as I understand, the mRNA just stays in the cytoplasm of the cell and gets used up by the ribosome to create spike proteins. The adenovirus vector used in the J&J (and other vaccines) injects DNA in the cell's nucleus, which seems at odds with the widely circulated "it doesn't change your DNA" statement.
Do people make this claim because the cell displaying spike proteins is basically always eliminated by CD8 killer T cells?
I'm a bioengineer. Everyone that gives an answer mostly ignores epigenetics and the fact that RNA can permanently alter the _shape_ (or conformation) of how your DNA is tightly wound up. For example, RNA can direct methylation of DNA and alter histones, which can lead to transgenerational epigenetic effects on gene expression and phenotype [1]. The fact is, molecular cell biology is incredibly complex and the models we have are just that, models. Saying that these mRNA strands don't affect the genome long-term may be correct, but this is an educated guess based on theoretical models. There's a reason why FDA approvals traditionally took 10+ years, we normally verify our educated guesses empirically.
It almost certainly won't have long-term affects, but it may not be trivial to identify if mRNA vaccines have been altering epigenetics.
Follow-up question: Do these effects (which are very unlikely) differ between vaccine and the virus itself? Or maybe: Is the epigenetic risk higher/different?
Everything in life has potential epigenetic effects! Not sure what you are trying to communicate with your comment but it sounds like you are saying people should avoid the mRNA vax but then you also say “almost certainly no long term effects.” Your thesis seems to be that 10 years is enough time to know for sure that they are safe. Why is 10 years the right amount of time? Why not 50 years or 5? In other words what’s your model for relative risk/reward and why is it better than what is being done in terms of public health outcomes?
You seem to be putting a lot of words in OPs mouth. I didn't see OP making any sort of suggestion about whether to avoid the vaccine or not. It looked like they were simply explaining some possible outcomes of the vaccine that are unknown.
OP also didn't say 10 years is enough time to know the long-term effects of these vaccines, just that it's traditionally been the minimum amount of time needed for some other drugs.
50 would certainly cover all life stages of humans. I assume you could be sure with shorter.
I have an aviation, biochem, and skydiving background. My rule is for aviation: "if it hasn't been out five years you're a test jumper."
Humans are way more complex than airplanes. I personally wouldn't take the mRNA vaccine because of this rule. Coupled with being unable to sue or get help from the government I think people IN LOW RISK groups have been way too enthusiastic to sign up.
I'd be happy to take the vaccine if I was in a higher risk group and I'll be happy to take the vaccine in a year or two, but right now I just don't think it's right decision for someone like myself.
Given my risk is very low I'm not too worried about COVID, but I am a little worried (perhaps wrongly) about the risk of finding out about some long-term side effect from these vaccines a few months down the road. I suffer from long-term side effects from another drug I took in the past, and at the time I was told there was no risk of long-term side effects and that it was safe to take. Only recently has the labeling been updated to reflect the discovery that permanent side effects can occur in some cases and for me it's too late, but I learnt my lesson to allow others to be the guinea pig for new drugs wherever possible.
It's really quite alarming how little we know about the body, espically considering the certainty of some "experts" about how extremely low the risk of adverse effects are from newly approved vaccines. I'm aware of a number of drugs which are approved and frequently perscribed which we don't even understand the mechanism of action for -- accutane, for example. Of course in this situation, we do know the mechanism of action, but it would still be wrong to assume we know the full surface area of possible side effects which could occur because our model of the human body is so basic.
I'm happy for someone to explain why I'm wrong on this. I'm obviously not an expert, just an average guy trying to assess the relative risk of two very unlikely events.
There is no reason to expect that side effects from the vaccine are not present or actually dramatically higher from the live virus. An infection by the virus, even if asymptomatic, will likely introduce way more alien genetic material and viral proteins into your body than the non-reproducing vaccine ever would. So one should trust the FDA panel of experts on risk unless there's strong evidence pointing otherwise.
> I think people IN LOW RISK groups have been way too enthusiastic to sign up.
About that...
> In December, we asked, “What percentage of people who have been infected by the coronavirus needed to be hospitalized?”
> The correct answer is not precisely known, but it is highly likely to be between 1% and 5% according to the best available estimates, and it is unlikely to be much higher or lower. We discuss the data and logic behind this conclusion in the appendix.
> Less than one in five U.S. adults (18%) give a correct answer of between 1 and 5%. Many adults (35%) say that at least half of infected people need hospitalization.
From what I can deduce using CDC data my chance of hospitalization is 0.5 to 2%. Assuming linear relationship of obesity in the population and assuming the same risk at the top of my cohort to the bottom.
Or maybe people are just terrible at judging acute risks? This isn't unique to covid - ask them about flying on an airliner or living next to a nuclear power plant and you would get some equally comical numbers. At any rate risk of hospitalization/death isn't the complete picture since some of those young people are ostensibly doing it to protect the people around them.
So let’s say hypothetically that white people were low risk relative people of color. You would have white people not get vaccinated because the consequences for their group, alone, might be slightly better?
Does that not seem a bit ... immoral?
I assume you eschew all other medical advances that are less than 50 years old? Would you eschew remdesivir? Sorry for the questions but thinking such as yours intrigues me and I want to grasp the logic behind it. Why not avoid all new technology for 50 years? Getting vaccinated seems to me like the logical and moral thing to do, but maybe I’m overlooking something.
Would this be an advantage for the Novavax vaccine as it doesn't do anything to hijack cellular machinery to create the spike protein, it just (as I understand it) has a bunch of pre-made spike proteins.
> Adenoviruses -- even as they occur in nature -- just do not have the capacity to alter DNA. Unlike retroviruses such as HIV or lentiviruses, wild-type adenoviruses do not carry the enzymatic machinery necessary for integration into the host cell's DNA. That's exactly what makes them good vaccine platforms for infectious diseases, according to Coughlan.
> And, engineered adenoviruses used in vaccines have been further crippled by deleting chunks of their genome so that they cannot replicate, further increasing their safety.
This sounds a bit like a technicality. The DNA makes it into the cell nucleus and is used by the cell machinery to make proteins. The changes aren't carried over after cell division, but lots of cells in your body last your whole life (nerves, brain cells, eye cells, important stuff).
Loss of neurons and cardiac muscle cells is permanent. Emergency medical personnel are usually taught "time is brain" and "time is heart" for this reason.
I think the argument hinges on the technicality that it's not splicing itself into the host genome, so no chance of it becoming a retrovirus or something like that (in the event that the cell's lineage is not extinguished by the immune system).
I'm not a genetic engineer (what a time to be alive, eh?), but I'm pretty sure an adenovirus that did permanently modify cell DNA would be more like CRISPR, including the risks that entails (such as the risk of incorrectly splicing the host genome and potentially creating a precancerous mutation)
I want to be perfectly clear that I didn't bring this up to be alarmist. Jesse Gelsinger's death shed a lot of light on the risks involved with adenoviruses [1]. Those lessons have been carried forward.
>> An autopsy and subsequent studies indicated that his death was caused by a fulminant immune reaction (with high serum levels of the cytokines interleukin-6 and interleukin-10) to the adenoviral vector.
>> The data suggested that the high dose of Ad [adenoviral] vector, delivered by infusion directly to the liver, quickly saturated available receptors ... within that organ and then spilled into the circulatory and other organ systems including the bone marrow, thus inducing the systemic immune response.
He was injected with >3 × 10^13 viruses [2]. The typical J&J dose contain: low-dose (5x10^10 viral particles) or high-dose (1x10^11 viral particles) [3].
Parent specifically stated DNA viruses. From your article:
> Most of these viral genes come from retroviruses, RNA viruses that insert DNA copies of their own genes into our genomes when they infect cells. HHV-6 is unique because it is the only known human DNA herpesvirus that integrates into the human genome and can be routinely inherited.
Why didn't they stop the vaccinations in women under age of 60/65?
I'm a 40 year old man, if I were a woman I wouldn't take J&J or AstraZeneca, but as I'm a man, I think it's worth to take the risk of the side effects of the vaccination.
Using a machete when you should be using a scalpel (though to be fair at the time it looked like a filet knife was the tool for the job) has been more or less how this pandemic has been handled since day 1. Why would that change now?
Now you have the logistical challenges of shipping 2 vaccines to some small town. One for the men, another for the women. Additionally, that town needs the not insubstantial refrigeration capabilities anyway.
So what’s the point if you’re a public health admin? Just get the moderna or Pfizer and save yourself and your staff a lot of headache.
The logistical benefits of J&J mean that it’s only logistically beneficial if it can be used for everyone.
Better to write the town off to the pandemic. I mean, we’re in the middle of a fourth surge, so realistically, double digit percentages of the town are likely to get covid if we delay even a few weeks, but 10% of 0.5% the population dying from covid and increased spreading of the new variants are reasonable prices to pay to avoid 1 in a million side effects.
We can make a statue for the people that die in the following weeks protecting the rest of us from the J&J vaccine. They’ll be heroes.
You think 10% of a towns population will die from COVID in a couple weeks?
Has that percentage of people in any county in the USA actually died from COVID in over a year?
Florida who has been pretty laissez-faire about COVID has 5,980 deaths in Miami-Dade County (their highest amount of deaths in a county).
2.717M population in 2019.
He estimates an additional 10% (increased spread of covid infection due to change in vaccine policy) of .5% (death rate given covid infection) of a towns population will die from covid due to vaccine hesistancy.
Only there is no vaccine hesitancy. Only public health admins saving themselves headaches by just using moderna or Pfizer in the first place. Since using J&J would require them to use moderna or Pfizer anyway.
The towns small enough to only need one shipment are easy, just thaw some mRNA in the nearest big city and someone drives it out the morning of the vaccine clinic.
The big enough cities to need many shipments can handle these logistic.
I'm only speculating, but serious blood clots are also known to be possible side effects of some forms of hormonal birth control. Given the relatively young ages of the women who had side effects on J&J, I would be really interested in learning if there could be a connection there.
They are not alleged at this point, they are real, and we have enough data that proves it. Using a language that pretends that vaccines can't have lethal side effects is just dividing people farther. It's all about the risk-reward calculation, which is still on the vaccine's side for most people.
For a 18 year girl though it may be better to wait 2 weeks more for the Moderna / Pfizer vaccine in lockdown at home than to take the J&J or AstraZeneca. As an example my parents did the same thing (watching TV and using the elliptic machine for training, waiting 2-3 weeks more than their friends who got the Chinese vaccine).
From what I understand, we have data that shows a few people per million have a serious health condition that appears to be similar in order of magnitude as the normal background rate of the same condition without the vaccine.
As someone else in this thread said, isn't that (potentially) like someone getting hit by a car, then calling that a side-effect? When dealing with very large numbers of people, there's going to be deaths at all ages due to the normal vagaries of life.
Do we have enough information to be certain that these clots are genuinely above the background rate?
This article [0] mentions 50% more blood clots observed during vaccine trials, which at the time was characterized as a slight numerical imbalance (15 blood clots versus 10 in the placebo group, in a trial of 20k people)
The 6 cases out of 7 million would appear to be the most serious/unusual/cerebral blood clots, but that number does not include all blood clots.
I don't mean to advocate against the vaccine with these numbers, just add data. I see the 6 out of 7 million number batted around a lot and that's not a complete picture.
This is misleading. If you’re young and healthy, the chances of dying from COVID are basically zero. The chances of dying from a blood clot from a rushed vaccine are not. The people who died from blood clots probably would still be alive had they not taken the vaccine.
Even then, let's assume they were. COVID is largely avoidable, if you don't mind being avoiding others. Directly getting a vaccine is not.
It's like saying X% of people riding in cars will be in accidents and die. Yeah, maybe, but that doesn't apply to you if you don't ride in a car in the first place.
I believe the data does support my statement that hundreds of young and healthy people have died from covid. The risk is close to zero, yes, but still greater than the reported risk from this vaccine.
Close to 3000 people ages 25 to 34 have officially died in the USA from covid-19. If the same 75%/25% division the cdc found for under 21 applies to this group, that’s 750 young and healthy people who died so far just in the age 25-34 age group.
> COVID is largely avoidable, if you don't mind being avoiding others
Huge assumption. Many workers need to work in person and are going to be exposed. Many others live in a home with someone who is an essential worker, or doesn’t believe in covid being dangerous or taking precautions.
It really isn’t fair to blame everyone catching covid today and say they could have simply avoided it. Also, getting a vaccine is absolutely avoidable. No one is being forcibly vaccinated right now.
> If you’re young and healthy, the chances of dying from COVID are basically zero
Death is not the only risk factor. Covid-19 carries the risk of serious complications for those who recover, even including those who are infected but asymptomatic.
> While the long-term consequences are still unknown
> Additional studies are required to fully understand the virus, but for now, follow-up testing is essential to understand the long-term effects of the virus.
The risk is low, but I think the last I saw was a 0.01% IFR in the young, which comes out to 1 in 10,000. Still a higher risk than COVID at this point, although it's possible that they'll discover a higher incidence like with AZ.
But there are 2 other vaccines that are still available so it's not like they're stopping all vaccinations. Another consideraton: J&J was/is having production problems so deliveries have been cut considerably - as such this probably won't be a very significant change to vaccination rates. I suspect the FDA will allow J&J vaccinations to resume in a couple of weeks. Maybe they'll recommend it not be used in women under 60 as has been done with the AZ vaccine in Europe. Even if they do that there would still be plenty of men eligible to get the J&J.
That tweet ignores that there are alternatives to the J&J vaccine, so implying that there is a binary decision between J&J or 1 in 330k death chance is flawed reasoning.
I think this is an illustration of an issue that has been seen throughout the entire pandemic. Medicine != Public Health Policy. In general, I would say medicine is too dogmatic to decide on public policy, and public policy is too loose to operate medicine.
Okay so I want to make something very clear here. The rule is to put it very very simply, is you can ship any drug that is approved but you have to list the side effects. This drug was approved under an emergency order and this side effect was not listed. This will get paused long enough for the side effects to be updated and then used again. The arguments about “well the birth control pill has a higher risk” are using a fact that while it is true, is not relevant as that data has no relationship to the rules that have to be followed. The valid argument would be, those that issue the emergence order for use to should amend the order to acknowledge the issue but not block use immediately.
> This drug was approved under an emergency order and this side effect was not listed.
Sadly, this is the case. The German regulator's FAQ explicitly called this out; they are not interested in determining the path that saves the most lives, they are simply following the process that checks all of the boxes that the regulations require. In the EU this regulatory pause of AZ has likely killed thousands of people.
> The valid argument would be, those that issue the emergence order for use to should amend the order to acknowledge the issue but not block use immediately.
Or, more generally, in the emergency-order regime, all decisions that can demonstrate a clear 10:1 improvement in expected deaths should be taken, regardless of regulatory red tape.
The FDA and other regulators have over-fitted their process for "minimize likelihood of another Thalidomide, for drugs which have a small chance of saving a life, and a very small chance of causing harm". This is defensible for testing a new statin, where we have existing safe drugs to choose from, and we're looking for incremental improvements. But it's shockingly harmful in an emergency.
One thing that has become very clear is that the FDA and other regulators are structurally incapable of making even rudimentary risk-based tradeoffs in emergency situations, and we need to fix this.
> The German regulator's FAQ explicitly called this out; they are not interested in determining the path that saves the most lives, they are simply following the process that checks all of the boxes that the regulations require.
A drug regulator should do its job, which is following established rules for approving and recommending new medicines. Not invent new rules, not push experimental drugs when new problems are being discovered on the go. Advocating for "greater-good" trade-offs and risks is a political effort, the regulator should be immune from political pressures.
I'm glad people there prefer to err on the side of going with established rules and caution.
If what you want is experimental drug being accessible to as many people as possible as soon as possible, you should advocate for the option to bypass the regulator and letting the people decide for themselves.
Do not advocate for corrupting the regulator.
> In the EU this regulatory pause of AZ has likely killed thousands of people.
I don't know how you came to that conclusion, but even if so, how many thousands of people would be eventually harmed or killed if the pause wasn't introduced? We don't know, because we are discovering properties and effects of the vaccines on the go. The data and estimates we have are based on short-term experience with the vaccines. They will change.
In treating people for illness it is a long established rule that "first, do no harm". And vaccine does not even help the patient with any illness - it is rather to help in case the patient would get one in the future. For many people, getting vaccinated has zero to negative benefit.
Nobody is entitled to get a fast-tracked rubber stamp to push vaccines on people. If you want to take experimental drugs, I support your right to do so, however I expect you let other people decide for themselves, including the regulators.
Why is the correct solution not to support people enough that the only reason anyone has to interact is to do "essential" work--for which the they should be paid hazard-level pay--and then do this slowly and carefully? We can offer the vaccine to people who would then feel better taking it--particularly if it means they get to make hazard-level pay--but it wouldn't matter if people didn't: the main risk of getting covid should be "I decided to interact with people, knowing the risks", and it isn't our job to prevent them from getting ill any more than it is our job to police peoples' home lives. This whole "the sky is falling" emergency scenario is a false dichotomy we have constructed to avoid actually staring at the problem of wage slavery :(.
I guess it‘s protocol. The same protocol that states that you need to list side-effects probably says if your side-effect list is wrong you have to re-list and get approved again. Until your approval is not done you don‘t get to sell.
Otherwise you could delay your updating your side-effects listing because you know FDA will take your druf off-market (and this delay will/could cause harm to people).
The pause is to figure out exactly which groups are affected, and to decide if/how to update guidance. They are presumably working as fast as possible on that. Don't forget that the doses aren't going to go bad, so it is just a short delay in administering them
Distributing the new document only would not be responsible.
In this case, the new side effect kills people. Very rarely, but if you belong to some unlucky group, you're screwed. It is better to figure out which people are endangered. The recommendations and documents have to be good for everybody, not just for the good statistics.
It's really not clear at all that the incidence of this type of blood clots is actually higher in the vaccinated. So it seems early to call this a side-effect.
I wish the health agencies were a bit more open about their thought processes. OTOH, the rate of incidence doesn't seem higher than baseline AFAIK, which seems absurd. It also seems absurd that the various health authorities around the world would all make such a big deal of if if there wasn't some elevated risk. So I don't really know what to make of it, but privately, I'm leaning towards the interpretation that the idea is to avoid backlash against the vaccines by being irrationally strict about any potential hazards.
However, regulator have to follow rules, and those rules probably err on the side of caution. Similarly to "first, do no harm".
I agree that the matter of public trust is also relevant here. In some countries large part of the population already does not want to get vaccinated. So the vaccinator is naturally motivated to prevent any PR screw-ups even at the cost of slowing down.
This is a vaccine for a disease that has killed over half a million people in the US over the past year, not a new breast implant.
The rules are not some holy writ handed down from above, they are our way of trying to properly manage risk. When the situation changes, the rules can also change.
This is what's been frustrating for me with world health organizations.
I get the need to make sure medicine is safe and effective, and we absolutely should follow those to a T when it comes to new medicines on the market in non-emergency situations.
However, that's not the case here. vaccines are well studied in general and J&J is one of the more "normally developed" vaccines on the market. After generally ensuring that it's safe (Phase I/II tests), there should have been a damn good reason to pull it even temporarily. The "we are seeing a small increase in blood clots" really doesn't seem like a valid reason to pull a vaccine.
Personally, I lay the blame primarily on anti-vaxxers. They've made us far too cautious around vaccinations. It has screwed up our risk management rules. I've no doubt that this pull back will result in anti-vaxxers publishing BS about the safety of J&J vaccinations to try and scare people away from it.
> Personally, I lay the blame primarily on anti-vaxxers. They've made us far too cautious around vaccinations. It has screwed up our risk management rules. I've no doubt that this pull back will result in anti-vaxxers publishing BS about the safety of J&J vaccinations to try and scare people away from it.
This has nothing to do with "anti-vaxxers". Vaccines usually take years to develop precisely because we give them to everyone, and rare, long-tail risks matter. This was the case well before the MMR autism scare defined "anti-vax" as it has come to be known today.
In this case, we bypassed that standard development process. It was the right choice, in my opinion, but it's not the right attitude to start claiming that our standard level of risk mitigation for vaccines is excessively cautious because "anti-vaxxers" exist. That's simply reactionary.
If anything, we've tossed out all of our usual standards of evidence in 2020, and did a bunch of stuff willy nilly, with no supporting evidence or rational consideration of trade-offs. We tore off all the safety belts. We don't need lower bars for evidence, we need less reactionary hysteria.
The only part of the safety process we bypassed was 6 moths of phase-3 data, we decided 2 was good enough. Everything else was just bypassing all the time where we were doing nothing at all because there wasn't money to run the next study.
That's not really true. The phase 1 trials were a good bit faster than they'd normally be. Also, even if you ignore that, having years of phase 2 and phase 3 trials gives you a lot of additional safety data, in the form of larger trials with longer duration. Also, better cross-tabs, so that it's possible to assess safety by age, gender, race, pregnancy, etc.
The vaccine trials were limited in their power to detect rare events. The Pfizer trial [1], for example, explicitly said that events rarer than 0.01% are less likely to be detected:
> This trial and its preliminary report have several limitations. With approximately 19,000 participants per group in the subset of participants with a median follow-up time of 2 months after the second dose, the study has more than 83% probability of detecting at least one adverse event, if the true incidence is 0.01%, but it is not large enough to detect less common adverse events reliably. This report includes 2 months of follow-up after the second dose of vaccine for half the trial participants and up to 14 weeks’ maximum follow-up for a smaller subset. Therefore, both the occurrence of adverse events more than 2 to 3.5 months after the second dose and more comprehensive information on the duration of protection remain to be determined. Although the study was designed to follow participants for safety and efficacy for 2 years after the second dose, given the high vaccine efficacy, ethical and practical barriers prevent following placebo recipients for 2 years without offering active immunization, once the vaccine is approved by regulators and recommended by public health authorities. Assessment of long-term safety and efficacy for this vaccine will occur, but it cannot be in the context of maintaining a placebo group for the planned follow-up period of 2 years after the second dose.
Even a 0.001% risk is not small, when you're talking about giving the vaccines to billions of people.
(I don't mean to single out Pfizer here. It's just the one I've read most recently.)
> This has nothing to do with "anti-vaxxers". Vaccines usually take years to develop precisely because we give them to everyone, and rare, long-tail risks matter. This was the case well before the MMR autism scare defined "anti-vax" as it has come to be known today.
Anti-vax hysteria has been around for longer than MMR and autism.
> rare long-tail risks matter
I agree, but at the same time I also think that it's an overblown problem with vaccinations. We aren't talking about medication that screws around with the metabolism in unusual ways. Vaccines (other than the newer mRNA stuff) are by and large large enough chunks of whatever we are vaccinating against to trigger an immune response when the real thing comes along + preservation/delivery medium.
At the end of the day, the worst case for vaccination is that you might be infected with the disease you are vaccinated against (when live viruses are used).
That's not the case for J&Js vaccine.
So the next question is, if the worst case scenario is you get a disease you were attempting to prevent, then what is the next real biggest threat from a traditionally developed vaccination?
> If anything, we've tossed out all of our usual standards of evidence in 2020, and did a bunch of stuff willy nilly, with no supporting evidence or rational consideration of trade-offs. We tore off all the safety belts. We don't need lower bars for evidence, we need less reactionary hysteria.
I'd argue that pulling a vaccine over a very minor number of reports of increased blood clots is overly reactionary.
Edit: And... reading this it makes it sound like I'm skeptical of mRNA vaxxes. Just to be clear, I'm not and I've gotten the pfizer vaccine myself. I do think they'd have more justifiable scrutiny to make sure they are safe as it's a new technique for mass vaccinations (even though it's been used in immunotherapy for a while now).
Read the post by timr above. The studies are very limited and can't reliably detect problems that occur with small part of population. This can be hundreds of thousands of people.
The worst case for vaccination isn't that you get the illness. It is that you are one of the unlucky ones that gets some severe reaction and gets killed.
Has that ever happened in vaccine studies? What would the biological path be that would cause you to have a severe reaction from the vaccine but not from the disease itself? Why wouldn't that already be present the data around the millions of people that have already been infected by the disease?
The type of severe reactions you'd expect are allergic reactions. They would show up right away, not as an event 2 weeks later. Given that J&J has already done 6 million dosages it seems pretty safe to say that those allergic reactions are pretty much non-existent.
I see a lot of maybe and mights, yet never any actual evidence or example of the fear around vaccine safety or a cogent explanation of HOW these things could happen. That's because you'd have to explain how proteins from the vaccination are somehow more dangerous than the same proteins present in the diseases.
The linked explanation would have been a reason for a longer and wider phase II/III study. However, now that the cat is out of the bag and we've got millions of people who've been dosed for multiple months, that's the study. Until we start seeing severe negative side effects in the 100s or 1000s of individuals, it doesn't make sense to pull a vaccine.
> there should have been a damn good reason to pull it even temporarily
And the damn good reason was that there's a bunch of people out there who don't want to take the vaccine for political reasons. And there's a smaller amount of people who don't want to take the vaccine because they're uninteresting in taking a new vaccine. They're looking for reasons to validate their fears.
If you just keep pushing the vaccine even though a bad thing happened to a small number of people, then there will be people who use this as an excuse to avoid all of the vaccines completely.
Take down the vaccine and make a bunch of lab coats spend a hectic two weeks double checking some figures and people will feel listened to and they'll have less arguments to not get the vaccine. The vaccine that you're taking is as safe as it can be. After all when we saw a problem we did something about it.
This is 100% about optics and PR AND that's 100% necessary right now in order to get the job done.
> I lay the blame primarily on anti-vaxxers
Don't even talk about anti-vaxxers right now. The only thing bringing up anti-vaxxers will do is grow that movement. The people who don't want the covid vaccine are not anti-vaxxers. They get the flu vaccine and they get their children vaccines. They're only afraid of the new covid vaccine. They don't like anti-vaxxers any more than you do, BUT if you call them that then some of them are going to decide they might as well join the anti-vaxxer movement.
These are two groups of people who I do not want to join forces. Covid hasn't exactly been a fun time, but I'm really not interested in seeing polio and friends come back.
Have rational debates, quit the name calling, go the extra mile to convince people who don't like your position to do something for the greater good. Otherwise, we're not going to see enough vaccinations to make a difference.
Here, risk management should be a personal decision. In this case, the right set of actions might be to grant people freedom, and let market forces rule.
I think some people would choose the J&J vaccine if it meant getting vaccinated faster. Some people would choose Moderna / Pfizer, later.
It really depends on things like whether or not you can work from home, how depressing it is not interacting with people, or how concerned you are about the risk of long COVID19. That's not something we can answer for anyone centrally.
From a public health perspective, vaccinating people now with Johnson is an obvious win.
I think this is unrealistic for medical application, not only for vaccinations but in general for anything related to side effects of drugs.
First of all, most people don't have the data and in this case part of the risk management is to get more data or consolidate and evaluate existing data more thoroughly. Second, while you might be an exception, the vast majority of people do not have the knowledge and skills to properly assess risks or perform multiattribute cost-benefit analyses. Layman cannot even compare small probabilities correctly and frequently mix up risks that differ from each other by multiple orders of magnitude. Even people with fairly good knowledge of probability theory will have a hard time judging small risks without extensive comparison data and maybe some didactic tools like "micromort" comparisons.
So do public health professionals. The passive death and disability from COVID19 is weighed far less than the active death of side-effects. Providing J&J to everyone in the US would obviously reduce spread and reduce the thousand-or-so deaths we're continuing to see in the US every day by far more than blood clots.
In general, doctors leave medical decision making to patients, is central to medical ethics. This even applies to patients with incomplete capacity.
No, I blame the anti-vaxxers for pushing the spec to be so strict that when 6 people out of 6.8 million people see a negative medical event, we pull the entire vaccine out of caution. We are pulling the vaccine because of a literally 1:1000000 chance that you might have a blood clot. Meanwhile, the risk of dying from covid is closer to 1:100 to 1:1000.
I'm understanding that your concern is that we should be protecting ourselves against covid instead of worrying about the rare side effects of the JJ vaccine.
However, keep in mind we are continuing the vaccinate people are a really high rate, we just are not using the JJ vaccine. No one is stopping all of vaccinations. A brief pause in JJ while they relabel is just a minor hiccup in our overall vaccination plans
> This is a vaccine for a disease that has killed over half a million people in the US over the past year
Serious question, how many of those people would have died in the past 12 months if they didn't get COVID? The number is most likely not 500,000, but it also probably isn't 0.
Is it most likely something insignificant like 5,000?
> Serious question, how many of those people would have died in the past 12 months if they didn't get COVID? The number is most likely not 500,000, but it also probably isn't 0.
This can be answered using “excess mortality” data.
Studies have shown during that time period, about 600,000 more people died than would have been expected compared to deaths in the previous year.
The official covid death count is likely an undercount of deaths caused by covid, because a number of people died from covid related complications and got recorded as pneumonia, Alzheimer’s, or heart disease/attack/stroke related deaths.
> The official covid death count is likely an undercount of deaths caused by covid, because a number of people died from covid related complications and got recorded as pneumonia, Alzheimer’s, or heart disease/attack/stroke related deaths.
That's a theory. Meanwhile, we know that many places are classifying anyone who dies within N days of a positive test (N is typically 30) as a "covid death", regardless of actual cause.
I can guarantee that not all of those people died from Covid-19. Point being: there's likely to be overcount and undercount, for different reasons.
I mean... there was a deadly global pandemic. It seems like you're just splitting hairs to discredit the fact that we're likely significantly undercounting COVID deaths.
You're asserting something without proof, what I'm telling you is a fact, and a "deadly global pandemic" doesn't invalidate facts and make assertions true.
There are also people not experiencing death by misadventure because people are doing fewer outdoor activities and most especially not hanging out with or showing off for the bad influences in their lives.
Also offset by excess deaths over the next few years due to long term effects of a sedentary lifestyle, stress, and all the overcompensating we are likely to see next year with people trying to “make up for lost time”.
Many national parks set monthly visitation records last year, campground reservations are at all-time highs, and SAR operations across the country are stretched thing. What else was there to do when other vacation and travel activities are closed?
I'm not sure how outdoors-y fatalities will be impacted by all of this, but people are definitely not "doing fewer outdoor actives" right now.
From the CDC:
In 2019, a total of 2,854,838 resident deaths were registered in the United States—15,633 more deaths than in 2018.
In 2020, approximately 3,358,814 deaths occurred in the United States (Table). The age-adjusted rate was 828.7 deaths per 100,000 population, an increase of 15.9% from 715.2 in 2019.
Assuming the rates stayed the same or roughly so from year to year, it appears that not many of them would have died sans COVID19. Certainly well over 5000. If there is a trend, none of the data I looked at on the CDC site supported this, raw deaths have been rising in the last 5 years but death's per 100,000 have held. So if it's a small increase per 100,000 is "normal" given those trends 16% is still well outside the normal, so it's likely something like 300,000 or there about. I sure someone here could do the math to verify that but I don't feel like it. :)
Initially the cdc data pointed to about 2/3rds would have died anyway in the same time period in the US, but that was a few months in. Now if you pull total deaths from the cdc, subtract deaths tagged as covid and fit a sinusoid with a 52 week period and a slope for population growth you get a pretty solid fit with the exception of the 2018 and 2015 flu, and last summer. But last summer the sinusoid is under the total daeths minus covid deaths. Integrating the area between I think we undereported covid deaths by about 50k over the summer. We are back down to predictded deaths now without counting covid deaths. So I think all half million deaths are in excess of expected value, plus another 50k.
Probably not that low. This study [1] says about 80,000. (There were about 420,000 excess deaths in the US last year.) That number isn't perfect in that it ignores any death reductions from accidents, say, that didn't happen because people were staying home. It also doesn't account for any deaths resulting from untreated conditions.
It would depend on the age and make up of the population, cross reference that with a mortality table and you can get a pretty good idea. For a 25 year old the odds of dying in a given year are about .03, and this obviously moves higher as the population grows older.
>The rules are not some holy writ handed down from above
I'm sorry, but when dealing with healthcare organizations and policy-makers, it's more like the "holy writ" than the idealized system you describe later.
The rules do not exist to manage risk. They exist to strike a balance between ethics and risk in emergency situations. If you’d like to change them going forward, feel free to advocate. I think it’s best we stick with our current rules this round.
We've changed the rules for every single part of life and society because of this massive emergency, with no idea what the long-term consequences of doing so might be. I'm not sure why the FDA should be excluded.
The FDA has a process in place as per the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013. If you find that legislation inadequate in some way, I think following due process to change it is the way to go. If how we handle pandemics should be more agile, let’s get legislation behind that.
I don’t think jerking our knees over an ethics safeguard that led to a pause in administration of a vaccine that soon won’t be widely available anyway is a great habit to get into.
The change in life is supposedly temporary restriction of freedoms for emergency reasons. Maybe it is wrong but governments have that power and people accept it.
Imposing political pressure on experts and forcing them to approve against their judgment would be a horrible corruption of these regulator institutions.
Maybe the expert regulator think that the bar should be lowered. But then they should come forward. This should not be ordered by politicians or their handlers.
Our current rules are what was done. You're the one advocating for more cautious rules because you consider 1 in a million side effects too great a cost compared to the cost of non vaccinated covid
I don’t understand your comment. I’m not advocating for more cautious rules. I’m advocating for due process. The rules should be what we feel is necessary.
The answer is yes, "as determined by the experts" that made the recommendation after looking at the data on this and also the data from what has happened in the UK/EU with the AZ vaccine which uses a very similar method. Are the experts correct here - no one knows at this exact second. It will take time and future studies to see if they made the correct call. One point that people are missing in the reported data is that this type of blood clot is not the usual kind where the normal treatment that I doctor would follow would fix it. The pause here is about getting the information out to the doctors and the public that says "Hey Public, if you get J&J and feel this way X,Y,Z with in X weeks of getting it go to the doctor. Hey Doctor, if someone comes in in X time of getting the J&J and feels this way X,Y,Z be aware that it could not be the NORMAL thing you think and look for XXX and treat it this different way to make sure you have a good outcome."
We will ask if the vaccine somehow cause those 6 people to be hit by a car, if we decide the vaccine caused that would be listed. (I don't see how a vaccine could cause people to be hit by a car, but I'm open to suggestions)
That would probably be listed as drowsiness, depression, dementia or something like that. They already tell you not to drive heavy manchinery after the J&J vaccine though.
Umm maybe because the blood clot issue is being underreported because no one is looking for it? We’re essentially doing mass experimentation with gene-based vaccines on the US population, all the vaccines use either mRNA or DNA insertion. Caution here is the logical and ethical thing.
Also: the side effect profile for the moderna and pfizer vaccines in the clinical trials was far WORSE than the jnj vaccine.
Yes, as a non medical/statistician person, I'd be really surprised if we had the same quality and quantity of data on the birth pills and this new vaccination.
The risks could be higher, but maybe our data is not yet there.
Just as a side note, the risks (and gains) are different, maybe I really don't want a child accidentally, but I don't consider the coronavirus too dangerous to me (it's just a hypothetical, this hypothetical person could be wrong, but in the end we all operate on incomplete data)
This is the J&J vaccine, which is not mRNA-based. It's an adenovirus vector vaccine, which is also not gene therapy but is a (tiny) bit closer than an mRNA vaccine.
Right but they are still gene-based. No gene-based vaccine has ever received approval for human use, and the present coronavirus vaccines have not undergone preclinical testing as normally required by international regulations.
A potential danger of DNA-based vaccines is the integration of plasmid DNA into the cell genome (1). Insertional mutagenesis occurs rarely but can become a realistic danger when the number of events is very large, i.e. as in mass vaccination of a population.
We don’t have “long term data” for the next week or two, anyway. Phizer and Moderna’s chances of winning full use authorization this spring look quite good.
I'm not a biologist, so I could be completely wrong here, but I disagree with you.
First of all, plasmid != viral vector. That's why the Nature paper you cited had to use electroporation to introduce the payload. As J&J is a viral vector vaccine, I would not be confident in using this paper to make the argument that an adenovirus-based vaccine could modify a host's DNA.
Second, your article does not make the claim you think it does. Specifically, the discussion says:
> Using simple intramuscular injection, the vast majority of plasmid DNA that persists is extrachromosomal, and the frequency of integration, if it occurs at all, is negligible.
> However, even if the residual plasmid in the gel-purified genomic DNA did represent integrated plasmid, one copy... would be at least three orders of magnitude below the frequency of spontaneous gene-inactivating mutations...
That is, the delivered gene does not integrate directly into the genome itself, but rather stays in the cell. To detect whether the gene stays in the host cell, the article compares molecular weight and uses a PCR test. Both methods do not tell us whether the gene inserts itself into the host DNA; one way to detect that would be to sequence the subsequent DNA, which would be monstrously expensive (because the modification incidence is extremely low).
The only way that a gene might integrate itself into the chromosome is if during DNA transcription, an error occurs and the foreign DNA is merged onto the host DNA. But this would be incredibly rare because it would require most base pairs to match up between the host & foreign DNA; otherwise, the cell would attempt to repair itself or induce apoptosis.
And even if the resulting base pairs match up, the resulting DNA might not have any behavioral differences because it's (approximately) the same sequence of characters. (And you would need another transcription error later on that happens to reduce the non-modified strand by approximately the same length. That's also extremely unlikely.)
Fourth, the Pfizer and Moderna vaccines use a mRNA-based vector, which (in my limited knowledge) is very difficult to integrate into the genome. The most plausible mechanism I could imagine would be:
1. (Optional) an enzyme which converts a modified nucleoside mRNA strand into one that mimics the mRNA chemical structure that is compatible with a reverse transcription enzyme [1].
2. A reverse transcriptase to convert the mRNA strand into a (foreign) DNA strand.
3. A restriction enzyme that cleaves the host DNA suitably so that the foreign DNA can be inserted.
4. A matching ligation enzyme which actually inserts the foreign DNA into the the host DNA.
All these above enzymes do not naturally occur in humans, so DNA modification through this mechanism would be incredibly rare.
Ermm, the jnj uses an adenovirus to deliver the plasmid DNA(1). I'm only referring to the jnj/astra here not the mRNA ones. And I think that article I linked represents a real risk it's not like we've tested for this danger before going ahead with a mass vaccination campaign where even rare events can become a real danger.
Additional dangers of DNA vaccines include production of anti-DNA antibodies and autoimmune reactions(2). I think we should be communicating these dangers to the public so that healthy individuals at no risk can make a proper benefit-risk decision, instead of just saying "vaccines good" and brushing over concerns.
> I think that article I linked represents a real risk
The article you linked estimates the risk of DNA integration is three orders of magnitude times lower than gene deactivation through regular mutations. I think we're safe.
> Additional dangers of DNA vaccines include production of anti-DNA antibodies and autoimmune reactions
Sigh yes this is a well recognized risk which even the FDA has guidelines for: "The administration of a DNA vaccine exposes the patient to foreign DNA or its fragments that could be inserted into the host’s chromosomal DNA [70]. In the case of incorporation into an exon, an insertional mutation or a frameshift mutation occurs. Such mutations can cause a gene to malfunction or inactivate (i.e., a tumor suppressor gene). The insertion of foreign genes into the host genome could also lead to constituent expression of previously silent bacterial/parasite genes that have been inserted."(1)
To date, there is no licensed DNA vaccine for use in humans, which is my whole point we aren't testing for this and instead just using the whole US population as test subjects without informing them of the risk.
In this pandemic, inaction costs lives. The logical and ethical thing to do is evaluate the cost/benefit and choose the path that kills fewer people. You wouldn't say "we should exit the burning house one at a time in case we get hit by a meteor outside, caution here is the logical and ethical thing"; you're making the same kind of logical error, just with a less-absurd difference between the risk of the two options we need to choose between.
> You wouldn't say "we should exit the burning house one at a time in case we get hit by a meteor outside, caution here is the logical and ethical thing"
The 9 day median length to development of the condition leads me to believe that this number will grow, and that they are smart to pause for a week or two to see what the real numbers are.
They also need to make sure the information is out there on how to identify and treat the condition if it does occur. Proper warnings and information are pretty important.
Meta-comment: The ratio of downvoting to discussion in here is rather worrisome. The current top thread isn't really even about COVID vaccines; it's primarily an argument of the "this isn't an argument, this is contradiction" variety about birth control, of all things.
It should be possible to have a mature, good-faith conversation about this, even on a pseudonymous web forum.
It should be possible, but for many people, another person's opinion on these vaccines is a binary value. It's either right or wrong, and if it's wrong the person is summarily dismissed as having any relevant input to the conversation. Worrisome is correct.
7 people out of 7 million dose's. That's why they stopped. My wife and I got the J&J shot on Saturday so I'm directly at risk and I'd take it everytime even if the risk was 10 times what it currently is. I've already seen a bunch of anit-vaxers referring to this in new articles this morning. So let's see, 1 in a million chance that the vaccine will make you sick (only 1 person has died so far, which is terrible but it's 1 out of 7 million) vs a worldwide pandemic that has killed millions. All these anti-vaxers talking about living in fear of a virus that has 98% survival rate are AFRAID of a vaccine that has a 99.999998% ( 7/7,000,000 == 0.000001) survival rate, oh and is 100% effective at stopping you from dying. Literally no one that has received the vaccine has died from COVID19. The fact that modern society can be SO smart some times and yet so incredibly idiotic is so frustrating to me.
I think it is a disservice to outright label people as anti-vaxers simply for questioning the risk-calculus of vaccines. The (1/7 million) is the current, unconditional and empirically observed adverse effect of the vaccine - this is a somewhat noisy measure of the true prevalence of this issue. It is okay to be cautious and there are legitimate concerns, and quite frankly, I trust the FDA have good reason to pause this if Moderna/Pfizer are readily available anywy. In countries where there are not alternative vaccines available, the risk calculations change, and as such, you might be better off taking J&J or AZ. In any case, to your earlier point of why they stopped it: they didn't stop it because (7/7 million), they stopped it because it was not observed in the trials and now they have to recalculate the risks for various age-groups and inform people, accordingly. If these events were observed in the trials and the prevalence was the same (in trial, and out of trial) then it would not be a cause for concern.
> The (1/7 million) is the current, unconditional and empirically observed adverse effect of the vaccine - this is a somewhat noisy measure of the true prevalence of this issue. It is okay to be cautious and there are legitimate concerns, and quite frankly, I trust the FDA have good reason to pause this if Moderna/Pfizer are readily available anywy.
How many injections do you personally need to feel comfortable? Seven million people is way more than any clinical trial for any drug you've ever taken, and I guarantee you any of them is more likely to kill you.
Every single year 150 people die from taking Tylenol in the US in the normal course of treatment -- and 500 die of acute liver failure due to acetaminophen overdose. 25,000 hospital admissions. 50,000 ER visits. If we pretend that 350,000,000 people take Tylenol each year, that makes Tylenol 50% more likely to kill you than this vaccine.
This comment is a prime example of why we’re in this mess with vaccine denial in the first place. You’re either not allowed to say anything negative about vaccines, or you’re an anti-vaxxer who thinks your kids will get autism and 5G chips. It’s so cult-like.
We should be honest about the (low) risks and benefits of vaccination without turning it into a political campaign of shame and bullying, and trust people to make the right choice for them and the public.
Exactly this. A lot of conversation seems to ignore how humans behave. Pausing, examining data and restarting with updated guidelines further encourages confidence in the process.
Imagine if the FDA says "no big deal, low chance of it happening, keep going", then a week from now "oh seem like the rate has doubled, still low, keep going", then a week later "ok, if you have any risk of blood clots don't take the J&J vaccine". That scream "we didn't think this would happen".
You've just eroded trust in the system and the next time some weird side effects comes up you won't have to pause, people will just refuse to take it.
IMO, no - I'm saying that folks risk management is completely out of wack. The chance the disease kills you is 1 in 100. The chance that the vaccine kills you is 1 in 7 000 000. One is bigger than the other. By, like, a lot.
The government's response is to pacify anti-vaxxers.
I’m 25 and I’m relatively healthy. The risk that the disease kills me is significantly less than 1 in 100; it’s hard to find numbers but one chart had the hospitalization rate for me at 1%, and the death rate 0.01% (edit: though the death rate only covered age and didn’t divide by other factors such as obesity). The “chance” the vaccine kills you is currently zero as there have been no recorded deaths that have been linked to a COVID vaccine. The blood clotting risk has been cited as 1 in a million, but we’re working with limited data. This is the problem with making such extrapolations.
I write all of this as I’m on day 2 of dealing with the side effects of J&J.
The reason everyone has to get it is so that the average goes down to 0, for everyone.
7 million trials is not limited data. It's dramatically, and I do mean dramatically more data than basically any other clinical trial for any other drug you've ever heard of. By probably 2 orders of magnitude. It's simply not limited data.
The average phase 3 trial has 300-3000 participants [1]. Not seven million.
It's 6 in 1000 if you listen to the CDC; personally I think the real number is closer to 3 in 1000. That's not too far off from what you said but I prefer being more explicit rather than using such a fuzzy resolution.
And just to be explicit, that's the general IFR, the IFR for, say, people in their 20's, or even people in their 40's, is a fraction of that.
---
Anyway, your point about risk management is somewhat true, but it is much more true if you apply that logic to the general public's fear of SARS-2 in the first place. I can't find it in my notes but surveys that have asked people what their chance of dying is if they catch the virus, are off by MULTIPLE orders of magnitude. And young people rank their individual risk of death higher than old people do (both estimate too high, even the old people), presumably due to them being more "plugged in" to "the system" so to speak.
Personally speaking, since I'm in my 20's, almost everyone I know who has gotten the vaccine has done so because they believe outright falsehoods about the virus that have been propagated not just by the media but by our so-called health experts themselves.
For example, I have multiple friends who had PCR-confirmed COVID-19, recovered months ago, and still got the vaccine. In the times I've probed at them to see why, they muttered some vague things about "the variants" and essentially said that the variants bypass naturalistic immunity which is just completely false.
I know for a fact that my likelihood of an acute adverse reaction (the all-too-common "feeling like death for a day" reaction) is far higher than the likelihood of comparable symptoms from SARS-2 infection. So I'm not getting the vaccine, and I'm not embarrassed to say so. For many people, the risks of the virus are less than risks of the vaccine; however, much less people than you would think. We don't have good enough data yet but I'd bet it crosses over somewhere in the 40's or 50's age range.
There's a huge difference between being an "anti-vaxxer" in the true sense of the word - i.e. you think all vaccines are inherently bad, period - and being someone who takes the same attitude towards vaccines that we do towards drugs: no drug is inherently safe; rather drugs that are proven to be safe are safe. By extension, no vaccine is inherently safe; vaccines that are proven to be safe are safe.
The latter statement is my personal view of it, and unfortunately such a statement can get you banned from social media platforms if you get unlucky.
This binary way of dividing the world into "anti-vaxxer" vs not, "AIDS denialist" vs not, etc is not just oversimplified but is intentionally done to suppress dissent. I refuse to participate in such a culture and I humbly implore you to do so as well.
> How many injections do you personally need to feel comfortable? Seven million people is way more than any clinical trial for any drug you've ever taken, and I guarantee you any of them is more likely to kill you.
Again, the point is, when we observe adverse effect in the out-of-trial phase, it has hard to pin-point cause and effect. It is not a guarantee that the 7 million necessarily represent a random sample so proceeding with caution is warranted. We know, for example, vaccines have been distributed by age, and chances are, the 7 million is bias towards the older demographic.
> Every single year 150 people die from taking Tylenol in the US in the normal course of treatment -- and 500 die of acute liver failure due to acetaminophen overdose. 25,000 hospital admissions. 50,000 ER visits. If we pretend that 350,000,000 people take Tylenol each year, that makes Tylenol 50% more likely to kill you than this vaccine.
Again, the point isn't that {insert_your_favourite_drug} is 10x more likely to kill you - the point is, when we do not understand why something is happening, it is better to pause and detect whether there is a more fundamental issue. For example, suppose that every single injection that caused an adverse reaction was produced at the same facility and as part of the same batch - we would definitely be better off in investigating the root cause than to leave it be. Until we fully understand what mechanism is causing this adverse effect and how to best counteract it, in my opinion, a pause is warranted.
Sure, in isolation, that's all true. However, in isolation, the cost of doing nothing is zero. In a pandemic where 70% of America will catch a disease somewhere between 0.3% and 1% fatal, the cost of doing nothing is dramatically higher than zero. In fact, it's dramatically higher than a vaccine that just randomly kills 1 in 1,000,000 people - which this one strictly does not.
My point is that yes, an investigation should be carried out, but stopping the trial obviously - trivially - does more harm than good due to the extenuating circumstances of the global pandemic.
Agreed, I've had all other vaccines, but this batch is rushed, experimental, and not necessary for me - labelling people such as myself "anti-vaxers" is just dishonest, bitter, childish, name calling. Very few people in my area of London have bothered with the so-called lockdown (too much was open to be called a lockdown), masks, etc - I expect I've had all variants, and apparently my immune system is on top of it, in which case there's nothing to pass on; and the people in my area clearly don't care if I did. I'm no more an "anti-vaxer" than I am an anti-martian.
Did you get an antibody test to confirm that you've already had it? I don't think data supports the assumption that you've already had it; it's a rare disease even where it's spreading widely. I also have a gut feeling that people didn't take "lockdown" or social distancing seriously, but some counterevidence is that nobody in the UK has gotten the flu in 2021: https://www.independent.co.uk/news/health/flu-cases-covid-en... That's not because they're already immune, it's because diseases simply aren't being transmitted. As bad as people are about masks and social distancing, there is some measurable effect.
I'll also point out some anecdata. I know someone in their late 20s that got COVID. They have felt miserable every day in the 9 months since having it. Others have relayed similar stories. Public health authorities are worried about severe consequences like death, but death isn't the only possible outcome. You could just feel like shit for the rest of your life.
To me, this is a nasty disease that I do not want to contract. I probably won't die if I get it, but there is more to life than merely not being dead. As a result, I got the vaccine as soon as I could.
Well, you may not be (or see yourself) an anti-vaxxer, and your right that it's not necessarily wise to label everyone as such who have concerns with these vaccines, but it also doesn't mean that your excuses make sense.
The batch is not "rushed" more than it's needed: there IS an emergency. It's also not experimental. The experiments have all been done (up to phase 3). It's perfectly normal to only see 1 in a million (or even 1:100 000) side effects after starting the vaccination of the general public. Simply because the phase 3 will never contain millions of people. I've checked, and the 30-40k studies we had with these seem to be indeed large. I.e. safe.
What you think about your immune system is kind of irrelevant for a few reasons, but talking up their immune system seems to be a general self-convincing strategy for a lot of people. First of all, it's not apparent that you have contracted the virus. Unless you have an antibody test showing that you are seropositive, you simply don't know, but the chances aren't very high. What you can be sure about is that you have not contracted "all" variants. If you live in the UK then you had the chance to meet the UK variant (B117, IIRC) and the base variant (D6.... whatever). Very likely not both. And the immunity for the base variant seems to work pretty well for the UK variant, so it doesn't even matter if you met both.
But even if you know you are already immune, the natural immunity doesn't last that long. The vaccines give you higher antibody levels (at least the mRNA ones do, again IIRC) and better immunity especially due to the second dose. (Which you can't really simulate with a second infection within a few weeks.)
And at last: you can't generalize from your own experience. Looking at the numbers, which we do have a lot of, people who haven't met the virus and don't have immunity should by all means get the vaccine. Because the virus is a lot more dangerous (several orders of magnitude more dangerous) than even the J&J or the AZ vaccine. Though the exact risk profile will depend on individual factors, of course, but since you've talked about all vaccines...
Zero experiments have been done on long-term effects, and you cannot, and no one can, counter this point.
That's the definition of "rushed".
Vaccines typically take several years of testing before being approved. These aren't approved according to those standards. Manufacturers are absolved from risks because of this "emergency use" status. Why absolve them if there are no risks? If they truly believed these were safe and of tremendously important benefit, they could stand up and say "we accept responsibility for negative outcomes in accordance with ordinarily approved medication, and waive our rights to emergency use protections". Then everyone would rush to take them as doubts would be broadly eliminated.
Things are "rushed" because it's an emergency. SARS-CoV-2 has existed for a little more than a year, and it's already killed 3 million people. At some point, you have to take the leap of faith that this thing that's very much like other things is going to actually be very much like those other things. mRNA vaccines are not new. Adenovirus vaccines are not new. Vaccines are brought to market in less than a year routinely; consider the seasonal flu vaccine.
(Why are we seeing mRNA vaccines for COVID and not other diseases, if it's not new technology? Because the vaccines for other diseases didn't work.)
You are totally right that there could be some magical protein in the vaccines that causes you to drop dead in two years. There probably isn't though, so what you call "rushed" other people call "saving lives".
9 million - including many children, and mostly people of colour - die each year of starvation. Where's the emergency, trillions and unprecedented worldwide cooperation and effort to eradicate that forever within less than a year? It doesn't even require the invention of anything new, and is primarily a logistical (/expense) problem. Would save three times as many lives just in the first year, overwhemingly more life years overall, and be much easier to implement, being confined to mainly a few known, poorly-resourced areas (rather than the entire earth).
If you've seen or lived the effects of starvation firsthand, you'd find it difficult to understand why suddenly everyone is willing to do anything, even destroy their own livelihoods or take rush-developed intravenous shots, to try and save the lives of a significantly smaller number of predominantly elderly people who were about to die of just about anything else anyway, at the expense of those 9 million (or any other of preventable causes of death that kill in higher numbers per year and have been known about for decades, for example: smoking).
Why not spend a year making the manufacturing of cigarettes illegal, have a worldwide crackdown with cigarette company executives hauled to jail for crimes against humanity, make it illegal to depict smoking in any media, censor all images of cigarettes, and launch a 24/7 every news channel, every street corner propaganda campaign, with celebrities publicly blacklisting smokers?
Save significantly more lives in the first year, and keep doing so year after year. Wouldn't need to trash the economy, ruin businesses, or risk plunging anyone into poverty, etc - and no need for anyone to take a rushed, long-term untested shot.
> 9 million - including many children, and mostly people of colour - die each year of starvation.
The sad thing about this kind of argument is that it never goes away. Whatever happens. I started an argument more than a year ago with a guy, when we had 3000 deaths. World wide, total. He kept saying that it's less than the number of people who die in car accidents in a day. And he was right. What he didn't get is that without counter-measures it would grow exponentially for quite a long time and to quite a large total.
And it did grow and we continued this argument for months (with 1-2 comments a month) he had to keep raising the stakes. Next it was less than the number of flu deaths per year, next it was less than the number of car accident deaths, this time per year, then the number of HIV deaths, and then he just stopped arguing. I pinged him at 1M last June, never responded. I don't think he changed his mind.
I see your argument as a continuation of that. You just raised the stakes again, but however much the total count will be, you guys will always find something bigger. Implicitly stating that it's only worth taking counter measures against the worst cause of death. (Be it lockdowns or vaccines.) But it doesn't make sense. This is ON TOP of all those. Also, let's not forget that the only way we managed to keep it down to 3M is by imposing pretty strict lockdowns worldwide. Without those it would have been a lot worse. And even with these lockdowns the health care system is waaay overloaded in a lot of places, which means that COVID kills indirectly as well.
Yes, help people who are starving: we can easily do so by donating money. As long as you have the money. But don't make it worse by not vaccinating and letting COVID kill others, kill even those who are very poor (they definitely have worse chances) and kill the economy which obviously means more people starving and less help for those who have already been starving.
9 million/year have not been helped by donations, that's why the number persists.
The "per year" number for COVID cannot change now, it's been a year. It is what it is.
COVID, in light of other preventable deaths, and especially in terms of life years lost, is not of justifiable greater concern compared to others, and from mortality rates/demographics and seroprevalence, this has been broadly known from not long after the beginning. The dollar cost versus life-years-saved is borderline insanity.
The argument lockdowns saved lives has been thoroughly debunked [0], and even the most cursory common-sense look at any per-capita chart by country and measures employed confirms that at a glance.
If you want to continue killing tens of millions per year so you can save the lives of far fewer, you have no standing. Frankly, that position disgusts me.
> 9 million/year have not been helped by donations, that's why the number persists.
I don't know where you are getting with this. As I said, this is at best an independent problem that can (and should) be handled. In reality it's worsened by the pandemic.
> The "per year" number for COVID cannot change now, it's been a year. It is what it is.
Though I think I didn't say the "per year" number would grow now, you are actually wrong for two reasons:
- while it's been a year, the beginning of that year was pretty mild, less deaths per day than during the summer or these days. So as we move the window, actually the per year number will increase. E.g. if you look at the "total deaths" graph on Worldometer [0], you'll see that it ramped up around the middle of October. It accelerated about 2x (but at least 1.5x).
- we got these "wonderful" results with various restrictions. And you are agruing for no restrictions, but you can't prove that no restrictions wouldn't yield much worse numbers.
> in terms of life years lost, is not of justifiable greater concern compared to others
I've already responded to this: it doesn't have to be a greater concern. It's a preventable concern. As far as I can remember, we were talking about vaccinations.
Also, years of life lost changes as the epidemic goes on and as the virus mutates and seem to get more aggressive (which is an affect of breeding it in a large number of humans). And let's not forget again, that the numbers are affected by how much the health care system is overloaded. Young people will die if they can't get into a hospital because too many people get sick at once.
> The argument lockdowns saved lives has been thoroughly debunked [0],
Yeah, I know. The whole pandemic has been "debunked" quite a few times. The first "debunk" I've read was a year ago, when a guy started lamenting that it would just die because of the network effect. It didn't. I've checked one random article from your link. It looks pretty weak. It just says that no matter what, the epidemic wave just stops after 6 weeks, because that's what it does. It lumps together countries like Sweden and Taiwan, which is crazy in its own right, because Taiwan has 11 deaths/30M people today and Sweden had like 8k/7M back in June (IIRC that's when that article was written). Needless to say, with the 3rd wave in Europe, the 6 week rule is out of the window: our 2nd wave (here in Hungary) was in a decline in mid February, when it started to rise, probably due to the spread of the UK variant. Without any change in the lockdown policy. Our hospitals have been full for about 1.5 months now. We've been world leaders in daily deaths for probably a month or so.
Yeah, so the article after just saying that the lockdowns don't do anything, because all countries seem to behave the same, concludes with "well, we certainly need to explain this..." (they seem to read my mind). And then say nothing about it. But they have included this (just to contradict you): "Certainly, a full complete lockdown reduces the spread of the virus."
People forget, that epidemiology is a well established field of science. It's only new for them. If I'd have to guess why the epidemic could start to decline on its own, I'd say that people just shit in their pants after a while and start to keep more distance. This could probably be seen in the mobile tracking data if anyone cared.
The sad thing about the lockdowns and the restrictions is that they work pretty well. If combined with all the other efforts and if people comply. Because in the end that's what matters: what people do. Not what governments say they should do. If you (or any of those authors) care to look at East Asia, Australia and New Zealand, you'd see that it can indeed be controlled pretty efficiently. Not for free, but for a lot cheaper than what most of the Western world ended up with. What they do is the complete opposite of what we're doing and what you re suggesting. Instead of ignoring, they react very quickly and vigorously. Closing entire counties if they found a few infected (that's e.g. what I've heard from a guy living in Thailand - they have 70 dead for 70M). And this allows them to have less restrictions overall. Because math. You can stop it when it's just a very low number or you can fuck around and stop it when you have a lot of dead people, when your hospitals are full. Of course, if you can stop it by testing, contact tracing, light restrictions (no mass gatherings), masks, etc., all the better.
Another piece of interesting (but not unexpected) information is that the economic effects indeed correlate with the number of deaths. [1]
> If you want to continue killing tens of millions per year so you can save the lives of far fewer, you have no standing. Frankly, that position disgusts me.
I don't kill anyone, but you definitely look angry and seem to handle this on an emotional level. Which I get, a lot of people do this but it doesn't help with having a logical argument.
You've linked to two sites that aggregate data, and provided armchair analysis of them to back up your position.
I've linked to 30+ studies supporting mine, none of which you've mentioned or shown studies that counter them (I'd expect at least 10's of counter studies if you have any kind of a point, hundreds if it has merit deserving of such servitude).
Your examples of lockdowns "working" are East Asia, Australia and New Zealand. Firstly, most of East Asia actually did comparatively little versus the West, especially early on - when they were at the epicentre - and is hampered in implementing lockdowns by a significantly higher population density, and in general, in the case of Japan, a significantly older population, placing them at an immediate disadvantage at that outset.
Your other examples of Australia and New Zealand are poor. If anything is prone to be an outlier, and worthy of less consideration versus other countries, it's these two. Especially New Zealand. It's one of the most isolated countries on the planet, has a tiny population and little through traffic. Compare numbers against any other pandemic (eg, Swine Flu 2009), and you'll see it's always going to do well just fine regardless of what measures may or may not be employed.
Considering the well-established link between the sun and the proliferation of these kinds of viruses (ie, a "flu season"), which happens for a variety of reasons (not least is Vit D production), nullifies those countries as useful controls, particularly against Europe and North America.
Finally, we have the figure of 9 million people who starve, and 8 million people who smoke, both of which are preventable, and both of which could be solved which much less effort, less expense and less social cost, and these are just two - but you still wish to persist in saving the lives of considerably fewer, the bulk of whom were already near death anyway.
None of your arguments make logical sense, and you are unable to back them up with science.
Further, you haven't bothered to even attempt to refute my core logical arguments or the bulk of science I've presented to back them up.
I'm not learning anything from this conversation, but thank you for your engagement. Go well.
You're mostly repeating the claims of GP and I have already responded to these. Esp. this one: "Vaccines typically take several years of testing before being approved."
The so called long-term effects have been mostly non-existent with any vaccine. First of all, the very expression "long-term effects" is vague. Do we mean effects that only materialize over the long term (i.e. a long time after being administered) or effects that last for a long time? The latter can be known (well, with a worst case estimation) even with short testing.
And as far as I am aware, there is very little evidence of the former happening with former vaccines. I.e. the vaccine inducing some systemic change in your body that remains undetectable for years.
> If they truly believed these were safe and of tremendously important benefit, they could stand
> up and say "we accept responsibility for negative outcomes in accordance with
> ordinarily approved medication, and waive our rights to emergency use protections".
First of all who? You seem to mingle several groups into one here. It's not the pharma companies who believe that that these are very important, but the society. (Well, at least the ones who don't live in denial.) The importance stems from the seriousness of the epidemic.
And safety is not a binary/boolean attribute. Safety can be measured and the accuracy of the measurement has a confidence (i.e. a probability that it's within the estimated limits). Now the claim is that this measured safety is way above the safety of contracting COVID. And this is the very reason we know that it's beneficial. For the society. It's pretty clear that pharma companies don't make nearly as much profit as much it is beneficial for the individual countries. Just try to add up the cost of the lockdowns e.g. for a year and then devide it by the number of doses and see how much they should cost if calculated like that. You know what, let me do the math for you: a year of lockdown has been estimated to cost 251bn GBP for the UK[1]. The UK has 66M population. Let's calculate with 266M doses. That would give you 19GBP/dose (~26USD) for the vaccines per dose. Per year. But they won't vaccinate everyone, 80% would already be an over estimation (which would increase the value of price/dose to 32.5GBP and we're not just talking about money we're also talking about lost lives and a lot of frustration, which would further increase the value of these shots.
Comprared to that, the AstraZeneca costs about 2USD, IIRC, the EU pays about 16EUR (14GBP) for the Pfizer/Biontech one.
So it's not that the tremendous value gets all snatched up by the pharma companies. Also, they do have a responsibility. In the US they have been waived, but not in the EU. And guess what: a lot of people keeps saying the same things over here. (Including* that they don't take responsibility.)
The reason the US waived these companies is exactly because the vaccines are so important and valuable for the sate (i.e. for the people). A quick rollout was more important for them, than for the pharma companies. As a side note: some politicians over here (EU) think that the US did it the right way by not wasting time on negotiating hard with the pharma companies and that the EU is behind exactly because of that and that we should have waived them as well. (I'm not sure I buy into it.) But the EU non-waiver is an assurance for everyone else, including the US citizens. Yes, you may not get a million $ check if you happen to be unlucky, but it still shows that the companies indeed do have the confidence in their product you were talking about.
Resorting to calling people "anti-science" is just as counterproductive and unnecessary as calling them "anti-vax". You're only solidifying animosity and mistrust. People have every right to question what they're being told by the same governments who mishandled this epidemic from the start - especially since there such strong political incentives that aren't necessarily aligned with scientifically based recommendations.
Everything should start from a place of questioning. If there is data and the data makes sense, that can replace questioning with certainty. But often the data has a limited or tenuous connection, possibly even a fraudulent connection. This is why it’s important to actually read the studies and understand the science, not just to hand wave it away as “evidence = value.”
The technology behind this vaccine has been actively worked on for over a decade. Yes, these vaccines have been sent to market faster than normal, but they certainly have not been "rushed".
I hear this line being trotted out all over - especially from the "experts" - and I find it nothing short of enraging. There is a difference between saying "an mRNA platform in general might not be safe" and the actual claim real people make which is "this specific vaccine has not existed for more than a year and is being hastily rolled out on the world population via implicit or explicit coercion". The mRNA platform in general can be safe and, say, the Moderna vax could still have a poor safety profile. This is why we perform rigorous long-term testing and why most vaccine approvals (not that these are FDA approved of course) take several years.
If you can't be intellectually honest enough to admit that there is a difference between "we've used this platform in theoretical research in small numbers" to "we mass-market and roll out this novel vaccine to billions of humans worldwide", you shouldn't be in the discussion, IMO.
It's the same thing with flu vaccines, mind you. They only get a few months testing before entering mass use
The speed of access for these vaccines is that they started mass production while testing was ongoing, rather than waiting until after testing to start production
Thanks for the important clarification; I didn't read closely enough.
My argument was definitely tailored for the mRNA discussion, although the purpose was more to illustrate the broader principle, but, not knowing a whole lot about adenovirus vector vaccines specifically, is it even the case that adenovirus-vector vaccines have been widely used in the general population?
I couldn't find great info with a cursory search (indeed the top result is the CDC which consistently fails to cite anything they ever claim, ugh), but I wonder if the general argument still applies for these types of vaccines as well.
Anyway, thanks so much for catching and pointing out my error there.
> fwiw, new and better better technologies need to get used for the first time, eventually.
No-one disputed that, I'm just pointing out that it is a very valid point for someone to say "I have concerns that we're rushing out an experimental vaccine". You might take issue with the specific wording (I don't) but the general point I hope we can agree on.
It's not dishonest. It's a very adequate answer to the over-simplifying claim above. I.e. there is a difference between a newer and an older platform and there is a difference between an experimental platform and a new platform (that's not experimental but has been in development for a long time).
You can always argue for making things slower and experiments longer, the problem is, that there is a pandemic going on with 3M deaths in the past year. Actually people seem to think that you can develop vaccines without being rushed, but it doesn't seem to be the case. There are several reasons why other vaccines took years:
- it was a long time ago and scientists had a lot less knowledge, experience and older technology. (Think e.g. the mRNA vaccines, which J&J is not one of, where the first candidate could be completed in something like 2 weeks after the isolation and sequencing of the virus.)
- they had to start from 0 for a new virus (because they new less, etc.). Like for the polio, or HIV. In the case of SARS-CoV2, they could build a lot on the experiments from SARS-CoV1. As far as I know, there was a vaccine candidate back in 2003, but by the time it would go into phase-3, the epidemic was over. Also, it seems that research never stopped about the coronavirus vaccines, so there were new results between 2003 and 2020 that the mRNA vaccines built on.
- some viruses are easier to develop a vaccine for. (E.g. the HIV is not one of them, because it's very good at evading the immune system)
- I've already mentioned this, but if the vaccine candidate doesn't get ready on time because of the above reasons, then you may have to wait for years before you can do a phase3 trial because there will be no people getting infected, so you won't be able to measure the effectiveness. This is what happened with the ebola vaccine in 2014. Now the vaccine is 7 years old, but it doesn't make it any safer, because there weren't people who could be vaccinated. (Well, of course, you could vaccinate them and wait for any long term side effect, just in case, that would show up without being infected, but that doesn't seem like a very important data point.)
But again: why would you want to wait for several years in a situation like this when we do have a pretty clear picture of both the worst case risks of the vaccines and the risks of the disease (which are higher than the worst case risks of the vaccines).
> It's not dishonest. It's a very adequate answer to the over-simplifying claim above.
I would disagree that calling it "rushed, experimental, and not necessary for [the original commenter]" is an over-simplifying claim. Indeed I find the "we've done theoretical research with platform X for years" to be the oversimplification. That being said I do agree that there is a difference between an experimental platform and a new platform.
> But again: why would you want to wait for several years in a situation like this when we do have a pretty clear picture of both the worst case risks of the vaccines and the risks of the disease (which are higher than the worst case risks of the vaccines).
Starting with the "higher than the worst case risks of the vaccines" part, FWIW, this is true in general but not for all individuals. For someone like me (20's, active, no major health conditions), the acute side effects of getting a SARS-2 vaccine far outpace the expected level of symptoms from SARS-2 infection itself. (Speaking from a personal risk reduction standpoint only, I don't want to get into the ethics of medical collectivism for the purposes of this discussion). I don't think you would dispute that, but just wanted to mention it because it's because taboo (and indeed you can get actively censored) to say "for my specific health circumstance the vaccine is more dangerous to me".
As for the more general point about understanding the risks of the vaccines and the disease fairly clearly, I would say that we understand the virus far better than the vaccines. Indeed it really saddens me how we've wasted public health dollars on messaging to people that immunity to reinfection is not a thing (when it is most definitely a thing) and to be super spooked about variants despite the fact that SARS-2 is not going to magically mutate away from the spike protein anytime soon (i.e. there's plenty of epitopes for our immune system to work with even for the highly artificial immunity produced by making the body's cells manufacture spike protein exclusively).
I will grant though that we have bounds on how bad short or medium-term adverse reactions could be to the vaccines. Personally I worry less about the (using mRNA as an example here to illustrate a general point) "it's going to turn me into a human GMO" pseudo-argument than I do things like (a) "is the rate at which spike proteins get produced in the body much more of a steep increase followed by a steep dropoff leading to greater potential for acute inflammatory episodes than via naturalistic infection" as well as (b) "could we be over-sentitizing the immune system to react too strongly when it detects spike protein, particularly for those who already had COVID-19 before ever getting the vaccine". If you're not aware, an absurd amount of people who have already gotten COVID-19 and therefore have naturalistic immunity are still getting the vaccine, either because they're "required" to (aka they don't know or want to fight their job's requirements) or more often because they've been brainwashed to think that the variants evade natural immunity which is just a total media-propagated falsehood.
> In the case of SARS-CoV2, they could build a lot on the experiments from SARS-CoV1
Totally agreed and I wish more people knew that the virus causes COVID-19 is called SARS-2 and that it is directly related to SARS-1 (I'm referring to layfolk here). As a separate tangent I wish more people understood that the emergence of SARS-2 means we don't really need to worry about SARS-1 anymore because anyone exposed to SARS-2 will be cross-reactive with SARS-1.
> I've already mentioned this, but if the vaccine candidate doesn't get ready on time because of the above reasons, then you may have to wait for years before you can do a phase3 trial because there will be no people getting infected, so you won't be able to measure the effectiveness.
This is simply not the case for an endemic seasonal respiratory virus. You'll have plenty of cases, especially since we're basically PCR-testing the whole globe (I don't think we should be, to be clear). But I totally agree that the apparent benefit of vaccines declines exponentially as time goes on, particularly with SARS-2 where the fact that it is deadly for the very elderly and harmless for the very young means that yearly recurring mortality is going to essentially vanish after it's propagated through the current world population (as an aside, this fact is one of many reasons why all the hysteria around the virus was absurd from the get-go; amortized over several years the mortality of SARS-2 is entirely unremarkable)
> But again: why would you want to wait for several years in a situation like this when we do have a pretty clear picture of both the worst case risks of the vaccines and the risks of the disease (which are higher than the worst case risks of the vaccines).
Yeah, to conclude I want to bring it back to my earlier point which is that once the virus has propagated through the current world population (more or less), the set of SARS-2-naive individuals will become dominated by the very young, who are not at real risk of COVID-19 and therefore they will develop immunological memory while young when they are incapable of being harmed by SARS-2. This means that recurring yearly mortality will fall off a cliff (albeit, if we keep labelling deaths the way we do we won't see that reflected in the numbers nearly as much as we should). Which is why I think the restrictions and everything else, even if they had worked in places like the US or Europe where they totally failed, were always a bad idea. But the other side of that coin is: yes, insofar as you do think SARS-2 is something worth really freaking out over, we absolutely have to rush the vaccines because if we wait 2 years then there won't be any real COVID-19 deaths left to mitigate.
They slapped the word "experimental" on the disclosure form and waived liability to the manufacturer... it was rushed... as it should be. I took it. But the reason people don't "trust the science" is that its obvious people are lied to on a regular basis around covid and trust has flatlined.
> Agreed, I've had all other vaccines, but this batch is rushed, experimental, and not necessary for me - labelling people such as myself "anti-vaxers" is just dishonest, bitter, childish, name calling.
No, it's not. That's a misunderstanding of how the vaccine development process works and what takes time.
What takes time in the normal course of development is testing the vaccine, yes. Specifically, determining how effective it is. The reason that takes so long is that in general there are very, very few cases of most of the diseases vaccines are developed to prevent -- and you can't just go giving people Ebola to check how many of them catch it.
It's fearmongering, plain and simple.
There's mountains of data for your perusal online explaining how and why it got done fast -- here's one example. [1]
Nine women cannot work together to produce a baby in one month.
Similarly, while wider population testing for safety and efficacy would likely correlate with long term safety, it’s not a total substitute.
I think it could be completely rational for young, healthy, low BMI people to delay vaccination till they’re more comfortable with any potential long term issues.
Well I guess it's a good thing nobody's trying to produce a baby, but rather, a vaccine. Because they succeeded, and you hand-waved away my completely rational explanation with a nonsequitur about pregnancy.
Those folks aren't being immunized to protect themselves but those around them. This is a team effort and everyone's gotta pitch in.
> I think it is a disservice to outright label people as anti-vaxers simply for questioning the risk-calculus of vaccines.
It's the same idea though, and should still be called out. It's people who have unqualified medical opinions, and who are then often spreading that opinion to others as if it's useful.
Let the agencies figure it out, pay attention to the latest recommendations from them, and go with that. Anything else is just the blind leading the blind and should be called out.
Careful to not play the appeal to authority. Anyone can understand anything, regardless of their so-called qualifications. Are they likely to? No, and that’s why someone’s qualifications are purely a heuristic, not a prerequisite.
It's extra frustrating because organizations like the CDC get held to lower standards than anyone else. They can make a pronouncement recommending the use of face masks for SARS-CoV-2 community transmission when the body of the research confirms that (a) such intervention has never been tried in an RCT and indeed the whole "my mask protects you" hypothesis is intentionally unfalsifiable, (b) the research literature documents numerous negative impacts whereas the positive impact on transmission is completely unproven at best, and yet their evidence-less pronouncement is considered evidence in its own right and such a pronouncement is used as a citation in Wikipedia articles, etc.
(Just using masking as an example, if any onlookers strongly believe that masking is efficacious for the stated purpose just imagine I gave a different example, although I don't see how anyone could reach that conclusion about masking specifically based on the research literature out there which is neutral at best)
Or as another example, the CDC loves to try to encourage people to take the flu vaccine, and yet I was shocked to discover that it takes 71 flu shots to prevent a single flu case, 29 flu shots to prevent one ILI (this is a better number than the flu case number since really we care about ILI in general, but even so 29 is an abysmal number), AND that regardless of the mediocre reduction in cases/ILI, it makes essentially no difference in hospitalizations.
I didn't realize until this year how much of "public health" involves (a) actively and intentionally lying to the public (for example, if you read about the AIDS crisis you learn about the "noble lies" told about who was vulnerable as well as the not-even-noble lies like when Fauci told people you could get AIDS from close contact with someone with AIDS when the scientific evidence showed that to be false), and (b) is really a giant marketing campaign for various big pharma interests (I say that as someone who is an unashamed free-market capitalist, not that the US is actually a true free market when it comes to the pharma/medical industry)
I'm not insisting that a claim is true just because an authority says it is. You can't just bring up "appeal to authority" and call it a day.
I'm insisting that the average unqualified individual should not think they have a better chance of being correct over the authorities in question.
There's no other rational option for unqualified individuals than to listen to medical authorities unless you have a medical degree yourself and have read and analyzed the research yourself.
There are actually a lot of reasons to be skeptical of experts — the same as why you should be skeptical of anyone. Appeal to authority has a contrapositive: the disappeal to lack of authority. The arbitrary person can be right just as much as the expert can. The whole point of logic and reason is that it’s about facts, not the people.
Critically the problem with your reasoning is the last sentence. No, you do not need to have a medical degree to be right when a doctor is wrong; ask anyone who’s had a medical issue that all doctors agree does not exist.
True, the word was wrong. The point though is that for this logical fallacy, there is an equal and opposite logical fallacy. Saying authority implies truth is just as wrong as saying lack of authority implies falsehood.
How does authorities being wrong / changing their recommendations factor in to what your consider a rational option? If you were a high risk individual back in January 2020 who ignored their advice and quarantined + wore a mask (an effective mask, i.e N-95), you made the right choice.
Despite how much smarter and informed humanity is, we still make decisions based on trust. Science can only explain so much and runs out of answers eventually.
> If you were a high risk individual back in January 2020 who ignored their advice and quarantined + wore a mask (an effective mask, i.e N-95), you made the right choice.
Did they? Or was the chance they'd come in contact with Covid at that point very low and those masks would be of much better use at hospitals where the chance of coming into contact with Covid was very high? At least, that was what the experts were saying at the time. I donated my N-95 masks (that I had from California fires) not because we thought they didn't do anything in January 2020, but because the experts said they were of better use in hospitals.
> Science can only explain so much and runs out of answers eventually.
You say this as if there's a better place to find answers. Where is that place?
> Did they? Or was the chance they'd come in contact with Covid at that point very low and those masks would be of much better use at hospitals where the chance of coming into contact with Covid was very high? At least, that was what the experts were saying at the time. I donated my N-95 masks (that I had from California fires) not because we thought they didn't do anything in January 2020, but because the experts said they were of better use in hospitals.
You're saying a high risk person (high risk meaning they would likely die from covid - immunosuppressed, etc.) wearing an N95 mask and quarantining was a bad choice? I'm not sure how those masks would be better used if the person is at a high risk of dying to covid.
> You say this as if there's a better place to find answers. Where is that place?
Interpreting all the data available to you. Would you have shamed a person for not choosing this man as their surgeon https://en.wikipedia.org/wiki/Christopher_Duntsch after they researched his past operations. There are more factors than just the research that need to be considered.
In 2012 if someone decided against their doctor's advice not to take an opioid which the FDA had greenlit as safe in far too many cases, would you call that "blind leading the blind"?
Iatrogenesis rivals strokes as a cause of death. Most doctors are just slavishly following official doctrines from authorities, and sometimes those authorities get it wrong. We don't even have to look to the Before Covid Times to see examples!
Yes. That's correct. That doesn't change what I said.
Answer me this: why do you think unqualified individuals are better suited to get it right?
Just because there are examples in the past of people who went against the recommendations who ended up being right, doesn't mean you should take everything else into your own hands. Unless, of course, it's literally your job.
It’s not a question of getting it right, really. I haven’t heard a single uneducated opinion say, “You should not get it because X”. I’ve seen several say, “I will not get it because X”
It’s a subtle, but IMO important distinction. If people wanna rationalize not getting the shot based on their own misunderstanding of the science, that’s fine. That’s okay.
We don’t need universal understanding here for the vaccine to do it’s thing. Let those who want to get it, get it. And those who don’t, to not get it.
> I haven’t heard a single uneducated opinion say, “You should not get it because X”.
It's not even 3 hours into my day and I've already received 3 texts from family saying something along those lines regarding J&J, even if it gets unpaused. It's a much more prevalent thing to say than you think.
> If people wanna rationalize not getting the shot based on their own misunderstanding of the science, that’s fine. That’s okay.
It's not okay. We need shots in arms. And you're doing your part by enabling those who are misunderstanding the science by making them feel like it's okay to not get the shot.
Deciding that your pain is well managed without opiates has always been a perfectly reasonable and medically-accepted option, and unsurprisingly there has never been any sort of social stigma against people who decline painkillers.
Most to the point, declining to take painkillers does not adversely impact other people's health.
This is not a good analogy.
eta: ironically, the problem with the opioid crisis was not too much regulation and oversight by "the authorities", but too little; too much freedom for doctors to prescribe stronger painkillers, and for patients to request them.
I agree that, unless you have specific concrete reasons to think a public health agency is distorting the facts or making decisions based on politics and ass-covering instead of optimizing for health, you should trust that agency. However, once you have concrete reasons to think that the public health agency is acting on politics and not science, you should not continue to blindly trust them.
There are other sources of information besides the public health agency of your particular country, for example public health agencies in other countries, or directly looking at the stats and research papers. In this case, looking at the stats makes it blatantly obvious that your risk from the J&J vaccine is much, much lower than your risk from getting COVID, so if your choice is "J&J" or "no vaccine for another month or two", you should probably pick J&J.
> I've already seen a bunch of anit-vaxers referring to this
It's not only a disservice, it's a biased way of thinking which only serves the one making the statement, given it allows them a way to alleviate their concerns about having received a level of uncertainty from their actions. I get them them because I also got that shot!
The problem isn't 7 out of 7 million odds. It is that it is an unknown side effect that did not come up in the original studies.
We have approved vaccines with worse side effects before. The difference is that we knew what those side effects were and weighed the risk vs reward and made the call to use it.
> an unknown side effect that did not come up in the original studies.
You shouldn't expect side-effects this rare to show up in the trials. The AZ trial was based on ~32k participants (https://www.astrazeneca.com/media-centre/press-releases/2021...). Your probability of observing a 1/1,000,000 occurrence in 32k observations is something like 3%.
It's impossible to uncover (with statistical significance) 1/1,000,000 side effects without giving millions of doses.
The fact that a rare side-effect has (maybe!) shown up should not negatively impact your priors for how safe the vaccine is. If anything, the fact that we're talking about 7 / 7,000,000 cases should reassure you that we're catching extremely rare stuff, which means we would have caught anything more serious too.
A more general way of putting this is that, by doing a trial you don't prove there are _no_ side-effects, you just put an upper bound on how common they can be. This is the best that science can do! Epistemologically speaking, you can never prove the non-existence of something, you can just show that it doesn't occur in the places you've taken measurements, at a frequency that your experiments would detect. (This is the "black swan fallacy", as John Stuart Mill originally formulated it.)
Yeah and we only just started to roll this vaccine out - so it's fair to say that the risk will likely grow beyond that.
You're right that 7 / 7,000,000 are good odds, and most people would likely take them - but it would be unwise to not give people an educated choice between vaccines if there are known risks.
> but it would be unwise to not give people an educated choice between vaccines if there are known risks
They are not giving people an educated choice, they are taking that choice away until they deem it okay to give it back. Education is knowing that 7/7,000,000 had a blood clot + the other tests that were done leading up to its release. We know that now. We're educated.
It is CVST not just blood clots. There are a lot more blood clots with or without the vaccine. CVST is rare so is the proverbial canary in the coal mine here.
The CVST incidents give a lower bound on risk. The trial data give a rough upper bound on risk (rough due to the small sample size). Knowledge is being refined here. We can't make educated choices without knowledge.
Hard to give people an educated choice without looking into the issue first. Once they know what is going on it will most likely be back to normal. There was a similar issue in Europe, but that neatly overlapped with a delivery shortage of the affected vaccine.
It is impossible to rule out unknown side effects. The blood clots are now known. Any side effect that is unknown will always remain unknown. You could always be the first person to experience a symptom, whether it's Tylenol or this vaccine.
> All six cases were in women aged between 18 and 48, with symptoms appearing six to 13 days after vaccination.
Presumably, some of the 7 million people who have gotten the vaccine did so in the prior 5-12 days. It is reasonable to expect to see more cases over the next 6-13 days from the moment we pause J&J vaccination.
Also, if the effected group is only young women, the denominator isn't really the same as the total number vaccinated. Not saying it isn't still very rare, but in young people COVID deaths are also very rare. We have alternative vaccines, it makes perfect sense to advise young women against J&J for the time being while this is sorted out.
And for anyone that thinks this is just normal incidence of blood clots being blamed on the vaccine - that's what was said about AstraZeneca originally, and if these clots are anything like those it is absolutely not the case. Those are serious clots that are very rare to see period, let alone in young people, and require different treatment than normal clots (they have surprisingly low platelet count).
I suspect US agencies had good reason to want to pause J&J given all of that - the AZ vaccine issues were also disproportionately affecting women interestingly.
I guess I wasn't being specific - good correction. Reporting medical side effects can easily lag with new treatments, especially when we're not sure what we're looking for.
I suspect that, as soon as we start looking for blood clotting post-vaccine, then you'll find more cases that may have not been caught otherwise due to their not being severe enough to be noticed.
This exact thing happened with the AstraZeneca vaccine, which works very similarly to J&J. The EMA is now recognizing thrombocytopenia (not the same fatal issue but possibly related) as a "common" side effect, i.e. somewhere between 1 in 10 to 1 in 100.
Provided a larger sample size, doesn’t an increasing rate of an outcome suggest existence a confounding variable that the smaller previously tested sample failed to identify, and (not absolutely- but more likely than not) would apply increasingly at the larger scale? Not a statistician here- and honestly asking.
Lets say these side effects only happen in certain populations.
If that is the case we could then target this vaccine to the rest and have it be much safer while giving out the Pfizer-BioNTech or Moderna vaccines to this group.
End result is everyone still getting their vaccine fast but less side effects (and possibly deaths due to worst case side effects). This is why we need more data or the time to study the data in this case most likely
Agreed. Another unknown is how many people may have had some clotting issues that were mild and unreported. As you note, even though the 7/7M odds are compelling, the effect is still unexpected and there are two other vaccine alternatives. Taking a pause to consider the issues and perhaps make adjustments in suitable patient profiles and/or adjust follow up observation and early intervention treatment protocols for the issue makes sense.
Don't know if it matters to anyone, but the "FDA has suggested that health care providers pause the use of the vaccine while the side effects are being studied. However, providers are not prohibited from using the vaccine if they feel the benefits to an individual patient outweigh the risks." [1]
So we stop giving out treatment and an extra 1000-10000(?) people die and we delay the economy getting back on track for a week or two with the delay. No skin off the FDA bureaucrats teeth, but they are hurting a lot of people with this decision.
> It is that it is an unknown side effect that did not come up in the original studies.
It's not clear that this even has to do with the vaccine. If you gave 7 Million people a glass of water on the same day, I'm sure at least 7 of them would experience some sort of moderate to serious health outcome in the days that followed.
For young people (it seems especially young women) I think the answer could end up going in either direction honestly. I think it's completely reasonable to redirect them to mRNA vaccine until we know more.
Not sure why the J&J vaccine had to pause for older population where clearly the vaccine has a much better benefit/risk profile though. But at least in my area of the US the vaccination rate for senior citizens is quite high already.
"Doctors For COVID Ethics" a (non anti-vax) group of 150+ medical professionals/university professors etc, warned in March about the likelihood of deaths resultant from exactly this issue. They went public with their previously private correspondence with the European Medicines Agency, as they were unsatisfied with EMA's responses. Who picked up their pleas? Conspiracy, fringe and some right-wing websites - that seems to be it.
To be clear, we haven't determined that it's actually a side effect. That's why they've stopped, to get a better handle on what actually happened, and what to do about it.
It could be related to the vaccine, it could not be. It could be 1 in a million, it could be 1 in 100k.
Nobody has investigated 7 million doses, so its at least 7, but probably more. The UK incidence rate (for the same issue in the AZ vax) was like 10X what was initially reported.
And its probable that these incidents are concentrated in a small segment of the population (young & health maybe women). So your denominator is very inflated.
If you can save 20-40 lives by just giving young women Pfizer and using J&J on 50+ year olds (for whom the risk might be literally nothing) then its a no brainer.
Not doing so is killing 20-40 people for no reason.
Yes this is the rationale Canadian authorities have used in making AZ 55+ only here. Some calculation based on risk of COVID mortality in that population vs the hypothetical AZ risk. At first I was skeptical of this but the more I read about it the more it seems like a reasonable approach.
Even more so because here in Canada we do not have much AZ yet anyways (and no J&J yet), mostly Pfizer and Moderna.
They didn't pause it because they're considering cancelling it. They're pausing it so they can communicate to patients and providers what to look out for after they take it. Once processes are in place to handle future blood clot events, they will resume vaccinations.
I’ve been thinking about this, the communication has been so bad from public and private health officials for 15 months straight.
When not considering any externalities, anti-vaxxers and everyone that comes up with anti-industry and anti-establishment conclusions is rational, but inaccurate only because they dont consider what was not said.
Even with regard to COVID itself, most of the official communication is about avoiding death when the reality is that its not about only avoiding death its about all the additional debilitating effects in the vast “recovered” statistic, so it is rational to decide to ignore that once you do your own math and noticing who is actually dying. But it is not accurate because it doesn't factor in the unsaid aspect.
The reason for the pause was explicitly stated by the health officials as quoted in the article, so I don't know why you'd say this was unclear let alone unsaid.
They might also add additional guidelines for who is eligible for J&J. A bunch of countries have set a minimum age for AZ vaccine, I could see something similar happening here with J&J. Perhaps excluding women under 50 for example.
But I agree J&J will definitely resume in some capacity in the near-ish future.
Multiple advanced health care systems in the world are independently pulling these vaccines. I wouldn’t brush it off as the FDA being overly cautious. None of these vaccines have been tested in humans for more than 12 months. And you’re assuming that health authorities can wave a magic want and instantly know who is having some kind of undetected brain clotting? I think the risks are extremely unclear even though people are throwing statistics around like they mean anything.
Not a single one of those health authorities allowed vaccine challenge trials. That tells you how much they care about saving lives versus how much they care about not getting blamed for any deaths.
> The main benefit of challenge trials is to speed up development as I understand it not to broaden risk estimates.
Right, which is why it was crucial to have such trials a year ago. We could have shipped vaccines 3 months sooner and saved hundreds of thousands of lives.
Unfortunately, no health authority was willing to risk blame for any disabilities or deaths stemming from deliberately exposing consenting people to covid. So we had to use much larger sample sizes and wait longer to know which vaccine candidates were effective.
I believe their concern is more of long term effects and not short term. A vaccine isn't meant to cause blood clotting, unless we know the specific mechanism of how that's happening it could be much more dangerous.
No doctor or expert. But I did follow the AZ story. I understood, that Covid can cause blood cloths. A vaccine triggers an immune reaction, in that case Covid, so a particularly strong immune reaction, maybe together with a preposition of developing blood clots, can be a reason. Not sure if we know already what causes these side effects with AZ an JJ.
From a risk perspective, I wouldn't restrict either vaccine. But since we can easily use Moderna and BiontechPfizer instead for the most at risk groups it doesn't really change things, does it?
Most immune reactions will cause blood thickening. If your arteries are already full of crap they will clot, this is why if you are at risk of blood clots you need to be careful even when you get the common cold.
More to the point, they have temporarily paused because the usual treatment for blood clots can make this particular type of blood clot worse. So they are pausing to give the medical community enough lead time to get up to date on treatment protocols.
Vaccines are held to such a high standard. We wouldn't have approved even Aspirin if we applied the same standards.
If I have my numbers approximately right, getting the J&J vaccine is a bit safer than taking a plane trip, while getting COVID is about as safe as taking a trip in the space shuttle.
Your chance of dying from COVID is heavily dependent on your age and any preexisting conditions, so any comparison that uses a single probability for everyone is totally wrong for a very large number of people.
One person, out of the 6.8 million who have gotten the J&J vaccine, died from blood clots. A second is in critical condition.
Yes, your risk of dying from COVID varies with age, but not to that extent. Even among children, the death rate for COVID is an order of magnitude over the 0.000015% to 0.000030% chance of death it would have to be for the decision to stop using the J&J vaccine to make sense, based on the numbers we're making that decision based off of. Among the people who are actually being blocked from getting the J&J vaccine (e.g. mostly 20s/30s/40s adults), the decision looks much worse.
> Your chance of dying from COVID is heavily dependent on your age and any preexisting conditions, so any comparison that uses a single probability for everyone is totally wrong for a very large number of people.
It also depends on the rate of community spread (and what's spreading) in the communities you're in.
The exact same caveat can be made for people who are vulnerable to the extreme side effects of the J&J vaccine. It depends on specific characteristics of the person taking the vaccine. “any comparison that uses a single probability for everyone is totally wrong for a very large number of people.”
Yes, with the key point that the people who are most at risk of dying from the vaccine are a different set of people than those most at risk of dying from COVID.
> I've already seen a bunch of anit-vaxers referring to this in new articles this morning.
So, take pause and examine the situation. Are these people actually anti-vaxxers, ie they oppose all vaccination due to weird paranoia about autism due to a discredited "study". OR are they against this one vaccine because of political affiliation.
I'm really concerned that if we call out the people who are afraid of this one vaccine as anti-vaxxers that we'll only succeed in introducing them to the wider world of being afraid of all vaccines.
Find a different term so that we don't introduce these two groups of people to one another and give them a reason to join forces.
> OR are they against this one vaccine because of political affiliation.
It's not easily attributable to "political affiliation." Trump was touting the vaccines through his whole campaign and is still bragging and taking credit for them. MSNBC did one of those TV segments where they go and interview backwards people from America's hinterland who weren't planning to get vaccinated, and although most were Trump voters, not a single one said they would change their mind if he advocated taking it.
The actual difference between these vaccines and others which is driving skepticism is that we have no observational data about their long-term effects.
It goes beyond "radicalizing" potential anti-vaxxers IMO, because at this point it's become like its own religion, where every vaccine must be equally good and questioning a vaccine is somehow outrageous.
US agencies are the ones recommending a halt. US refused to approve AZ, and Europe halted it, in many countries imposing additional restrictions when resumed. Doctors specializing in the field agree these are legitimate concerns.
If people want to argue cost/benefit tradeoffs, or speculate on things we aren't sure about yet that's totally cool, as long as they are upfront about it. And I understand if someone still wants to get J&J and is upset or just generally disagrees with the total/forceful pause.
But I don't understand treating anyone that has a concern about J&J like a brainwashed neanderthal, when literally the actual medical community has reservations about this particular vaccine. As a young woman I would not get J&J right now. Luckily I was able to get Pfizer instead.
Anyway, I agree there is a problem more generally with scientific education that can push "moderately misinformed" people into much deeper rabbit holes instead of working to educate them. I guess my point is just that I think this is a good example of how people have gotten so entrenched in the issue that it has reached a new level. There will be cases when the science is legitimately unclear, but the popular sentiment will all of a suddenly decide "science says X" and then the internet runs with it.
Another example - there was an ~2 week period last March where I had multiple educated/"science supporting" friends talk down to anyone considering a mask. No it was not coming from a hoarding perspective and it had 0 sense of uncertainty about it. These were strongly worded statements about how "masks don't do anything for COVID, the science is pretty clear".
On the medical benefits alone it seems obvious to continue giving J&J. The counter-argument I understand is that J&J's supply is severely limited due to manufacturing problems right now, so pausing it doesn't significantly slow down the vaccine rollout. There are a lot of people right now that saw headlines about J&J's manufacturing defects, and now this one death, and are convinced those are related. Visibly pausing something that is such a small percentage of the vaccine rollout might be a good political move.
Full disclosure: I took the J&J vaccine last Thursday, and would do so again right now.
We usually test vaccines for a decade because of the risk of unknown short term and long term side effects. If we don't know why people are getting blood clots from the vaccine, then we don't understand the vaccine and could be creating long term issues for many people.
We don't. Vaccines are monitored, called phase 4 trials. Taking place after approval. No vaccine was tested for decades before approval. It is only that development and approval takes longer, in case of the Covid vaccines approval red tape was cut. And not trials.
It's not the risk of clots. It's the risk of vaccine hesitancy because people fear a cover up. I think that's outweighed by the increased vaccine hesitancy because people only hear this scary story and not the low numbers (see also AstroZeneca).
Unfortunately this "pause" will also result in vaccine hesitancy (on top of vaccination delays). We know this from the EU experience with the AstraZeneca vaccine which is now distrusted by many people.
This will almost certainly now be a problem with the J&J vaccine in the US. More people will get sick and die because of this.
You know, for all the continual fear mongering about coronavirus last year, the constant reminders of who was most at risk, the hyper importance put on masks and cleanliness, etc it is shocking to see things put this way now.
That's because long term consequences of COVID are real, and worrying just about the worst case (the death rate) is like saying that data leaks are no big deal because only 2% of them lead to the loss of their customer's life savings.
I am not so sure those long term effects (except those that lead to blood cloths) are real.
A quick duck duck go shows that these are the symptoms:
Tiredness or fatigue
Difficulty thinking or concentrating (sometimes referred to as “brain fog”)
Headache
Loss of smell or taste
Dizziness on standing
Fast-beating or pounding heart (also known as heart palpitations)
Chest pain
Difficulty breathing or shortness of breath
Cough
Joint or muscle pain
Depression or anxiety
Fever
Symptoms that get worse after physical or mental activities
Apart from the loss of smell, those are all things that are hard to quantify and could be something you are not aware of until you start looking for them. At which point you might become anexious and really start to notice them.
I’d probably be careful using this as a public health communication tool; you’re comparing these risks to things like flying, which people are viscerally afraid of. Not to mention that the CVST issue is a poorly understood and evolving picture, so it’s hard to confidently assert that the risk is actually a micromort.
The perceptive gap between zero risk and extremely small risk is enormous. If I’m young and healthy, I can easily avoid the additional 1 micromort risk of taking the vaccine by simply not taking it. Now what?
That is of course true, and you're free to weigh up the risks however you like. Also true that there are unknowns. But the benefits of the vaccine are known too, and the risks of COVID include death and long covid, which also has unknowns and does not look nice.
Let me try one more way I have been thinking about it. I'm also weighing up whether I should get the vaccine and TBH made this site as much for myself as anyone else.
The point of the site is really to show the fallacy of there currently being zero risk in your life. Comparing 'none' to 'additional' isn't really what is happening. You have risks in your life every day, every time you do anything.
On any given day you already have about 1 Micromort's chance of dying from any unnatural causes. So that's 365 a year. So getting that vaccine puts it up to 366.
That's an increase in risk of just under 0.3% for the year, from an already pretty low baseline of likelihood of dying that we enjoy these days.
This way of thinking helps me. I'm hoping it might help some others too.
I'm not sure where you're getting your stats, but so far I've gotten
> That's about 10 times less risky than walking down the stairs
and
> That’s the same risk as driving for 5 hours
Which implies that walking down some stairs is equivalently risky to driving for 50 hours. That seems... unlikely.
There are about 150 deaths per 10 billion passenger-miles in the US [1]. That means that a micromort (a 1 in a million chance of death) corresponds to about 66 miles driven, which would probably be about 2 hours of driving.
In 2000, 1,307 people died from falling down stairs[2]. The US population in 2000 was about 280 million, so 1307 / 280e6 / 365 = 1.27e-8, so the average person had about a 12.7 in 1 billion chance of dying by falling down stairs on a given day. It seems reasonable to estimate that on average, each American goes down stairs about once per day (some people never go down stairs, others go down them multiple times per day). As such, I think the estimate for "risk of going down the stairs" should be more like 10 in a billion and less like 10 in a million.
Hey thanks for this. I have the sources next to each. Just click the link in the bottom left corner. Let me know if you don't think they're accurate after having a look.
I took the driving risk as being 250 miles of driving with an average 50mph speed (The risk of dying must be higher at high speed so wanted to take a high average to be fair).
The source on the "10x less risky than going down a flight of stairs" is https://static.guim.co.uk/sys-images/Guardian/Pix/pictures/2.... That shows that in the UK in 2010, 655 people died from falling down stairs. That translates to a 1 in 100,000 annualized risk from falling down stairs -- the relevant comparison is "10x less risky than using stairs a typical amount for an entire year".
Interestingly, running the numbers for the UK shows that the annualized per-capita risk of dying on stairs in the UK is more than twice as high as it is in the US.
Thanks. I'm going to take that one out. Makes it simpler not to do annual risk. Risk difference UK/US is odd! We thought you guys had it bad with gun crime, and didn't think about the stairs....
This is brilliant, I manage IT systems for hospitals and clinics and hear the front desk staff using analogies like this to put the risk into perspective. For something like this it shouldn't matter if you're even an order of magnitude off, the point is to help the non-mathematically-inclined general population understand how low the risks are in a context they understand (and anecdotally I'd say this strategy works well).
This is true, but I find it funny and frustrating that people are so ready to selectively treat rare odds as catastrophic in other circumstances that suit their worldview. For example, urbanists are ready to accept the premise of Vision Zero, which aims to push road fatalities down to zero. Today, there is approximately 1 traffic fatality per 100 million miles traveled in the US. It's so rare that it doesn't deserve attention, but here we are, with people looking to force cars to drive slowly (or ban them outright) to try and chase a world with perfect risk-free conditions. I am betting the same cohort that supports Vision Zero overlaps significantly with the group that thinks none of these vaccines should be paused. I'm sure there are similar examples of logical inconsistency that we can highlight for any political/social cohort as well - that's just one example. But my point is people tend to selectively make data driven arguments only when it suits them.
I don't get your logic? I would have thought people supporting project zero - essentially believing there should be zero risk to any individual at society's expense (having to drive slow) would want the vaccine paused for the same reason. To save individuals from getting a blood clot at the expense of society not being able to reopen.
I think there is another relevant part to it. I’m probably on the cusp of risk between Covid and vaccine at 39. But getting the vaccine stops it spreading and protects other people and will generally help the would and country get back to normal. So I’ll get the vaccine as soon as it’s offered to me.
I'm not sure about under 30, but if you take natural causes out of it, you have around about the same chance of dying today - check out 'the micromort' for more details!
It could be that the side effect has delayed onset, so there could be many people out there who are about to have the side effect but haven't showed up in stats yet. In that case I think it makes sense to pause for a while and wait for updated numbers
"The MHRA said about four people in a million would normally be expected to develop this particular kind of blood clot - though the fact they are so rare makes the usual rate hard to estimate."
That was my first thought as well. However, both vaccines with this issue are viral vector vaccines. Might be coincidence of course, but it gives me pause.
You are mixing certain numbers. It absolutely makes sense for my grandfather to get any vaccine, because of his risk, but the age braket for me means that I am more at risk of dying from Astra-Zeneca than Covid, but I am also a man and those who have died so far have been women.
I haven't seen enough numbers for J and J, but you have to untangle the various risk factors before you can say anything about what you should do as an individual.
I know this pandemic is fustrating as hell, but if you call people who use science and numbers to see problems with the current vaccines anti-vaxers then you will be taken as seriously as you deserve.
7 people in a fairly specific demographic (women 18-38, I believe), when there are 2 other alternative vaccinations available.
Do we have any data on the total number of women 18-38 who received this vaccine? It may actually be fairly low given we may have selection bias to give these vaccines to an older population.
The outcome may simply be to recommend that members in this demographic avoid this particular vaccine until further analysis is done.
Though rates of increasing the risk of blood clots for different birth controls vary, the ones that do range from 2-6x. The FDA estimates that in US out of every 10 thousand women using combination oral contraceptives or birth control pills 3 to 9 will develop blood clots each year while for comparison the same rate for women who are not pregnant and do not take COCs is 1 to 5 which is interesting considering the age range of the six cases.
That said research is beginning to understand the mechanism of these rare blood clots in connection to adenovirus vector meds and since it is so rare it's hard to get a precise number but other studies predict an excess increase of severe blood clots in the range of 1 in every 500 thousand to million patients.
I think that's not a very charitable take on "anti-vaxers". People are against injecting something new that has not stood the test of time. We have no idea what the actual frequency of this issue is (maybe more reports will come in), or if there are other lurking side effects waiting to be observed as a pattern, or if there are long-term effects. What if news of this spurs others to make the connection with the J&J vaccine and more such cases are reported to the CDC? Or looking at the other vaccines, what if in 30 years we somehow establish a link between mRNA vaccines and cancer?
I'm sure people will be tempted to jump in here and state their case as to why certain long term effects are not possible, and why this is conspiracy theory misinformation. But that's not the point. The reality is that humans regularly fail to understand infrequent or long-term consequences of new innovations, despite the best of intentions and despite the use of the best science available at the time. This has happened repeatedly in the past - see numerous prescription drugs that were recalled, or the use of phthalates in shampoos, or asbestos, or whatever else.
In the case of J&J, consider that this is happening against a backdrop of a continuously changing story about the AstraZeneca vaccine, increasing reports of COVID vaccines affecting menstruation (https://vajenda.substack.com/p/the-covid-19-vaccine-and-mens...), and a rushed emergency use authorization process that bypasses typical methodology for approvals of vaccines. The comparison isn't between the IFR of COVID-19 and the fatality rate associated with this vaccine. It's between the IFR of COVID-19, which is known to be very low, and the unbounded potential of near-term or long-term fatality or other side effects from the vaccine.
In addition, I'm very concerned that if we call people afraid of the covid vaccines anti-vaxxers that they will decide to join forces with real anti-vaxxers.
I know several people who are not interested in covid vaccines for what as far as I can tell are political reasons (although there are a few concerns about using a new technology before long term studies are performed). Right now they aren't anti-vaxxers. They get vaccines and they get their children vaccinated. It's just the new covid ones that they're hesitant about.
If we just lump them in with anti-vaxxers then they might decide to go make friends with the real anti-vaxxers. And as a big of a problem as covid has been, I'm more concerned about polio making a comeback tour.
I am not concerned with impossible to predict future events, but all effective vacines[0] will cause cancer in that they prevent people from dying early and so make it more likely they get cancer.
> oh and is 100% effective at stopping you from dying. Literally no one that has received the vaccine has died from COVID19.
This is misinformation (and I call it that because it is being widely repeated in major new sources). It's an improper generalization from what was observed in a very small sample of confirmed Covid cases in the vaccine trials.
>So far, more than 74 million people have gotten fully vaccinated in the United States. It's unclear how many have later gotten infected with the coronavirus anyway. But Michigan, Washington and other states have reported hundreds of cases. Most people have gotten only mildly ill, but some have gotten very sick. Some have even died.
This really is a sad, sobering reality. "6 cases in 6.8 million", ~0.00000089% chance of death via J&J vaccination. Extremely disheartening to see, but rather telling, where priorities lie. Politics aside, this is sheer stupidity, as you mentioned. Brace for another year as mutations continue to develop throughout the developing world while we waffle over infinitesimally minimal risk.
>Vaccination is also about stopping the overall spread of infections.
Then why are people still asked to wear masks in stores even if they are vaccinated? I've heard from the media non-stop that even if you have the vaccination you need to wear a mask - it doesn't make sense.
a) it's not entirely whether vaccinated people can still be carriers. I think it's now /mostly/ clear that they don't.
b) people are fscking awful. If you let vaccinated people not wear masks, you're going to have a bunch of philosophical zombies lying about their vaccination status to avoid wearing masks in public spaces. So, everybody wears masks until this thing is over and then some.
> All these anti-vaxers talking about living in fear of a virus that has 98% survival rate
Please cite a source here. Survival rate usually means IFR not CFR, and even the CDC's own number (the CDC is going to be incentivized to overstate risk) puts it at around a 99.4% general survival rate. Other estimates put it closer to 99.7% or even higher.
Good point, I hadn’t considered this. Also there was the factory QA issue. Possibly much like in aviation , multiple small factors here that need to be addressed and they’re using this as easy excuse to put pause.
This is possible, but I work in medical research, and this pause is pretty standard practice. When there is a potential problem, you pause, gather more data, come up with a mitigation plan (if needed) and submit all this to the ethics authority (usually IRB). Its rote standard practice. And i think much more likely that they are following standard practice than there are hidden issues that haven't otherwise been revealed publicly yet.
That said, this is not a usual situation at all, and I think it's absurd, not least because of lives potentially saved during this pause, but because of the carry on effects with vaccine hesitancy, etc.
Wrong. In a war you win by outsmarting other people. Maybe that's through democracy, maybe it's by moving faster, maybe it's by having better technology, maybe it's by having more technology.
This is a pandemic. A health crisis caused by a virus. In this situation you win by carefully understanding the nature of the virus and then determining what needs to happen in order to shut it down. Making rash decisions because it's "wartime" doesn't actually stop the virus. We can't blitz a virus. We have to take time to understand the consequences of our actions.
> coddle
Actually, we do have to coddle. If we squash people's concerns about the vaccine, then they just won't get it because they don't feel listened to. On the other hand, if we show people that we're taking their concerns seriously, they're more likely to go and take one of the other vaccines. Because the "unsafe" ones were pulled after all, so the ones left over have to be safe (not true, but it's going to work for a non-trivial number of people).
I don't think you're appreciating the magnitude of the error here. This kind of complacency, typical of the public health bureaucracy, has led to a large net increase in death.
Here's a question for someone smarter than me. Is there a chance that this number (six cases in seven million doses) will rise as regulators comb through previous reports of adverse effects?
Not an expert in but one of those expert drug regulators is my friend.
1 per million adverse effects is nothing. If that would be a solid fact, there would be no reason to pause vaccinations. The pause happens very early so that experts have time to check the data and methodology and verify that it's all that there is.
When a new drug is given for emergency evaluation or a new side effect is discovered he works 14 hours per day 7 days a week with a team going through a massive amount of data and documentation to verify and check everything.
The media and most commentators don't understand why decisions can take weeks. Why you don't have the scheduled emergency approval meeting just now. They fail to understand that fact-finding is not happening in the meeting just by people giving their expert opinions. Experts work around the clock without taking any time off to figure out what is happening. But lazy bureaucratic regulators, right?
I have some friends in this field as well (though they are in small sample size things, like specific breast cancer trials). Some of the fact-finding looks like calling up every patient who has gone through their treatment, but they have agreed to cooperate extensively in order to get into their trials. I can't imagine how painful it is to do fact-finding on this scale.
I'm probably not smarter, but based on what happen with AZ I don't think it will rise. AZ clot cases rised after people became more aware of the issue so it was reported more often as the vaccine side effect
Yes, but not from previous reports. See the other responses about how previous reports are handled. I would expect cases to rise as unreported things get reported, and as doctors start to ask the right questions when they see these events and report things that previously wouldn't have been reported but probably should have. Not to mention that with these reports I expect doctors to ask the right questions and so previously misdiagnosed events get diagnosed correctly (some of these might be unrelated to the vaccine though making the data messy).
6 cases doesn't seem high enough to rise above the baseline incidence rate that I would expect for a population of millions that have received the vaccine.
The reported data simply doesn't explain stopping use of this vaccine. It seems like either:
1) They are overreacting based on sparse data, which will cast doubt on the validity of their actions.
2) There is information being withheld that implicates, though perhaps without certainty, that the vaccine is the specific cause of these issues.
Either way, the net result will be more distrust & greater reluctance to get vaccinated. There has to be a better way to handle this problem.
This vaccine is similar to the AZ one which seems to have an elevated rate over a much larger sample size. Thus a pattern here that matches patterns we expect of the AZ vaccine suggests this has the same problem even though if we take the data alone it is still within the range of normal.
As such 1 is no longer correct, if we didn't have a compare these numbers are high but within expected chance. However these numbers are looking like within the range of the compare even more than normal.
I agree that 1 seems unlikely, and yet #2 just feels too close to a conspiracy theory. The only explanation for #2 that I can think of that doesn't verge into crazy land of coverups is that there may be very specific reasons to believe the vaccine is the cause, but not enough confidence in that conclusion to release the details publicly without risking the vaccination effort if it turns out the vaccine was not the issue.
It would help if details were released about the physical condition of the 6 people impacted by this. If all of them were otherwise perfectly healthy people with no risk factors for this sort of issue, then yes-- that's a bit of a smoking gun.
But where things stand right now I just don't know what to make of the issues, which is just so damn frustrating because I know it gives ample reason to anyone inclines to doubt the experts or avoid vaccination a reason to do so.
> The US has by far the most confirmed cases of Covid-19 - more than 31 million - with more than 562,000 deaths, another world high.
The BBC is usually pretty good about sticking to relevant information (at least compared to US media), so I was a bit disappointed to see this blurb - especially since it's only the fourth sentence in the article. What does it add? It has nothing to do with the subject (ie the safety of the J&J vaccine) and isn't even particularly useful data in almost any other context aside from half-baked political jabs between nations.
It also ignores differences in population. Several European countries have more deaths per capita than the United States. So far, the UK had 200 more deaths per million (11% more). The Czech Republic had 900 more per million (53% more).
The section I have italicized here stood out in the statement from the FDA/CDC, in my opinion. This is not about putting vaccinations with the Johnson & Johnson vaccine on hold infinitely. For a good part, it seems to be about being aware of and prepared for this serious adverse effect, not to avoid it at all costs.
"Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.", from https://www.cdc.gov/media/releases/2021/s0413-JJ-vaccine.htm...
The thing I'm trying to understand is whether Johnson & Johnson and AstraZeneca are meaningfully different. All the media just assumes they are (until proven equivalent), but is the genetic code publicly known so we can compare? The Pfizer and Moderna ones are extremely similar. Now, I imagine the adenovirus ones have an order of magnitude more genetic material, but is the code publicly know to compare?
As far as I can tell, they both should have been approved ages ago, if only to depress prices and get more redundancy.
J&J uses a very rare human adenovirus, AZ uses a more common chimpanzee adenovirus. J&J also has the so-called 2PP modification on the Spike protein compared with the AZ vaccine. Good writeup here: https://berthub.eu/articles/posts/genetic-code-of-covid-19-v...
One difference is that J&J has been tested for only one shot and AZ is tested for two shots. Also the amount of vaccin you get shot in your arm could be different. The clotting incidents between the two are certainly different, AZ has much more at the moment.
That’s not the difference the parent is asking about. He’s asking if the adenovirus based vaccines available are meaningfully different.
Reaching beyond the parent’s words, both AstraZeneca and J&J have now had issues with blood clots. If it’s a similar formulation then perhaps you’ve found something and Adenovirus vaccines with a different formulation are unaffected. If they’re very different then perhaps other variations of Adenovirus vaccines need more attention.
> whether Johnson & Johnson and AstraZeneca are meaningfully different
Grammatically, that asks about the difference between J&J & AZ. Your response instead compared them collectively to the mRNA vaccines, rather than comparing them to each other. Thus the response saying "[t]hat’s not the difference the parent is asking about."
> 6 cases out of 7 million people. What a disaster. This is going to get people killed. And it's going to create more vaccine hesitancy. These people don't understand cost-benefit analysis. They keep making mistakes by orders of magnitude.
I am seeing this argument from people of all political views this morning, but I am most surprised to see it from the political left. Why isn't the same data-driven approach used when we're talking about policing, or gun violence, or traffic deaths? In all these cases, the frequency of negative outcomes (policing deaths of unarmed black people, homicides committed with guns, traffic fatalities per mile traveled) is very low and when weighed with the positive outcomes, it is clear that people are acting irrationally when they try to defund police, or ban firearms, or restrict driving. And yet, the data is never brought up so directly in those conversations by either everyday people or news media.
The J&J vaccine issue is frankly less alarming to me than this open hypocrisy or disconnect in our societal discourse.
Interesting to find out if this is again correlated to blood type. Type O has a lower risk of clots from COVID in general, thought to be related to the amount of von Willebrand factor in the blood:
"...since the ACE2 receptor belongs to the renin-angiotensin system (it regulates blood pressure), the virus cannot but affect the blood vessels. Apparently, it is capable of causing local inflammation of the walls of blood vessels and capillaries. This results in an increased release of VWF into the blood, which, in turn, provokes clotting." [0]
I see a lot of arguments that are basically "people are too stupid to understand risk". That, in turn, comes from the fact that the FDA/CDC/NIH has not covered itself in Glory the last many years. Covid just uncovered the rot, while Trump danced around it, and poured gasoline on the fire.
The best thing to get people to understand risk is to actually follow the process in the EUA. Pause, evaluate the outcomes, change the labels and dosing. Which this does.
At the same time, the FDA/CDC need to start taking other countries data into account. At this point, there is no excuse not to be using a UK style "first dose first" strategy, especially if mRNA is all we have for a while.
I’m not sure I understand your argument (and I’m guessing the downvoters aren’t either). This is a situation where the process will definitely, unambiguously, kill more people than moving forward with the vaccine.
I guess you’re suggesting culling a small fraction of the population might encourage better behavior at the voting booth? We already have plenty of historical evidence suggesting that’s not true.
I'm not sure how your last graph followed from GP's post - are you replying to the right comment?
GP was saying that the US health agencies haven't looked very good in the past few years, and on Covid, they really have fumbled the comms execution. Before Covid, these issues existed in the agencies, but that was highlighted by the emergency + executive branch that was either incapable or unwilling to make it a priority. That's when it's even more important for our processes, led by our major agencies, to be crisp.
None of this past year was unpredictable. If these health agencies are so affected by the whims of politics, it reveals a systemic flaw.
Given COVID prevalence in my state (approx 1 out of 10,000 people test positive each day, so assume 20 out of 10,000 are infectious at the moment), and the IFR for those under 50 of about 0.01% (1 out of 10,000 coincidentally), I would have to come into close contact with 20 people over the time from when I could get the J&J shot to when I could get Pfizer or Moderna.
That's not anti-vax denialism, those are the actual numbers. A one in a million risk isn't a good deal for the individual when case rates and IFR are low.
This would be a good deal if you were in Michigan, or if you were over 65.
Birthday paradox means ten not 20 and while I MIGHT be able to go two weeks without encountering ten others my oldest son works at a restaurant, my wife at a school, and my youngest son is full-time HS student. They meet 20 people a day easily and live with me at home.
It's a very interesting dilemma indeed. Obviously, if it's 7 out of 7 millions, then pausing it for the duration of the investigation does way more harm than good, given how many infections happen these days.
On the other hand this extra cautiousness shows how robust the safety of the system is: even minor glitches get caught and examined which practically pretty much rules out that there are side effects of orders of magnitudes more likely that we don't realize. And that may indeed worth it overall. Though in practice it would still make more sense if they continued until it reached a higher threshold (if it is ever to reach it).
Unfortunately, while this should be seen as very reassuring WRT the safety and the level of trust we can have in the vaccines, fear is irrational and for some people it proves that the vaccines are not safe.
E.g. here in Hungary, we have the EMA licensed vaccines (same as the FDA licensed ones) and also a Chinese (Sinopharm) and a Russian (Sputnik-V), with a permission from the Hungarian authorities. Now when the blood clotting issue emerged with AstraZeneca, some started to say "see, that's how much the EMA license is worth. BUT the Sputnik-V is good because you never heard about such issues with it". Which is, needless to say, completely upside down. (Not suggesting that the Sputnik does have the same problem, though I wouldn't be surprised, since it's the same technology as the AZ and the J&J. Also, I wouldn't be surprised if all vaccines had the same issue as the virus itself causes clotting.)
The online argument about this is raging about whether this is a stupid decision and I’d like to side step that well-trodden path of vitriol to ask more broadly: what’s the deal with Covid and blood clotting?
I know personally a long hauler who has blood clotting issues and low platelets. They fall into the demographic of concern with the JJ and AZ vaccine. Anecdotally we have lost both a close relative and a young and healthy friend to Covid blood clotting related issues.
Again, I’m not weighing in on the FDA’s job. But just saying: as someone who’s anecdotally been hyper-aware of the blood related aspects of Covid, this thread has picked up my ears and I’m really interested in finding out what the linkage here is.
I think that simple news reporting inadvertently screws up how the general public perceives low-probability events.
Whether it's an airplane crash or a blood clot caused by a vaccine, human minds simply can't 'feel' that a phenomenon is rare when it is repeated over and over again in their newsfeed.
The theory is that it is the same reaction that a tiny percentage of people have to heparin (AZ vaccine in this study but mechanism presumably the same) There is a treatment but imperative that doctor knows that this is the cause for appropriate response.
https://www.nejm.org/doi/full/10.1056/NEJMoa2104840
The paper details several cases (and index case in more detail) as well as a plausible mechanism behind the thrombotic events. Even better, there are some therapeutic possibilities as well arising from the heparin induced analogue condition.
I haven't seen any news articles provide a point of comparison of how the number of people receiving the J&J vaccine and experiencing this particular kind of clotting. The first academic-ish article on the subject I could find indicated a typical baseline of 15.7 cases per million (https://www.ahajournals.org/doi/full/10.1161/STROKEAHA.116.0...). If that's true, I don't get it - why would we stop roll out of any vaccine when the baseline (15.7) is higher than the problem that is being claimed (1 per million)?
These vaccines have only got emergency approval . It is true that reliability of vaccines have caused some nervousness in society and that is obvious because no vaccine in history is out so early for use Must read https://www.weforum.org/agenda/2020/06/vaccine-development-b...
Whole world is going through tough time. I hope suffering ends sooner than later
"Over 189 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through April 12, 2021. During this time, VAERS received 3,005 reports of death (0.00158%) among people who received a COVID-19 vaccine."
Honestly I think they should have had their meeting before telling the public. It seems unnecessary to pause it before figuring out if its worth it unless theres something else they're not telling us, which in that case it's also hurting trust in the system.
No matter what they come back with, the JnJ vaccine is done. We might as well start shipping them out to other countries that desperately need them, especially if we supposedly have enough mrna vaccines coming for everyone.
As is typical for this comment thread, in this comment I will claim that pausing the Johnson & Johnson vaccine will lead to hundreds of thousands of deaths because that is how many people will die if we do not have a vaccine. All this to save 1 out of 7 million lives. In passing I would like to call everybody involved in the decision idiotic.
As is typical for this comment thread, in this top-voted [0] reply to this comment I will point out that pausing one vaccine is not the same as stopping the entire vaccination program forever. I would in addition like to point out that once cannot simply compare the risks because they can vary wildly across populations, and that the one out of seven million might not be a reliable estimate. Might it not be good to wait until we know the actual risk, given also the abundance of other types of vaccine?
As is typical for this comment thread, in further replies we can happily claim the effect that this has on the anti-vaxxing crowd, whose thinking we are all extremely familiar with. Of course, since we are all careful people we will also balance the effects of the decision to pause the vaccine against the decision not to pause in the face of potential blood clotting issues.
Nobody seem to discuss that this issue appears around 10 days after getting the vaccine. And I believe most of the doses have been given over the last 10 days. So we actually don't know yet the real incidence of this issue. It makes sense for the FDA to be cautious here, there are other vaccines which are fully available.
Covid itself causes blood clotting in many seriously ill patients. A friend, who was in ICU in March 2020, was given Herparin (due to clotting concerns), and was told to take aspirin at home after release.
Is it surprising that the vaccines cause clotting too? Isn't this sort of obvious?
Vaccines for tetanus don't cause lockjaw. Vaccines for measles don't give you bumps all over your body. Most vaccines, except for those that used to work by actually infecting you with a related virus, do not cause the same symptoms as the diseases they treat.
No this is a very different form of clotting caused by auto antibodies that causes both clotting and low platelet counts. It's similar to HIT. Giving heparin in this situation would make things worse.
There is a well established link between oestrogen and increased blood coagulability. Whilst it is possible females are more affected by the vaccine I suspect one factor is that their baseline coagulation risk increases their likelihood of thrombus due “reaction induced coagulability” compared to males.
CVST normally affects women at significantly higher rates than men.
> Cerebral venous sinus thrombosis is rare, with an estimated 3-4 cases per million annual incidence in adults. While it may occur in all age groups, it is most common in the third decade. 75% are female. [0]
Interesting. Almost definitely something to do with adenoviruses then. I would imagine that Sputnik probably also has this side-effect. I wonder if "wild" adenovirus infection does this too.
Deciding whom to give these vaccines to is a complicated decision for each country to make and depends on:
a) The incidence rate for each demographic of CSVT-type clotting from the vaccine[s].
b) The expected distribution of clinical outcomes from those events, making reasonable assumptions about likelihood of early detection and outcomes with treatment for heparin induced thrombosis.
Those two give you the clinical cost.
Then you compare those with the clinical benefit from:
1) The relative likelihood of infection for a person, given their demographics, personal exposure profile etc.
2) The absolute likelihood of infection in the country / region in question based on assumptions about the future of the pandemic
3) The expected distribution of clinical outcomes from infection given the person's characteristics
(2) is important because you're comparing a one-time risk of side-effects with a time-related risk of infection.
Clearly, the same person in Manaus or Adelaide is not really making the same trade-off even if in the abstract, the side-effects and IFR are the same.
You also need the counterfactual: If you decide not to give an ad vectored vaccine, you are not deciding never to vaccinate, you are deciding that this person will get a different vaccine, probably later. How much later depends on the location. If you're in the US, you've got Moderna and Pfizer/Biontech coming out of your ears so it might only delay any individual vaccination by a few weeks. If you're a healthy 25 year old who can work from home, the risk trade-off of having to wait an extra 6 days is very different than that same person if they have to wait another 6 months.
As a result, different countries, looking at the same data will rationally make different decisions. The US has lots of mRNA vaccines so will choose one thing, the EU has been badly hit by the failure of Sanofi/GSK to deliver a working vaccine (and by AstraZeneca scaling problems) but has quite a lot Pfizer production capacity, the UK has used up its Pfizer stocks and will now only use it for second shots. CureVac and Novavax may be able to supply some doses at some point but aren't in the picture yet. Several European countries are negotiating to get Sputnik but that is also ad vectored so may have the same problem. That changes the risk calculation because it changes the time that people will remain unvaccinated in the counterfactual where ad vectored vaccines are not used for their age group.
All of this is before the complicated public health element of keeping messages for the public simple and the issues caused by changing that message frequently.
I don't know to what degree countries that had set relatively high minimum ages for the use of AZ had been counting on J&J for younger people. In many cases, AZ deliveries were sufficiently slow due to yield problems that it was "free" from a scheduling point of view to restrict it to only the oldest since the expectation was that they would only receive enough for those anyway and could use other vaccines for younger groups. If J&J was a big part of that, then they now have to update that calculation because the counterfactual to using AZ for those people is no longer "do them with J&J next week". That may be hard to communicate to people who had been told that a particular vaccine was not safe in their age group previously but may now be asked to take it anyway.
I'm glad that I don't have to make these decisions. They are not easy ones.
I was planning on getting the J&J because I will most likely only be able to get one dose. Is a single dose of the mRNA vaccines effective in any meaningful way?
We’ve completely transformed human civilization in a desperate attempt to slow down the spread of this virus that kills 1 in 200 people, and now we don’t want to use one of the miracle cures because of a literal one in a million chance of issues.
People are absolute garbage at thinking about scale.
It kills less than that in the demographic in question, not to mention that is only of those who contract the virus.
> People are absolute garbage at thinking about scale.
I don’t think it is that, I think it is that for better or worse humans tend to view wrongs through inaction as less atrocious than wrongs through action. Additionally - they already have better alternatives and plenty of supply in the US (Moderna and Pfizer vaccines) so they are opting to just use those at the moment.
Second, there’s evidence that even if people don’t die, there can be long term neurological effects [2].
Third, even if we accept your number, 1 in 200 would still be 1.5 million Americans dead, not even considering the rest of the world. I am personally not comfortable doing nothing to stop that number.
I agree that being super worried about a 1 in a million blood clot might be short sighted, especially since the death rate from catching the virus is 2 in 100.
That's probably true, so maybe the 2% death rate is too high, again, let's assume that the OP's point of 0.5% is accurate.
As I said, that still implies that if everyone in the United States got it, 1.5 million of them would die (320,000,000 * .005). That's a lot of people.
If a government did nothing to prevent a terrorist attack that killed 1.5 million people, most people would (rightly) be pretty upset.
EDIT:
Also, forgot to mention, it's totally disingenuous to only look at "deaths". We do not fully know the long term health effects, but as I stated there's potential neurological effects, potential risks of type 1 diabetes, and people permanently losing smell.
While I can appreciate where you are coming from, countering a terrorist attack typically has something that we don't have with COVID and that is information. The world was introduced and expected to react to this disease without any sort of "tactical" knowledge. Even if you include the other four variants of coronavirus, the availability of information can still be considered sorely lacking. Discounting government-provided information, even medical sources had a harder time providing a consensus on how the disease was transmitted during the first few months. That the larger questions like why we have such a large population that appears to be asymptomatic remains unanswered while we are still being pushed to "one-size-fits-all" remedy (and a remedy that appears to only be there to debase the severity of symptoms) doesn't help. Unfortunately, we need information, and information is going to take time. The long term arguments for health side effects are on both sides of the coin here.
It's also similarly absolutely disingenuous to use any other number that's not based on measured (or measurable) facts. CFR is the only one we have right now, what else do you suggest?
This is absolute and total BS. 2% death rate? Who comes up with this total garbage?
You have 100M infected in US as the estimate. A 2% death rate is 2M deaths from COVID alone. I've not seen anything like that as credible death rates - it's at least half if not a quarter of this rate - more like 0.5% or less. Do the same thing in countries with 70% infected rates - if fatality was really 2%+ death counts would be insane.
You really start to understand how people start to doubt the crap COVID "experts" put out when basic math shows it is garbage.
Johns Hopkins University. I don't feel like that's typically considered a bad source. Maybe it's a bit high or they're looking at different data sets.
But again, and I cannot overstate this enough, even if I accept the 0.5% number, that's still a lot of deaths, about 1.5 million if everyone in the US gets it.
According to the NYTimes [1], there's been about half a million deaths from COVID. If your provided number of 100M infected people is correct, then that would be consistent with 1.5M dying if everyone gets infected (US population ~= 3 * 100M, 3 * 500,000 = 1.5M).
It’s not a sim city decision. In young healthy people the risk of covid death is much lower than 1/200 , so you gotta see why this would make people hesitate.
As a young healthy people myself, I'm not tremendously concerned about either risk on a personal level, but I'm very concerned about getting vaccinated as fast as possible so I can do what I'd like without spreading disease. (To their credit, the agencies seem to have evaluated this and concluded the pause won't have a huge impact on vaccination timelines - but that won't do much for the people who were hoping to get it today!)
Deaths from COVID aren't seen as the direct 'fault' of the regulatory bodies. Deaths from a vaccine will be... and fundamentally, regulatory bodies aren't really incentivised to take risks anyway.
If they follow your line of thinking and it's all fine... no-one's going to be writing articles praising them.
If they follow your line of thinking and more people die form blood clots... people will write articles attacking them. Questions will be asked, and careers may be harmed. Etc.
1 in 200 people? Maybe if you're above the age of 75 and have significant comorbities. If it was 1 in 200 for all age groups you wouldn't have to convince people that lockdowns and maskwearing isn't all theater, they'd be so scared you wouldn't have to convince them of anything.
> If it was 1 in 200 for all age groups you wouldn't have to convince people that lockdowns and maskwearing isn't all theater, they'd be so scared you wouldn't have to convince them of anything.
Not really. 1 in 200 is fewer than how many die a year anyway of all causes.
I don’t think the parent comment meant to downplay the virus. I read it more like “we had to make great sacrifices to contain a 1 in 200 death problem but now we’re turning our noses at a cure that has a 1 in 1M serious side effect rate”.
Why only this 2 companies? Why don't we mobilize all pharma of the world to produce more mRNA vaccines quickly? Intellectual property? I think it's an extraordinary time so we should all agree to vaccinate all earthlings quicker is much higher priority than commercial interests.
intellectual property is one reason[1] but for the mRNA vaccines, the technology/machinery required to mass produce them is also part of the bottleneck along with raw materials[2]
> Novartis announced today that it has signed an initial agreement to leverage its manufacturing capacity and capabilities in order to address the COVID-19 pandemic by supporting the production of the Pfizer-BioNTech COVID-19 Vaccine. The agreement will see Novartis utilizing its aseptic manufacturing facilities at its site in Stein, Switzerland.
> On March 2, we announced a partnership with Johnson & Johnson to expand manufacturing capacity and supply of its COVID-19 vaccine. Under the Biomedical Advanced Research and Development Authority (BARDA) agreement, our company is adapting and making available some of our existing manufacturing sites to accelerate manufacturing efforts for the vaccine and enable more timely delivery and administration.
> Under the terms of the agreement, the companies plan to establish manufacturing suites at Lonza’s facilities in the United States and Switzerland for the manufacture of mRNA-1273 at both sites. Technology transfer is expected to begin in June 2020, and the companies intend to manufacture the first batches of mRNA-1273 at Lonza U.S. in July 2020.
> AstraZeneca and IDT Biologika also intend to strengthen Europe’s vaccine manufacturing capability with a joint investment to build large additional drug substance capacity for the future. Details of the agreement are to be finalised. Both companies plan to invest in capacity expansion at IDT Biologika’s production site in Dessau, Germany to build up to five 2,000-litre bioreactors capable of making tens of millions of doses per month of AstraZeneca’s COVID-19 vaccine. The new assets are estimated to be operational by the end of 2022.
It probably works the same in most places. In the Netherlands it's usually called Janssen, while the Oxford one is called AstraZeneca. I'm guessing in the US they usually leave out BioNTech, while in Germany BioNTech comes before Pfizer.
Everyone posting here confidently saying that the FDA is clearly wrong is pretty disappointing to me.
I think of all the comments about how "MBAs" and "marketing people" just don't get software development. And then I look at software development people who seem to think they clearly get medical research and regulation.
The problem is with how they are handling their data. You don’t have to know anything about biology per se to see the issue. It is entirely mathematical. By the way, the medical establishment has a terrible track record surround use of and understanding of statistics. I don’t think it’s right to suggest that self described experts are somehow infallible.
I appreciate what you’re doing but I’m still avoiding the vaccine as long as I can. I’ve got a class 1 medical , a PPL and I hope [ha] one day to get paid to fly planes. I really don’t want another Pandemrix because with my luck I’d end up with the side effect. Also I’m MASSIVELY allergic to certain drugs and I get the NHS third choice for antibiotics and anti inflammatories.
FAA mandates only a two day wait after vaccination. I suggest the risks from "long covid" should you recover from an initial infection are worse than most problems a vaccine could cause. I waited too, but after millions of okay doses of Pfizer I took one. I did suffer two days of 2nd shot malaise (fevers and lethargy) which is expected as my immune system ramped up to fight the mRNA "invasion" of the spike protein.
Everyone should make their own decisions. I'm just trying to put out some truth about the risks so people can make informed choices.
TBH I've made this site for myself as much as anyone - I'm just under 40 so the risk/benefit is tight for me personally, but I want to do my bit for everyone else and stop the spread so I'll take any vaccine they'll give me.
Haha! This was not my intention! I deliberately tried to find things that you could not worry about. I'd already seen a lot of comparisons like 'don't worry about a 1/1,000,000 blood clot, you have a 1/100 chance of getting a brain tumour in your lifetime' and thought that would freak you out more.
(It's true though by the way, go enjoy the sun while you still can...)
I'll gladly accept additional micromorts (I do dangerous things often) but it must come with an appreciably worthwhile reward. My chances of dying from COVID (if you include the risk of catching it weighted by dying from it) isn't large enough to make the "gap" worth it. It may not be pro-social but there's no requirement in society to be pro-social.
Good point! I was focussing on the UK since that's where the majority of AZ vaccine users are, but you're right. I'll swap in a more international first risk!
Maybe tonight I can work out do an IP address lookup and personalise it for your locality ;)
I guess you may be confused by the missing "from". It should be "driving from London to Liverpool", whereas the present phrasing suggests we move a city with millions of inhabitants.
That might actually be the problem - however, it's kind of a stretch to say it "should" be expressed that way. "Driving A to B" is a common phrase (as for whether it's technically correct, despite the ambiguity of meaning, I actually am not sure).
Risk of... dying? Being injured? Being hospitalized? Developing a life-threatening clot? Also it's missing a word "from" but I worked that out. Thanks for your contribution.
Awful decision. Everyone involved should be fired or removed from office for grotesque lack of judgement leading to a significant net increase in mortality.
I think this is an example of where government transparency would greatly aid the discourse and build trust.
Where is the math that suggests that pausing the J&J vaccine is prudent? Inputs being risk of getting covid, risk of getting a blood clot, risk of injury/death from covid, risk of a new covid variant appearing, etc.
Without that transparency we’re all just guessing.
I'll guess that you might be aware this is the reason, but just in case, I'm pretty sure the reason is that nobody who makes these decisions is actually doing any cost-benefit analysis (aside from the costs and benefits to them personally and their organization, maybe).
The comment by Barleyman on the Ars Technica article on this [1] has a graphic from someplace called the Winston Centre for Risk Analysis that shows the benefits in COVID reduction vs the harms from the AZ vaccine by age group.
According to that graphic, if you are in a time of medium COVID infection rates (60 per 100k per day), the risk from COVID outweighs the vaccine risks in that age group. If you in a time of low rates (20 per 100k per day) the vaccine risks outweigh the COVID risks.
The vaccine risk goes down as patient age goes up, and the COVID risk goes up as age goes up.
The J&J risks will probably follow a similar pattern and it also appears that the J&J clots require unusual treatment. That suggests a pause to at least figure out where the risk curves cross and to make sure that doctors and hospitals are prepared to recognize and treat the J&J clots.
That’s excellent, thank you for sharing! The comment you linked to suggests that the gender disparity can be attributed to women being over-represented in getting the vaccine, but I’m not sure the logic holds. Medical professionals were mostly done being vaccinated prior to J&J being approved.
An analysis of the relative risks is obviously the objectively correct answer from a rational perspective, but most people aren't making decisions based on that kind of statistical reasoning (though we'd doubtless have better outcomes if they did). There's a serious risk that problems like this can spark a backlash against all COVID vaccines if not handled conservatively--there are plenty of people just waiting to have their anti-vaccine confirmation biases triggered. How to handle these events is as much a question of social behavior and public relations as it is of science.
One could argue (and many have, persuasively, I think) that Europe making a big show of being highly conservative about the blood clot non-issue with the AZ vaccine caused people to dramatically overestimate the risk of getting any kind of COVID vaccine. e.g., I recall an anecdote about a person in the US, who was going to get a different vaccine in any case, who decided to not get a vaccine because a family member from Europe assured them that blood clots were a serious risk that they should definitely be worried about.
> there are plenty of people just waiting to have their anti-vaccine confirmation biases triggered
You’re probably right, but if we keep trying to front-run people’s reactions to events over and over again, I’m not sure we’re going to get great results in the long run. I get the impression that anticipating how people will respond to news is engendering more extreme responses to future events.
Looks like it was 6 cases after about 7 million doses. Even if it were caused the vaccine, the risk there is incredibly low. Much lower than the risk of an adverse COVID case, I would think.
Does pausing to investigate such an incredibly rare occurrence increase the public's trust in vaccines (because they see the government is being extra careful with safety data) or decrease it (because skeptics will use this as evidence that there are problems with the vaccines)? I feel like it's mostly the latter, but I dunno.
Not to mention all the COVID cases that might have been prevented while the rollout is paused to investigate a potential side effect that's less than one in a million.
> Looks like it was 6 cases after about 7 million doses. Even if it were caused the vaccine, the risk there is incredibly low. Much lower than the risk of an adverse COVID case, I would think.
Right, but the clots happened about 2 weeks after the vaccine, so that what portion of those ~7 million were administered over two weeks ago? Clots happened to a similar demographic, so what portion of those ~7 million were to women in the right age group? What about clots that cause damage that’s not immediately obvious (and thus not spotted).
I hesitate to dismiss the risk outright, but I do think that we should hold the CDC/FDA to the standard of “methodical.”
> “This announcement will not have a significant impact on our vaccination plan: Johnson & Johnson vaccine makes up less than 5 percent of the recorded shots in arms in the United States to date,” White House Covid-19 response coordinator Jeff Zients said in a statement.
At least they have alternatives. Meanwhile, in Europe ...
I think it's more an application of the principle of non-maleficence. (https://en.wikipedia.org/wiki/Primum_non_nocere) Consider this a temporary pause while they make sure they understand the relative risk factors.
Cigarettes and raw milk are, regrettably, a specious comparison. In the USA, the rules concerning both are handled by different governing bodies. For the longest time, cigarettes had been explicitly excluded from the FDA's jurisdiction, according to a law passed by Congress, and confirmed by a Supreme Court decision. And rules concerning raw milk vary from state to state, but are generally also set by legislatures. In both cases, what you see there is political interests come into conflict with, and perhaps override, the more level-headed, science-driven, technocratic approach that the FDA is theoretically expected to take.
I'm trying to understand why this isn't ridiculous, and I'm not sure what that reason could be.
The disease left to its own accord has the potential to kill millions (someone please correct me on this). Why would we pause a vaccine because 6 people in 7 million got blood clots? Why would we do that and risk fueling anti-vaccine viewpoints?
Because the rate of vaccination is still supply-limited at the moment. If everyone who would have received the J&J vaccine could get a safer alternative in the same time frame this might make sense. But they can't, so it doesn't. Do the math. It is all but certain that more people will die as a result of this pause than without it, even if you assume a worst-case clotting risk scenario under the current data.
I only know my corner of the globe well. In this area, vaccine appointments are pretty easy to get and everyone 16+ is eligible. It certainly looks like any delay caused by this would be minimal.
What part of the country are you in? And what counts as "pretty easy to get"? In California, the most populous state, people under 50 are not generally even eligible to try to get an appointment for another two days. I don't know how it is in other states, but I don't think this is unusual.
That the vaccination rate is supply-limited is manifest in the fact that less than a third of the U.S. population has been vaccinated at all.
Yes, there are places where there are vaccine surpluses, but this is not because the supply isn't the limiting factor. It's because in some rural areas there are large numbers of vaccine denialists who are choosing to forego the vaccine altogether. That leaves some localized surpluses. But overall supply is still the limiting factor, and it will continue to be until everyone who wants a vaccine can get one without having to wait.
South Carolina -- availability varies, but most parts of the state have at least some appointments and they seem to be becoming more readily available.
> there are large numbers of vaccine denialists who are choosing to forego the vaccine altogether. That leaves some localized surpluses.
The people that do not want the vaccine are a part of why. There are different reasons for this, with some just wanting others to get a chance first. But noone is going to force people to take it.
Its also really unfair to characterize this as "rural areas" with "large numbers of vaccine denialists". We have urban areas with vaccines available and rural areas with full appointment books.
Be careful to click through to the actual pharmacies, though. It is often out of date with actual availability being lower than indicated. Our state has also been running mobile events that have generally not been fully booked.
I'm in no hurry personally, but I'm not seeing where it would be difficult to get for me.
> It is often out of date with actual availability being lower than indicated
My experience with VF was the exact opposite: it was showing lots of availability where in fact there was none.
But the burden of proof is still on you: what urban areas in the U.S. has good vaccine availability? By which I mean: anyone who wants one can get one same-or-next day.
All of these vaccines are approved under emergency authorization- the long-term effects are still unknown. At this same rate (6 in 6 million+), there could easily be unnoticed issues lurking in the alternatives as well.
What we do know is that the alternative to not being vaccinated is much worse.
What you may be overlooking is that this is a biology problem, not a physics problem, so you cannot assume a uniform population of spherical humans with identical characteristics. :-)
COVID risk goes up with age. In the other COVID vaccine with a clotting issue (the AZ vaccine) clotting risk goes down with age. If that turns out to also be the case with J&J, then for a lot of people in the US (up to 20% or so) at the current levels of COVID the vaccine has a good chance of being more of a danger to them than COVID.
A short pause to determine if they should add a minimum age (possibly a variable minimum age that depends on the overall COVID rates) for J&J is prudent.
> Why would we pause a vaccine because 6 people in 7 million got blood clots?
Because J&J isn’t the only vaccine in the inventory, and the others don’t have that problem (or, IIRC, the same level of other adverse reactions), and because:
> Why would we do that and risk fueling anti-vaccine viewpoints?
What risks fueling anti-vaccine viewpoints is ignoring adverse impacts which are known and plowing forward, especially giveb that people often don’t have a choice of which vaccine they are administered.
> What risks fueling anti-vaccine viewpoints is ignoring adverse impacts which are known and plowing forward, especially giveb that people often don’t have a choice of which vaccine they are administered.
Your point about other vaccines being available is totally valid and sound, but... what is our standard here, then? For absolute-zero people to die of any vaccine we produce? What if it was 1 person who got a blood clot? It probably sounds like I'm being pedantic, but I'm serious in that I want to know why people find it reasonable to pull an otherwise effective vaccine because of this. It just doesn't seem worth it to tell everyone that the vaccine is dangerous enough that it had to be pulled entirely.
Ignoring adverse impacts definitely fuels anti-vaccine sentiment, but so does giving people concrete evidence that the vaccine can possibly kill people, possibly leading them to be resistant to getting any COVID vaccine at all until they're forced to get it. I mean, if I were at all skeptical of getting a COVID vaccine, and I was told the J&J vaccine was so dangerous they had to pause it, why would I get any of the more experimental vaccines knowing that they also have the potential to kill me but we don't even know yet because they're experimental?
I don't think people on HN realize the full magnitude to which the public can be timid and irrational. It just doesn't seem worth it to me for us to possibly fuck up the rollout of vaccinations when we are facing a possible 4th wave of COVID and more virulent variants.
Let's compare some numbers here.
The number of known blood clot cases with the J&J vaccine seems to be 6 in 7 million. That's a ~0.00000085% chance of getting a blood clot caused by the vaccine, give or take a zero since I suck at math and calculators refuse to not use scientific notation. According to the CDC, around 100,000 people die of blood clots in the United States every year, and the US population is 308,401,808, meaning that Americans have a ~0.0003% chance of dying of a blood clot in their lifetime. The only concerning factor as far as I can tell is that the people who got the blood clots were women under 50.
I mean, fine, if that's a risk profile we are averse to, then so be it. I don't really understand that.
I agree with your numbers above. But wondered about factoring the below into these calculations [0]:
> During Johnson & Johnson's clinical trial, there were reports of other types of blood clots, too. Some are relatively common, such as deep vein thrombosis, so it wasn't surprising that among roughly 20,000 participants who received the vaccine, some would experience those clots.
> What made FDA scientists take note, however, is that in the trial, about the same number of people received a placebo -- a shot of saline that does nothing -- as received the vaccine. However, when comparing the two groups, more study participants developed clots after receiving the vaccine than the placebo.
> Calling it a "slight numerical imbalance," the FDA noted that there were 15 events in 14 participants who received the vaccine, compared to 10 events in 10 participants who received the placebo.
I think the 6 in 7 million people are the serious and unusual blood clots, but would not include the +50% increase in blood clots of any type noted above. However I appreciate that you did include the extra data about 100,000 people dying per blood clots per year.
I also like to pay attention to the numbers for this stuff. I was scheduled for a J&J shot today, which was cancelled. It wasn't my first vaccine choice. I'll be trying to get an appointment for one of the other vaccines, I guess.
> Your point about other vaccines being available is totally valid and sound, but... what is our standard here, then?
The standard is not to distribute a vaccine with a known side effect that standard treatment protocols will catastrophically fail for without pausing to get information about it to healthcare poviders needed to implement protocols to identify and properly treat it.
That’s explicitly what the pause is for per the article.
> The number of known blood clot cases with the J&J vaccine seems to be 6 in 7 million.
It’s not, because the effect is seen 6-13 days after vaccination, and much of the 7 million (per the article, 6.45 million is the most recent cumulative figure I can find elsewhere but its two days old, if both are accurate that's over 0.5 million doses in the last two days...) J&J doses that have been delivered are within 13 (and even 6) days. And the clots have all been in women 18-48, who aren't the only people getting the vaccine, so, unless that’s a fluke (and the numbers are small enough that that’s merely unlikely but not implausible) the prevalence in that demographic is even higher.
Isn't that as true, if not greater, for the mRNA based vaccines, despite them not having that observed side effect? For all we know, everyone's butts might fall off because of them in the future. (yes, I'm being somewhat facetious)
My understanding is the that AstraZeneca and J&J are also new tech. Vector-based and mRNA are different than attenuated (weakened) form of the virus which is used in most vaccines.
(I'd be good if someone with more knowledge could comment)
It's bad policy. But it's important to get the analysis right: the choice here isn't between a very safe vaccine and an unvaccinated world population facing a pandemic to completion (which matches "the potential to kill millions").
It's between "continued rapid vaccination with all three approved US vaccines" and "somewhat delayed vaccination with one of the three approved US vaccines". That's not remotely a million-person delta, though the number is surely much higher than the 1/1M case rate on these blood clots.
Honestly the worst effect isn't with the vaccinations per se, it's the potential that this may delay vaccine acceptance rates among people sitting on the edge, due simply to fear.
For many people the risk of serious complications from COVID is similar. I am a young, healthy introvert working from home and enjoying the social isolation in a location that does not have explosive spread right now. The product of "probability of getting COVID" * "having serious long term effects or death" is in the same ballpark for me.
I would still get this vaccine (or the AZ one) if offered because I consider it my duty to be part of the herd immunity. But not everyone will do that, and the moment you have people in privileged position refusing one of the vaccines, you start (1) exacerbating inequalities (2) fueling conspiracy theories, mistrust, and vaccine hesitancy.
If you assume that the world is perfectly rational, then you are right, but it is a running joke on HN to point out how economists used to make that same mistake and derive silly conclusions.
The risk of a vaccine is very low. But emotionally it is hard to accept.
It is my actual choice to have the vaccine and go from 0 chance of vaccine-related blood clots to some non-zero value. Whereas catching covid feels more like I'm in control of not catching it by not leaving the flat, and even if I did catch it, chances are it'd not affect me that much.
I know this is not totally logical, but it is difficult to get past emotionally. Imagine if I did get blood clots from the vaccine - I'd go from safe in my flat and healthy, to dead, and for what? To protect me from a virus that has an even lower chance of causing long-term problems, and from which I can protect myself by being careful.
“I think this is a very low risk issue, even if causally linked
to the vaccine: 6 cases with about 7 million doses (lower than
the risk of clots with oral contraceptives) is not something to
panic about,” Dr. Amesh Adalja, an infectious disease expert
at the Johns Hopkins Center for Health Security in Baltimore,
said in an email.
so, let me get this straight. you have vaccines that use a new tech (mrna) that are awesome and vaccines that use “old tech” and at least 2 of then produce blood clots?
something is weird here. i’m not saying this is due to mass hysteria generated by people that don’t want the vaccine but this does sure look like a case where we don’t understand relative risk.
i may be ignorant and not understand all the factors but I don’t see the data that allows me to understand if suspending this vaccine is a good thing or nkt.
The J&J and AstraZeneca vaccines are both based on adenovirus vectors. This platform has a little more history, having been used in a recent ebola vaccine, but the number of doses administered has been relatively tiny. I'd say both vector-based and mRNA very new, pioneering tech.
> Public health bureaucrats have some weird habits in how they reason under uncertainty and how they communicate to the public. It might help if they sought out experts from economics, sociology, psychology, etc., instead of telling everyone to stay in the their lane.
* Hormonal birth control - years of research. Years of evidence and practice. Knowing what to do when this and that happens. Recommendations for women with known conditions not to take this and that hormonal birth control.
* Novel vaccination - barely month of research. Weeks of evidence and practice. We don't have best practices yet.
I'm fine with anyone to make a decision on them own to take these vaccinations. As someone with a not-so-uncommon mutation causing thrombosis easily, I'm happy I hesitated and haven't received either J&J or AstraZeneca.
> * Novel vaccination - barely month of research. Weeks of evidence and practice. We don't have best practices yet.
That is completely untrue. This vaccine has been through several clinical trials for months. We know that there are no side effects that are common enough to be of real concern. The reason we are only seeing this one now is that it is so rare.
The clinical trials have been for months on limited numbers of people. Given this seems to be a 1 in a million situation the odds are against those trials discovering them.
Actually they did notice extra blood clots during the trials, but didn't think it was statistically significant [0] (15 blood clots versus 10 in the placebo group, in a trial of 20k people).
Not a doctor, but from what I've heard from immunologists, vaccines in general are incredibly unlikely to have long-term side effects on the scales that you think about. When an immunologist talks about "long-term side effects" of a vaccination, they're usually considering time ranges on the order of 6-8 weeks. Meanwhile, the 10000s of patients from the big Phase 3 trials have been vaccinated for 6-9 months, so the usual scale of long-term side effects has long been registered.
That's not to say that it's completely out of the question that there will be long-long-term side effects. But if anything is going to cause long-term issues, my money is on the virus, not any vaccine.
Apparently there were studies on adenovirus 5 vector vaccines against HIV in 2007. The vaccine was not successful, but I cannot find any data on long-term adverse effects.
Plenty of replication deficient things cause cancer, for example asbestos or igf-1. I highly doubt you can rule out accidental crosstalk between elicited immune antibodies and every oncogenic human receptor.
mRNA vaccines are a new way to cause the body to develop an immune response - it's not using dead/deactivated tissue of the virus that the body detects and then its holistic system develops a response to. From my current understanding with this new type of vaccine it's skipping step(s), bypassing mechanisms, that leads to the body producing something that targets the "spike" of the virus - basically making it inoperable.
I don't think we know long-term how this may impact the immune system: does bypassing certain systems/mechanisms cause other problems with future immune response?
It took how long for us to realize as common sense that use of antibiotics allows superbugs to more likely evolve?
> Not a doctor, but from what I've heard from immunologists, vaccines in general are incredibly unlikely to have long-term side effects on the scales that you think about.
Fair enough, but the comment I responded to said: "We know that there are no side effects that are common enough to be of real concern."
Given this statement is not qualified for timescale, I want to know what the basis for it is.
How does the person who made it know there are no side effects on the order of six months or a year that are common enough to be a concern?
Look I am all happy chappy with the vaccine, I will inject that sweet MRNA Pfizer or Moderna vaccines as soon as someone lets me at it, but I still think we need to avoid what Fauci does, which is knowingly lie in order to get people to do what we want them to do.
There is blood clotting risk from AZ? Great, tell me what the risk is and I can deal with it, but lie to me and we are done talking.
You can never know anything for sure. This is why science, medicine and drug approvals are all about probabilities and calculated risks. If everyone suddenly dropped dead 10 years after taking a drug that was approved in 2015 there is no way we could know that right now. But we know it's very, very unlikely, so we accept that risk.
With vaccines we know from decades of experience that severe side effects tend to occur very shortly (days or maybe weeks) after the injection. So this is why vaccine trials observe participants for weeks or months, not years, before concluding that the vaccine is safe. Of course this doesn't guarantee that the Covid vaccine don't happen to be an exception. But if that was the approach we took then we would never be able to approve anything, and never get the benefits we know for sure it brings.
Fair enough, I clearly should have phrased that differently. I simplified the wording at the cost of accuracy. The correct wording would be "We know that it is highly unlikely that there are any side effects that ...".
Thanks, that is a much more reasonable statement, and I agree. On the one hand we don't know, but on the other hand a lack of knowledge does not mean everything has equal probabilities.
I personally don't see any good reason to think that the risk for long term side effects from the vaccine is higher for the vaccine than for COVID itself.
Your deficiency is that you're not a time traveller. You can't know what the long term consequences are no matter how many studies you do, until the long term has come to pass.
You can however guess, and make good guesses (I'm planning on getting the vaccine). But it does no one any good to fail to outline unknowns that are steelmanned by "we can't possibly know".
People need to remember that we're not taking the vaccine for fun, we're taking it because COVID is out there and we know for certain that it has some lethal side effects as well as non-lethal side effects and possibly other long-term side effects that we don't yet know about. We weigh that risk against the risk that there might be some long-term side effects of the vaccine. To the best of our knowledge, the risks posed by COVID are more dire than those posed by the vaccines and we basically have to choose one.
Maybe you responded to the wrong person. I am in no way suggesting it is better to not take the vaccine, or that there is good reason to think that the risks posed by COVID are less dire than those posed by the vaccines.
> Given this statement is not qualified for timescale
Keep in mind that we also don't know the long-term effects of COVID-19. It's possible that people who were infected with mild cases drop dead 1 year and 6 months after the infection. The disease hasn't been around that long, so we simply don't know.
mRNA has a short life span. It merely tricks the body into producing the spike protein. It breaks down in the body fairly rapidly. What long term effects would you anticipate from this?
There is a good chance for long term effects from covid. Completely the opposite for the vaccine.
I think the concerns would be around the delivery vehicle, which presumably is some big polycationic lipid thing.
From what I can gather, there’s not terribly much info on what’s known about what’s going into people’s bodies, and what info does exist has arisen from a thick soup of trade secrets and conflicts-of-interest.
> What long term effects would you anticipate from this?
Maybe you are responding to the wrong person? I never made any claims regarding what long term effects to anticipate. I asked how the person I responded to know there are no serious side effects on time scales longer than we have tested things on.
> There is a good chance for long term effects from covid. Completely the opposite for the vaccine.
You kind of answer your own question : only time will tell, ironically, and nobody else.
Also, to all those saying "clinical trials have succeeded", I strongly suggest them to read said published trial results and look at _measured_ sample sizes used in the results, not total inoculation numbers.
Applying the precautionary principle, particularly if you are not at risk, is a perfectly reasonable position, IMHO.
> We know that there are no side effects that are common enough to be of real concern
No, we can't know that. Some affects don't show up for a long time. One example is women.
Women's bodies are complex because they go through so many changes. These changes affect how they respond to medical treatments. In other words:
- Just because pre-menopause women respond well doesn't mean post-menopause women will.
- Just because pre- or post-menopause women respond well doesn't mean women who are going through menopause respond well.
- Just because non-pregnant women respond well to the vaccine for a month doesn't mean that pregnant women will respond well.
- Just because 6-month pregnant women respond well doesn't mean 3-month pregnant women will respond well.
- Any issues with the vaccine during pregnancy may not show up until after the child is born.
- Women's hormones are fluctuating wildly at the beginning and after pregnancy. These are also times that need a lot of representation in the study.
In fact, the amount of change women's bodies undergo affects medical treatment so much that many clinical trials deliberately under-represent women to simplify the study, and then use the results of the trial to recommend prescriptions for women.
Factor V Leiden gang represent. Afaik AZ clotting is caused through a different mechanism though. Have there been any official recommendations for us thick-blooded folk?
Citing "years of research" that nevertheless demonstrate a product has side effects as bad or worse as a reason something should be allowed is status quo bias.
It goes even deeper than that. I have seen that meme catch on in so many feminist Twitter and Instagram accounts that it is essential to look at the play here.
The "you woudn't care about women dying" narrative completely derails the essential discussion (aka when do we determine vaccine to be save) by selectively picking facts from a completely unrelated health area to turn it into an activist subject.
It reminds me on the magnet-troll-logic memes, only this one trying to come up with the completely insane narrative: "If you are concerned of a few more people dying because of a vaccine, you hate women."
The narrative - and I think it's a correct one - is "we accept far riskier interventions in our everyday lives already, of which birth control is one good example".
I'm not saying your calculus is wrong but this does make an assumption that all clots are created equal and I don't believe that is the case.
The specific issue being observed is "cerebral venous sinus thrombosis (CVST)" in combination with "low levels of blood platelets (thrombocytopenia)" per the Joint CDC and FDA statement (1).
Low blood platelets means anti-clotting treatments can pose a substantial bleeding increase, making this already dangerous condition difficult to treat.
To add, from the German Federal Institute for Vaccines (regarding AZ not J&J):
> Birth control pills can also cause thrombosis. So why is there all the fuss about the COVID-19 Vaccine AstraZeneca?
> It is true that for birth control pills thromboses, even with fatal outcome, are known as a very rare side effect. They are listed in the Summary of Product Characteristics (SmPC). The birth control pill is available only on prescription. Every woman must be informed of this risk by the prescribing physician. For the COVID-19 Vaccine AstraZeneca, there is currently a suspected very rare side effect of sinus vein thrombosis with accompanying platelet deficiency, sometimes fatal. It is not listed in the SmPC.
And we know adenoviruses interfere with the coagulation cascade through FX binding, so it’s well worth taking a pause and taking a closer look into what’s going on. With two well-tolerated and safe mRNA vaccines in the market, we can afford — to a degree! — to put Ad-based vaccines through additional scrutiny, especially since they’re likely to be the primary vaccine type on a global level.
I agree if you're in the US or in any other place with abundant supply of other vaccines. If you're in a place like the EU, like myself, every single dose counts and a setback can seriously screw things up.
Yeah, that “to a degree” is US-centric and, even then, doing a lot of work — in the US, J&J is probably about 1/3 of the total vaccinations when accounting for the prime/boost mRNA protocol, so even here it’s a mess, and we’re in much better shape than the rest of the world.
Sorry, what’s the effect adenoviruses have on FX? I’m a male with a mild hypercoag disorder and history of DVT. Am scheduled to get the JJ vax today and will be skipping and seeking out mRNA instead.
Not a doctor, so talk to your hematologist! Ads bind to blood factors (Ad5s to FX, HAdVs to FIX, etc), which facilitates organ uptake and interferes with the coagulation cascade and triggers complement activation. Thrombotic thrombocytopenia is a known complication from gene therapy studies, so it’s not surprising, but concerning, that rare but serious coagulatory disorders are appearing in the widespread use of a zoonotic adenovirus. I’m certain quite a few other folks on here are better-informed than me, so hopefully we’ll get some more discussions going on this topic.
I’ll also say that the most significant risk is probably mistreatment of clots, since most doctors probably wouldn’t go right to non-heparin/warfarin DTIs unless they had reason to suspect HIT or had gotten a CBC back.
> Cerebral venous sinus thrombosis is rare, with an estimated 3-4 cases per million annual incidence in adults. While it may occur in all age groups, it is most common in the third decade. 75% are female. [0]
6 cases in 7 million over 3 months with mostly women being affected is exactly what we'd expect to see.
There's lots of other things to compare it to as well. It's a roughly 1 in a million chance of dying - which is called a Micromort https://en.wikipedia.org/wiki/Micromort
We 'spend' about one micromort of risk per day of being alive. Or you can spend one walking for 6 hours, or driving 250 miles (or 6 miles on a motorbike)
I just made a website to show all the other stuff we do all the time without worrying with the same (extremely low) level of risk
One caution here; at least with AZ, apparent rate of clots varied dramatically by country, and rates generally went up once people knew what they were looking for. It's plausible that a lot of early ones were missed entirely or misattributed.
That's 6 unusual/dangerous cerebral clots per 7 million doses, not all blood clots. There were 50% more clots of any types in the vaccine trials of 20k people [0] (15 blood clots in vaccinated group versus 10 in the placebo group).
Ah yes, that is true! This site is based on AZ, but you're right it might be a different story with J+J. I wonder if as well, they'll get better at spotting the blood clots and treating which could also be happening - but that's just conjecture / hopeful thinking at this point.
I see IPv4 A records. I am guessing what's happening is that when you look up the DNS over IPv6, it gives you AAAA records instead of A records. Or, it can depend on locality. Cloudflare is not a DNS provider that gives the same answer to everyone -- its goal is to direct traffic to the cache that's closest to the end user.
Edit: I looked into it more and I can get IPv6 and IPv4 DNS servers to serve me both A and AAAA records. The site is now down, however :)
It meant that anyone not using IPv6 or a dual stack provider wouldn't be able to view the site through the non-www domain. However, they look identical now, so you're good.
Note that in EU it also started with 7 cases ~1 month ago. Then doctors went through the records and now there are 200+ sick, 25 people dead from CVST alone (clotting that causes bleeding in the brain) with incidence in Norway 5 out of 130000 vaccinated. If you look at women only it will probably go even higher. And if you compare that to CFR from COVID for person <50 years old without diabetes and hypertension it will be within an order of magnitude
> Then doctors went through the records and now there are 200+ sick, 25 people dead from CVST alone (clotting that causes bleeding in the brain) with incidence in Norway 5 out of 130000 vaccinated.
The point he’s trying to make is that if you’re in a low risk group (let’s say under 30 for example) maybe it’s a better idea to just skip the vaccine.
I would still take the vaccine but the point I'm making is that it's serious enough to offer younger people some other vaccine, investigate why is it happening, how to fix it (use a different vector, adjuvant or dosage?) and roll it out safely. Call it version 1.1
1 in a million chance of vaccine death for AZ. Maybe 1 in 10m for JJ. 0 in 10 for the mrna vaccines.
10 in a million chance of death from covid in the 5-9 age group (the lowest risk group)
This is the perfect example of anti-vacc logic. They pick the latter because they heighten the risk of the former in their mind, while ignoring or downplaying the risk of the latter. Looking at the actual numbers, it makes no sense for anyone at any age to take their chances with covid over the vaccine.
Can't you still spread covid if you are vaccinated? Don't you still have to wear a mask and social distance? That doesn't add up with what we are being told.
> Can't you still spread covid if you are vaccinated? Don't you still have to wear a mask and social distance?
There's been jumbled messaging on this.
The "you still need to wear a mask" thing was, if you dig in on the actual statements instead of the media headlines, "because we don't know yet". An abundance of caution.
Since then, we've gotten quite a bit of good data on that front.
> Data analysis in a study by the Israeli Health Ministry and Pfizer Inc found the Pfizer vaccine developed with Germany’s BioNTech reduces infection, including in asymptomatic cases, by 89.4% and in syptomatic cases by 93.7%.
I was just riding a government-run subway, and they had an automated announcement saying “Masks are required over the mouth and nose even for fully vaccinated people as vaccinated people can still spread coronavirus.” There was nothing muddled at all about the message. (Of course the message itself is probably wrong, but the public messaging itself is pretty clear.)
If I'm vaccinated, I'm protected. I don't really care if anyone else is vaccinated or not, as I'm not at risk from their decision. Or is this not true?
No, vaccines effectiveness can be substantially lower than 100%, so if you're vaccinated, depending on the vaccine type, you still might not be protected. It's much like the normal vaccines for the normal diseases, you don't always know if you're fully protected yourself so you end up relying on other people being vaccinated too.
We have been told we have to wear masks and socially distance with or without vaccine, so you can ABSOLUTELY still spread it even if fully vaccinated. Please follow the health guidelines and do not spread disinformation.
> "It may be that we will show that if the level of virus in your nasopharynx because you're vaccinated is so low that you don't have to worry about transmitting, that's going to be a game changer for what a vaccinated person can or cannot do," Fauci said.
> The doctor explained that if the findings are corroborated, Americans will likely see a pulling back on some restrictions, but emphasized "we're not there yet."
Note that other vaccine's that prevent infection also reduce your risk of spreading the disease (measles etc).
So the fact that COVID spreads (not just in rare cases, but enough we all have to remain masked AND socially distant even if vaccinated) is a CRAZY big difference here.
The messaging has been clear - even if vaccinated you MUST wear masks and socially distance - which shows how different this is then other viruses. Given that, it's understandable that people are a bit more meh on the vaccines - because you can still spread it to others either way.
I do wonder about the experts messaging at times. Initially I thought airbone virus, began wearing my leftover N95's from wildfire season. Then they said those don't stop this airborne virus and to take them off. Then they said put them back on. and on it goes.
It's highly likely that natural infection provides worse protection that vaccination and we have real world evidence that already suggests this.
1. Two exposures to the spike protein are likely to create a much better long term immune response simply because of multiple exposures in a short period of time.
2. The spike protein produced by the mRNA and J&J vaccines is engineered to produce better response against variants.
3. We've already seen evidence of natural infection performing poorly in rural parts of Brazil with very high initial infection rates (> 70% which is near the herd immunity threshold) like Manaus where we're seeing significant evidence of reinfection where it should be have been difficult for COVID to spread.
1. The current mRNA vaccine, only produces antibodies to the spike protein. A natural immunity produces antibodies to several components of the virus. If the virus mutates its spike, a natural immunity will still provide some protection.
2. A vaccine producing (IIRC) two orders of magnitude more antibodies than natural immunity is not necessarily a good thing.
Put your life on the line for the community, comrade! And sign away your right to legal recourse should you die as a result. You're on your own! You owe the community your life, and the community owes you nothing!
I think there's a really big difference between being FORCED to get the vaccine, and being reminded that your actions have consequences on other people and not just on yourself. Nobody is saying that you should be required to get vaccinated. So really this is just a straw man that you're burning down.
I'd rather all the people gaslighting the public by saying the vaccines are completely safe, totally worth any risk, "trust the experts", etc - when in reality young people seem to have a better chance of dying from CVT than COVID - move to a deserted island.
If the real argument is "the cure has a better chance of killing you than the disease, but please risk your life for the community", I'd rather people be honest and say that in the first place.
Please link results of the study that supports your statements of mortality among young people. In USA alone more than 10k young people died from COVID so far. JJ vaccine has one potentially linked death after 6 million doses.
Possibly they are nervous because it could signal deeper problems. If there is anything people should have learned from the pandemic is that it takes a few months for the medical profession to sort themselves out when new data appears on the scene.
This is the thing. A similar issue was seen with heparin a decade or so back. Basically the heparin molecule (an impurity I believe) was causing an immune reaction that cross reacted with a protein that activates platelets. Not a minor side effect and until the full extent of the issue is known (who is at high risk? How do we treat if it happens) I don’t blame them for being cautious.
Your sympathy for them being cautious begs the question of whether the vaccine, with its uncertainty, is worth using. The cost of waiting to use it is significant - people will die from COVID.
It's not enough to say you're being cautious. You have to explain why you think it is better to be cautious about administering the vaccine with its attendant risks or to pay the QALYs incurred by the delay when people who would have received this vaccine don't.
Pausing this one vaccine type to collect data and determine appropriate actions to mitigate this side effect is reasonable.
This is a low probability event, and the appropriate mitigation may be to do nothing; but there may be some common factor for these patients that might indicate use of a different vaccine or maybe informing people of symptoms of blood clots and what to do if they see symptoms.
The real risk here is eroding confidence in government health sources in general, and vaccines in specific. There were certainly unknown risks before, but now there is a known risk which deserves some study.
We've now got a known risk that's quantifiable, but hasn't been quantified. You can estimate the risk based on the current information, but now that it's a known risk, I would expect to have more complete information in a few weeks.
If this turns out to be about what it looks like now, unpause and go forward. If it turns out to be much more significant, all the better for having stopped; maybe restrict this vaccine to populations at higher risk of COVID or lower risk of blood clots (if that risk can be determined). Both mRNA vaccines and modified adenovirus vaccines are new types of vaccines not used before on a wide scale; pausing to get clarity on a major negative side effect is warranted.
You've hinted at a framework for making a decision but left out an important component.
A credible decision would give your estimates of harm/benefit for delaying vaccinating people. You seem all too willing to ignore the people who will become sick or die because of delaying the vaccine. You are only looking at potential harm from not delaying the vaccine. Unfortunately, you have a lot of company.
> A credible decision would give your estimates of harm/benefit for delaying vaccinating people.
It seems to me that the delay imposed by a pause in use of the J&J vaccine to make sure healthcare providers are informed of and have appropriately updated diagnostic and treatment protocols is minor, its basically pulling forward by a few days the effects of the 80% week-over-week drop in J&J vaccine supply that was just in the news.
The risk isn't just the blood clots, it's that the vaccine is perceived as rushed (it was) and warning signs were ignored, so maybe other things were ignored.
Leading to more people delaying their vaccination. Supply is currently at a level that all doses available are administered, but to the extent lost confidence results in longer delay for high risk patients, that has a cost. When supply exceeds demand, lost confidence will have a cost for those low risk people who delay, as well as the general population which loses out on wider immunity. Delaying the vaccine now certainly also has some cost of the same type, but it's bounded. Another case of a vaccine campaign ignoring warning signs and proceeding without pausing to consider appropriate response to issues as they arise will affect this campaign as well as future campaigns.
I don't think anyone would disagree that if there were no cost to delaying supplies of the vaccine then we should do that. But that's simply not credible. The governor of Michigan seems to think that additional vaccine doses would be helpful.[1]
Suggesting that effects on the order of the ones seen here is a good reason to delay the vaccine should make people doubt the ability of our public health authorities to make reasonable tradeoffs.
All of a sudden we need a QALY analysis to justify an immediate reaction from the government? Things sure have changed in the past couple hours when it comes to What people think is required of America’s COVID19 response.
I doubt the correct communication strategy is obvious. Rumors about people dying from a vaccine can be worse than a pause.
A legitimate reason for the pause is to assess whether the people impacted have anything else in common. There are alternative vaccines that can be used if a commonality is identified.
As far as hesitancy, the idiot media already does a story for every vaccinated person that gets sick, this isn't going to tip huge swaths of people in either direction.
People keep saying this will add to vaccine hesitancy but I'm not convinced. The vaccine-hesitant are already skeptical of authorities and aren't going to be especially reassured just because US agencies say it's fine, when it's already hit the news that European agencies have halted J&J.
Seeing US agencies halting J&J while continuing the other vaccines could even be reassuring. It shows that US agencies really are pretty cautious, and are willing to halt vaccines that show signs of problems.
What we've seen in the US is that the J&J was the choice of people who legitimately wanted a vaccine but were leery of the novelty of the mRNA vaccines. This is going to crush that group of candidates and some non-zero number of them will wind up in the camp of people who don't get vaccinated at all.
What you will find is that the vaccine-hesitant are perfectly happy to take the word of authorities who say "this vaccine is unsafe" and only have trouble accepting the word of authorities who say "this vaccine is safe".
I think that is likely because the two states have different levels of confidence, similar to how "not guilty" is not the same state as "innocent". It is relatively easy to identify unsafe, especially when negative effects arise quickly. It is harder to reliably determine safe as it may just be a matter of time before negative effects arise.
For people who won't accept the vaccine regardless, it doesn't matter either way. For people who can be convinced, I think that obvious evidence of caution may be helpful in convincing them.
Seems like a “damned if you do, damned if you don’t” kind of scenario. If you don’t pause the rollout, there will be news articles that the government ignored deadly side effects, resulting in lack of trust and vaccine hesitancy. If you do pause the rollout, you get vaccine hesitancy.
Agreed that if everyone is rational/good at math the optimal outcome is proceed with dosing, but sadly that is not the world we live in and the “broken trust” scenario might be more damaging.
This is a highly unusual situation insofar as phase III monitoring is far from complete and there is no 'phase IV' (confirmatory) trial data at all yet. In the normal course of research, this is how we'd catch rare but consistent adverse effects.
So, if we had complete trials on a normal timeframe, then obviously there's a different calculus to apply.
But given what we know at this moment, these six incidents might actually be far more normal than the crude use of six as numerator and seven million as a denominator.
A pause to assess the data and allow any lag to resolve seems prudent.
And, while this will be very difficult to quantify until much later, if then, I surmise that this will only create temporary vaccine hesitancy and only outside the high-risk tier, which is perfectly rational.
For people in the low-risk tier, there's nothing wrong with waiting until the conclusion of the RCT monitoring in the first place, even if adverse events weren't the basis of that decision.
I don't disagree. But I will observe that many people in the low(er) risk tier are going to be traveling, eating out, having parties, etc. sooner rather than later--vaccine or not. In my very Blue state people are very obviously relaxing a whole lot more. So the question isn't whether things open up or not. It's whether people are vaccinated when they do. (Which doesn't mean all vaccines are equally safe.)
It seems like people in the low-risk tier might be more likely to get J&J. Firstly, it's just the one shot and secondly, people who are worried about COVID are vaccine shopping because they want the perceived "higher efficacy" of the mRNA vaccines vs J&J (whereas lower-risk people might be more interested in vaccine passports than preventing symptoms).
Maybe. In a lot of places you don't really have a choice and, in the US, AFAIK the mRNA vaccines are more common. Also, while "vaccine passports" have started being discussed, they're not really a factor yet--given how many people still need to vaccinated--and may never be outside of scenarios like schools. (That said, I have heard people who see getting a vaccine as more pro forma saying they prefer J&J because it's just a single shot.)
It's pretty easy to "vaccine shop" (if you care about it) at least in the US with all of the scheduling being done online. Sure, if you go to one of the big vaccination sites, you may not get a choice, but it seems that sites offering J&J have been advertising that and ones that don't indicate seem to be Pfizer & Moderna (or if J&J, give you a choice, at least around Massachusetts).
J&J is also widely used in the US for people who might have issues with scheduling a second shot, for example people who are homeless, or are home-bound.
Fair enough. It was still quite hard to get one when I scheduled and I was going to take whatever I could get even if I favored the mRNA ones. That said, if I didn't really care about getting a vaccine but was going to get one anyway, I'd probably just choose whatever I could get most easily.
None of our societal systems are setup to do rational cost-benefit trade-offs in a pandemic.
“Don’t wear masks.” “No, no: wear masks.” “COVID kills over 10%.” “COVID kills less than 0.1%.” Once we realized the difference in makeup between the over-10% and sub-0.1% populations, we still couldn’t bring ourselves to make data-backed differentiations for many, many months (and still today have many small businesses closed or restricted based on what they do rather than the risk profile of their owners and employees).
These are difficult decisions to be sure, but when being seen as on the “safe side” confers benefits without a commensurate charge for the risk of the “safe” action, you get a society which moves in the direction of perceived safety (and where perceived safety may be strongly sub-optimal).
> 'These are difficult decisions to be sure, but when being seen as on the “safe side” confers benefits without a commensurate charge for the risk of the “safe” action, you get a society which moves in the direction of perceived safety (and where perceived safety may be strongly sub-optimal).'
yes, security theater abounds. it's a multidimensional optimization problem with no absolutely safe side in the long run, only relatively, but often initially unintuitively, safer non-linearly intertwined sets of actions. it's hypocritical to discount the tiny risk of vaccines while dramatizing the tiny (but larger) risk of death by covid. further, it's myopic to look at the risks of covid in isolation (which is what all the frenzy around it has been doing for over a year) rather than in relation to all the similar risks in our lives and couching our responses now within our existing responses to those other ongoing risks.
That's the thing. Pausing the vaccine will kill people. Judging by the numbers so far - probably more people. But different and older people.
How does one do that math ethically? There are risks if you do and risks if you don't. The FDA is the wrong group to make that call, because they're only concerned with the first kind of risk.
In Canada we reserved the Astra Zenica vaccine for people over 55 because of the blood clot issue. I think that's probably the right call.
This article [0] mentions 50% more blood clots observed during vaccine trials, which at the time was characterized as a slight numerical imbalance (15 blood clots versus 10 in the placebo group, in a trial of 20k people)
The obvious difference is that the vaccine is being forced upon people. A woman can talk to her doctor, understand the risk, and decide to take birth control or not.
The vaccine was given to people, under threat of exclusion from society, without knowledge of the side effects. Not comparable.
Why is it relevant? So far nobody forces me to take birth control and threatens for exclude me from the society if I refuse to do so (UK wants to require vaccine passports to go to cinema, for example). Nobody paints me as stupid anti-vaxxer if I just say I don't want to take BC pills. Nobody tells me that I won't be able to travel unless I agree to take BC.
I am a guy, so maybe I don't know what I am talking about. But I have a strong suspicion that the consequences for young women that chose not to take birth control pills can be felt as well and that they often feel quite a pressure from friends, boyfriends, parents, etc. to take the pill.
I am sorry, this is the whole other level. First of all, you are not obliged to discuss your medication with friends or parents. Second, your reply is pretty much like:
>> In China you disappear if you publicly say bad things about CCP.
> Yeah, I know what you mean, I called somebody motherfucker and got banned on HN. Freedom of speech is nowhere these days.
People keep repeating this myth of birth control. I don't know how doctors do their job in other countries but if they look at the patients health history this number is a myth. Luckily health officials here (ETA: Denmark) inform about these myths on television whenever the government holds a press conference about new Covid-19 measures but this isn't so everywhere so please stop spreading FUD.
ETA: I see you made ninja edits to your comment....
Edit 2: So now you replied that you only added a word or two and then deleted you comment while I were replying. Your comment was only half as long when I replied (all the Twitter stuff wasn't there for example).
> The former is rarely lethal, the latter most often is.
Again, we're looking at one in a million stats for getting the clots, and one in six deaths amongst that tiny group of cases - without information yet on their comorbidities.
COVID itself causes clots. A lot more than 1/1,000,000. If you're afraid of clots, get the vaccines. Even the J&J one.
Seriously I can't believe this is that simple. There is no way public health bureaucrats don't understand this common sense logic. Otherwise they would all become vaccine deniers.
Healthcare is extremely weak on science. The profession existed before the scientific method so there is a tendency to value authority over science.
Even today Physicians still think the body is Art, or a combination of Art and Science.
And the only reason we don't have a science based alternative to the Physician cartel is that they spent literally $400,000,000 on lobbying/bribery in the last 30 years.
Edit- for further reading look up "evidence based medicine debate"
> The profession existed before the scientific method so there is a tendency to value authority over science.
Anecdotally, my pediatrician has an inverted "trust pyramid" in some of their examination rooms. At the bottom—least trust—is "expert opinion."
> Even today Physicians still think the body is Art, or a combination of Art and Science.
I'm not sure why you would think these two things are opposed?
Science most broadly speaking means knowledge, and the scientific method is a means (but certainly not the only means) of acquiring knowledge. But what you do with it is art/craft. Separating the two seems unnecessarily dualistic.
I agree that on the surface these numbers are not alarming. That said I trust that the government agencies know what they are doing here. If anything there is tremendous political pressure to NOT scrutinize the vaccines.
There is enough anti-vaccine & Covid rhetoric that we should all cool it a little bit and let the experts do their jobs.
They're letting perfect -- even a single death is too many -- get in the way of good -- a small number may have shitty outcomes, but the overwhelming majority will not.
Same framework that's lead to all of the poor policy decisions over the past year.
> That said I trust that the government agencies know what they are doing here.
If 2020 didn't finally shatter that trust, is there anything that can? FDA was already obviously a regulatory capture vehicle for pharma. And CDC got nearly everything wrong in the ebola outbreak of 2014. Then, both of them blundered their way through this pandemic.
For example, we know from the email leaks that FDA felt it was under pressure from Trump to approve vaccines[0], and then never disclosed this fact to the public. That doesn't seem like dispassionate science and expertise to me.
By contrast, many of the medical journals, preprint houses, and academic institutions have looked like far more stable sources of knowledge.
It seems to me that the internet age asks us to replace our state institutions of expertise with something more thoughtful and genuinely connected to science.
Something that has fascinated me about the last year is that the pandemic has sped up the feedback loop on decisions like this. Seeing the impact of this decision won't take years and the outcome won't be unclear. In another few weeks, we'll very likely know that this was an overly cautious call that directly led to even more vaccine hesitancy, and lives lost as a result.
Paraphrasing one famous science commenter, we're playing Pandemic Trolley Problem and running over hundreds of people because we're not sure if the other path has one or two persons.
It may be ridiculous, but it seems necessary if you're managing populations of people:
Build a dam, which if it broke would kill hundreds-of-thousands, or let millions die for lack of water? Oh, we'll just over-engineer it, now we can't afford to buy food to keep the people alive long enough to need the dam; or the lead engineering firm embezzles the money and installs dodgy iron.
We can't wait around for long term studies, whatever point we decide to start vaccines - where they can still be effective for the current population - it's always possible we should have waited a bit longer.
Deaths by COVID implies that those at risk will forego all other options to decrease risk of infection, such as masks, distancing, etc. Those options are opt in the same as a vaccine, though the vaccine is 2x and done.
Nonetheless, just because version 1/2 COVID vaccines are good enough for you does not others should just jump on board when other options exist that can vastly reduce risk of infectionand/or death.
In short, blowing the death problem our of proportion unless the options are only nothing vs vaccine.
> Deaths by COVID implies that those at risk will forego all other options to decrease risk of infection, such as masks, distancing, etc.
Masks are supposed to protect others from you. Wearing a mask is not meant to help a person who may be at risk decrease his/her own risk of infection.
In any event, now that spring weather is here in the northern hemisphere and the vaccination campaign has given people hope, social-distancing rules are being flaunted in many countries and at-risk populations may find it hard to properly distance when they leave their homes for e.g. basic shopping. So, since the "other options" don’t always work, keeping up the vaccination campaign is very important to reducing infections.
While mask effectiveness may be skewed the direction you state, you can't tell me that wearing one along with other precautions has no positive impact on your own infection risk.
For those willing to receive vaccination right now under informed consent, I'm all for it. I agree people are over the pandemic and making the situation worse. I disagree with many commenters here that are shaming and/or implying that people like myself are anti-vax vs simply being willing to wait for much more evidence before jumping on board with incredibly widespread usage of an incredibly not well understood treatment.
> shaming and/or implying that people like myself are anti-vax.
I'm in a low risk bracket. My country saw an uptick in people canceling vaccination appointments. 40% of 60+ people here are now 'unsure' of taking the vaccine.
I've done nothing but work and follow the rules since this whole thing began. Young people without partners, or young people in general, that are active, have a social life did a complete 180* in their "allowed lifestyles".
I've paid with money, time, a year of my otherwise busy life, for people in risky age brackets, at _little_ benefit to myself. *
But I'm so done, don't tell me you're asking people like me to be stuck in our anti-social and unhealthy living arrangements, while there's a solution that's _safer_ than going to a covid shower?
People like me are done paying, I'm not going to wait around another year, you take the vaccine or you take covid for all I care.
Also: losing weight, getting more exercise, improving your diet, getting proper amounts of vitamins. All things that will greatly reduce your risk of death from many causes, not just COVID. But requires some effort compared to taking a pill or a shot.
Who cares how many clots birth controls produce? What matters is the outcome compared to the thing birth controls prevent - pregnancy.
Do you get more blood clots from being pregnant or from being on the pill? It's order of magnitudes more from being pregnant, therefore if you're sexually active it's safer to be on the pill compared to not.
How is this the top post? People have no knowledge of basic Bayesian statistics.
No, because there are other vaccines that don't give you blood clots at all. Your entire point is moot. Pausing temporarily to investigate is hardly controversial. The comparison with birth control is nonsensical.
A vaccination for COVID is not the same as getting birth control. Even if it was, why would you get J&J if you could get Pfizer that doesn't have the same issue?
If all vaccinations had the same blood clotting issue then perhaps you and the original poster would have a point. Given a huge disparity between them with regards to blood clotting taking a moment to investigate this is simply prudent. Making nonsensical comparisons to birth control, well, is not.
Sure, but J&J isn't being permanently discontinued. Why are you against simply pausing vaccinations to investigate this? If the USA was this prudent with COVID in its beginning we wouldn't even be having this conversation.
Your argument would be reasonable if it was being permanently suspended.
> The skepticism shows no sign of slowing, YouGov reports. While trust for the Pfizer and Moderna vaccines rose in all country surveys between December and March, trust for the AZ vaccine slipped in Germany over that span. By early March, 40% said the AZ vaccine was unsafe, an increase of 10% since its earlier December poll.
> The result? Anecdotal reports in Germany and across Europe of people refusing the AZ vaccine and supplies sitting unused in warehouse, YouGov reported—real-world evidence of “the extent of the damage done to the perceived safety of AstraZeneca vaccine.”
> The AstraZeneca jab, which is cheaper to produce and easier to store and distribute than the vaccines currently being administered across Europe from Pfizer-BioNTech and Moderna, was meant to be a workhorse of the continent’s vaccination drive. That plan could be in trouble, however, if citizens across Europe continue to believe that the AstraZeneca vaccine is unsafe and, as a result, refuse to bare their arms for it.
I believe there are significant public health implications to how information is released to the public that need to be considered better than they have been in the case of this pause and the similar case with the AZ vaccine.
I believe, as with software, that immediate release of unvetted, incomplete, and still-being-investigated information can be actively harmful to people.
J&J is paused because there are alternatives that don't have clotting to the same degree.
A comparison with birth control makes no sense. Is there some magical birth control that's used orders of magnitude more (Pfizer) and orders of magnitude safer with respect to blood clotting and also prevents pregnancy?
There currently isn't enough vaccine to meet demand. Pausing J&J distribution will cause a larger gap between supply and demand. The 7 day average of deaths from Covid in the U.S. is 985. Even a week's delay in getting to full deployment of the vaccine thus means thousands of deaths.
I am not saying outright that the pause is not justified. But it has a substantial cost, and it would be good to see that our health authorities have considered this and weighed the balance of costs and benefits. e.g. it might have made sense to pause J&J for under age X and continue it for over age X, based on relative risk.
I don't agree with your analysis, I think you can see it entirely the other way, that both this pause and the initial "wait and see" attitude towards Covid are the result of an excessive bias towards the status quo. I remember back in January-February 2020 when people were saying it would be crazy to just shut down air travel, think of the massive economic cost.
The primary concern people have here isn't the review, it's the immediate withdrawal. People who had appointments to get the J&J vaccine will now go vaccine-less until they can be rescheduled, even if they would have been happy to take it knowing about the blood clots.
The bigger problem is that many people no longer trust the institutions providing the data. As such, they can understand statistics but will mistrust the conclusion as the data could be bunk.
Your math is off, there was only one death after around 7 million shots. And this has only been seen with the J&J, which will only be a fraction of the total shots given.
At least a third of the market of hormonal birth control is progestogen-only pills, and those do not raise the risk of blood clots. At best your comment is reductive, at worst misleading and the tone is uncalled for.
While this is an interesting point to consider it's not completely equivalent. In short, taking an action that might harm in exchange for a small possibility of a benefit is much less appealing than taking an action which might harm you but will definitely bring a benefit.
To expand, people accept a level of risk depending upon the benefit they expect to get from it. In the case of the contraceptive pill the user has a clear & definite benefit (e.g. they are very unlikely to get pregnant from the sex they are definitely having). The benefit of the vaccine for the individual is less clear & loosely defined. It's another probability that's hard to know. The recipient might not get Covid-19 and if they did they might not get it badly. So it's a much more difficult benefit to weigh against the risk.
The assessment is easier the more at risk the recipient is (hence restricting use to older generations) and on a larger scale, where policy makers can compare that 1 in a million increase to the x in a million that will die from Covid-19. But for individuals, most people are not good at making those judgements correctly.
Not the OP, but my take is that the name is terrible. The concept is probably needed in some places, though. It'd be fairly shocking if there aren't some strict entry requirements on crowded venues for a while, though maybe a recent test can substitute for a vaccine.
> Hormonal birth control boasts clot rates of 1 per 10k
This differs depending on the age from my research. Your overall seems too high when risk adjusted. I asked you to post your source so we could discuss from the same source. In any case per (https://www.healthline.com/health/birth-control/pulmonary-em...):
- Out of every 10,000 women taking birth control pills, 3 to 9 of them will develop a blood clot.
- Out of every 10,000 women who are not pregnant and who do not use birth control pills, 1 to 5 of them will develop a blood clot.
- Out of every 10,000 pregnant women, 5 to 20 of them will develop a blood clot.
- Out of every 10,000 women in the first 12 weeks after giving birth, 40 to 65 of them will develop a blood clot.
In other words, taking birth control pills actually reduces blot clot rates compared to pregnancy, the very thing birth control pills prevent. Your entire point is moot.
Whoa - you can't post flamewar comments like this one and others. We've banned this account. If you don't want to be banned, you're welcome to email hn@ycombinator.com and give us reason to believe that you'll follow the rules in the future. They're here: https://news.ycombinator.com/newsguidelines.html.
> A pause on vaccines will cause far more deaths than a 1 in 1 million chance of blood clots.
Its not “a pause on vaccines” it’s a pause on one vaccine. And its not 1 in 1 million, because many of the 6.45 million doses administered of J&J are still, or even not yet, within the 1-2 week window after administration where this complication has been observed. And the pause is to get information to healthcare providers and permit them to establish appropriate protocols for handling the clots, not for open ended study. And it coincides with the timing of a short-term supply drop (-80% from prior week) in J&J vaccines that was going to force a sharp drop in the rate of adninistration at some point in the very near future anyway.
It's unethical to give people a vaccines that can cause a blood clot without informing them first of the risk.
It doesn't matter that globally it could cause more deaths. It's not the job of the FDA or CDC to act as your parent and decide for you what risk is and isn't acceptable.
Informed consent is a cornerstone of medical policy.
What will happen is they will modify the consent form to let people know about the risk, and let them decide for themselves.
Message to anti-vaxxers: As you can see the government is very carefully tracking any kind of safety issues with vaccines. They are being open and telling you about issues despite people fearing it would cause vaccine hesitancy.
So this should actually give you more confidence in vaccine safety, because if there are problem, you will be informed.
Unfortunately I think the anti-vaxxers can twist the logic however they want. The government is putting on a show about how transparent they are to win trust... etc.
I'm not sure how to get through that... from what I understand it takes alot of effort and time per person.
Sadly, as news papers discovered years ago, publishing corrections makes you seem less trust worthy than papers that never publish any, even though the later at best equal, and often worse.
I see this as making the safety of the specific vaccines an unfalsifiable proposition. If the absence of side effects proves that it's safe to vaccinate and the identification of side effects proves it's safe to vaccinate, what could ever prove that a specific vaccine is unsafe?
The CDC and FDA have done a terrible job in my opinion with the pandemic. They are prime example of government institutional decay. The consiquentalists will win because the J&J vax helps more people than it hurts. This will only add to vax hesitancy. When the dust settles this decision will kill more people than it saves. I had the J&J vax. I got side effects but I now have some immunity to COVID-19 and it's worth it.
I love how people are complaining about this decision without addressing the fact that there are two other vaccines that don't have this issue that have been used orders of magnitude more.
Why wouldn't you pause J&J? It's just a drop in the bucket in total vaccinations anyway and the other two don't have this issue.
According to the article, 6.8 million people in the US have received the J&J shot. Without the J&J vaccine, those people (6.8 million others) would not be vaccinated due to lack of supply.
The US CDC website[1] currently says the 7-day death rate per 100k people is 1.4. Without the J&J vaccine, that's almost 100 additional people dying per week - and just in the US.
J&J is an adenovirus vector vaccine, which is barely less experimental than mRNA. AFAICT the only licensed adenovirus vector vaccines are for Ebola, and those have not been used very widely.
Earlier attempts to use adenovirus vectors for gene therapy had issues due to, wait for it, thrombocytopenia.
The the one and only COVID vaccine that uses more or less tried and true technology and looked excellent in trials is Novavax. (AIUI Novavax’s adjuvant is newish, fancy, and not necessarily that easy to scale, and it may well be responsible for the excellent performance.)
Given there are some organizations that are forcing you to get a vaccination. 1 in a million chance of dying from something you were forced to do is different than 1 in a million chance of a pseudo-random event. Makes no sense to continue with J&J given the other two don't have this issue at the moment.
Of course, the utilitarian approach is to simply continue vaccinating with J&J since surely more people are helped than harmed. I'm sure they'll reverse this decision soon enough.
As of today about 560,000 people in the US have died of COVID, or roughly 1 in 574. I think it’s safe to say the odds are higher than “1 in a million”.
What organizations are forcing you to get vaccinated. I’ve heard a lot of speculation and honestly there should be more forceful, but I’m not aware of any. Plenty of jobs force you to drive which is absurdly risky
I trust the experts here in the FDA and the CDC. These are people that have been working their entire lives in vaccines and vaccine approval. They understand the medicine, the understand the policy.. if there's anything that most people here could think of, the odds are astronomically low that they haven't considered it.
It is very encouraging that this appears to be a science led decision.
Unsure why I've been downvoted, but if you've worked in FAANG level tech and with scientific staff of the CDC/FDA, you would not think that the caliber of people on either side was much different. There are a very, very large number of Moderna and Pfizer/Biontech doses going out at this point. The bigger risk is 501Y.V2 and company evolving to escape the vaccine, and that is not going to be fixed by a week long pause in J&J/Jannsen to identify the source and treatment for the errant platelet response.
I must say, the general state of discourse on HN has severely deteriorated over the past year (mostly in line with other online platforms, I suppose)
COVID is the single worst thing to happen to civil discussion in my lifetime. The virus is obviously a risk. So are the vaccines. Acting any other way is just downright disingenuous.
At the end of the day, any person with a working brain is free to calculate those risks on their own. No persuading, name-calling, or outright rudeness is needed. (Yes, the top 5 comments I'm talking about you)
In times like this, I'm reminded of most historical calamities...in which a small minority stood on one side, another small minority on the other, but the vast majority simply stood in the middle and thought "Please let this end"
Please upvote this if you're just an average person waiting in the middle.
The pandemic is one of those scenarios that challenges the soul of a nation like the US.
Oh, your society believes, at a deep ethical and philosophical level, in individual freedoms, personal responsibility, and general laissez-faire attitude regarding behaviors that do no harm to others? Okay. Here's an invisible threat that is on average low-probability fatal but with wide error bars and a step-function if enough people decide to ignore it. If enough people take collective actions that are uncomfortable, inconvenient, and in some cases heavily disruptive (possibly resulting in loss of individuals' livelihoods), the odds of dying from it are minimized for everyone (but nonzero). If not enough people do these things, the odds spike up (hard to say by how much). In terms of personal responsibility, you don't know if you're spreading the disease and if someone catches it and dies, we only have probabilities to estimate responsibility regarding who it came from.
Oh, and a handful of the mitigations might also have nonzero risk of harm or death, with some noteworthy error bars on the estimates.
... and all this on top of a population that barely understands what probability is in general, let alone error bars. Most citizens are, in fact, not nearly educated enough to calculate those risks. But they sure want to think they are, because we put personal responsibility for one's health on the person.
It's like the crisis was hand-tuned to be everything Americans hate.
I don't think most people are looking for the truth anymore. They are more interested in finding out what team you're on and who else says what you believe and what team they're on. A logical argument with references means absolutely nothing to most people these days. Questioning certain "truths" will quickly get you banned on many social media platforms and the list of "truths" gets longer every day.
I was in a zoom call with a large number of people I consider educated. They were talking about the California propositions and they didn't want to talk about what they said or to argue for or against, they just wanted to know who supports and opposes which one and if they were on the right team.
Being very conservative with vaccine rollout means more people will die. I think the risk-averse folks that approved of harsh lockdowns may want this harsh measure as well.
Yesterday, Covid19 killed 8,803 people (according to worldometers).
We don't want anyone to die from vaccination, and we don't fully understand what the clotting issue is, so it probably makes sense to pause using J&J as long as the mRNA vaccines (Pfizer, Moderna) have not been implicated (which they haven't). OTOH, if this being in the news causes fewer people to get vaccinated, pausing it may be a mistake that will cause more overall deaths.
Now, your risk of dying either from vaccination or Covid19 depends on various demographic factors not accounted for in my math above. But, nonetheless, the risk of dying from the J&J vaccine is really, really, really tiny.
Like, if I knew there was a 0.00009% chance my car were going to explode every time I got in it and started it, I would not be at all nervous about starting my car everyday for the rest of my life. I'm way more likely, even accounting for my age demographic, to choke to death eating dinner tonight (5,051 deaths from choking in the U.S. in 2015 of which 2,848 were older than 74).
Edit: lifetime risk of car exploding assuming I start it every day for 50 years is about 1.6%. Okay, maybe I wouldn't play that game.