Shouldn't there be a _lot_ of very good data about this in the general case, not just for widely recognized anomalous events? I suspect adverse reactions are under-reported. A recent experience does nothing to dissuade me from that notion. (I know, confirmation bias). But the sheer number of vaccinations that take place would provide some very good data. Of course, that data would also probably show at least some occasional quality control problems with vaccines. No matter how much I may respect the science behind vaccination, I refuse to simply have faith that there are never any QC problems with the mass production of vaccines (or any product for that matter).
Our youngest developed a _very_ bad cough in the days/weeks after receiving the DTaP. We called the pediatrician who gave us the standard advice, to monitor the baby and bring her in if it worsened. We later did take the baby in for the cough. The doctor began dissuading us from the idea that it was Pertussis or related to the vaccination, before seeing the baby, and despite local news reports indicating a local increase in Pertussis cases[1]. The doctor had a look at the baby, and told us again it probably wasn't Pertussis, everything was normal (except the cough and low grade fever), ran a blood test for Influenza (tests confirmed that it wasn't Influenza), and told us to use a humidifier. I asked what the procedure (WRT both treatment and reporting) would be if it had been a possible or suspected vaccine adverse reaction. The doctor said they had _never_ had any reportable cases of vaccine adverse reaction and indicated a general lack of knowledge of adverse event reporting requirements. The clinic where this occurred was right across the street from the hospital that baby was born in, in the Medical Center in Houston, Texas, and is part of a large and well respected practice. Considering the number of patients that clinic has (it is a busy practice, with several clinics), even considering the low expected rate of serious adverse vaccination events, it is not possible that this clinic has never had a reportable event, and very unlikely that there were no serious adverse events. Baby might not have had Pertussis and baby is fine now. But, the experience turned my skepticism into a lack of confidence, at least with that particular clinic.
To report a problem, go to http://vaers.hhs.gov/index , which is the Vaccine Adverse Event Reporting System.
Did you get any paperwork about the immunization? There should have been a flyer or handout like http://www.cdc.gov/vaccines/hcp/vis/vis-statements/dtap.pdf . This has information both about VAERS, as well as about the National Vaccine Injury Compensation Program.
The "ap" in DTaP vaccine means "acellular Pertussis", which means it uses antigens of the pertussis pathogen rather than whole cells. There should be no infectious material that could cause a bad cough a week later. (It also has fewer side-effects than, but is also less effective than the whole cell vaccine.)
I read that newspaper article you mentioned. It said "Infants under 2 months of age are at the highest risk, accounting for five of Texas' [six] deaths this year" and "80 percent of those were children under 2 months old, who are too young to be vaccinated against the disease."
This is a very different situation than what you are describing, where a cough starts a week after the vaccination. I don't think you can make the inference that it's a side-effect of the vaccination itself based on that article.
The article points out that the new vaccine formulation doesn't seem to be as effective for as long as the old one. What's likely happening is that adults whose immunity has worn off are acting as carriers for the disease, and infecting babies and children who haven't received any immunization for the disease.
This is probably one of the reasons that the Td immunization (DTaP is for children) recommends "All adults should get a booster dose of Td every 10 years."
(While it doesn't confer a life-long immunity, the goal is to prevent pertussis in children; they have the highest risk of death if infected.)
I don't know what to say to you, other than that I, some anonymous person on the internet, agrees with your doctor that "it probably wasn't Pertussis."
> "even considering the low expected rate of serious adverse vaccination events, it is not possible that this clinic has never had a reportable event"
There are different styles of reporting. First off, 25% of the children who receive the DTaP vaccine get a fever, 25% get redness or swelling where the shot was given, and 25% get soreness or tenderness where the shot was given. Your doctor has almost certainly seen those side effects.
But they aren't reported because they are expected. Again, they should be in the handout you got as part of the information about immunization. No doctor is going to report such mild problems.
Then there are the "moderate problems", like seizure, non-stop crying, and a fever of over 105°F. These occur in less than 1:1000 children, which means there should have been a couple of children in your clinic who have had these reactions.
However, it's up to the doctor to decide if this is severe enough to report. The
VAERS guideline include "clinically significant adverse health events following vaccination", "vaccination error [that] may pose a safety risk", "or that the error would be preventable with public health action or education" but "accepts all reports."
These moderate problems are likely not 'significant adverse.' The severe cases seem to happen in 1:1 million cases or rarer for the vaccinations I looked at. Even across all of the vaccinations, it's unlikely that your doctor's office would have had that happen to one of their patients.
So, that's one style of reporting. Another style occurs when they get the above statistics in the first place. In that case, they enroll doctors into the program, and have the doctors report all problems that arise after the vaccination. This can be compared to a baseline reference from children who haven't yet had the vaccine. (Eg, the three weeks before the vaccine compared to the three weeks after.) That's used to weed out coincidental correlations. After all, kids do get sick even with vaccines.
This second style of reporting is what's used to list the known risks of the vaccine, with the first style of reporting use to get information about the very rare cases.
What should the doctor have done to improve your sense of confidence? Run a test for pertussis even though your child didn't have the symptoms for the disease? Make a report even though it wasn't a severe adverse effect? The information you wanted - what to do if there was a severe affect - should have been information you already had. I'm somewhat surprised that the staff didn't know that, since I (an anonymous stranger on the internet) knew it existed, but I also only know your side of the story.
>Umm, what makes you think there isn't a lot of very good data?
Because there isn't. Good data on vaccine outcomes would mean that blood samples would be taken and used to assess the effectiveness of vaccines. Good data would require a follow-up tests post vaccination. Good data means I'd get a report in the mail, and maybe every once in a while the report might say to come and get another X because the test indicates that the last X vaccination was ineffective. Thanks, I've been all over the FDA's and the CDC's websites.
>To report a problem, go to http://vaers.hhs.gov/index , which is the Vaccine Adverse Event Reporting System.
Yes, VAERS is voluntary reporting system that is sporadically used by practitioners, and may also be filled with reports from randoms, some of which may be junk. It has some value, it is better than nothing; but, we certainly aren't going to draw many conclusions from it. I was very dissatisfied with baby's first pediatrician for failing to mention VAERS when I asked, as anyone should be.
>Did you get any paperwork about the immunization?
Of course, parents are showered with CDC pamphlets; and showered with them again every time you tick a box on forms that say your child isn't up to date on ALL vaccinations.
>There should be no infectious material that could cause a bad cough a week later.
I know there shouldn't! I described an experience as I remembered it. I did not draw a conclusion, I cannot. I do not have my own immunology lab. But, neither can I dismiss the possibility that the cough was related to the vaccination (maybe baby was exposed in the waiting room). Nobody else should draw a conclusion from a secondhand anecdote, either. Baby could have been exposed several other ways, either to Pertussis or something else.
>I don't know what to say to you, other than that I, some anonymous person on the internet, agrees with your doctor that "it probably wasn't Pertussis."
Nor do I know what to say to you other than, you're probably right. You'll probably always be right because both Pertussis infection, and vaccine adverse reactions are fortunately rare.
I didn't ask the ped to make a VAERS report over the visit. I asked what would happen in the event of a serious problem, following a vaccination. If you're my child's pediatrician, and your response to my question indicates a lack of knowledge, or possible willingness to mislead me for your own convenience; then you probably aren't going to be my child's pediatrician much longer.
> The severe cases seem to happen in 1:1 million cases or rarer for the vaccinations I looked at. Even across all of the vaccinations, it's unlikely that your doctor's office would have had that happen to one of their patients.
Unless death is the only thing you qualify as serious, you are mistaken. Even with the shabby state of data collection, and the even shabbier state of medical studies, severe adverse reactions are evidently more common than 1:1e6. Look at pretty much any vaccine label for evidence to support that. I haven't access to our former ped's books, but I would expect them to have given tens maybe hundreds of thousands of vaccinations per decade as a conservative estimate. Consider the number of vaccines recommended by the CDC schedule http://www.cdc.gov/vaccines/parents/downloads/parent-ver-sch...
>What should the doctor have done to improve your sense of confidence? Run a test for pertussis even though your child didn't have the symptoms for the disease?
The child did have the symptoms of the disease[1][2].
Additionally, as I stated, about that time, there was a "Massive Pertussis (fear mongering) Outbreak" in the news, with periodic reporting and shaming of vaccine refuseniks. Yes, absolutely, the ped. should have run a test. But the main thing that any ped. can do to inspire confidence is not to be dismissive of parents' concerns or questions. If instead of waving more CDC pamphlets at us, she had mentioned VAERS, or anything resembling even a vague and non-specific something like VAERS she would probably still be our ped.
Is it not enough that I vaccinate my kids for infectious diseases, despite my suspicions that all may not be right in the world of vaccines[3], but you expect me to do so with unreserved faith in the manufacturers of vaccines, and the government?
[2] Pertussis symptoms are quite like the symptoms of Influenza, and many other childhood ailments.
[3] I don't question the science of immunology or epidemiology. I question the claim that in practice, vaccines are manufactured, distributed, and administered with a near miraculous failure rate.
Yes, we have different definitions of "good data."
"Good data" for me is enough to establish if there's a public health need. "Good data" for you is much, much higher.
"the test indicates that the last X vaccination was ineffective"
And perhaps impossible. Do these tests even exist? In the various papers I read, there are tests for given antibodies, but the only hard numbers I saw are the infection rates. What's the false positive/false negative rate for these tests? How much do they cost? Who should pay for them, and what's the effective benefit?
Also, the test doesn't need to be 100% effective in everyone in order to be useful. That's the logic behind herd immunity.
"Look at pretty much any vaccine label for evidence to support that."
I did look at the Vaccine Information Statements for several vaccines. I pointed you to one as well.
DTaP: Severe Problems: 1) Serious allergic reaction (less than 1 out of a million doses), 2) Several other severe problems have been reported after DTaP vaccine ... These are so rare it is hard to tell if they are caused by the vaccine.
Hepatitis B: Severe Problems: Severe problems are extremely rare. Severe allergic reactions are believed to occur about once in 1.1 million doses.
MMR: Severe problems: 1) Serious allergic reaction (less than 1 out of a million doses), 2) Several other severe problems have been reported after a child gets MMR vaccine ... These are so rare that it is hard to tell whether they are caused by the vaccine.
Then there's the ones that don't even have numbers, which I assume puts it in the "greater than 1 in a million" probability.
Meningococcal: Severe problems: Serious allergic reactions, within a few minutes to a few hours of the shot, are very rare.
Pneumococcal Conjugate (PCV13): Life-threatening allergic reactions from any vaccine are very rare.
Haemophilus Influenzae Type b (Hib): The risk of Hib vaccine causing serious harm or death is extremely small
Since I couldn't find one with < 1e6 probability of severe problems, perhaps you can point it out to me?
If your clinic has done 100,000 shots, then that's still under a 10% probability that any of their patients have had a problem. But the math doesn't work out as simple as that. If someone isn't allergic to DTaP the first time then that person likely isn't allergic to it the next 4 times. I estimate more like a 2% rate.
> there was a "Massive Pertussis (fear mongering) Outbreak"
Which was an outbreak mostly among those who have not been vaccinated. Your child had been vaccinated. (Well, you didn't say if this was after the 2 month, 4 month, or 6 month shot. If it started the day after the 2 month shot then the immunization wouldn't have started being effective. I don't have enough data to go on.)
> the main thing that any ped. can do to inspire confidence is not to be dismissive of parents' concerns or questions
Agreed. You have every right to make that decision. It is a proper one.
My argument is that your demands on the quality of the information you expect - personalized tests after every vaccination, for example - is not possible. It's expensive, even if feasible, and the major benefit seems to be that it makes people like you more confident.
But that data will also have vague and uncertain parts. It won't be a simple statement of "the last vaccine did not provide enough immunization" but "the number of antibodies is 10% lower than the recommended level. This may increase the risk that your child will be infected in the future by between 1% and 15% compared to full immunization. Enough other children have been immunized so the overall probability is very low, unless <list of circumstances>. Should you wish a booster shot, please contact your physician."
You complained about "waving more CDC pamphlets at us" -- interpretation of this additional data leads to still more CDC pamphlets.
"I question the claim that in practice, vaccines are manufactured, distributed, and administered with a near miraculous failure rate."
Why do you think it's 'near miraculous' any more than having potable fresh water come out of your tap? A clean water supply has probably saved more lives than all the vaccinations ever done in the US. We bathe in drinking water!
The vaccines which have the higher failure rates, like anthrax, aren't part of the normal schedule. The allergic reaction rate to the anthrax vaccine is ">100,000" so 10x higher than those children get.
The yellow fever vaccine lists "Severe allergic reaction to a vaccine component (about 1 person in 55,000)" and "Severe nervous system reaction (about 1 person in 125,000)" and "Life-threatening severe illness with organ failure (about 1 person in 250,000). More than half the people who suffer this side effect die." That's much higher than anything I saw on any of the childhood vaccines.
Let's look at some less successful vaccines.
The RTS,S malaria vaccine only reduced the chance of infection in children by 31%, which it lower than the 50% that the researchers had hoped for, and much lower than the 90+% from the best childhood vaccines.
The RV 144 HIV vaccine is estimated to be 31.2% effective, but "there is no more than a 71 percent chance that the vaccine was effective at preventing HIV." There are of course many AIDS vaccines which just plain didn't work.
The attenuated form of the polio vaccine would sometimes revert to a more virulent form, which caused vaccine-induced polio in about 1 in 750,000 cases. The US switched to the less effective inactivated form, because those rare polio cases aren't worth the advantage.
And so on.
The first vaccine was for smallpox in 1796. The first compulsory vaccine law was in England in 1853. The rabies vaccine was in 1885. The first polio vaccine in 1955. There's a lot of work behind that "near miraculous failure rate." Why are you so astonished?
For that matter, there are failure rates, just not at the level where you're looking. People get the wrong shots, last year "160,000 doses of the Novartis vaccine, Agrippal, [were] recalled after 'particles' were found in the vials", and this year Merck recalled "1 lot [27,000 vials] of Recombivax HB hepatitis B vaccine (adult formulation, 10 μg/mL) because some of the vials may be cracked."
And so on.
Why does any of this require you have "unreserved faith in the manufacturers of vaccines, and the government", any more than you have faith in the builders of your car, the maintainers of the traffic lights, or the pilots and builders of the plane you fly?
For a start "Good data" is data from independent sources, not merely clinical trial data provided by manufacturers. The need to collect "Good Data" doesn't stop after the clinical trial ends because there are many opportunities to screw up between the end of clinical trials and mass vaccination.
>what's the effective benefit?
It closes the loop. Researchers and manufacturers get data with which to improve their products. Patients get more confidence in the products they are administered. Increased confidence means more vaccinated people, and better herd immunity.
>Which was an outbreak mostly among those who have not been vaccinated.
It was also mostly fear mongering, and there were a fraction of those who contracted Pertussis who were vaccinated. Ped's shouldn't be surprised if this sort of thing biases the opinions of worried parents. I think baby's cough happened after the first or second of the series. Can't remember exactly, doesn't really matter. Baby is doing fine.
>Why do you think it's 'near miraculous' any more than having potable fresh water come out of your tap?
Because manufacturing and distributing pharmaceuticals is more complicated than digging a hole, pumping water through sand filters and adding Chlorine, a task that is routinely accomplished by people without even a high school education.
> A clean water supply has probably saved more lives than all the vaccinations ever done in the US.
Yes, I know, isn't it great? But vaccines often get the credit.
>We bathe in drinking water!
The significance of this isn't lost on me. I have visited developing countries, and lived in China, where tap water is usually not considered safe to drink.
>My argument is that your demands on the quality of the information you expect - personalized tests after every vaccination, for example - is not possible. It's expensive, even if feasible, and the major benefit seems to be that it makes people like you more confident.
It probably is too expensive to achieve 100% testing, that's a high bar. Continuous sampling? I think it not too big a challenge or too expensive. I'd bet that some people would even pay extra for it if they had too.
>the major benefit seems to be that it makes people like you more confident.
Do you want herd immunity or don't you? It's not as though I am the last doubter.
>But that data will also have vague and uncertain parts. It won't be a simple statement of "the last vaccine did not provide enough immunization" but "the number of antibodies is 10% lower than the recommended level. This may increase the risk that your child will be infected in the future by between 1% and 15% compared to full immunization. Enough other children have been immunized so the overall probability is very low, unless <list of circumstances>. Should you wish a booster shot, please contact your physician."
We need some meeting place between the raw data in .csv vs "Just Take, All The Vaccines" Maybe I'd trust Nate Silver to tell me, if he showed me some pretty charts. It needs to be understandable by a lay-person.
>You complained about "waving more CDC pamphlets at us"
Well, obviously, they aren't effective on everyone. Why would more of them be more effective?
>For that matter, there are failure rates, just not at the level where you're looking. People get the wrong shots, last year "160,000 doses of the Novartis vaccine, Agrippal, [were] recalled after 'particles' were found in the vials", and this year Merck recalled "1 lot [27,000 vials] of Recombivax HB hepatitis B vaccine (adult formulation, 10 μg/mL) because some of the vials may be cracked."
No, that's exactly the sort of thing that worries me. And no amount of historical safety data can prevent a mishap like those you mentioned from occurring.
>Why does any of this require you have "unreserved faith in the manufacturers of vaccines, and the government", any more than you have faith in the builders of your car, the maintainers of the traffic lights, or the pilots and builders of the plane you fly?
Cars are not a great example, I can choose not to buy a crappy car because they performed poorly in crash tests. Planes are a little better, and you know what? I don't really want to ride in a 787 until they fix those batteries, and I can choose not to fly Northwest because of their maintenance problems (well before they went under). But in general, I am mostly unimpressed with the FAA. But, I have very small latitude WRT my choices of vaccines. A gov't agency purposefully crashes example cars to prove their safety, it is unethical to try the same thing with people. But neither the FDA nor the CDC appear to take much interest in providing better oversight. I expect more. Sorry if you think it is too expensive or not worth it. I don't agree.
Our youngest developed a _very_ bad cough in the days/weeks after receiving the DTaP. We called the pediatrician who gave us the standard advice, to monitor the baby and bring her in if it worsened. We later did take the baby in for the cough. The doctor began dissuading us from the idea that it was Pertussis or related to the vaccination, before seeing the baby, and despite local news reports indicating a local increase in Pertussis cases[1]. The doctor had a look at the baby, and told us again it probably wasn't Pertussis, everything was normal (except the cough and low grade fever), ran a blood test for Influenza (tests confirmed that it wasn't Influenza), and told us to use a humidifier. I asked what the procedure (WRT both treatment and reporting) would be if it had been a possible or suspected vaccine adverse reaction. The doctor said they had _never_ had any reportable cases of vaccine adverse reaction and indicated a general lack of knowledge of adverse event reporting requirements. The clinic where this occurred was right across the street from the hospital that baby was born in, in the Medical Center in Houston, Texas, and is part of a large and well respected practice. Considering the number of patients that clinic has (it is a busy practice, with several clinics), even considering the low expected rate of serious adverse vaccination events, it is not possible that this clinic has never had a reportable event, and very unlikely that there were no serious adverse events. Baby might not have had Pertussis and baby is fine now. But, the experience turned my skepticism into a lack of confidence, at least with that particular clinic.
[1] http://www.chron.com/news/houston-texas/article/Whooping-cou...