Sometimes taking chances is worth it. As far as I have heard, every single vaccine trial has concluded “yeah, our vaccine is effective.” So if people had been allowed to take experimental vaccines, the pandemic would have been a lot better.
In this circumstance as well, taking a chance is worth it. Even if the virus mutates, changing the mRNA vaccines shouldn’t take more than a week.
> So if people had been allowed to take experimental vaccines, the pandemic would have been a lot better.
> In this circumstance as well, taking a chance is worth it.
Nope nope nope nope. This is the literal example of survivor bias. You can't look at the results and use them to inform prior behaviour. The vaccine could have had catastrophic side effects.
All first 5 to be developed vaccines are pretty successful. So don't think survivor bias applies here. Also, what exactly are those catastrophic side effects? All the cases of "vaccine gone wrong" are pretty mild and most of them don't apply to BionTech/Moderna vaccines (since it doesn't include virus) or related to product problems, which don't depend on trials. If vaccines were started to be used after phase 2, thousands and thousand of lives could be saved. I think it's worth discussing. Especially with these new mRNA vaccines, where new one can be created within a month, it could be a new way to battle upcoming pandemics.
I think it is clear the regulatory framework wasn't ideal.
The last stage of the trial (which took three months) was not about if they were safe - but simply if they worked. Meaning, they were cleared to have minimal side effects, just unclear if it worked.
If you had approved people to choose to take the vaccine in August we could have had 50M people with shots already.
A lot of people have my skepticism that the main reason that the FDA didn't want to do that since it might be a bit of a media heartache for them, but so what. Even if you thought it would only work 20% of the time that 20% of the time it saves 100,000+ lives.
50M doses isn't something that gets suddenly summoned. It's a big logistics problem. Your assumption is valid only if the pharmas have capacity to make a extremely big amount of vaccine doses. That costs money and (I guess) materials, and both of those things could go towards a vaccine that is proven to be effective.
They had the vaccines in storage in October. Not as many as they had in December but they were just awaiting approval. The rollout would have been slower then with less to go around - but a headstart on the vulnerable population or potential spreaders would have been significant.
I think you misunderstand the clinical trial approval process. Yes, phase 2 is primarily about safety, but these are much smaller trials than phase 3, which in turn is much smaller than the post-marketing patient population (cohort). Safety issues routinely arise in phase 3, or even after, due to the much larger cohort sizes. Good phase 2 results are not proof of safety, rather an indication of safety. It is bordering on genocidal levels of reckless endangerment to release a vaccine for general use after Phase 2 in the hopes that it might be effective and is probably safe.
Whether or not it would have been a full three months I stand by my belief the current system was not designed for the cost-benefit of a raging pandemic.
The three month time of phase III had nothing to do with safety. That long period was only used because it took that long time for enough people to catch Covid naturally for them to prove statistical effectiveness. In the current system, if Covid had been raging at an extreme rate they would have had enough positives in the control group after a month and ended the trial then. If it had been under control, it actually would have taken many more months to declare effectiveness even though the extra wait time would have shown no more data on safety.
Whether or not phase II was sufficient on its own they could have declared the vaccine probably safe a month after phase III began instead of after three months. This would have still saved 50,000 lives in the US at minimum.
Do you think there were a bunch of experimental vaccines just floating around on the . . . dark web? ... That's not how it works. The vaccine makers themselves have no interest in distributing unproven vaccines. I myself was highly confident (and posted such on HN) that we would have a successful coronavirus vaccine, based on the scientific information available early in the pandemic. But it wasn't a surety. You must have a randomized trial or you risk very very bad outcomes. Some experimental vaccines (e.g., dengue) actually make the viral infection worse. Some don't work at all (e.g., Sanofi's covid vaccine). Heck Sanofi's vaccine is likely the easiest to manufacture and distribute. If we followed your "plan", it would likely be that most got the ineffective Sanofi vaccine and we would be moving dead bodies around with bull dozers as "vaccinated" people failed to practice social distancing.
They had to pull a few because of side effects during the trials and some just not working. Producing vast amounts before they have been tested at all would have been costly when they had to throw them out.
> Producing vast amounts before they have been tested at all would have been costly when they had to throw them out.
I'm under the impression that's precisely what the world governments did? There were bar charts going around saying that XX% of each country's supply commitments came from Pfizer or Astrazeneca or Moderna or whatever.
>The program promotes mass production of multiple vaccines, and different types of vaccine technologies, based on preliminary evidence, allowing for faster distribution if clinical trials confirm one of the vaccines is safe and effective. The plan anticipates that some of these vaccines will not prove safe or effective, making the program more costly than typical vaccine development, but potentially leading to the availability of a viable vaccine several months earlier than typical timelines.
In this circumstance as well, taking a chance is worth it. Even if the virus mutates, changing the mRNA vaccines shouldn’t take more than a week.