Would you give alpha version to people you love? Why is this concern downplayed? I understand statistics but we have no clue what could go wrong in an early version of a new technology and no data on long-term impact. It's all a big experiment.
Drug development is usually serialized because it's so expensive. Why produce a bunch of drugs if it's going to be thrown away? Operation warp speed said let's just throw money at the problem so we can parallelize as much as possible, knowing that if it doesn't work out (effective, safety) then we as a country just ate the cost of trying. My understanding is the clinical trial parts weren't any different than would normally be done.
AFAIK vaccine safety is usually determinable within a few months. That is to say, if anything bad happens, it'll happen soon and not years later. Because enough months had past with larger and larger groups looking ok, plus extreme effectiveness, then emergency authorization was passed.
You could say emergency authorization is alpha/beta. But that alpha/beta has now been rolled out to hundreds of million of people and the safety profiles haven't changed from the clinical trial modeling. And if the failure probability is all up front, and we've already passed those milestones, then are we really still in alpha/beta territory?
mRNA vaccines are also not a new technology. They've been used for years now.
> Would you give alpha version to people you love?
If the option is an alpha which is passing all the 'unit tests' so to speak, or let them get covid and have far higher risk of dying or permanent disability, I'd for sure choose the alpha.
I wouldn't say alpha testers and probably not even beta testers. They did clinical trials for these vaccines in 2020 with tens of thousands of volunteers long before these were approved by the FDA and other regulatory bodies! And as I will explain in a second, these clinical trial patients were actually more like beta testers than alpha testers.
The short version is that mRNA vaccines have been around for ~40 years with pretty well identified side-effects and risk profiles. The use of an mRNA vaccine for COVID is a new application of existing technology. One comparison might be the flu vaccine. You get an annual flu vaccine that has <1 year of testing for that specific vaccine because the flu mutates every year. But the underlying technology is the same across all major flu vaccines, so you don't need multiple years of testing to ensure the safety and efficacy of it. You really only need to make sure that certain risk profiles aren't exacerbated and that the efficacy remains within reasonable expectations. In short, the mRNA vaccine that powered the COVID vaccine has already been well-tested, and the testing Moderna, Pfizer, and others did in the last 18 months were more about testing the safety and efficacy of the specific version of the vaccine than the overall technology.
Another comparison for the HN crowd might be that it's more like the difference between the iOS 14 and iOS 15. That is, the vast majority of the OS hasn't changed that much and has been thoroughly tested, and most of the testing is focused on the new features/major changes. You don't need 5 years of testing to uncover every bug in iOS 15 -- one year should be plenty to find the major offenders. When Apple releases iOS 15, they do so basically saying "based on our testing, this is stable enough to be a benefit to >99% of our users and we think you would be best served by upgrading from iOS 14 to iOS 15." They are not promising no bugs at all, but rather saying that the major vulnerabilities and side effects have been patched/mitigated. Similarly, the pharmaceutical companies and the regulatory bodies like the FDA are suggesting "this is safe and effective, with the risk of side effects A, B, C, D..."
(Source: my wife is a microbiologist who works on vaccines for pharma companies)
I'm having trouble reconciling your statement with Wikipedia's claim that the Pfizer vaccine is "the first mRNA vaccine to be authorized for use in humans"
https://en.wikipedia.org/wiki/Pfizer%E2%80%93BioNTech_COVID-...
Absolutely I would.
What's the alternative?
Waiting 3 years for data whilst the virus continues to kill indiscriminately and desperately hoping that you or your loved ones don't get infected?
Someone else in these comments summed up my feelings about the whole thing pretty well:
> Are they safe? Almost certainly. Do we know that for sure yet? No. Do the benefits outweigh the risks? For me, yes.
If the alternative is a O(1%) chance of dying from the disease? You'd better believe I would (and did).