From a quick Google, it seems that Phase III trials are about comparing a new treatment to existing alternatives, rather than monitoring side-effects. Perhaps the testing simply can't be complete before 2023, since it involves checking long-term immunity? In this case, the FDA may have approved the vaccine because they are confident that the risk of negative side-effects is sufficiently small, and that the vaccine gives some benefit - even if testing hasn't established exactly how much.
[0]: https://www.theguardian.com/commentisfree/2021/jun/28/alzhei...
Also to be fair it's not like they just rushed it out the door. There are probably very few things on the market (short of fully approved pharmaceuticals) that have been through more testing than these "rushed" vaccines.
edit: https://www.fda.gov/vaccines-blood-biologics/vaccines/emerge...
A drug should be approved once it is very likely causing more good than harm. But obviously that doesn't mean you should stop researching that drug.
What's happening here makes perfect sense. We have more than enough information to conclude that it is extremely likely that the vaccine helps a lot and causes little harm. However if there are any rare side effects then we'd still like to know that, therefore it is a good thing that the patients in the trials are still being observed for anything unusual.
Err, that sounds really scary and wrong to me. Seems to me that a drug should be approved when all the side effects are known, results are well characterized among a large sample set over a sufficiently long time frame, and it is determined that the drug is "safe" in the absolute sense.
It may be the case that we are better off taking a vaccine in a pandemic _even though we are not 100% sure it is safe_ due to the opportunity cost, and that's what emergency authorizations are for.
Even if the FDA really did their due diligence here, it will not convince anyone who was not already convinced; it is obvious that they were going to approve it no matter what, because the political fallout of not approving it after so many people have taken it would permanently destroy what trust remains in the US public health system.
How long is sufficient? How large of a test group is sufficient?
In the "absolute" sense, there is no known drug that is safe. That is extremist thinking that only serves to muddy the waters of the actual debate, which should be: "how safe is safe enough?"
> we are not 100% sure it is safe
Note that "100% sure" does not mean "100%" safe. So how much safety do you need a 100% assurance for? How do you quantify the safety?
> that sounds really scary
How does this not just describe life in general? And how does that help policymaking? I don't think our species would have made it to the agricultural revolution if that was the overriding force for anything.
> it will not convince anyone who was not already convinced
This also strikes me as a poor consideration for any policymaker, as they likely know that at the onset to any such policymaking. This adds nothing new or interesting to the debate.
