[shajznnckfke]

There’s no hard line where we need to test for t months, and then we will find out if the vaccine is safe. There is no magic threshold where suddenly we know the answer for sure. It’s more like: the size of the error bars on our estimate of the harm y in quality-adjusted-life-years (QALY) is constrained by some function on the time t, where there is diminishing returns as t increases. It’s always going to be possible that there’s some side-effect that doesn’t show up until t+1 months.

Further, we could build an expression of our estimate z of the total harm caused by the virus (including downstream harms like “deaths of despair” from economic damage). By minimizing y-z over t, we can find out the best time to release the vaccine (maybe to the most at-risk populations first).

I don’t think anyone at the FDA is doing this calculation. I think they are just trying to get y below some threshold, which is probably quite low compared to z. My goal in this conversation is to advocate for the people who will suffer and die because of that gap - and hope there is someone better qualified than me that fills that role in the government helping decide what to do. My fear is that the FDA is a highly conservative institution using processes that aren’t well-adapted to the current epidemic.

To add more color, I think if the vaccine comes out with unexpected side-effects, heads will roll at the FDA. But no heads will roll at the FDA over the many thousands who could have been saved by releasing a vaccine sooner.

[hilbertseries]

I don’t think your fear is well founded. The fact that these vaccines are already in phase 3 trials, despite being developed earlier this year, is a testament to how much the FDA understands the current situation. Look up how long it usually takes a vaccine to get from development to phase three trials, I can guarantee you it’s not six months. People in this thread are quite alarmist. Vaccine trials usually take a long time, because whatever is trying to be cured isn’t a pandemic. In a pandemic you can run trials and get results quickly in a large area. Any side effects of these vaccines are going to show up quickly, it runs through your bloodstream and then your immune system takes care of it. We’re running large phase three trials and we’ll have a sense of effectiveness and general safety in a few months.

[nfw2]

Fauci spoke on this matter recently. He said that phase 3 completion is not dependent on time, but rather dependent on the number of events (infections) in the control group.

This to me suggests the main blocker for approval now is proving efficacy, and that we already have enough data to conduct the time-based safety analysis you described with reasonable confidence.

There is another potential safety concern that the vaccine could exacerbate COVID infections. I don't know how critical this concern is, but it would also be constrained by number of infection events, not time.