Pfizer submitted their vaccine to the FDA for Emergency Use Authorization the other day. The FDA says they'll have a meeting to discuss the application on December 10th.
By then at least 40,000 more Americans will have died of COVID — more than ever died in the Korean War.
I disagree that the FDA should get a say over whether people can take a vaccine — that should be up to those people to decide what risks they're willing to take.
But even setting that aside, while the trial may produce 100,000s of pages or millions of pages, what really matters is a statistical analysis of COVID cases in the treatment vs control, and of adverse outcomes / side-effects in the treatment vs the control.
That data is presumably already tabulated and it shouldn't take 20 days to reach a preliminary decision.
If there's not a prima facae case that it's more dangerous to take than not — especially for front line medical staff who will be getting it first and keeping in mind that 1 in 10,000 Americans will die of COVID in the next 2 weeks — they should allow them to roll it out, at least conditional on the people who receive it feeding back data on their COVID and side-effect outcomes.
If they keep analysing and change their mind they can withdraw the emergency use authorization.
It seems like a lot of why the FDA is content costing lots of net lives by being overly strict, is their own self-image as the world's super-cautious, super-conservative 'gold standard'.
And it does seem useful for there to exist a gold standard like that in the world. But I don't exactly see the need to make that organization identical with the organization that makes it legally permissible for people to buy medications in the US.
Why not have two separate designations, like 'FDA-approved' and 'allowed at your own risk', where the latter requires you to include lots of big warning labels and disclaimers on your product (and still requires you to prove some weaker level of harmlessness and/or obvious-net-benefit), but doesn't have to meet extremely demanding standards like current vaccines and medications?
The hope would be that 'Allowed at your own risk' could suffer reputational damage over the years, without that damage spilling over to FDA approval.