The problem is also that there is political pressure to approve it. That sucks. Whatever time it takes to go through the process is the time it takes. Pushing it through is only going to do two things: 1) show that the process is political and that FDA approval is fungible and 2) make us wonder what the purpose of it is and why we should ever do it at all after this, if it can just be bypassed when politically convenient. Is it just fat to be trimmed?
FDA approval does not confer safety and efficacy. It it there to report empirical safety and efficacy.
FDA regularly revokes approval. That should count for something.
Yeah, it's a tough situation for sure. I've been wondering if there's a more creative solution that could be implemented here. Like someone from the FDA coming and saying, hey, we obviously won't know long term effects with 100% certainty until a few years pass, but all the signs we're seeing indicate the vaccines are just as safe as any other vaccines up to this point, we've gotten it ourselves, and it's our belief that you should feel safe getting it too. Or the FDA inventing a new type of temporary approval for epidemics or something like that that basically means "we feel this is safe enough to mandate amid outbreaks, but not otherwise". (An EUA seems almost similar, but to me it means "this is safe enough to use in an emergency", not mandate.)
The FDa is keenly aware of the political load in arriving at a decision, but knows getting it wrong means the FDA itself could dissappear. They they have yet to blink on the matter.
Therefore they err on the side of logic and let time do its thing (uncover hidden risks) for which the populace should be grateful
I think it's more of the limitation of liability at this point. Whether or not any central authority endorsed it is moot when 100 million doses have been given.
The big problem for me is in making light of the process that, perfect or imperfect, is a extremely important in a for-profit pharma paradigm.
> I think it's more of the limitation of liability at this point.
Yeah that's definitely a big part of it. But that's for something for people to factor in on their own, if they so choose. It's not really a fact for the government to base mandates on, unless you only look at public health and ignore all other facets of the issue.
> Whether or not any central authority endorsed it is moot when 100 million doses have been given.
It might be moot from a public health standpoint, but it's not necessarily moot from a public policy or governmental standpoint. Like it or not, rightly or wrongly, it can have significant impact and repercussions if the government starts doing something half the population doesn't like, and then turns around and says, "Ok well, now we all agree the issue is moot, right? so let's force this thing onto everybody. Despite our own experts not having approved it yet."
>It might be moot from a public health standpoint, but it's not necessarily moot from a public policy or governmental standpoint.
100%.
We need to continue to be vigilant and to keep public trust. That's currently at stake.
Also agree on everything else you bring up. Especially:
> now we all agree the issue is moot, right?
This is exactly what I was trying to say initially. If the attitude is: what's done is done and therefore we don't do this going forward; then that's a major loss for society. That can't be the outcome.
I agree, but it's too late for the process to work to be protective of the population from a drug defect. If FDA finds that there is a critical issue, that's good to know, but what do we do now?
FDA approval does not confer safety and efficacy. It it there to report empirical safety and efficacy.
FDA regularly revokes approval. That should count for something.