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I'm confused by the FDA. So last June, there were 3 COVID vaccines that passed phase I clinical trials and animal challenge studies. There was an active pandemi

I'm confused by the FDA. So last June, there were 3 COVID vaccines that passed phase I clinical trials and animal challenge studies. There was an active pandemic raging, and vaccines were almost certainly had 100x less risk for those over 65 (a statistical no brained) But somehow, they kept all vaccines banned for another 6 months killing hundreds of thousands. Nothing. But in the last week they approved an Alzheimer's drug that basically doesn't work (they have 9 years to prove it) and a smallpox drug with no human studies. Why couldn't we have unbanned the vaccines long before we did? Those that said we can't possibly approve something without following an exact process this week we're just totally proven wrong. I think the bar for "not banning" should be lower. The bar for "medicare must pay infinity dollars for it" should be higher.

peter422 5y ago
Not all the vaccines worked. You are taking for granted the knowledge we have now about the vaccine efficacy. If there were no efficacy studies we could easily have wasted precious manufacturing and logistical resources in an ineffective vaccine which would have cost even more lives. Not to mention increasing the vaccine hesitancy which is already a massive problem.
jrowley 5y ago
> FDA approved Tembexa under the agency’s Animal Rule, which allows findings from adequate and well-controlled animal efficacy studies to serve as the basis of an approval when it is not feasible or ethical to conduct efficacy trials in humans. How doesn’t this make sense?
aaomidi 5y ago
Vaccines are usually tested for a much higher standard because It's generally taken by a LOT of people and to PREVENT something. It's a proactive medicine rather than reactive. FDA is a lot less strict with reactive medication, especially in cases where the disease is just fucking awful. This is also the technical reason why male birth control hasn't hit the market yet. They don't consider pregnancy to be an issue for men, but do for women. Hence they tolerate the side effects of BC for women a lot more.

peter422 5y ago

Not all the vaccines worked. You are taking for granted the knowledge we have now about the vaccine efficacy. If there were no efficacy studies we could easily have wasted precious manufacturing and logistical resources in an ineffective vaccine which would have cost even more lives. Not to mention increasing the vaccine hesitancy which is already a massive problem.

jrowley 5y ago

> FDA approved Tembexa under the agency’s Animal Rule, which allows findings from adequate and well-controlled animal efficacy studies to serve as the basis of an approval when it is not feasible or ethical to conduct efficacy trials in humans. How doesn’t this make sense?

aaomidi 5y ago

Vaccines are usually tested for a much higher standard because It's generally taken by a LOT of people and to PREVENT something. It's a proactive medicine rather than reactive. FDA is a lot less strict with reactive medication, especially in cases where the disease is just fucking awful. This is also the technical reason why male birth control hasn't hit the market yet. They don't consider pregnancy to be an issue for men, but do for women. Hence they tolerate the side effects of BC for women a lot more.