I’m not antivax or anti-medicine in any way but shouldn’t the null position be don’t inject things into your body and then it takes at least some evidence to overcome that?
Well, there are plenty of approved drugs with tests and clinical trials that were later withdrawn from the market for being dangerous. What I'm saying is that the process is not infallible and in some cases it proved to be susceptible to corruption. We need to improve the process and that's not going to happen by blindly trusting Big Pharma.
Of course it's not infallible but you have to "put up or shut up". Saying the FDA is fallible is not evidence that vaccination recommendations are in error. A country not recommending a vaccine is not evidence that the vaccine doesn't work or is dangerous. What data did they use to make that decision?
Suppose the FDA, as opposed to Norwegian authorities, approved the vaccine with an indication of over 65, pregnant women, and those with serious underlying conditions. It could be taken off label by others but that was the approval. Would you then say healthy 18-22 year old should not take it?
Clinical trials gets a drug approved for use. It proves that the drug meets certain safety requirements.
Just because a drug is approved doesn't mean you should take it indiscriminately. It is "safe" to drink NyQuil every night. Doesn't mean you should. If it confers no benefit to you in your unique circumstance, you shouldn't take it. Hence, the booster is not recommended for certain groups - because it is not needed and provides no benefit.
> If the Phase 2 trials indicate that the drug may be effective--and the risks are considered acceptable, given the observed efficacy and the severity of the disease--the drug moves to Phase 3.
Yeah but the FDA is famous for approving expensive drugs that have no/little effect. So at least in the USA if a drug is approved it doesn’t mean it does anything useful
Fame is about one spectacular thing not usally a body of work. There are lots of drugs they routinely approve but it’s how they handle the big controversial ones that shape the public image