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Re:Harvard mandates the bivalent Omicron-specific Covid-19 b... by bradleyjg on Tuesday November 29, 2022 @09:09AM (#33787747)
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?
Re:Harvard mandates the bivalent Omicron-specific Covid-19 b... by 2OEH8eoCRo0 on Tuesday November 29, 2022 @09:22AM (#33787905)
It is, hence tests and clinical trials.
Re:Harvard mandates the bivalent Omicron-specific Covid-19 b... by dahfizz on Tuesday November 29, 2022 @10:09AM (#33788480)
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.

Re:Harvard mandates the bivalent Omicron-specific Covid-19 b... by 2OEH8eoCRo0 on Tuesday November 29, 2022 @10:29AM (#33788735)
Safety is half of it. Clinical trials also gather evidence of beneficial effects.

https://www.fda.gov/drugs/information-consumers-and-patients...

> 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.

Re:Harvard mandates the bivalent Omicron-specific Covid-19 b... by rdtwo on Tuesday November 29, 2022 @10:52AM (#33789066)
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
Re:Harvard mandates the bivalent Omicron-specific Covid-19 b... by 2OEH8eoCRo0 on Tuesday November 29, 2022 @12:19PM (#33790339)
They're famous for it? How many total drugs have they approved and how many were later found to have issues?

This year it appears they've approved 30 and last year they approved 50. That's quite a few.

Re:Harvard mandates the bivalent Omicron-specific Covid-19 b... by rdtwo on Tuesday November 29, 2022 @12:52PM (#33790779)
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
Re:Harvard mandates the bivalent Omicron-specific Covid-19 b... by sfusato on Tuesday November 29, 2022 @11:12AM (#33789366)
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.
Re:Harvard mandates the bivalent Omicron-specific Covid-19 b... by 2OEH8eoCRo0 on Tuesday November 29, 2022 @11:53AM (#33789984)
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?
Re:Harvard mandates the bivalent Omicron-specific Covid-19 b... by bradleyjg on Tuesday November 29, 2022 @02:56PM (#33792394)
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?