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Re:Pfizer Covid vaccine approved for use next week in UK by refurb on Wednesday December 02, 2020 @09:15AM (#25276484)
proven it safe and effective

Having worked in the pharmaceutical industry, if I ever said my FDA approved drug was "safe and effective" I'd have the FDA dropping the hammer on me.

The FDA does not prove a drug is safe. No drug is 100% safe. The FDA determines whether the risks of the treatment are outweighed by the benefit.

I have no doubt that additional safety signals will pop up from Covid vaccines as the treated population expands by 100x. Most likely they will not be severe and the risk will still outweight the benefit.

But to say "we've tested the vaccine on a 15,000 people so we know it's safe to vaccinate 1B+ people" is not something the FDA would agree with.

Re:Pfizer Covid vaccine approved for use next week in UK by njarboe on Wednesday December 02, 2020 @11:06AM (#25277653)
Nothing is 100% safe. The word "safe" is used by almost everyone to mean a feeling they get. Something is safe to them if it feels safe. Flying is "safe" if you don't fear flying. It is not if one is afraid of getting on an airplane. Is driving a car "safe"? It is if you don't feel scared when driving in a car. Any other use of the word would need to have some statistical evaluation of the situation. Saying the risks of the treatment are outweighed by the benefit is a great rational way of saying drug is safe enough to use, but most people don't use the word safe in that way.

To me a chainsaw is a safe tool to use. Dangerous, but safe. To others it is not. Is a chainsaw a "safe" tool?

Re:Pfizer Covid vaccine approved for use next week in UK by MauranKilom on Thursday December 03, 2020 @03:17PM (#25294149)
I don't know if it's different in pharmaceutics, but for medical devices it is literally all about proving a product "safe and effective".

And the FDA itself talks about approved drugs being safe and effective: https://www.fda.gov/drugs/drug-information-consumers/fdas-dr...

Re:Pfizer Covid vaccine approved for use next week in UK by refurb on Friday December 04, 2020 @07:00AM (#25301370)
It might be a matter of "do as I say, not as I do". If you look up prior FDA violations, you'll see the FDA get pretty ticked about not clearly laying out the safety risks of a medication - as such, using language such as "our drug is safe" would go directly against that.

The FDA is incredibly strict when it comes to advertising. I remember reading about one violation where the ad had a tagline for an ADHD medication "So you can concentrate on the important things" and showed a picture of a child studying. The FDA said "the image implies that your medication will improve the ability of a child to study and you have submitted no data to the FDA to support this claim".

Re:Pfizer Covid vaccine approved for use next week in UK by johnisgood on Wednesday December 02, 2020 @02:55PM (#25280759)
Oh boy, these people completely have missed the approved, and then later withdrawn medications. There have been quite a fuckton of them, or late black box warnings.
Re:Pfizer Covid vaccine approved for use next week in UK by ulfw on Wednesday December 02, 2020 @01:17PM (#25279440)
Using a laptop isn't safe either. It's batteries might literally explode in your face.

Happens extremely rarely though.

Re:Pfizer Covid vaccine approved for use next week in UK by vkou on Wednesday December 02, 2020 @12:15PM (#25278618)
A seatbelt might strangle you in one in a million crashes, but colloquially, we can all agree that seatbelts are safe.

No drug is safe, but in this case, not taking a drug is not safe. If it's safe enough to vaccinate 15,000 people, when 300 of them are expected to die without vaccination, it's incredibly unlikely that side effects discovered on 1 billion people will not make the vaccine the safe choice.