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Re:Pfizer Covid vaccine approved for use next week in UK by samcheng on Wednesday December 02, 2020 @03:36AM (#25274432)
The 'beta' test already happened. Tens of thousands of people have proven it safe and effective. Haven't you been following the news?

Selfishly, I guess we should be happy that there is an anti-vaxxer sentiment; it means the rest of us will get our vaccines faster.

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.

Re:Pfizer Covid vaccine approved for use next week in UK by J-dawg on Wednesday December 02, 2020 @05:48AM (#25275237)
Conversely, I am finding the reaction to anti-vaccine sentiment from some politicians to be pretty creepy. Already there is talk of compulsory vaccination or "vaccine passports". Labour (the UK opposition party) were even calling for spreading "misinformation" online to be illegal.

I find this ridiculous considering the massive challenge we have ahead of us just to get the vaccine to the millions of people who desperately want it.

Sure, if we get to the point where everyone who wants the vaccine has had it, and there are still people dying from COVID, then we can discuss illiberal measures to increase vaccine take-up. (I'd still be opposed to them).

Getting worked up about this stuff when not a single person (outside of the trial groups) has been vaccinated yet just demonstrates our politicians' (on all sides) tendency towards authoritarianism.

Re:Pfizer Covid vaccine approved for use next week in UK by spuz on Wednesday December 02, 2020 @09:24AM (#25276552)
I'm not sure I agree. The maths says that we need about 70% of the population to take the vaccine in order for it to no longer be a threat. We also have polling that says about 53% will refuse to take the vaccine. So we're already at the point where something else must be done such as adding incentives, a passport system or better advertising etc. OR continued lockdown measures and enforcement of mask wearing. It's not a theoretical problem we're already there.

https://www.itv.com/news/2020-11-10/covid-vaccine-will-enoug...

Re:Pfizer Covid vaccine approved for use next week in UK by J-dawg on Wednesday December 02, 2020 @09:33AM (#25276637)
> The maths says that we need about 70% of the population to take the vaccine in order for it to no longer be a threat

...to no longer be a threat to an unvaccinated person.

This isn't like the childhood vaccines, where we need herd immunity to protect the children who are too young to be vaccinated.

Provided that everyone who wants the vaccine can get it, I don't see the problem with letting everyone else make their own decision.

The current priority list of people is nowhere near 70% of the population anyway. Most people under 50 won't have the opportunity to be vaccinated for months. So this absolutely is a theoretical problem, at least for now.

Given that Covid is such a mild disease for most young people, I predict that by the time the elderly and vulnerable have been vaccinated, this will be a non-issue anyway.

Re:Pfizer Covid vaccine approved for use next week in UK by throwaway3699 on Wednesday December 02, 2020 @10:04AM (#25276941)
Yeah, the only reason I'm holding to the guidelines is for elderly and immunocompromised. I don't care about catching covid and nor anybody I know not in one of those categories.

This whole thing becomes moot once the vulnerable are vaccinated, no need for creepy immunity passports.

Re:Pfizer Covid vaccine approved for use next week in UK by sbilstein on Wednesday December 02, 2020 @11:52AM (#25278293)
I used to agree but a few of my 20-29 year old friends have had much worse experiences than expected. One had some neurological side effects, which is rare but happens, that affected his eye movement and made it impossible for him to read or work comfortably.

It wasn't healing and it turned out he had an undetected issue processing folic acid I believe, which has an effect on how your body heals from neurological damage. He's recovering now after 3 months but has to take folic acid and other supplements 5 times a day.

Other friends have had persistent diminished lung capacity for months on end; these are folks who had no co-morbidities and in their 20s.

Re:Pfizer Covid vaccine approved for use next week in UK by throwaway3699 on Wednesday December 02, 2020 @12:33PM (#25278834)
There are much more dangerous things to worry about in life. I'm happy to take chances with Covid, the only thing I won't do is risk hurting others.
Re:Pfizer Covid vaccine approved for use next week in UK by sbilstein on Wednesday December 02, 2020 @04:26PM (#25281860)
Yea I'm not totally concerned about catching it but if I do, I increase my likelihood of hurting others. That's been the logic of most of my peers (early 30s, late twenties).

However, through my partner I am friends with many classical singers. They are absolutely worried about damaging their instrument.

Re:Pfizer Covid vaccine approved for use next week in UK by cr1895 on Wednesday December 02, 2020 @10:20AM (#25277088)
>This isn't like the childhood vaccines, where we need herd immunity to protect the children who are too young to be vaccinated.

It's not only too young children who might not be legitimately unvaccinated...some people who are immunocompromised or otherwise medically unable to take certain vaccines must also rely on herd immunity for protection.

Re:Pfizer Covid vaccine approved for use next week in UK by kazinator on Wednesday December 02, 2020 @10:29AM (#25277169)
Where I live, two-month-olds are scheduled for a comprehensive vaccination.

https://immunizebc.ca/sites/default/files/graphics/vaccine-s...

Re:Pfizer Covid vaccine approved for use next week in UK by bluGill on Wednesday December 02, 2020 @10:58AM (#25277551)
That isn't comprehensive. Some vaccines don't work until the kids are older.
Re:Pfizer Covid vaccine approved for use next week in UK by macintux on Wednesday December 02, 2020 @10:37AM (#25277268)
> ...I don't see the problem with letting everyone else make their own decision.

Pandemics have, since time immemorial, been an exception to the "I can do what I want" rule.

Much like allowing parents to fall into conspiracy theory traps and refuse to allow their children to be vaccinated against measles, resulting in that disease suddenly becoming a threat again, if we're going to get back to normalcy we can't let half the population ignore the vaccine.

But, since we are going to let half the population ignore the vaccine, prepare for a long, drawn-out period of time during which the disease will flare up, lockdowns will be imposed, more people will needlessly die, and conspiracy theories will continue to make a mockery of civilization.

Re:Pfizer Covid vaccine approved for use next week in UK by nkohari on Wednesday December 02, 2020 @12:59PM (#25279188)
If there is an effective vaccine which is readily available to anyone, there is no need for lockdowns.
Re:Pfizer Covid vaccine approved for use next week in UK by macintux on Wednesday December 02, 2020 @01:33PM (#25279630)
People who don’t use the vaccine and get sick still have an impact on healthcare systems.

People who do take the vaccine are likely still able to spread the virus.

The pandemic is not going to go quietly any time soon.

Re:Pfizer Covid vaccine approved for use next week in UK by nkohari on Wednesday December 02, 2020 @02:52PM (#25280729)
It's still unknown whether vaccines convey sterilizing immunity. Even if they don't, there will be no political will to institute lockdowns if the people who are getting sick could have been vaccinated. If unvaccinated people getting Covid-19 creates undue strain on the healthcare system, the calls will be for mandatory vaccination, not for lockdowns.

Restricting social interaction and business is a crushing approach to solving the problem, with severe consequences to health and economics. It's brute force, like securing a computer using an air gap. The only reason lockdowns have been used in 2020 is because we have no other options available, but a free and readily-available vaccine changes the calculus.