Pfizer-BioNTech coronavirus vaccine wins full FDA approval, potentially persuading the hesitant to g
Source: Washington Post
Federal regulators Monday granted full approval to the Pfizer-BioNTech coronavirus vaccine a milestone that could help increase inoculation rates and spark a wave of vaccine mandates by employers and universities amid a surge of new cases and hospitalizations fueled by the ferocious delta variant, according to two individuals with direct knowledge of the decision.
The Food and Drug Administration action marks the first licensing of a vaccine for the coronavirus, which has swept the United States in repeated and punishing waves since early 2020, exhausting nursing staffs, filling intensive care units and raising fears among the vaccinated and the unvaccinated.
Critics for weeks had demanded that the FDA move faster on approving the vaccine, arguing that the millions of inoculations administered since late last year under an emergency authorization demonstrated the shots safety and effectiveness. But even as the FDA redoubled its efforts, increasing staff and computer resources dedicated to the review, the agency insisted on six months follow-up data for people enrolled in the pivotal clinical trial.
In the end, the vaccine approval was the fastest in the agencys history, coming less than four months after Pfizer-BioNTech filed for licensing on May 7. The individuals with knowledge of the decision spoke on the condition of anonymity because they were not authorized to speak publicly.
Read more: https://www.washingtonpost.com/health/2021/08/23/pfizer-vaccine-full-approval/
Full Headline: Pfizer-BioNTech coronavirus vaccine wins full FDA approval, potentially persuading the hesitant to get a shot
No-Paywall Link: https://wapo.st/2XQFzxa
Scrivener7
(50,956 posts)chia
(2,244 posts)teach1st
(5,935 posts)Will more than likely find another excuse like "the approval was rushed."
chia
(2,244 posts)that they'd ever actually acknowledge safety or efficacy.
quaint
(2,566 posts)...are thrilled to be jabbed now knowing Medicare will pay if they have side effects.
chia
(2,244 posts)I don't know yet if minds have changed
Any minute now, that'll be a rallying cry of the dead enders.
Hortensis
(58,785 posts)is that the vaccines are giving delta TO vaccinated people, who are spreading it to all the sensible unvaccinated people. Apparently even they felt that, as excuses, freeeDUMM! and fighting the Jewish world order needed augmenting. And the list grows longer.
underpants
(182,834 posts)BumRushDaShow
(129,129 posts)Saving that!
BumRushDaShow
(129,129 posts)ETA to note this from the OP article -
Critics for weeks had demanded that the FDA move faster on approving the vaccine, arguing that the millions of inoculations administered since late last year under an emergency authorization demonstrated the shots safety and effectiveness. But even as the FDA redoubled its efforts, increasing staff and computer resources dedicated to the review, the agency insisted on six months follow-up data for people enrolled in the pivotal clinical trial.
In the end, the vaccine approval was the fastest in the agencys history, coming less than four months after Pfizer-BioNTech filed for licensing on May 7. The individuals with knowledge of the decision spoke on the condition of anonymity because they were not authorized to speak publicly.
Its been remarkably fast, said Holly Fernandez Lynch, a bioethics expert and lawyer at the University of Pennsylvania who said careful handling of the approval was crucial to potentially persuading the vaccine hesitant to receive the licensed product. You cant have it both ways. You cant have people saying they wont get vaccinated until theres full approval and then say the FDA has to hurry up and grant that approval.
Some experts predicted there would not be a huge bump in vaccinations following the approval, saying they were skeptical that vaccine-avoidant people would change their minds.It will provide an additional nudge but not make a huge difference, said Jesse Goodman, a former FDA chief scientist who is a professor of medicine and infectious diseases at Georgetown University.
(snip)
IMHO, this will move the needle for a fractional few, but I expect the rest only gave this as an excuse. However it will open the door for mandates because there are literally WHOLE SWATHS of people who have refused - and instead of them pointing at and blaming "black people" for not getting vaccinated - For. Reasons. - they need to look at people like the thousands of their own white cops or white nurses/health workers and other frontliners like some teachers, who have refused.
The critical thing to note here regarding all the RUSH RUSH RUSH push that was magnified by the media, is that if something weird happens later, the same media will be guaranteed to have amnesia, and then pivot to magnify the "they rushed it" nonsense.
The critical piece here is that they DID make sure they had a thorough review and also had the benefit of not only the actual trial data (from the original 44,000 participants), but have millions and millions of "real world" recipients data (along with any adverse events reports).
So there was actually WAY WAY more data available for this to determine efficacy compared to probably any previous vaccine in history - just due to the fact that we were and still are, deep in a pandemic.
Mr.Bill
(24,303 posts)was "rushed through" and normally it takes many years for it to be approved. I wonder how they think the annual flu shot gets approved every year?
BumRushDaShow
(129,129 posts)Which means the "full approval" was never their real reason.
But we need to make sure the media doesn't flip the switch to generate controversy about this effort and start touting the "it was rushed" narrative.
If anything, what really sped up the process for approvals of all types of products, whether drugs, devices, or biologics like the vaccines, was the advent of - hold onto your seat - "electronic transfers of documents" (instead of dozens of boxes of printouts being shipped).
Rebl2
(13,527 posts)It was just an excuse that many used.
wnylib
(21,497 posts)the ability to mandate vaccinations for employees, visitors, and members.
and I am very pleased with this.
BradAllison
(1,879 posts)The same assholes who want zero testing/regulation for anything?
SergeStorms
(19,204 posts)How can we trust a vaccine that was railroaded through the FDA, just so they can fill us full of tracking chips and alien DNA? Not me, I'm wise to their tricks. I'm not going to wind up being a government controlled zombie. 😤
They wouldn't get the vaccine before, ostensibly because it wasn't FDA approved.
Now that it's FDA approved, they'll find some other reason to reject it.
They'll always find a reason to reject the one thing that might save their lives.
That excuse is so transparent. Here we have people who hate the government, who think the government is evil, claiming that the vaccine is "experimental" because it hasn't been approved by that same government that they hate.
I can't ever wrap my head around the so-called logic these people use. Kinda like how they LOVE the military and the police so much, while apparently forgetting that the military and the police are government agencies.
SergeStorms
(19,204 posts)if they get in the way of their "constitutional right" to overturn a fair election that their messiah lost.
I don't know what Constitution they're referring to, but my pocket U.S. Constitution says nothing about being a complete, violent asshole if your guy loses (BIGLY!) a free and fair election. Nothing in my copy of the U.S. Constitution about that at all.
bucolic_frolic
(43,196 posts)It's merely a label on an ongoing successful vaccine. Those who view it as a political liberal plot to corrupt their mental purity will ignore the vaccine. You'd have to convince them the shot will give them death ray vision against liberals and minorities before they'd even consider vaccination for themselves.
BumRushDaShow
(129,129 posts)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
wnylib
(21,497 posts)justified and comfortable about mandating vaccines for employees, members, and visitors. That should move up the vaccinated numbers.
aggiesal
(8,919 posts)so Pendejo45 can not take or deserve any credit for this.
Hehehehe
IronLionZion
(45,462 posts)Fine with me. All this time unvaccinated people have been the control.
I do hope vaccination numbers will go up after this. Employers can mandate it for their employees now. Antivaxxers are welcome to go complain on tiktok about imaginary hippo rights or whatever.
Lasher
(27,598 posts)At last employers will be more empowered to require all their workers to get vaccinations. This will make a difference but I don't know how much.
And there is now no reason schoolchildren 16 years old and above cannot be required to get the vaccine. The test could come after the end of September.
From the linked article:
Moderna and Johnson & Johnson are also working on studies in children.
ETA: Changed schoolchildren 12 years old to 16, as it looks like the full FDA approval only covers kids down to 16.
any news there?