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teach1st

(5,935 posts)
Mon Aug 23, 2021, 09:38 AM Aug 2021

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 agency’s 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
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Pfizer-BioNTech coronavirus vaccine wins full FDA approval, potentially persuading the hesitant to g (Original Post) teach1st Aug 2021 OP
Great news! Scrivener7 Aug 2021 #1
Welp... takes away THAT excuse I've heard so many times... chia Aug 2021 #2
The people I know who use that excuse teach1st Aug 2021 #4
Oh, you can count on that. They'll move the goalposts as often as necessary to maintain the illusion chia Aug 2021 #6
The people I know who used that reason quaint Aug 2021 #11
One of the people I know spent 2 weeks in the hospital with Covid. chia Aug 2021 #14
+33. Harker Aug 2021 #19
As you say. A relative told me her dingdong daughter's latest excuse Hortensis Aug 2021 #21
Just turned to Fox News to see how they will move the goalposts underpants Aug 2021 #7
!!!!!!!!!!!!!!!! BumRushDaShow Aug 2021 #23
It's showtime. BumRushDaShow Aug 2021 #3
Now they will say the approval Mr.Bill Aug 2021 #20
Yup. BumRushDaShow Aug 2021 #22
No it won't Rebl2 Aug 2021 #5
But the approval gives many organizations wnylib Aug 2021 #25
True Rebl2 Aug 2021 #28
Please BradAllison Aug 2021 #8
That was too quick. SergeStorms Aug 2021 #9
Yeah moose65 Aug 2021 #16
And they'll beat the tar out of them..... SergeStorms Aug 2021 #27
This will change nothing, persuade no one bucolic_frolic Aug 2021 #10
In reality, the main change is that Pfizer can give it a brand name and has permission to market it. BumRushDaShow Aug 2021 #24
But now various organizations can feel more wnylib Aug 2021 #26
And Pfizer was not part of Warp Speed ... aggiesal Aug 2021 #12
yOu dumMIes ArE tHe eXPerIMenT!!! IronLionZion Aug 2021 #13
Hooray! This will make a difference. Lasher Aug 2021 #15
Moderna? nvme Aug 2021 #17
I was wondering that, too obamanut2012 Aug 2021 #18

teach1st

(5,935 posts)
4. The people I know who use that excuse
Mon Aug 23, 2021, 09:41 AM
Aug 2021

Will more than likely find another excuse like "the approval was rushed."

chia

(2,244 posts)
6. Oh, you can count on that. They'll move the goalposts as often as necessary to maintain the illusion
Mon Aug 23, 2021, 09:44 AM
Aug 2021

that they'd ever actually acknowledge safety or efficacy.

quaint

(2,566 posts)
11. The people I know who used that reason
Mon Aug 23, 2021, 10:07 AM
Aug 2021

...are thrilled to be jabbed now knowing Medicare will pay if they have side effects.

chia

(2,244 posts)
14. One of the people I know spent 2 weeks in the hospital with Covid.
Mon Aug 23, 2021, 11:00 AM
Aug 2021

I don't know yet if minds have changed

Hortensis

(58,785 posts)
21. As you say. A relative told me her dingdong daughter's latest excuse
Mon Aug 23, 2021, 12:43 PM
Aug 2021

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.

BumRushDaShow

(129,129 posts)
3. It's showtime.
Mon Aug 23, 2021, 09:41 AM
Aug 2021


ETA to note this from the OP article -

(snip)

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 agency’s 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.

“It’s 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 can’t have it both ways. You can’t have people saying they won’t get vaccinated until there’s 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)
20. Now they will say the approval
Mon Aug 23, 2021, 12:41 PM
Aug 2021

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)
22. Yup.
Mon Aug 23, 2021, 01:02 PM
Aug 2021

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).

wnylib

(21,497 posts)
25. But the approval gives many organizations
Mon Aug 23, 2021, 03:02 PM
Aug 2021

the ability to mandate vaccinations for employees, visitors, and members.

SergeStorms

(19,204 posts)
9. That was too quick.
Mon Aug 23, 2021, 09:52 AM
Aug 2021

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.

moose65

(3,167 posts)
16. Yeah
Mon Aug 23, 2021, 11:19 AM
Aug 2021

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)
27. And they'll beat the tar out of them.....
Mon Aug 23, 2021, 03:48 PM
Aug 2021

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)
10. This will change nothing, persuade no one
Mon Aug 23, 2021, 09:55 AM
Aug 2021

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)
24. In reality, the main change is that Pfizer can give it a brand name and has permission to market it.
Mon Aug 23, 2021, 01:09 PM
Aug 2021

$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$

wnylib

(21,497 posts)
26. But now various organizations can feel more
Mon Aug 23, 2021, 03:07 PM
Aug 2021

justified and comfortable about mandating vaccines for employees, members, and visitors. That should move up the vaccinated numbers.

aggiesal

(8,919 posts)
12. And Pfizer was not part of Warp Speed ...
Mon Aug 23, 2021, 10:07 AM
Aug 2021

so Pendejo45 can not take or deserve any credit for this.
Hehehehe

IronLionZion

(45,462 posts)
13. yOu dumMIes ArE tHe eXPerIMenT!!!
Mon Aug 23, 2021, 10:41 AM
Aug 2021

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)
15. Hooray! This will make a difference.
Mon Aug 23, 2021, 11:12 AM
Aug 2021

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:

Pfizer has said it expects to have vaccine trial data on children ages 5 to 11 by the end of September, and the company could apply to have its vaccine authorized for those younger ages shortly after. The company also has said data for even younger children, ages 2 to 5, could be available shortly after.

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.
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