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BumRushDaShow

(128,551 posts)
Fri Aug 20, 2021, 05:29 PM Aug 2021

The F.D.A. is aiming to give full approval to Pfizer's Covid vaccine on Monday.

Source: New York Times

The Food and Drug Administration is pushing to approve Pfizer-BioNTech’s two-dose Covid-19 vaccine on Monday, further expediting an earlier timeline for licensing the shot, according to people familiar with the agency’s planning. Regulators were working to finish the process by Friday but were still working through a substantial amount of paperwork and negotiation with the company.

The people familiar with the planning, who were not authorized to speak publicly about it, cautioned that the approval might slide beyond Monday if some components of the review need more time.An F.D.A. spokeswoman declined to comment. The agency had recently set an unofficial deadline for approval of around Labor Day. The approval is expected to pave the way for a series of vaccination requirements by public and private organizations who were awaiting firmer regulatory backing before implementing mandates.

Federal and state health officials are also hoping that an approved vaccine will draw interest from some Americans who have been hesitant to take one that was only authorized for emergency use, a phenomenon suggested by recent polling.Some universities and hospitals are expected to mandate inoculation once a vaccine is fully approved. The Pentagon earlier this month said it plans to make Covid vaccinations mandatory for the country’s 1.3 million active-duty troops “no later” than the middle of next month, or sooner if the F.D.A. acts earlier.

The timing of the approval could result in an uncomfortable messaging problem for the Biden administration, which on Wednesday announced that fully vaccinated people should prepare to get booster shots eight months after they received second doses. Approving the vaccine and encouraging boosters at the same time may suggest to some that the vaccine as licensed is inadequate without an extra shot.

Read more: https://www.nytimes.com/2021/08/20/us/politics/fda-pfizer-covid-vaccine-full-approval.html



I really do think that they have most of what they needed from the clinical data and pending any haggling over the branding and labeling (particularly with respect to the language on any product packaging and probably A huge insert. with dosing/adverse reactions/contraindications, etc.), they should be ready to go with it.
19 replies = new reply since forum marked as read
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The F.D.A. is aiming to give full approval to Pfizer's Covid vaccine on Monday. (Original Post) BumRushDaShow Aug 2021 OP
That'll be a game changer on mask mandates and what insurance will pay. LiberatedUSA Aug 2021 #1
Let's see what the anti-vaxxers' excuse will be after that happens. Ocelot II Aug 2021 #2
Well now you know what the excuse will then be BumRushDaShow Aug 2021 #4
"It was only approved under undue political pressure by the deep state." Lucky Luciano Aug 2021 #9
That will be cause for celebration genxlib Aug 2021 #3
Yes!!! StarryNite Aug 2021 #5
Does this speed up the timeline for approval in kids? NickB79 Aug 2021 #6
I sure hope so. It is looking good, but who knows? I feel your concern. Mine are older and got their Evolve Dammit Aug 2021 #7
That will depend on the data from field trials now being conducted. Ocelot II Aug 2021 #10
My question, too. That would make a huge difference in time for kids returning to school next month Rhiannon12866 Aug 2021 #15
Good, full speed ahead on mandates. Jon King Aug 2021 #8
agree. no more excuses. Past time to be an adult and get the jab. riversedge Aug 2021 #12
Biden's socialist FDA rushed it through IronLionZion Aug 2021 #11
That would pave the way for all military personnel to be vaxxed 70sEraVet Aug 2021 #13
I think that is a biggy that this will let them get done BumRushDaShow Aug 2021 #14
I got both doses of the Pfizer-BioNTech's two-dose Covid-19 vaccine over a month ago. Worried2020 Aug 2021 #16
Right now BumRushDaShow Aug 2021 #17
I gave that poll a bump. Worried2020 Aug 2021 #18
Since the thread is old BumRushDaShow Aug 2021 #19
 

LiberatedUSA

(1,666 posts)
1. That'll be a game changer on mask mandates and what insurance will pay.
Fri Aug 20, 2021, 05:34 PM
Aug 2021

The unvaccinated won’t be covered and won’t be working. And they won’t be getting beds first come first serve.

Ocelot II

(115,617 posts)
2. Let's see what the anti-vaxxers' excuse will be after that happens.
Fri Aug 20, 2021, 05:38 PM
Aug 2021

The idea that the fully-approved vaccine is ineffective because a booster is recommended is stupid. A lot of vaccines need booster shots - the smallpox vaccine was one of them; its effectiveness decreases over time (I remember having to get a second one before going overseas in the late '60s). And we know what happened to smallpox.

BumRushDaShow

(128,551 posts)
4. Well now you know what the excuse will then be
Fri Aug 20, 2021, 06:04 PM
Aug 2021

"it was rushed".

And as an example of what you're talking about - I know the tetanus shot (originally included in what was called a DTP shot - Dipheria, Tetanus, Pertussis, now the latest version called DTaP), was supposed to be given about every 10 years.

genxlib

(5,519 posts)
3. That will be cause for celebration
Fri Aug 20, 2021, 05:39 PM
Aug 2021

Although I have my doubts that people won't just find another excuse to not take it.

I am sure many will just say that it was approved to fast

Mostly, I am looking for private institutions to have more justification to just require it.

Evolve Dammit

(16,702 posts)
7. I sure hope so. It is looking good, but who knows? I feel your concern. Mine are older and got their
Fri Aug 20, 2021, 06:51 PM
Aug 2021

two part Pfizer back in June. Take care

Ocelot II

(115,617 posts)
10. That will depend on the data from field trials now being conducted.
Fri Aug 20, 2021, 07:05 PM
Aug 2021

Since those data might be different, this approval might not change the timeline for approval for kids' vaccine. But I hope that comes quickly.

Rhiannon12866

(204,856 posts)
15. My question, too. That would make a huge difference in time for kids returning to school next month
Fri Aug 20, 2021, 09:26 PM
Aug 2021

Jon King

(1,910 posts)
8. Good, full speed ahead on mandates.
Fri Aug 20, 2021, 06:55 PM
Aug 2021

Enough is enough, either get vaccinated or not be able to participate in large parts of society.

IronLionZion

(45,380 posts)
11. Biden's socialist FDA rushed it through
Fri Aug 20, 2021, 07:07 PM
Aug 2021

will be their excuse.

Hoping for Moderna next. The J&J people probably want some answers on booster shots.

Worried2020

(444 posts)
16. I got both doses of the Pfizer-BioNTech's two-dose Covid-19 vaccine over a month ago.
Sun Aug 22, 2021, 07:51 AM
Aug 2021

.

First was in June, second in July, but I could have gotten them earlier if I'd been paying attention.

I'm an old loner that pretty much self-isolates by habit, been wearing masks and distancing for over a year,

and no intention to stop.

OH! - and I had ZERO reactions to both doses although I was prepared for some. I haven't taken good care of this old body so I figured I was overdue for some discomfort.

Not a bit!



W

ps: and I got Certificates in my email for both of them, by the time I got home from each jab!

BumRushDaShow

(128,551 posts)
17. Right now
Sun Aug 22, 2021, 08:10 AM
Aug 2021

it appears Canada is still debating boosters - https://nationalpost.com/news/covid-booster-shots-are-being-rolled-out-for-all-americans-what-about-canada

And as a note - DU skews "old" so you are among kin.

I keep this bookmarked although it was from over 1 1/2 years ago and obviously not "all" of DU but it gives you an idea - https://www.democraticunderground.com/100213017831



Worried2020

(444 posts)
18. I gave that poll a bump.
Sun Aug 22, 2021, 08:24 AM
Aug 2021

.

56 - 75 year olds represent 66% of the membership here, as per the poll.

It could be quite different in reality,

but I think not

W

BumRushDaShow

(128,551 posts)
19. Since the thread is old
Sun Aug 22, 2021, 08:58 AM
Aug 2021

it won't actually bump it (the thread was already archived). But I like to reference it...

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