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BumRushDaShow

(129,478 posts)
Tue Aug 3, 2021, 07:45 PM Aug 2021

F.D.A. Aims to Give Final Approval to Pfizer Vaccine by Early Next Month

Source: New York Times

WASHINGTON — With a new surge of Covid-19 infections ripping through much of the United States, the Food and Drug Administration has accelerated its timetable to fully approve Pfizer-BioNTech’s coronavirus vaccine, aiming to complete the process by the start of next month, people involved in the effort said. President Biden said last week that he expected a fully approved vaccine in early fall. But the F.D.A.’s unofficial deadline is Labor Day or sooner, according to multiple people familiar with the plan. The agency said in a statement that its leaders recognized that approval might inspire more public confidence and had “taken an all-hands-on-deck approach” to the work.

Giving final approval to the Pfizer vaccine — rather than relying on the emergency authorization granted late last year by the F.D.A. — could help increase inoculation rates at a moment when the highly transmissible Delta variant of the virus is sharply driving up the number of new cases. A number of universities and hospitals, the Defense Department and at least one major city, San Francisco, are expected to mandate inoculation once a vaccine is fully approved. Final approval could also help mute misinformation about the safety of vaccines and clarify legal issues about mandates.

Federal regulators have been under growing public pressure to fully approve Pfizer’s vaccine ever since the company filed its application on May 7. “I just have not sensed a sense of urgency from the F.D.A. on full approval,” Dr. Ashish K. Jha, the dean of the Brown University School of Public Health, said in an interview on Tuesday. “And I find it baffling, given where we are as a country in terms of infections, hospitalizations and deaths.”

Although 192 million Americans — 58 percent of the total population and 70 percent of the nation’s adults — have received at least one vaccine shot, many remain vulnerable to the ultracontagious, dominant Delta variant. The country is averaging nearly 86,000 new infections a day, an increase of 142 percent in just two weeks, according to a New York Times database.

Read more: https://www.nytimes.com/2021/08/03/us/politics/pfizer-vaccine-approval.html

14 replies = new reply since forum marked as read
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F.D.A. Aims to Give Final Approval to Pfizer Vaccine by Early Next Month (Original Post) BumRushDaShow Aug 2021 OP
What happens if they don't approve it? JohnSJ Aug 2021 #1
Then... BumRushDaShow Aug 2021 #3
Since they are both mRNA based, it would be the same outcome. I was not being serious though JohnSJ Aug 2021 #5
Oh I know BumRushDaShow Aug 2021 #7
+++ JohnSJ Aug 2021 #8
Chuck Norris Opens Up A Big Old Can COL Mustard Aug 2021 #10
+++ JohnSJ Aug 2021 #11
That's great news! All those folks swearing they Phoenix61 Aug 2021 #2
That's one of the biggest excuses BumRushDaShow Aug 2021 #4
I'm sure your right, sadly. nt Phoenix61 Aug 2021 #12
Yaaaaaay! SheltieLover Aug 2021 #6
Good. Once It's Fully Approved, COL Mustard Aug 2021 #9
+1000 Rhiannon12866 Aug 2021 #14
I'm sure Abbott will write another executive order banning mandates once FDA approved. LeftInTX Aug 2021 #13

JohnSJ

(92,403 posts)
5. Since they are both mRNA based, it would be the same outcome. I was not being serious though
Tue Aug 3, 2021, 08:01 PM
Aug 2021

It would have never gotten EUA, if it approval wasn’t almost assured

All they are doing is dotting the i(s) and crossing the t(s)

Bureaucracy

BumRushDaShow

(129,478 posts)
7. Oh I know
Tue Aug 3, 2021, 08:09 PM
Aug 2021

I was just being silly (as a Moderna recipient knowing they are running just behind Pfizer, time wise, for in their full approval submission).

But having been a federal "bureaucrat" for 30+ years (now retired), there is a reason for much of it, least of all the consequences of a poor decision to rush something, like what happened just last month (which is now under IG investigation) - https://www.govexec.com/oversight/2021/07/fda-asks-ig-review-alzheimers-drug-approval-process/183643/

So it's always prudent to follow the process to make sure you dot those "i"s and cross those "t"s.

COL Mustard

(5,923 posts)
10. Chuck Norris Opens Up A Big Old Can
Tue Aug 3, 2021, 09:28 PM
Aug 2021

Of whoopass. Nobody wants that. Even COVID is afraid of Chuck Norris.

Phoenix61

(17,019 posts)
2. That's great news! All those folks swearing they
Tue Aug 3, 2021, 07:48 PM
Aug 2021

are just waiting for full approval before the get vaxed will have to ante up.

BumRushDaShow

(129,478 posts)
4. That's one of the biggest excuses
Tue Aug 3, 2021, 08:00 PM
Aug 2021

by many healthcare workers and first responders (including police, fire, EMTs, etc) who still haven't vaxxed. They keep claiming "well it's experimental". Yet we are going on 8 months of "public" use of it and that's not counting trials that have gone on for 15 months now.

I expect a chunk of them will still refuse it and will come up with a new excuse like "Well it was rushed" or some other thing.

COL Mustard

(5,923 posts)
9. Good. Once It's Fully Approved,
Tue Aug 3, 2021, 09:27 PM
Aug 2021

Make the goddam thing mandatory. No excuses. No whining. Get your goddam shots.

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