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Author Topic: FDA aiming to give final approval to Pfizer vaccine by early next month  (Read 544 times)

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Offline thackney

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FDA aiming to give final approval to Pfizer vaccine by early next month
« on: August 04, 2021, 07:49:44 am »
FDA aiming to give final approval to Pfizer vaccine by early next month
https://www.reuters.com/business/healthcare-pharmaceuticals/fda-aiming-give-final-approval-pfizer-vaccine-by-early-next-month-ny-times-2021-08-03/

The U.S. Food and Drug Administration is aiming to give full approval for the Pfizer (PFE.N) COVID vaccine by early September, the New York Times reported on Tuesday, citing people involved in the effort.

The FDA gave emergency use authorization to the Pfizer vaccine late last year. Full approval by the FDA could push more Americans to get the COVID-19 vaccine as it might reduce their fears about the safety of the shot.

The agency's unofficial deadline for the approval is the Sept. 6 Labor Day holiday, the Times said....
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Offline txradioguy

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Re: FDA aiming to give final approval to Pfizer vaccine by early next month
« Reply #1 on: August 04, 2021, 08:38:01 am »
Not looking forward to that happening.

The minute it gets FDA approval it will become mandatory for the DoD.
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Offline Hoodat

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Re: FDA aiming to give final approval to Pfizer vaccine by early next month
« Reply #2 on: August 04, 2021, 08:46:00 am »
Quote from: txradioguy on August 04, 2021, 08:38:01 am
Not looking forward to that happening.

The minute it gets FDA approval it will become mandatory for the DoD.

Once the FDA give emergency authorization for children under 12, it will become mandatory at my kid's school.
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If a political party does not have its foundation in the determination to advance a cause that is right and that is moral, then it is not a political party; it is merely a conspiracy to seize power.     -Dwight Eisenhower-

"The [U.S.] Constitution is a limitation on the government, not on private individuals ... it does not prescribe the conduct of private individuals, only the conduct of the government ... it is not a charter for government power, but a charter of the citizen's protection against the government."     -Ayn Rand-

Offline txradioguy

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Re: FDA aiming to give final approval to Pfizer vaccine by early next month
« Reply #3 on: August 04, 2021, 09:20:27 am »
Quote from: Hoodat on August 04, 2021, 08:46:00 am
Once the FDA give emergency authorization for children under 12, it will become mandatory at my kid's school.

IMHO that's child abuse.
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The libs/dems of today are the Quislings of former years. The cowards who would vote a fraud into office in exchange for handouts from the devil.

Here lies in honored glory an American soldier, known but to God

THE ESTABLISHMENT IS THE PROBLEM...NOT THE SOLUTION

Republicans Don't Need A Back Bench...They Need a BACKBONE!

Offline PeteS in CA

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Re: FDA aiming to give final approval to Pfizer vaccine by early next month
« Reply #4 on: August 04, 2021, 10:58:04 am »
Pfizer and BioNTech began this Biologics License Application process in early May, https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-initiate-rolling-submission-biologics .

Quote
NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the initiation of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for approval of their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. Data to support the BLA will be submitted by the companies to the FDA on a rolling basis over the coming weeks, with a request for Priority Review. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA will be set once the BLA is complete and formally accepted for review by the agency.
...
Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. This includes the most recent analyses from the pivotal Phase 3 clinical trial, where the vaccine’s efficacy and favorable safety profile were observed up to six months after the second dose. The companies will submit the required manufacturing and facility data for licensure in the coming weeks to complete the BLA.

Translating "Biologics License" into normal-people plain English, it means full FDA approval (for use with people ages 16 and older).

For the terminally curious, Moderna initiated the BLA process on June 1st, https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-initiation-rolling-submission-biologics .
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I am not and never have been a leftist.

If, as anti-Covid-vaxxers claim, https://www.poynter.org/fact-checking/2021/robert-f-kennedy-jr-said-the-covid-19-vaccine-is-the-deadliest-vaccine-ever-made-thats-not-true/ , https://gospelnewsnetwork.org/2021/11/23/covid-shots-are-the-deadliest-vaccines-in-medical-history/ , The Vaccine is deadly, where in the US have Pfizer and Moderna hidden the millions of bodies of those who died of "vaccine injury"?

Millions now living should have died. Anti-Covid-Vaxxer ghouls hardest hit.

Offline rustynail

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Re: FDA aiming to give final approval to Pfizer vaccine by early next month
« Reply #5 on: August 04, 2021, 11:52:43 am »
My working days are numbered.
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Offline Smokin Joe

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Re: FDA aiming to give final approval to Pfizer vaccine by early next month
« Reply #6 on: August 05, 2021, 02:23:57 am »
This is a prerequisite to making it mandatory.

Then all hell will break loose.
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How God must weep at humans' folly! Stand fast! God knows what he is doing!
Seventeen Techniques for Truth Suppression

Of all tyrannies, a tyranny sincerely exercised for the good of its victims may be the most oppressive. It would be better to live under robber barons than under omnipotent moral busybodies. The robber baron's cruelty may sometimes sleep, his cupidity may at some point be satiated; but those who torment us for our own good will torment us without end for they do so with the approval of their own conscience.

C S Lewis

Offline cato potatoe

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Re: FDA aiming to give final approval to Pfizer vaccine by early next month
« Reply #7 on: August 06, 2021, 03:18:44 am »
Why is the approval window compressed?  Are they skipping a few steps for political reasons? 

Guess we already know the answer to that one.
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Offline Hoodat

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Re: FDA aiming to give final approval to Pfizer vaccine by early next month
« Reply #8 on: August 06, 2021, 08:38:41 am »
Quote
The U.S. Food and Drug Administration is aiming to give full approval for the Pfizer (PFE.N) COVID vaccine by early September

They should be aiming to find out whether or not it is safe and effective over the long term.
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If a political party does not have its foundation in the determination to advance a cause that is right and that is moral, then it is not a political party; it is merely a conspiracy to seize power.     -Dwight Eisenhower-

"The [U.S.] Constitution is a limitation on the government, not on private individuals ... it does not prescribe the conduct of private individuals, only the conduct of the government ... it is not a charter for government power, but a charter of the citizen's protection against the government."     -Ayn Rand-

Offline rustynail

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Re: FDA aiming to give final approval to Pfizer vaccine by early next month
« Reply #9 on: August 06, 2021, 08:56:15 am »
 FDA aiming ....I'm triggered by this violent language.
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Offline mountaineer

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Re: FDA aiming to give final approval to Pfizer vaccine by early next month
« Reply #10 on: August 07, 2021, 09:47:26 am »
Dr. Anthony Fauci: Expect 'a flood' of COVID-19 vaccine mandates after full FDA approval
Elizabeth Weise
USA TODAY
Aug. 6, 2021
Quote
As soon as the Food and Drug Administration issues a full approval for a COVID-19 vaccine, there will be "a flood" of vaccine mandates at businesses and schools across the nation, Dr. Anthony Fauci told USA TODAY's editorial board on Friday.

Mandates aren't going to happen at the federal level, but vaccine approval will embolden many groups, he predicted.

"Organizations, enterprises, universities, colleges that have been reluctant to mandate at the local level will feel much more confident," he said.

"They can say, 'If you want to come to this college or this university, you've got to get vaccinated. If you want to work in this plant, you have to get vaccinated. If you want to work in this enterprise, you've got to get vaccinated. If you want to work in this hospital, you've got to get vaccinated.'"

Fauci doesn't see more lockdowns in the nation's future. They were issued early in the pandemic to keep hospitals from being overwhelmed, known as "flattening the curve."  ...
More
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Offline Smokin Joe

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Re: FDA aiming to give final approval to Pfizer vaccine by early next month
« Reply #11 on: August 09, 2021, 02:46:46 am »
Will the liability exclusion come off once the FDA approves it?

If not, my answer still hasn't changed (and likely will not anyway).
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How God must weep at humans' folly! Stand fast! God knows what he is doing!
Seventeen Techniques for Truth Suppression

Of all tyrannies, a tyranny sincerely exercised for the good of its victims may be the most oppressive. It would be better to live under robber barons than under omnipotent moral busybodies. The robber baron's cruelty may sometimes sleep, his cupidity may at some point be satiated; but those who torment us for our own good will torment us without end for they do so with the approval of their own conscience.

C S Lewis
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