Posted on 08/26/2021 11:48:23 AM PDT by NoLibZone
The Food and Drug Administration’s “full authorization” for the Pfizer-BioNTech vaccine for Covid-19 was announced with a fair amount of hooplah and fanfare. The President of the United States announced the monumental development and touted it as rationale for the vaccine mandates to commence in the private sector, throughout the government, and in the U.S. military.
President Joe Biden was on the spot Monday morning with a quick reaction to the FDA’s “full authorization” of the Covid-19 vaccines.
But a closer examination of the “full authorization” documents has some Americans feeling deceived. There is the matter that Pfizer-BioNTech still appears to be afforded the legal protections that accompany Emergency Use Authorization, all while it purportedly has “full” FDA approval. How did the pharmaceutical company manage such a commercial ‘coup’?
Upon a more critical look at the documents, it now very much seems to be the case that the company, along with the indispensable aid of a complicit media and the Biden administration, has engaged in a classic bait-and-switch.
On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.”
PhD. biochemistry and molecular biology student Kathleen Lee picked up on the change in language and decided to press further.
I called the Pfizer BioNtech number 1-800-666-7248,” she said. “The recording clearly states that it has not been approved by the FDA. Pfizer BNT162B2 is still under EUA. This clears up that messy FDA authorization between Comirnaty and Pfizer BioNtech.”
Except that isn’t the case. Buried deep within the footnotes of the Pfizer-BioNTech documents is one footnote that puts into rather jolting perspective that the currently labeled vaccines are still under Emergency Use Authorization (EUA).
“Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years of age and older, there is not sufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of this EUA. Additionally, there are no products that are approved to prevent COVID-19 in individuals age 12 through 15, or that are approved to provide an additional dose to the immunocompromised population described in this EUA.”
The profound implications of this admission was mentioned by notable vaccine critic Alex Berenson, formerly of the New York Times and a best-selling author on the subject.
Robert Barnes @barnes_law There is no *available* FDA approved licensed vaccine. Here's what is happening. If FDA approved & licensed COVID19 vaccine, it would have to revoke the EUA vaccines & subject the vaccine maker to more liability risk. So it only approved a future vaccine that isn't "available". 3:01 PM · Aug 25, 2021
Did you fail to read the part of the FDA letter where it said the licensed vaccine isn't "available" yet? How is there ANY EUA vaccines when the law does not allow them if there is a licensed vaccine available? 3:54 PM · Aug 25, 2021
## I am utterly amazed at how many Freepers trust the Biden administration.
I’m not. We’ve had an issue with long-term fed postings since ... forever. They will always support the party line. There are nicks that I’m pretty sure have had at least 3 different people behind them over the last 20 years.
With all the talk of "off label" use of drugs, it's important to me that the label be followed.
If the label says Comirnaty in the FDA approval, then it is ONLY Comirnaty, and not some prior labeled drug, that is approved, if "on label" vs "off label" use is to be respected.
To me, they can't have it both ways. They can't say the drug prior to being labeled Comirnaty (and produced prior to the FDA approval) is really Comirnaty so it's also approved, but that HCQ which has been in use for 70 years is not approved for COVID use.
Does the FDA approval only pertain to drugs being produced from this point forward under the Comirnaty label?
for certain uses that are not included in the approved BLA
Then should I assume that those "certain uses" are not included in any mandates?
-PJ
8 The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.
They're the same but different? Notice the “legally distinct” and “certain differences”? As for the claim about safety or effectiveness, who knows but they ARE different.
Better call a lawyer then and fight fedgov. LOL
How many times do people need to be told: There is no liability issue. By law, you can sue vaccine makers.
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