There’s Definitely Something Very Wrong with Pfizer-BioNTech’s ‘Full Authorization’ Docs

Kyle Becker ^ | August 25, 2021 | Kyle Becker

[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

[NoLibZone]

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

[Bob434]

https://gab.com/Portland-jet

[Sacajaweau]

Approval just in time for the next booster contract.

[PMAS]

****

[SkyDancer]

The media is complicit in all these vaccine deaths as well as those that shame people into getting jabbed.

[duckman]

I heard on Fox last night, it was approved by FDA and off EUA status for 16 y/o and older. EUA and liability still on for 15 y/o and younger. Go figure.

[Pollard]

Not this shit again.

The FDA says it’s FDA approved.

It doesn’t matter how some right wing news blogs say. It doesn’t matter what Dr Malone says. The FDA is the FDA and they are not.

[NoLibZone]

I am utterly amazed at how many Freepers trust the Biden administration.

[NoLibZone]

I get it.

you trust the Biden administration

[jimwatx]

You literally can’t trust a single thing these liars say.

[Bob434]

https://gab.com/Portland-jet

[eyeamok]

How dare You read through the fuzzy ambiguous language and determine that everything isn’t really on the up and up, Shame on You

[G Larry]

Masking their Incompetence:

We are witnessing a bunch of incompetent tyrants mandating ineffective measures because they fear being seen as doing nothing.

They have been paid off to prevent the use of cheap, effective, widely available therapeutics, so they could get rich of some marginal, expensive medicine that is being passed off as a vaccine, when in fact it has nothing in common with the definition of a vaccine.

I make these charges without assigning any evil intent regarding the negative medical effects the so called “vaccines”.

[mosaicwolf]

"The FDA says it’s FDA approved. It doesn’t matter how some right wing news blogs say. It doesn’t matter what Dr Malone says. The FDA is the FDA and they are not."

Simple solution to this dilemma.

Never believe anything from the government, its agencies, or the media. Now go create a nice day.

[Yo-Yo]

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".

This is semantics.

The FDA approval letter states:

MANUFACTURING LOCATIONS

Under this license, you are approved to manufacture COVID-19 Vaccine, mRNA drug substance at [redacted].
The final formulated product will be manufactured, filled, labeled and packaged at Pfizer [redacted].
The diluent, 0.9% Sodium Chloride Injection, USP, will be manufactured at [redacted].

Any vaccine manufactured prior to this letter isn't covered by this letter, so all existing stocks are still under the EUA.

Only new Lots manufactured after this letter date and at the specified (but redacted) factories will be approved.

So of course there isn't any "approved" vaccine available yet.

[Political Junkie Too]

Here is what I would like to know. Maybe you can explain it to me.

It seems that the FDA approved a product called COMIRNATY, which Pfizer says is not yet available.

The Biden administration is using this FDA approval to mandate vaccinations to the military, and is encouraging businesses to do the same for their employees.

Since the only available vaccine is not COMIRNATY, but the one only approved for emergency use only, isn't the mandate unenforceable?

Isn't it truly a bait and switch to use the authorization of one vaccine to mandate the use of another one?

-PJ

[tatown]

I think one thing is clear...the FDA has purposely made this as unclear as possible. The question is why?

[dadfly]

thanks for the post. i’m still studying this, haven’t made a decision on what this “approval” is. i’ve read enough to conclude that there is an adulteration of the normal timelines and processes, though. there’s apparently a bunch of conditions too. but there is definitely something “rotten” in the FDA concerning this new style “vaccine.”

another apparent thing in the “approval” letter was the vote for approval. that vote wasn’t unanimous. it was apparently 17 votes for out of 22 for license approval (think there was one abstention). that’s a big tell, imo. even their kangaroo court committee didn’t vote unanimously.

also over the last few months. there has been a lot of concern about whether this is a vaccine or something else. i now see why the folks who didn’t want to call it a vaccine were so adamant about it. i wasn’t concerned about this as the drug was ultimately producing antibodies like a vaccine.

but now i see their point, this is probably not legally vaccine but some kind of gene therapy which can function as a vaccine. if it’s a gene therapy, then their immunity from law suits takes a big hit. even if they call it a vaccine.

the laws about vaccines do not give blanket immunity for pfizer or a vaccine either. i’ve found sites for law firms out there that apparently make their living suing for vaccine injuries (like their pneumonia vaccine given to children for which there are many injuries according to the law firms i’ve perused online).

there may be compensation pools out there set up by the gov’t/big pharma for vaccine injuries. if so, then logically, law suits could be filed to drain these pools since we have millions of covid19 vaccine injuries reported now, thus getting to pfizer and their ilk.

anyway that’s what i’ve seen so far, i don’t know much about the law and vaccines, but i’m starting to learn.

[NoLibZone]

Correct.
The FDA did in fact approve a Covid vaccine.
The FDA approved a vaccine that is not currently available.
And they approved one that is currently available the EU A’s for Moderna and Johnson and all the rest would have to be pulled

[NoLibZone]

Had they approved one that is currently available They would have to pull the EU A’s for all the other vaccines