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
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.
What booster shot? That specifically says no approved additional dose to the immunocompromised - which to me “additional dose” is a booster shot.
“Isn’t it truly a bait and switch to use the authorization of one vaccine to mandate the use of another one?”
EXACTLY!!!!
NoLibZone wrote:
“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”
What they did was label some empty vials “Comirnaty” and leave the full ones labelled “Pfizer BioNTech”....
The Comirnaty was OK’d, not available now, but legally actionable, and the BioNTech was still EUA’d, available now, but legally not actionable.
Weasels.....
They need some good lawyers to go after them big league....
dadfly wrote:
“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.”
I wonder if the changing of the definition of a ‘vaccine’ from ‘provides immunity’ to ‘provides less severe symptoms’ have any bearing on the potential lawsuits?
And the govt etcetera are mandating based on EUA shots.
I thought anything under EUA couldn’t be mandated.
Has anyone challenged the mandates on that basis?
That was under Trump's watch. That's also how N95 dust masks suddenly became a virus protection device after decades of not being that. They were the only masks we had a lot of because millions of blue collar workers use one or more per day, as have I, for dust and particles, their sole purpose up to that point. Unfortunately, Trump's main concern at that time was that covid might ruin his chances at re-election, which technically it did. Just not in the way he feared or was concerned about.
The part that was giving me cows was the bit about countermeasures.
It sounds like docs are protected if they refuse to prescribe prophylaxes and/or therapeutics...?!
My reply to No Lib Zone’s comment under the story...
“To tie in with what Barnes Law said, my question is:
If they approved the Pfizer, and not Moderna and J&J, does that mean they can’t use Moderna and J&J?
And does the EUA for Moderna and J&J negate using the Pfizer?”
How does my question figure into all this?
“To tie in with what Barnes Law said (see NoLibZone’s post #1), my question is:
If they approved the Pfizer, and not Moderna and J&J, does that mean they can’t use Moderna and J&J?
And does the EUA for Moderna and J&J negate using the Pfizer?”
yeah. the past documents i’ve read about this vaccine always called out the purpose of preventing infection. now it’s some sort of treatment? if so, it doesn’t have the purpose vaccines use to.
another interesting thing in the document was the apparent extension of the expiration dates on the current EUA drug. they’re trying to use up the existing stuff and obviously take the money and run.
Well I'm not a lawyer, doctor or a bureaucratic but I'm guessing the EUAs for all still apply but if one prefers an "approved' jab, there is one but more importantly in the eyes of totalitarian types, they can mandate it and people can't make the argument that it's experimental. This is all about politics and control freak communists, not about health.
As far as them choosing Pfizer, it could be for a few different reasons but I doubt it's for any good reason. It seems to be weaker against Delta. On the other hand, Israel is having a helluva time due to that. It's almost like Delta + Pfizer is more deadly then Delta alone. That would mean they prefer Pfizer because it will kill more people.
Another reason could be that with Pfizer, they can call for people to get a jab every 6 months which they're already talking about.
It's hard to make sense of crazy. It's hard to know what's real when we don't get real data or much of any truth.
“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).”
Please link to sites that have the COMIRNATY labeled vaccines available.
Anyone.
Thank you.
They say they are legally distinct. Okay. But they did not say they were the same product. They said they had the same formulation. They could have said it is the exact same product but will be licensed differently or labelled differently. They did not. Why not?
Formulation?
Where did you get “identical in composition”?
I am not be a contrarian but am looking for blurred references such as formulation.
“EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation” which means what?
Who would have thought the gubmint would be playing 3-Card Monty with the vaccines?
I called the phone number in the article.
The lady on recording said it was approved.
I am still not getting the shot. Already had the chinese flu.
bkmk
Been saying that since 2020.
Just getting approval for the massive increase in price.
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