Update: See further legal analysis from an attorney at the bottom of the story.
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.
“The FDA has officially approved the Pfizer COVID-19 vaccine,” Biden said. “While all three COVID vaccines have met FDA’s strict standards for emergency use, this FDA approval should give added confidence that this vaccine is safe and effective. If you’re not vaccinated yet, now is the time.”
Biden’s announcement followed upon the widespread media coverage that the Pfizer-BioNTech had “full” approval for the use of the vaccine in the United States.
“The Food and Drug Administration granted Pfizer and BioNTech full U.S. approval of their Covid-19 vaccine – becoming the first in the U.S. to win the coveted designation and giving even more businesses, schools and universities greater confidence to adopt vaccine mandates,” CNBC reported.
“Up until now, the mRNA vaccine was on the U.S. market under an Emergency Use Authorization, which was granted by the FDA in December. Since then, more than 204 million of the Pfizer shots have been administered, according to data compiled by the Centers for Disease Control and Prevention,” the report added.
The Pentagon on Wednesday finally issued its order that U.S. troops get the vaccine — or else.
“To defend this Nation, we need a healthy and ready force,” the Defense Department memo said. “After careful consultation with military experts and military leadership, and with the support of the President, I have determined that mandatory vaccination against coronavirus disease 2019 (COVID-19) is ncessary to protect the force and defend the American people.”
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.
Before proceeding, examine the technical language used in the awkwardly phrased release. The new label for the ‘fully authorized’ vaccine is called ‘Comirnarty.’
“On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19 for individuals 16 years of age and older pursuant to Section 564 of the Act,” the FDA stated in a letter to the Global Senior Director of Pfizer Ms. Elaine Harkins. “FDA reissued the letter of authorization on: December 23, 2020, February 25, 2021, May 10, 2021, June 25, 2021, and August 12, 2021.”
“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.”
Overlooking the odd choice for an area code, I decided to call and confirmed this is still the case. But it could just be an old recording. Lee continued to express her analysis of the apparent discrepancy.
“It’s deceitful,” Lee claimed. “If the vial says Comirnaty- It’s FDA approved. It the vial says Pfizer BioNtech- it’s under EUA and they’re not subject to liability. There’s millions of doses to get rid of first.”
Yet if the next batch of vaccines being dispensed were being produced under the Cominarty label, then that would appear to reconcile the issue.
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.
2/ Or is this another reason @us_fda is going out of its way to say Comirnaty is not available?
“although COMIRNATY (COVID-19 Vaccine, mRNA) is approved… there is not sufficient approved vaccine available for distribution to this population.”https://t.co/XrqIORQZVt
— Alex Berenson (@AlexBerenson) August 25, 2021
“So now that Come-Here-Naughty is approved (ish), the [Moderna] and [Johnson & Johnson] lose their Emergency Use Authorizations, right?” Berenson asked. “Because there’s an approved alternative and you can’t have an EUA when there are ‘adequate, approved, and available alternatives’.”
“Or is this another reason [the FDA] is going out of its way to say Comirnaty is not available?” Berenson continued. “[A]lthough COMIRNATY (COVID-19 Vaccine, mRNA) is approved… there is not sufficient approved vaccine available for distribution to this population.”
Attorney Robert Barnes got to the heart of the matter in a post on Wednesday night:
“There is no *available* FDA approved licensed vaccine,” Barnes said. “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’.”
When a user questioned his analysis with the extremely persuasive point “full stop,” Barnes countered with an indisputable point.
“Did you fail to read the part of the FDA letter where it said the licensed vaccine isn’t ‘available’ yet?” Barnes asked. “How is there ANY EUA vaccines when the law does not allow them if there is a licensed vaccine available?”
Dr. Robert Malone, who is described as the inventor of the mRNA and RNA as a drug, appeared on Steve Bannon’s war room on Monday and also delved into the Pfizer-BioNTech/Cominarty controversy.
“So, the little trick that they’ve done here is they have issued two separate letters… The Pfizer vaccine, which is what is currently available… is still under Emergency Use Authorization,” Dr. Malone said. “Once again, the mainstream media has lied to you.”
The entire vaccine rollout has broken the public trust — from the lies about “15 days to stop the spread” to the lie that the COVID vaccine prevents transmission and thereby protects “the public” — the pharmaceutical companies, as well as the Biden administration and its bureaucratic arms, no longer get the benefit of the doubt.
If the Pfizer-BioNTech vaccine is being treated as a ‘fully authorized’ vaccine, then it should no longer be afforded the protections offered by EUA.
There is one way the American people can find out for sure: Let the lawsuits begin.
OPINION: This article contains commentary which reflects the author’s opinion.
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