Something is very wrong: “Pfizer-BioNTech’s ‘Full Authorization’ Docs”

Monday, the U.S. Food and Drug Administration (FDA) approved a biologics license application for the Pfizer Comirnaty vaccine. Or did it…

The press reported that vaccine mandates are now legal for military, healthcare workers, college students and employees in many industries. New York City Mayor Bill de Blasio has now required the vaccine for all teachers and school staff. The Pentagon is proceeding with its mandate for all military service members.

But there are several bizarre aspects to the FDA approval that will prove confusing to those not familiar with the pervasiveness of the FDA’s regulatory capture, or the depths of the agency’s cynicism.

First, the FDA acknowledges that while Pfizer has “insufficient stocks” of the newly licensed Comirnaty vaccine available, there is “a significant amount” of the Pfizer-BioNTech COVID vaccine — produced under Emergency Use Authorization (EUA) — still available for use.

The FDA decrees that the Pfizer-BioNTech vaccine under the EUA should remain unlicensed but can be used “interchangeably” (page 2, footnote 8) with the newly licensed Comirnaty product.

Second, the FDA pointed out that the licensed Pfizer Comirnaty vaccine and the existing, EUA Pfizer vaccine are “legally distinct,” but proclaims that their differences do not “impact safety or effectiveness.”

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".

— Robert Barnes (@barnes_law) August 25, 2021

There is a huge real-world difference between products approved under EUA compared with those the FDA has fully licensed.

EUA products are experimental under U.S. law. Both the Nuremberg Code and federal regulations provide that no one can force a human being to participate in this experiment. Under 21 U.S. Code Sec.360bbb-3(e)(1)(A)(ii)(III), “authorization for medical products for use in emergencies,” it is unlawful to deny someone a job or an education because they refuse to be an experimental subject. Instead, potential recipients have an absolute right to refuse EUA vaccines.

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.

U.S. laws, however, permit employers and schools to require students and workers to take licensed vaccines.

EUA-approved COVID vaccines have an extraordinary liability shield under the 2005 Public Readiness and Preparedness Act. Vaccine manufacturers, distributors, providers and government planners are immune from liability. The only way an injured party can sue is if he or she can prove willful misconduct, and if the U.S. government has also brought an enforcement action against the party for willful misconduct. No such lawsuit has ever succeeded.

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?

— Robert Barnes (@barnes_law) August 25, 2021

Read the entire article here and here

PDF  FDA-Final_Pfizer LOA to issue with BLA approval 08.23.21_v2

The Painful Truth called the Pfizer BioNtech number 1-800-666-7248, and confirms what the author says is true.