The confusing FDA approval of "Comirnaty" Updated:
The FDA approved an mRNA drug similar to Pfizer- BioNTech, not currently on the market yet.
Update: CHD, Children’s Health Defense Sues FDA Over Approval of Pfizer Comirnaty Vaccine.
Children’s Health Defense (CHD) on Aug. 31 filed suit in U.S. District Court, Eastern District of Tennessee against the U.S. Food and Drug Administration (FDA) and its acting director, Dr. Janet Woodcock, for their allegedly deceptive, rushed licensure of Pfizer’s Comirnaty vaccine.
According to the lawsuit, the FDA violated federal law when it simultaneously licensed Pfizer’s “Comirnaty” vaccine and extended Pfizer’s EUA for its vaccine that has the “same formulation” and that “can be used interchangeably,” according to the FDA.
The law (21 U.S. Code § 360bbb-3-(3)) on “authorization for medical products for use in emergencies” requires the EUA designation be used only when “there is no adequate, approved and available alternative to the product for diagnosing, preventing or treating such disease or condition.”
The lawsuit alleges once the FDA approved and licensed Pfizer’s Comirnaty vaccine, there was no further basis for the FDA to preserve the EUA status for the Pfizer-BioNTech vaccine that Pfizer acknowledges has the “same formulation” and is “interchangeable.”
There also is no basis to retain EUA status for other COVID vaccines for the same use and for the same population as Pfizer’s Comirnaty vaccine, according to the complaint.
“The FDA must justify its actions in open court,” said Mary Holland, CHD president and general counsel. “The language of its licensure is nearly incomprehensible, and the result of licensed and unlicensed vaccines for the same indication is arbitrary.”
CHD is asking the court to vacate and remand the FDA’s decisions to license Pfizer’s Comirnaty vaccine and to extend EUA for the Pfizer-BioNTech vaccine.
Attorneys Robert F. Barnes and Derek Jordan of Barnes Law are the lead attorneys along with CHD Chairman and Chief Legal Counsel Robert F. Kennedy, Jr. and other counsel for CHD.
CHD had also previously initiated a Citizen Petition to revoke all current Emergency Use Authorizations, the FDA response can be read in this document, which paved way for legal redress.
Take it from civil rights, and constitutional lawyer Robert Barnes:
In light of the large legal, difference of an FDA-approved product, vs. a EUA product in phase 3 Clinical Trials, Executive Order 14043 issued by Joseph Biden on September 9, 2021, is in dire need of being challenged in courts, due to its misleading phrasing and inaccurate statements on FDA approval and equality of the Comirnaty product and the Pfizer mRNA shots.
The wording in said Executive Order states the following:
“As of the date of this order, one of the COVID-19 vaccines, the Pfizer-BioNTech COVID-19 Vaccine, also known as Comirnaty, has received approval from the Food and Drug Administration (FDA), and two others, the Moderna COVID-19 Vaccine and the Janssen COVID-19 Vaccine have been authorized by the FDA for emergency use.”
About the Bait and Switch Approval of Comirnaty:
"Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved... there is not sufficient approved vaccine available for distribution to this population."
Here is the headache for anyone with a logical mind: The EUA ( Emergency Use Authorization) process is conditional.
According to the FDA, part of the criteria that need to be met is that there can’t be any other adequate, approved, and available alternative to the emergency use of other products to allow for EUA.
The real information here is hiding in the footnotes:
“Although COMIRNATY (Come-here-naughty) is approved to prevent Covid-19 in individuals 16 years and older, there is not sufficient approved vaccine available for distribution in this population in its entirety at the time of resistance 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.”
Translation: The newly approved product is not actually on the market yet, and the product is NOT the same as the Pfizer drug, even legally distinct.
The Defender writes:
“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 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.
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.”
What is the justification to rush approval of a product not even on the market yet? How is the FDA able to re-issue Emergency Use Authorization in this shady way, only to claim that there is now a legally approved “status” for a vaccine, to be believed by the people, for legal ways of Coercion in the workplace, and for other purposes?
