The "Approved" COVID Vaccine is Not Yet Available in U.S.
Sacramento, CA - The U.S. Food and Drug Administration's announced that it had granted "full approval" to the Covid shots being offered by Pfizer. But to be clear, what was actually given full approval was a separate Pfizer-BioNtech vaccine product which goes by the name Comirnaty. But Comirnaty is not currently available in the U.S.
The 13-page "approval letter" is addressed to BioNTech Manufacturing GmbH and Pfizer Inc. in New York City, and approves a biologics license application (BLA) for BioNTech Manufacturing GmbH in Mainz, Germany, for COMIRNATY.
Then a letter to Pfizer Inc. on the same date states: "FDA is reissuing the August 12, 2021 letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA."
Footnote 8 reads: "The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness."
The "certain differences"are not specified, but it is perfectly clear that the two products are legally distinct. An analysis by the Association of American Physicians and Surgeons notes these differences and concludes that "It appears that there are two legally distinct if otherwise mostly identical products. The remaining doses of the 'Pfizer-BioNTech COVID-19 vaccine' are still under an EUA and are not fully licensed."
As of this date, the FDA has not approved the non Cominaty branded vaccine such as the Pfizer BioNTech vaccines, nor any COVID vaccines for the 12- to 15-year age group, nor any booster doses for anyone.
The FDA acknowledges that while Pfizer has insufficient supplies of the newly licensed Comirnaty vaccine actually available, there is "a significant amount" of the Pfizer-BioNTech COVID vaccine - which has been produced under Emergency Use Authorization (EUA) and will continue to be offered under the same EUA status.
EUA-licensed 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.
Phizer's Cominaty vaccine likely does not have that liability protection for Pfizer. The abundant U.S. supply of EUA authorized Pfizer-BioNtech vaccine product does protect Pfizer. Instead, the government has created a comparatively stingy compensation program, the Countermeasures Injury Compensation Program, - compared to tort law - to redress injuries from all EUA products.
The FDA-approved package insert for Comirnaty reads: "13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility. COMIRNATY has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility." It mentions one study in female rats. The package inserts warns of myocarditis, but omits mention of Guillain-Barré syndrome, thrombotic complications, and other serious events.
Now the thorny issues. Can an employer mandate that employee's take a vaccine that is "legally distinct" from the approved Cominaty product made by Pfizer? And if they do, does that bring any potential side-effect related problem within the workers' compensation system?
Federal Regulations provide that no one can force a human being to take an EUA drug. Under 21 U.S. Code Sec.360bbb-3(e)(1)(A)(ii)(III), "authorization for medical products for use in emergencies," parties need to be informed of their "option to accept or refuse administration of the product." What is also not clear is if the employer's vaccine mandate under threat of termination interferes with this right.