AAPS Statement on FDA’s “Approval Decision” on Pfizer-BioNTech COVID-19 Vaccine

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On Aug 23, 2021, the U.S. Food and Drug Administration (FDA) decided to issue an “approval decision” regarding the Pfizer-BioNTech product, to be marketed as Comirnaty, for individuals 16 years of age and older. The Pfizer product will continue to be available under Emergency Use Authorization (EUA) for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

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.

A letter to Pfizer Inc. on Aug 23 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.”

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.

AAPS makes the following observations:

  • The Biden Administration is already calling for mandates, also by private organizations, now that the prohibition against mandates on products available only under an EUA is removed. However, full approval does not actually apply to vials not labeled “Comirnaty.”
  • The difference between “approval” and EUA is important. The Vaccine information Fact Sheet has the following question and answer: “WHAT IF I DECIDE NOT TO GET COMIRNATY (COVID-19 VACCINE, mRNA) OR THE PFIZER-BIONTECH COVID-19 VACCINE? Under the EUA, it is your choice to receive or not receive the vaccine. Should you decide not to receive it, it will not change your standard medical care.”
  • From an ethical and human rights standpoint, bureaucratic approval does not abrogate the right of individuals to give or withhold informed consent to medical interventions.
  • Minors are not capable, or in most instances legally authorized, to consent.
  • The approval was granted in record time, more than a year earlier than studies are scheduled for completion, and without the normally required advisory committee or public comment period.
  • An unprecedented number of lethal or serious adverse effects have been reported to the Vaccine Adverse Events Reporting System (VAERS).
  • The FDA-approved package insert 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.
  • Long-term adverse events cannot be assessed this early.
  • FDA is requiring additional post-marketing studies, on myocarditis and other issues, with up to 5 years follow-up.
  • Efficacy studies concerned the original virus, not the emerging variants, such as the Delta variant, which may be evading vaccine-induced immunity.
  • Pre-approval safety studies excluded children and pregnant women; post-marketing studies will be required.
  • FDA acting commissioner Janet Woodcock stated the product should not be given to children because of lack of information on safety or an appropriate dose.

                AAPS opposes vaccine mandates, supports the need for fully informed consent, and affirms the right of patients to refuse medical treatment even if it is recommended by their physician(s).