While it’s no surprise that Pfizer continues to doubled-down on the lie that their FDA-approved COVID-19 mRNA vaccines are still protected under the EUA shield, it is somewhat shocking that the FDA is also lying in government briefing documents and on their website that FDA-approved COMIRNATY and Pfizer’s EUA BNT162b2 are the same products and interchangeable.
Pfizer’s EUA immunity shield was broken onAugust 23, 2021, when the FDA approved COMIRNATY. Per the statements made in 2022 FDA briefing documents and the FDA’s own website, it appears that the FDA is attempting to cover for Pfizer by projecting the false perception that Pfizer still maintains their iron-clad EUA immunity shield, regardless of the fact that it was broken by the FDA themselves.
Per the FDA’sJune 15, 2022, Vaccine and Related Biological Products Advisory Committee (VRBPAC) Briefing Document, the FDA claims that the FDA-approved, ‘Comirnaty was called BNT162b2 during clinical development,” and that, “Comirnaty contains mRNA encoding the viral (S) glycoprotein for SARS-CoV-2.”
These statements are easily proven to be false claims by the FDA’s own documents and statements from 2021.
False Claim 1: COMIRNATY was called BNT162b2 during clinical development.
Per Pfizer’s Initial New Drug Application (IND), it is true that BNT162b2 is the mRNA formulation used in the clinical trials.
However, per the FDA’s August 23, 2021, BLA approval, the FDA clearly states that COMIRNATY and BNT162b2 are similar, but different biosynthetic agents.
In August of 2021, the FDA legally acknowledged that the mRNA formulation of COMIRNATY is different and not interchangeable with BNT162b2 by issuing aDear HCP Letter distinguishing the mRNA formulations by lot numbers.
If the FDA believed that BNT162b2 was the same formulation and interchangeable with COMIRNATY, the Dear HCP Letter would not have been issued.
Conclusion: The statement made in the June 15, 2022, FDA briefing document that COMIRNATY and BNT162b2 are the same and interchangeable are false and intentionally misleading claims.
False Claim 2: COMIRNATY contains mRNA encoding the viral (S) glycoprotein for SARS-CoV-2.