by CDR Jay Furman, USN at Revolver News
At the turning point of the Spanish American War, a single American officer volunteered to hand carry a critical message through impossible enemy lines to a fateful ally named General Garcia, forever changing the course of that war and our country. Today, one million COVID-19 non-vaccinated brave military messengers would deliver a, no less, existential dispatch: the U.S. Military is being misled by the U.S. Food and Drug Administration (FDA), the Center for Disease Control (CDC), and the Pfizer and BioNTech drug companies, resulting in the current mandatory COVID-19 vaccination policies. While some media outlets reflexively cheer on the deadly shell game, is our military leadership prematurely mandating a vaccine that their personnel cannot, or should not, legally receive? Could that decision prove to be more detrimental to military readiness than the disease itself, thereby posing a greater threat to U.S. national security?
Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine [BioNTech’s COVID-19 Vaccine, mRNA, not Pfizer]. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine [Pfizer’s non-FDA licensed vaccine], and will now be marketed as Comirnaty (koe-mir’-na-tee) [only available in markets outside U.S.], for the prevention of COVID-19 disease in individuals 16 years of age and older (emphasis added).
The agency charged with the public’s health in pharmaceutical matters issued two related official letters confounding the announcement, above. Reconciling those letters and the ensuing policy is tedious, leaving the truth one-layer too deep for most media outlets. Unfortunately, the resulting confusion appears more goal than incidental. Bottom-line, the FDA did not license a COVID-19 vaccine physically available to consumers in the U.S.
In their first letter, the FDA issued the only COVID-19 vaccination license for COVID-19 Vaccine, mRNA (Comirnaty) owned by German company BioNTech (not Pfizer). It is not produced for a U.S.-licensed label anywhere in the FDA’s jurisdiction. In their second letter, the FDA re-issued the Emergency Use Authorization (EUA) for Pfizer-BioNTech COVID-19 Vaccine (not a FDA license). The letter officially designates Comirnaty as the licensed name for COVID-19 Vaccine, mRNA. This EUA explicitly states that Pfizer-BioNTech COVID-19 Vaccine “[…] has not been approved or licensed by the FDA, but has been authorized by emergency use [EUA] by the FDA […]” (emphasis added). It goes on to assert that Pfizer-BioNTech COVID-19 Vaccine and Comirnaty (COVID-19 Vaccine, mRNA) formulations are the same and thereby can be clinically substitutable. The FDA notes the abundant supply of Pfizer-BioNTech COVID-19 Vaccine and the non-availability of Comirnaty (COVID-19 Vaccine, mRNA) in the U.S. market. They then explicitly re-affirm that Pfizer-BioNTech COVID-19 Vaccine is, in fact, experimental and only covered by the EUA, not FDA licensed.
FDA License Letter:
EUA Re-issue Letter Excerpts:
Confused yet? The CDC did not help matters, either. On Monday, August 31, 2021, their Advisory Committee on Immunization Practices (ACIP) released an inaccurate statement. The committee’s public announcement unanimously endorsed the FDA license for the “Pfizer-BioNTech licensed vaccine.” They misstated the vaccine name and license holder, never mentioning the actual owner of the FDA license, BioNTech, conflating legal ownership of Comirnaty (COVID-19 Vaccine, mRNA) as Pfizer’s. They neglected to mention it is not available in the U.S. and therefore not possible for consumers here to receive. Those inaccuracies further aided the public misperception that Pfizer-BioNTech COVID-19 Vaccine is FDA licensed. Concurrently, two high-level career FDA officials resigned at the time of the CDC ACIP board announcement, citing frustration with overreach into FDA affairs by other parts of the Executive Branch.
The Pfizer company issued a “forward-looking” press release, that was also easily misinterpreted. Perhaps they were hoping the mundane went unnoticed, as the pharmaceutical giant intermingled complex terms and concepts: Pfizer, BioNTech, Comirnaty, COVID-19, mRNA, EUA, authorized, approved, licensed, manufacturer, legal owner, national markets, and etc. The corporate relationship between Pfizer and BioNTech is no less convoluted. The joint venture and vaccine names, also similar, only add to the confusion. All of which potentially prevented a clear understanding of important legal and regulatory nuances, and allowed a fearful U.S. public to believe an available vaccine was now regulatorily licensed for their safety and legal recourse, when in reality, it was not. In brief:
- BioNTech is the marketing arm of the two company enterprise in the U.S., Europe, and UK.
- Pfizer produced Comirnaty (COVID-19 Vaccine, mRNA) for BioNTech, while both submitted supporting material for the license.
BioNTech, alone, received an FDA license for Comirnaty (COVID-19 Vaccine, mRNA).
- Both Pfizer-BioNTech COVID-19 Vaccine and Comirnaty (COVID-19 Vaccine, mRNA) were covered, in-part, by the re-issued EUA.
- Both Pfizer-BioNTech COVID-19 Vaccine and COVID-19 Vaccine, mRNA may be available in other countries. Yet, Comirnaty (COVID-19 Vaccine, mRNA) is not available anywhere under FDA jurisdiction.
- If and when this occurs, Comirnaty (COVID-19 Vaccine, mRNA) will be “[…] manufactured, filled, labeled, and packaged at Pfizer.”
- Both Pfizer produced vaccines are, at times, marketed as Comirnaty outside the U.S. While only COVID-19 Vaccine, mRNA) is officially recognized as Comirnaty in this country.
Recent U.S. military vaccine mandates look to be a direct result…Continue Reading