As many have correctly noticed, the FDA has not approved any of the COVID-19 vaccines. All currently used Covid-19 vaccines are still under Emergency Use Authorization (EUA). So, the obvious questions are:
- Has the FDA approved the BioNTech COMIRNATY vaccine, as alleged?
- Why would the FDA approve a vaccine not supplied to the US, instead of approving the equivalent formulation, manufactured and distributed by Pfizer, which has been injected in half of the US population, allegedly with enormous success?
- Finally, why has the FDA created an artificial legal distinction between batches of the same product, manufactured at different plants?
The FDA Approval Letter in the question is dated by August 23 and is signed by two directors of CBER offices. One of those directors is Marion Gruber, PhD, who has announced her future resignation, due to the CDC’s attempts to force an approval of a COVID-19 vaccine.
The first thing that we notice in the letter is that it lacks the language “We have approved your BLA for <product description> effective <date>”, typically appearing at the beginning of such letters. BLA stands for Biologics License Application. This letter does contain a few sentences authorizing BioNTech to manufacture a COVID-19 Vaccine and approving certain ways and undisclosed locations of manufacturing. It also approves labeling with the name COMIRNATY. This said, such form is used sometimes and is considered as an approval.
The next important fact is that the alleged Approval Letter actually prohibits distribution of the drug named in it:
“Please submit final container samples of the product in final containers together with protocols showing results of all applicable tests. You may not distribute any lots of product until you receive a notification of release from the Director, Center for Biologics Evaluation and Research (CBER).”
This language is not unusual in such approval letters. A company receiving such an approval letter from FDA/CBER considers the drug approved and frequently issues a triumphant press release.
But this case is different. There is already a surplus of Pfizer’s product in the US, its manufacturing continues, and its EUA is re-issued on the same day. BioNTech has no intent to distribute COMIRNATY in the US, and probably has no right to do so under its agreement with Pfizer. Therefore, it is unlikely BioNTech would submit to CBER the requested samples and “protocols showing results of all applicable tests”. Pfizer and BioNtech have barely announced the alleged FDA approval in a joint press-release.
The “approval” is incomplete. Each side must take at least one more step to complete the process – BioNTech must ship samples and test results and CBER Director must send a notification of release after that. Neither party is interested in taking these last steps.
This answers our first question as to COMIRNATY being truly approved. No, it is not. The FDA approval letter is a fictitious document. Continue reading FDA Fiction — Fictional Approval of COVID-19 Vaccine