One of the main, if not the main, takeaway from last week’s House Judiciary Committee hearing on the licensure of the Pfizer-BioNTech COVID-19 vaccine appears to be that FDA official Marion Gruber, who was at the time the Director of the FDA’s Office for Vaccines Research and Review, opposed the fast-track licensing of the vaccine. According to the standard spin, Gruber and her deputy Phillip Krause would even resign from the agency in protest. But what has gone virtually entirely overlooked in the related buzz about Gruber’s and Krause’s alleged opposition, is that Marion Gruber herself signed the letter approving the vaccine and granting full authorisation.
She only resigned after authorising. In fact, she did not resign. She retired, having reached the eligible retirement age the year before.
The August 23rd 2021 letter granting the biologics licence is available here. The top of the letter can be seen below. It should be noted that the biologics licence was granted to the German firm BioNTech, not to Pfizer. The reason the letter was addressed to BioNTech c/o Pfizer is that Pfizer served as BioNTech’s U.S. agent. As a foreign company, BioNTech was required by law to appoint a U.S. agent. This is indicated in the May 6th 2021 Biologics Licence Application, which is available here. The applicant is BioNTech. Contrary to what was stated in the committee hearing, BioNTech was also the sponsor of the clinical trial.
The bottom of the FDA approval letter can
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Where are the fact checkers when you need them?
They’re currently at choir rehearsals. They are currently practicing:
“La la la,
la la, la,
We can’t hear you”
Apparently they know it pretty well…..