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German FDA Official Did Not Oppose BioNTech-Pfizer Licensure

German FDA Official Did Not Oppose BioNTech-Pfizer Licensure


One of the main, if not the main, takeaways from the recent 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 and Krause’s alleged opposition is that Marion Gruber herself signed the letter approving the vaccine and granting full authorization! 

She only “resigned” after authorizing. 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 license is available here. The top of the letter can be seen below. It should be noted that the biologics license 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 US agent. As a foreign company, BioNTech was required by law to appoint a US agent. This is indicated in the May 6th, 2021 Biologics License 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 be seen below.

Furthermore, though there was talk in the committee hearing of Gruber objecting to the compressed timeline for the application review, in testimony to the committee she in fact defended the timeline, insisting that there had been “a complete and thorough” review by the time of the August 23rd licensing of the vaccine. (See here, Appendix A, pp. 112-13.) How indeed could she have said otherwise given that she signed the approval letter?!

In a surreal exchange with subcommittee Chair Thomas Massie, Gruber even outright denied that there had been more deaths in the vaccine arm of the clinical trial than in the placebo arm. Though as a matter of fact, which she then went on to acknowledge, there were. “I am not concerned,” she said, “…the data do not suggest to me that there were a higher number of deaths in the vaccine group compared to the placebo group”. This was her response when presented with data showing 15 deaths in the vaccine group and 14 in the placebo group! See here, Appendix A, p. 119, and below. 

These are not the words of an opponent of the licensure. They are clearly the words of an apologist, who is prepared to go to some mind-boggling lengths to defend the licensure.

It should be noted that the above testimony was non-public testimony given to Massie’s subcommittee in 2023. Unlike her deputy Krause, Gruber did not testify at the public hearing last month.

Had she appeared in the public hearing, one thing would have become immediately clear from her accent. Marion Gruber is German. You can listen to her contribution to a September 2021 public meeting on booster doses here. She completed her PhD in microbiology and immunology at the University of Kiel in 1986 and came to the US as a postdoc shortly thereafter. After two decades working at the FDA, she was appointed Director of the FDA’s Office for Vaccines Research and Review in 2012.

Given the German government’s sponsorship of BioNTech and the exceptional importance it has attached to the success of the company’s Covid-19 vaccine (as documented, for instance, here, here, here, and here), questions might have been raised about the German FDA official’s impartiality in overseeing the review of specifically this product.

It was perhaps to avoid such questions that even Gruber persistently referred to the “Pfizer” Biologics License Application in her testimony to the House committee, even though she, of all people, knows perfectly well that the applicant was BioNTech. Not only is BioNTech clearly identified as the applicant in all the relevant regulatory documents, but the letter from BioNTech appointing Pfizer as the German company’s US agent was addressed to none other than Marion Gruber – as can be seen below.

Republished from The Daily Sceptic

Published under a Creative Commons Attribution 4.0 International License
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