The fast tracking and approval of Pfizer’s experimental gene therapy shots for COVID-19 was questioned by none other than the FDA’s own top vaccine official, Marion Gruber.

Gruber had been with the agency 32 years and was the agency’s director of the Office of Vaccines Research and Review when she suddenly resigned. Her deputy, Phil Krause, resigned shortly after the shots were approved.

Both Gruber and Krause, along with vaccine proponent Dr. Paul Offit, publicly questioned giving the shots to younger adults in a letter in The Washington Post. Now, newly released emails from the FDA show that Gruber not only was concerned about the review process being “hyper-accelerated,” but also about reports of myocarditis, especially in young males, associated with the shots.

Neither Gruber nor Krause were available for comments on the emails; the FDA declined to comment. 

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Endpoints January 25, 2023