Two Top Vaccine Officials Resign From FDA Amid Political Pressure From Biden Administration

The Food and Drug Administration’s (FDA) top two vaccine officials are resigning from the agency, a top leader within the agency told staff in a letter Tuesday.

Marion Gruber, director of the Office of Vaccines Research & Review (OVRR), and Phil Krause, OVRR deputy director, will leave the FDA at the end of October and in November, respectively. Gruber has been at the FDA for 32 years and Krause has worked at the agency for more than a decade.

The two officials are leaving the FDA in part because they are frustrated with the Centers for Disease Control and Prevention’s (CDC) involvement in the vaccine approval process, as well as with White House pressure to move forward with booster vaccines for COVID-19 without FDA’s approval, a former top FDA official told Endpoints.

Gruber and Krause reportedly believed the CDC and its Advisory Committee on Immunization Practices (ACIP) have been too heavily involved with decisions on COVID-19 vaccines that should be left to the FDA. They reportedly became upset with Center for Biologics Evaluation and Research (CBER) director Peter Marks, who oversees OVRR, for not fighting harder to keep those decisions within the halls of the FDA.