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.
An @US_FDA spokesperson confirms departure of @FDACBER‘s Dr. Marion Gruber and Dr. Phil Krause
Email from Dr. Peter Marks announcing the “two retirements” calls Dr. Gruber’s departure “a huge loss” and thanks Dr. Krause for “incredible contributions to public health” https://t.co/Ko5KzfhZzc pic.twitter.com/e5aolUwQ6v
— Alexander Tin (@Alexander_Tin) August 31, 2021
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.
The rift over booster shots emerged after the Biden administration announced earlier this month it expected to have booster shots for vaccinated Americans beginning around Sept. 20, and that it expects most Americans to need a booster around eight months after they are fully vaccinated. The announcement has been panned by some experts, as the FDA has thus far only approved boosters for the immunocompromised.
There is also disagreement among some medical professionals on not only the necessity of boosters for the general public at this time, but the ethics of providing third doses to some while billions around the world remain unvaccinated. (RELATED: ‘Natural Immunity Is Really Better’: New Israeli Study Fuels Debate On Vaccination Versus Natural Immunity)
The FDA only granted full approval to Pfizer’s COVID-19 vaccine Aug. 23.
