After two senior FDA officials announced their intent to retire, CBER director Dr. Peter Marks will take the reins of the agency’s Office of Vaccines Research and Review.
Marks assumed the role of acting director of the office on Monday.
The departing officials, director of the FDA’s Office of Vaccines Research and Review Dr. Marion Gruber and deputy director Dr. Phil Krause, plan on leaving in October and November, respectively.
In an internal memo dated September 27 obtained by Endpoints News, Marks wrote that he would be “assuming responsibilities as the Acting Office Director, and Marion [Gruber] will transition oversight and management of the activities of the office to me.” The move “will allow Marion and Phil time to transfer their activities and take care of close-out activities prior to departing and help to assure a smooth transition.”
Dr. Peter Marks
The two officials had questioned the federal government’s plan to endorse COVID-19 booster shots for the broader public with what they perceived as insufficient evidence. In addition, Gruber and Krause had co-written a Lancet article questioning the immediate need for boosters for most people.
Gruber was the signatory authority for an amendment to the emergency use authorization for the Pfizer-BioNTech vaccine that allowed its use as a booster in some individuals.
FDA is currently gearing up to decide whether to make the Pfizer-BioNTech vaccine available to children between the ages of five and 11.
Marks was involved in establishing Operation Warp Speed, the Trump-era program designed to accelerate the development of COVID-19 vaccines and therapeutics. He, however, left the program in May 2020.