Disputes at FDA over COVID boosters put spotlight on Friday panel
Advisory committee meeting could give airing to FDA’s internal disagreements about booster shots
Intra-agency disputes over pandemic policy played out in public Monday as FDA’s top vaccine regulators, Marion Gruber and Phil Krause, advocated against authorizing booster doses for most Americans at this time, while the Director of the Center for Biologics Evaluation and Research, Peter Marks, argued that third shots may be essential for protecting public health. The dispute sets up the Sept. 17 meeting of FDA’s Vaccines and Related Biological Products Advisory Committee as an opportunity to adjudicate the controversy.
News that Gruber and Krause, director and deputy director, respectively, of the Office of Vaccines Research & Review (OVRR) at CBER have submitted their resignations adds to the tension as former FDA officials and the larger scientific community have privately lined-up on opposite sides in the most fraught COVID-19 decision FDA has made during the Biden administration. ...