Three recent decisions by two US agencies regarding vaccines have sidestepped the usual path of consulting outside advisors, a move that two former Food and Drug Administration officials write at the Washington Post prevented the pros and cons of the decisions from being fully aired.
In their opinion piece, Philip Krause, former deputy director of the FDA's Office of Vaccines Research and Review, and Luciana Borio, a former acting chief scientist at FDA and current senior fellow with the Council on Foreign Relations, write that had the FDA or the Centers for Disease Control and Prevention convened outside panels, they would have heard some opposition to their decisions to authorize boosters for all US adults and the FDA's decision to lower the booster eligibility age to 16.
Such debate, they add, is critical, especially as new variants emerge. "Emergency situations call for rapid high-stakes decision-making with limited data," Krause and Borio write. "Exigency might be offered as an excuse for bypassing the advisory process, but that's the exact circumstance when expert discussion and interpretation of the data can make the biggest difference."
Krause recently departed FDA. Endpoints News reported that he and a colleagues who also recently left, Marion Gruber, were frustrated with "the White House getting ahead of FDA on booster shots."