FDA retirements reignite debate over Biden booster plan
The retirement of two top federal vaccine regulators has intensified the spotlight on the Biden administration’s plan for booster shots of COVID-19 vaccines, reigniting the debate about its commitment to following the science.
Former health officials and outside experts have questioned the need for booster doses, stating they were concerned that when the Biden administration announced that boosters could be available to all adults on Sept. 20, political leaders were getting ahead of the typical process.
Those concerns were amplified this week when the Food and Drug Administration (FDA) confirmed the retirements of two top agency vaccine regulators. Marion Gruber, director of the FDA’s Office of Vaccines Research and Review, is scheduled to depart the FDA at the end of October. Phil Krause, the office’s deputy director, will retire in November.
The Biden administration rolled out a plan last month to make booster shots widely available to the public on Sept. 20, but the start date was announced before any of the relevant agencies had examined the evidence.
The recommendation will only happen, administration officials have emphasized, if both CDC and FDA sign off. But that commitment to the data could be tested if agency scientists don’t agree on the timing or method.
New development: Top health officials are reportedly pushing back on the Sept. 20 deadline and warned White House officials that they may not be able to approve widespread boosters for every American by that date. The recommendation may only be for Pfizer-BioNTech, and it may also only be for a limited group of people, depending on what the scientists say.
The FDA has only partial data on Moderna and Johnson & Johnson boosters. Neither the White House nor FDA have commented publicly on if the plans will change.
Mark your calendar: The FDA has scheduled a meeting of its outside vaccine advisory panel for Sept. 17 to discuss the data from Pfizer-BioNTech. It’s likely the discussion will not be limited to the particulars of Pfizer’s application, and will examine thorny issues including the debate about boosters among health experts.
