Departing FDA leaders join other experts to rebuff Biden booster plan

We now have a pretty good idea what led two leading FDA vaccine regulators to announce their retirement.

Marion Gruber and Phil Krause, two longtime FDA officials who have been leading the agency’s review of COVID-19 vaccine applications, were among the co-authors of a paper in medical journal The Lancet published Monday that threw cold water on the Biden administration’s plan for booster shots.

The paper argued that none of the current evidence on the COVID-19 vaccines shows a need for booster doses in the general population.

The Lancet paper’s authors noted the effectiveness of all available COVID-19 vaccines against severe disease remains strong, even as protection against symptomatic infection has decreased slightly due to the delta variant.

“Current evidence does not, therefore, appear to show a need for boosting in the general population, in which efficacy against severe disease remains high,” the authors wrote.

Neither FDA official has spoken publicly about their reasons for leaving their longtime posts, but the announcement they were stepping down came as the agency defended the Biden administration’s approach to vaccine booster shots.

The paper’s publication comes as the administration is pushing for boosters to be widely available to all Americans beginning Sept. 20, despite disagreement from outside scientists and some health agency officials who argue it’s premature, and that the data are not strong enough to support such a move.

Coming attraction: An FDA advisory group is scheduled to meet on Friday to discuss the evidence around Pfizer’s application for a booster, and is almost sure to address the wider issue of boosters in general.

FDA’s Peter Marks, the agency’s top vaccine official, said he thinks the data will be very clear. Speaking during a conference of regulatory affairs professionals on Monday, Marks said he is “fully confident”  that people attending the meeting will leave with “a good rationale for why boosters might be necessary.”

U.S. first: Marks also pointed out that taking care of U.S. citizens is his top priority. “As a United States government employee it is my obligation to ensure that the health of the United States population is best cared for and not to make global political decisions. So, if it turns out that a third dose is appropriate for everyone in the world to help prevent COVID-19 from coming around in cycles, we should be doing that, and if we happen to get to it before others realize that that’s the right thing to do, that’s just the way it is.”