Two Senior FDA Officials Resign Over Biden Administration Booster Shot Plan

Two senior officials have resigned from their positions within the US Food and Drug Administration over frustrations with the Biden administration’s plans to move forward with recommending COVID-19 booster shots without their prior approval, according to a report.

Marion Gruber, director of the FDA’s Office of Vaccines Research & Review, and deputy director Phil Krause are set to leave the agency this fall, with sources telling Politico that the two officials were at odds with the FDA’s top vaccine official, Peter Marks, and were discontented over the roles of the Centers for Disease Control and Prevention and the Advisory Committee on Immunization Practices in decisions that they believed should be handled by the FDA.

According to trade publication Endpoints, the officials felt they were sidelined on major decisions, that the administration’s plan for boosters was jumping the gun, and that Marks should have pushed for the FDA to have more autonomy on the matter.

Marks played a leading role in helping the administration craft its August announcement of calls for an additional vaccine for most adults after eight months.

Marks announced the resignations in a letter to colleagues obtained by Endpoints.

@US_FDA is losing two giants who helped bring us many safe and effective vaccines over decades of public service. https://t.co/hkLJPDo2HK

— Luciana Borio, MD (@llborio) August 31, 2021

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