Thursday, February 19

An FDA official is getting his job back as the agency’s top vaccine regulator, less than 2 weeks after he was pressured to step down at the urging of biotech executives, patient groups, and conservative allies of President Donald Trump.

Vinay Prasad, MD, MPH, is resuming leadership of the FDA center that regulates vaccines and biotech therapies, an HHS spokesperson said in a statement Monday.

Prasad left the agency late last month after drawing ire of right-wing activists, including Laura Loomer, because of his past statements criticizing Trump.

A longtime critic of FDA’s standards for approving medicines, Prasad briefly ordered the maker of a gene therapy for Duchenne’s muscular dystrophy to halt shipments after two patient deaths. But that action triggered pushback from the families of boys with the fatal condition and libertarian supporters of increased access to investigational medicines.

Prasad’s decision to pause the therapy was criticized by the Wall Street Journal editorial board, former Sen. Rick Santorum (R-Penn.), and others. The FDA swiftly reversed its decision suspending the therapy’s use.

Loomer posted online that Prasad was “a progressive leftist saboteur,” noting his history of praising liberal independent Sen. Bernie Sanders (I-Vt.).

But Prasad has had the backing of FDA Commissioner Marty Makary, MD, MPH, and HHS Secretary Robert F. Kennedy Jr., who have both called for scrutinizing the use of COVID-19 vaccines. Under Prasad, the FDA restricted the approval of two new COVID-19 shots from vaccine makers Novavax and Moderna and set stricter testing requirements for future approvals.

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