Ousted FDA vaccine chief Vinay Prasad is returning to the agency

Key Points

• Dr. Vinay Prasad is returning to his role as the FDA's top vaccine regulator after a brief ousting, following pressure from various groups, including biotech executives and conservative allies of former President Trump.
• His previous departure was due to backlash over his past criticisms of Trump and FDA approval standards, sparking significant public and political reactions.
• Prasad had recently paused a gene therapy for Duchenne's muscular dystrophy after two patient deaths, leading to controversy and a reversal of the FDA's decision on the therapy's use.
• While under Prasad’s leadership, the FDA imposed restrictions on two new COVID-19 vaccines and established stricter testing requirements for future vaccine approvals.

WASHINGTON (AP) — A Food and Drug Administration official is getting his job back as the agency's top vaccine regulator, less than two weeks after he was pressured to step down at the urging of biotech executives, patient groups and conservative allies of President Donald Trump.

Dr. Vinay Prasad is resuming leadership of the FDA center that regulates vaccines and biotech therapies, a spokesperson for the Department of Health and Human Services 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 a 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 experimental medicines.

Prasad’s decision to pause the therapy was criticized by The Wall Street Journal editorial board, former Republican Sen. Rick Santorum 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.

But Prasad has had the backing of FDA Commissioner Marty Makary and health 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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