Agency commissioner Dr. Marty Makary announced Tuesday that Dr. Vinay Prasad, a prominent COVID–19 vaccine critic, has been appointed to lead the Food and Drug Administration Center, which oversees the approval of vaccines and other biologics products.

Prasad, currently a physician-scientist and professor at the University of California, San Francisco, gained a following during the pandemic for criticizing mask mandates, lockdowns, and COVID-19 vaccine boosters. 

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Makary and Prasad co-authored a paper in 2022 in the British Medical Journal, finding that COVID-19 booster mandates for teenagers and young adults did more harm than good, particularly causing severe cardiac problems for young males.

Makary posted on X on Tuesday afternoon that Prasad would lead the Center for Biologics Evaluation and Research.

“With 500+ peer-reviewed publications and two books, Dr. Prasad brings the kind of scientific rigor, independence, and transparency we need at CBER—a significant step forward,” wrote Makary. 

Prasad has long been critical of mRNA COVID-19 vaccines and the FDA’s decision to grant emergency use authorization. He has questioned the yearly booster vaccines encouraged by the FDA and the Centers for Disease Control and Prevention. 

Prasad last week published an article on his Substack arguing for randomized clinical trials for COVID-19 booster shots. He cited that booster uptake rates “remain abysmal” because “the American people have shown they are unwilling to get an unproven annual booster.” 

Prasad has also been highly critical of Dr. Peter Marks, who headed CBER from 2016 until he resigned in March. Marks played a central role in Operation Warp Speed during Trump’s first term to develop mRNA COVID-19 vaccines.

Marks, in his resignation letter, alluded to the anti-vaccine rhetoric of Health and Human Services Secretary Robert F. Kennedy Jr., among others in the Trump administration, as the reason for his departure. He said that using the FDA to undermine confidence in vaccines “is irresponsible, detrimental to public health, and a clear danger to our nation’s health, safety, and security.”

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Shortly before Marks resigned, Prasad called him “a bobblehead doll that just stamps approval and you would have the same outcome at FDA with lower administrative fees.”

The health biotechnology sector reacted poorly to Prasad’s appointment, as stock prices in the industry fell by more than 6% by Tuesday afternoon. As a specialist in cancer and blood disorders, Prasad has published research showing that several cancer drugs fast-tracked by the FDA were not proven to improve patient outcomes or extend their lives directly, instead shrinking tumor size and conferring other indirect benefits.