FDA Names Vinay Prasad as New Head of Vaccines, Biologics (1)

FDA Commissioner Marty Makary named Vinay Prasad, a hematologist oncologist and critic of the Covid-19 vaccine for children, as the next director of the Center for Biologics and Research.

Prasad joins the Food and Drug Administration from the University of California at San Francisco, where he served since 2020 as an epidemiology professor. Prasad previously worked at the National Cancer Institute, where he completed a fellowship in cancer prevention and was a fellow in hematology and oncology at the National Institutes of Health.

Shares of makers of vaccines and immunotherapies plunged Tuesday after the news. Moderna Inc. dropped as much as 13% while Novavax Inc. slumped as much as 7.2%. Gene therapy maker Sarepta Therapeutics Inc. sank as much as 27%.

“The Street is reacting negatively to the news given some of the color around Prasad and his stance on covid-19 vaccines, the broader drug approval process including accelerated approvals and other comments that on the surface appear to be more anti-industry versus amicable,” according to Jared Holz, a health-care analyst at Mizuho Securities USA LLC.

The FDA has seen significant change under the Trump administration’s effort to reorganize and slash the federal workforce. Prasad replaces Peter Marks, the former director of CBER, who departed his post in March after holding opposing viewpoints from US health secretary Robert F. Kennedy Jr., a vaccine skeptic.

“He brings a great set of skills, energy, and competence to the FDA, and I know that he is eager to begin immersing himself in the important work of CBER and the agency as a whole,” Makary said Tuesday in an internal FDA letter obtained by Bloomberg Law.

Prasad criticized some of Marks’s FDA decisions, specifically for overruling review teams to speed approvals, according to posts on the social media site X. He’s written that the media stoked “Covid alarmism” and overstated the threat of the virus. Prasad has also written opinions that children don’t need the Covid-19 vaccine and it shouldn’t be mandated in schools.

Prasad’s YouTube channel has been responsive to President Donald Trump’s selections of health leaders, showing support early on for Makary after his nomination hearing.

—With assistance from Angel Adegbesan (Bloomberg News)