• Posted May 7, 2025

Dr. Vinay Prasad to Head FDA Vaccine, Biologics Division

WEDNESDAY, May 7, 2025 (HealthDay News) — The U.S. Food and Drug Administration (FDA) has chosen Dr. Vinay Prasad, a professor at the University of California-San Francisco, to lead its Center for Biologics Evaluation and Research. 

The division oversees vaccines and biologic medicines, including gene therapies, CNN reported.

Prasad is a hematologist-oncologist, a specialist in treating cancers of the blood. He has been a vocal critic of the U.S. government's response to the COVID-19 pandemic. He has questioned school closures, mask mandates and COVID booster shots. 

He takes over from Dr. Peter Marks, who led the division for 13 years and played a major role in the COVID vaccine rollout. Marks resigned in March, writing in a letter that U.S. health secretary Robert F. Kennedy Jr. did not value science and transparency.

FDA Commissioner Dr. Marty Makary praised Prasad’s background, saying he has a "long and distinguished history in medicine" and highlighted his oncology research, according to CNN.

Prasad’s appointment comes as the FDA plans to require future vaccines to be tested through placebo-controlled trials. 

Public health officials are also reconsidering recommendations for COVID vaccines for children — recommendations Prasad has questioned, because kids face lower risks from the virus than older people and folks with weakened immune systems.

Amid news of his appointment, biotech stocks fell more than 5%. Sarepta Therapeutics, which makes a gene therapy for Duchenne muscular dystrophy, saw its stock drop nearly 25%. 

Prasad had criticized the FDA’s approval of that treatment, Elevidys, saying its benefits were uncertain.

In a social media post earlier this year, Prasad wrote, “The FDA did nothing to speed gene therapy, other than talk about how they will use uncontrolled endpoints. But we want to speed effective gene therapy, not ineffective gene therapy. The FDA had no solution for that.”

More information

There's more about vaccines at John Hopkins' Institute for Vaccine Safety.

SOURCE: CNN, May 6, 2025