The Food and Drug Administration announced Tuesday it has picked a new head of its center charged with vaccine approvals and other biologics products: Dr. Vinay Prasad, a vocal critic of the agency’s moves to greenlight COVID-19 vaccine boosters.
Prasad replaces Dr. Peter Marks, who served as the director of the Center for Biologics Evaluation and Research at the FDA and played a key role in launching Operation Warp Speed — the Trump administration’s effort to speed up the development of vaccines during the COVID-19 pandemic. The center has been operating with an acting director since Marks left the FDA in March.
“Dr. Prasad brings the kind of scientific rigor, independence, and transparency we need at CBER — a significant step forward,” FDA Commissioner Dr. Martin Makary posted on X on Tuesday.
Prasad has long criticized the FDA for granting emergency use authorization for COVID-19 vaccine boosters, saying last year that Marks was “either incompetent or corrupt to authorize a booster without clinical, randomized data.”
After Marks was forced out by Health and Human Services Secretary Robert F. Kennedy Jr., Prasad called Marks “one of the most dangerous, pro-pharma regulators of the 21st century” and a “mediocre academic” before joining the government.
“You could replace Peter Marks with a bobblehead doll that just stamps approval and you would have the same outcome at FDA with lower administrative fees,” Prasad posted on March 20, the week before Marks was ousted.
Prasad, a professor in the Department of Epidemiology and Biostatistics at the University of California at San Francisco. joins the agency at a time when the FDA says it is looking at whether it will approve annual updates to the COVID-19 vaccines this fall, as part of a routine process that had been due to start next month. Officials have floated the possibility of requiring new randomized trials before approving future updates to COVID shots.
A week ago, Prasad said he backed the idea of new randomized clinical trials before approving COVID shot updates, calling it “absurd” that the U.S. was still offering COVID vaccinations to young children and warning that strain changes could result in changes to efficacy and safety.
“Without trials, it is only a matter of time before the FDA approves a vaccine that causes some bad outcome like vaccine-induced narcolepsy. If this happens, you can kiss faith in vaccines goodbye. You will see vaccine hesitancy like you have never seen before,” he wrote.
Prasad’s following grew during the COVID-19 pandemic, as he criticized measures like vaccine mandates and called for Moderna’s vaccine to be banned in men under 40.
During the pandemic, he was accused alongside Makary and Dr. Tracy Høeg of being a prominent purveyor of misinformation about COVID-19 vaccines.
Høeg now works for the FDA as a special assistant to Makary, and replaced the agency’s representative on the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
In an email to employees shared with CBS News, Makary said that Prasad “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 also commended Prasad’s “long and distinguished history in medicine.”
