Dr. Vinay Prasad will serve as head of the Center for Biologics Evaluation and Research.
The Food and Drug Administration’s (FDA) new top vaccine official is a university professor who has expressed criticism of how the agency handled COVID-19 vaccines.
Dr. Vinay Prasad will head the FDA’s Center for Biologics Evaluation and Research (CBER), FDA Commissioner Dr. Marty Makary said on May 6.
Doctors with Sensible Medicine, a website with which Prasad was involved,
said on Tuesday that Prasad was leaving the site to become the director of the CBER.
Prasad did not respond to a request for comment by publication time.
Prasad has frequently criticized in recent years the decisions FDA officials made, including the promotion of COVID-19 vaccines without clinical trial data, particularly for people who had previously been infected with COVID-19. He
wrote in a 2024 review that there was “misplaced utilization, contradictory messaging, and poor deployment in those who would benefit most—the elderly and high-risk—alongside unrealistic messaging, exaggeration, and coercion in those who benefit least—young, healthy Americans.”
Prasad, an epidemiology and biostatistics professor at the University of California–San Francisco, was also one of the first outside experts to
raise concerns about heart inflammation that was appearing in young people who received the shots.
“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,” Makary
said in a post on social media platform X.
The CBER regulates vaccines and other biological products. The agency’s website still
lists Dr. Peter Marks as its director.
Marks
resigned in April over disagreements with Health Secretary Robert F. Kennedy Jr. In his resignation letter, Marks said he was willing to work to address Kennedy’s concerns with vaccine safety and transparency, but alleged that he later realized Kennedy “wishes subservient confirmation of his misinformation and lies.”
A spokesperson for the Department of Health and Human Services, the FDA’s parent agency, told news outlets at the time that “if Peter Marks does not want to get behind restoring science to its golden standard and promoting radical transparency, then he has no place at [the] FDA under the strong leadership of Secretary Kennedy.”
Marks rushed the approval of Pfizer’s COVID-19 vaccine in order to enable vaccine mandates, according to
internal documents, resulting in the resignations of two of the FDA’s top vaccine officials in 2021. Marks has said the officials were not acting urgently enough in light of the COVID-19 pandemic.
“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
wrote on X in March, in one of his
many posts critical of the former official.
Scott Steele, who has been with the FDA since 2017, began serving as acting CBER director shortly after Marks stepped down.
