Dr. Vinay Prasad, the Food and Drug Administration’s top official for vaccines and related biologics, is departing the agency for a second time in under a year, officials said. FDA Commissioner Marty Makary informed staff in a late-Friday email that Prasad will leave at the end of April and return to his academic post at the University of California, San Francisco.
Prasad was briefly removed from his role in July following disputes with biotechnology companies, patient advocates and conservative allies of President Donald Trump. He was reinstated in under two weeks after support from Health Secretary Robert F. Kennedy Jr. and Commissioner Makary.
His most recent exit comes after a string of high-profile, often public disagreements during FDA reviews of vaccines, gene therapies and other biotech products. In several cases the agency has shifted prior positions or asked firms to perform additional trials, prompting criticism from industry executives, investors and some members of Congress.
One prominent episode involved Moderna’s investigational mRNA seasonal influenza vaccine. The FDA initially declined to accept the company’s application for review — an unusual step that led Moderna to challenge the agency publicly. Days later the agency agreed to review the submission but said it would require an additional study from the company.
A separate dispute played out between the FDA and UniQure over a gene therapy for Huntington’s disease. UniQure said the agency demanded a new, sham‑controlled surgical trial for its brain‑administered treatment, a request the company argued conflicted with earlier guidance and raised ethical concerns. The FDA held a press briefing to explain its view, criticized the company’s original data and said the evidence did not demonstrate effectiveness.
Prasad’s tenure was marked by frequent clashes with companies developing treatments for rare or hard-to-treat conditions. More than half a dozen developers working on such therapies received rejection letters or requests for extra trials during his time leading the vaccine and biotech review office — actions that can substantially lengthen timelines and increase development costs.
An academic known for questioning historic FDA approval standards, Prasad joined Commissioner Makary in announcing initiatives aimed at streamlining and speeding reviews. At the same time, he pushed for new warnings and additional studies for certain biotech products and vaccines, including some COVID‑19 vaccines that have been a focus of Health Secretary Kennedy, who previously was an outspoken critic of vaccines.
Prasad’s departure marks another leadership change in an office that has been at the center of contentious decisions about emerging and specialty therapies.