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FDA Vaccines and Biologics Chief Vinay Prasad to Leave at April’s End

The move follows months of high-profile disputes across vaccine reviews, gene therapy trials, public statements.

Overview

  • FDA Commissioner Marty Makary said Prasad will exit at the end of April and return to his post at the University of California, San Francisco.
  • Makary said the agency will name a successor before Prasad departs from the Center for Biologics Evaluation and Research.
  • Prasad’s tenure featured contentious calls, including an initial refusal to review Moderna’s mRNA flu vaccine that the FDA later agreed to evaluate after adjustments.
  • The agency has been in a public clash with UniQure over a Huntington’s disease gene therapy, with HHS accusing the company of misleading the public about regulators’ requests.
  • Controversy also stemmed from a November memo in which Prasad claimed Covid vaccines killed at least 10 children, a statement denounced by a dozen former FDA commissioners, and from his brief July departure before a rapid reinstatement.