Overview
- Dr. Vinay Prasad was appointed director of the FDA’s Center for Biologics Evaluation and Research on May 6 and later named the agency’s chief medical and scientific officer.
- Under Prasad’s leadership, the FDA tightened COVID-19 vaccine approvals by overruling internal reviewers to restrict Moderna and Novavax shots to high-risk populations.
- He pressed safety reviews of gene therapies, including a temporary halt of Sarepta’s Elevidys for Duchenne muscular dystrophy after patient deaths.
- His resignation followed a high-profile campaign by right-wing influencer Laura Loomer and reported White House pressure for him to step down.
- HHS publicly thanked him for his reforms and the FDA is preparing to install new leadership while vaccine and gene therapy policies remain under debate.