FDA Vaccine Official Restricts COVID Vaccine Approvals Against Agency Advice
Dr. Vinay Prasad, FDA's vaccine chief, overruled agency staff to limit COVID vaccine approvals for those 12 and older, citing safety concerns amid declining COVID risks.
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Overview
- Dr. Vinay Prasad, the FDA's vaccine chief, restricted COVID vaccine approvals for individuals 12 and older, contrary to agency staff recommendations.
- The decision was influenced by declining COVID-19 death and hospitalization rates and concerns over potential vaccine side effects.
- Prasad's intervention came after he was appointed in May, following the resignation of Dr. Peter Marks due to disagreements over vaccine policies.
- FDA officials advised updating vaccine labels for Moderna and Pfizer to include warnings about myocarditis, a rare heart condition linked to mRNA vaccines.
- The FDA's review teams supported the favorable risk-benefit assessment of vaccines, despite Prasad's restrictions against broader approvals.
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Analysis
Center-leaning sources frame the FDA's vaccine approval process as contentious, highlighting internal disagreements and the intervention of officials like Dr. Vinay Prasad. They express concern over the implications of restricting vaccine access, emphasizing public health risks while questioning the decision-making transparency and alignment with scientific recommendations.
"Instead Prasad decided the shots should be limited to those who face special risks from the virus— seniors or children and adults with underlying medical issues."
ABC News"Prasad decided the shots should be limited to those who face special risks from the virus— seniors or children and adults with underlying medical issues."
Associated PressArticles (3)
FAQ
Dr. Vinay Prasad is a physician and academic who was appointed as the director of the FDA's Center for Biologics Evaluation and Research (CBER) in May 2025, overseeing vaccine and biologic reviews.
Dr. Prasad restricted approvals citing declining COVID-19 death and hospitalization rates and concerns over potential vaccine side effects, diverging from FDA staff recommendations that supported broader vaccine use.
FDA review teams supported a favorable risk-benefit assessment of COVID vaccines for individuals 12 and older and advised updating vaccine labels to include myocarditis warnings, a rare heart inflammation linked to mRNA vaccines.
Dr. Peter Marks resigned due to disagreements over vaccine policies and cited concerns that the Department of Health and Human Services leadership did not value science and transparency.
Prasad’s appointment drew attention due to his critical stance on COVID-19 policies and prior FDA decisions, leading to notable market reactions such as biotech stock declines following his leadership announcement.
History
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