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.
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.
Prasad disagreed with staff who wanted to approve COVID-19 shots for ages 12 and older, as shown in internal correspondence.
Prasad emphasized the need to reassess the benefits of the COVID vaccine due to decreasing death and hospitalization rates, as well as the potential for vaccine side effects.
COVID-19 has caused 32,000 to 51,000 deaths and over 250,000 hospitalizations in the U.S. since last fall, remaining a significant public health concern.
Top FDA leaders do not usually participate in the evaluation of specific products.
Prasad was hired in May to lead the FDA's vaccine center after the previous director, Dr. Peter Marks, resigned due to disagreements with Kennedy.
He collaborated with FDA Commissioner Mark Makary on guidelines restricting future COVID booster approvals to high-risk Americans.
Both vaccines received FDA approval in May following extensive analysis by FDA reviewers.
Scientists have determined that the benefits of COVID-19 vaccines outweigh the rare risk of side effects, with data from a study on the Novavax vaccine supporting this assessment.
The FDA's top vaccine official went against agency experts to recommend limited use of two Covid-19 vaccines.
Dr. Vinay Prasad disagreed with reviewers' conclusions on vaccine safety and the ongoing threat of Covid-19, leading to restrictions on Novavax and Moderna vaccines.
Articles (3)
Center (2)
"…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·5d·"…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 Press·5d·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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