Overview
- In May Dr. Vinay Prasad issued override memos diverging from career scientists to limit Novavax and Moderna shots to those 65 and older and people with underlying health conditions.
- FDA reviewers had recommended broad approval for ages 12 and up after analyzing safety and efficacy data from trials involving tens of thousands of participants.
- Prasad’s memos cited a reduced risk of severe COVID-19 and persistent myocarditis concerns as tipping the benefit-risk balance against mass vaccination of low-risk populations.
- These interventions align with HHS Secretary Robert F. Kennedy Jr.’s policy to prioritize high-risk groups and mark a rare instance of political appointee override at the FDA.
- The agency has also mandated updated myocarditis warnings on mRNA vaccine labels and required additional post-approval safety studies before expanding authorizations further.