Risk-Stratified COVID-19 Vaccine Framework

Summary

On May 20, 2025 — two weeks into his tenure as CBER director — Dr. Vinay Prasad co-authored a New England Journal of Medicine article with FDA Commissioner Marty Makary announcing a new framework for COVID-19 vaccination policy. Under the framework, the FDA would limit future COVID-19 vaccine authorizations to people aged 65 and older or those at high risk of serious illness, and would require manufacturers to conduct additional large studies to demonstrate benefit before extending shots to children and healthy younger adults.

Prasad had argued for years prior to joining the FDA that COVID boosters for young, healthy people lacked randomized-evidence support. Once at CBER, he implemented the policy directly: the agency restricted Moderna and Novavax COVID vaccines to high-risk groups, overruling career staff in at least one case, according to reporting.

The framework represented a sharp break from the prior universal-access posture of U.S. vaccine regulators. It drew support from critics of earlier booster campaigns and condemnation from former regulators and public-health commentators who said it erected unnecessary barriers to vaccination. It remained FDA policy through Prasad’s departure in April 2026.

Timeline

• May 20, 2025 — Prasad and Commissioner Makary publish the framework in the New England Journal of Medicine, announcing risk-stratified COVID vaccine authorizations.
• Summer–fall 2025 — Under Prasad, CBER restricts Moderna and Novavax COVID shots to adults 65+ and high-risk groups, overruling staff in at least one case.
• April 30, 2026 — Prasad departs the FDA; the risk-stratified framework remains in place as agency policy.