MedPageToday FDA officials have outlined their new approach to COVID-19 vaccine approvals, allowing immunogenicity endpoints for high-risk groups, while calling for randomized controlled trials for those at lower risk.
FDA Commissioner Marty Makary, MD, MPH, and Center for Biologics Evaluation and Research Director Vinay Prasad, MD, MPH, detailed the new framework in a “Sounding Board” piece in the New England Journal of Medicine
The agency will allow immunogenicity data to approve COVID shots for adults ages 65 and up, and for all people 6 months and up who have one or more risk factors for severe disease, Makary and Prasad wrote.