Overview
- CNN reports the FDA is preparing to add a boxed warning to COVID-19 vaccines by year-end, with chief medical and scientific officer Vinay Prasad overseeing the effort.
- No decision has been announced, and an HHS spokesperson said any claim about pending action is “pure speculation,” with scope and age-group applicability still unclear.
- The push follows an internal Prasad memo alleging at least 10 pediatric deaths likely tied to vaccine-related myocarditis based on VAERS reports, as federal officials broaden a review across multiple age groups.
- Existing labels already cite a rare risk of myocarditis and pericarditis, and outside experts warn a boxed warning for vaccines would be unusual and could reduce use without transparent data and public advisory review.
- Pfizer and Moderna emphasize extensive safety monitoring and favorable risk–benefit profiles, while clinicians note a black box could make providers more hesitant to recommend shots to higher-risk patients.