Overview
- An internal memo by FDA vaccine chief Vinay Prasad says at least 10 of 96 child deaths reported to VAERS from 2021–2024 were related to COVID-19 vaccination, with myocarditis cited as a possible cause.
- Prasad outlines plans to toughen vaccine approvals, including larger randomized studies across subgroups, stricter rules for use in pregnancy, reassessment of giving multiple vaccines at once, and a review of the annual flu-shot framework.
- The memo provides no ages, medical histories, timelines, or vaccine manufacturers for the cases, and the findings have not been published in a peer‑reviewed journal.
- Outside experts, including Dr. Paul Offit and former FDA vaccine head Dr. Peter Marks, criticized reliance on passive VAERS reports and called for transparent case-level data and rigorous review before changing policy.
- HHS did not immediately comment, and a CDC advisory committee meets next week on vaccine matters as broader policy shifts under Secretary Robert F. Kennedy Jr. have already narrowed COVID vaccine eligibility.