Overview
- FDA chief medical and scientific officer Vinay Prasad told staff an initial review of 96 pediatric deaths from 2021 to 2024 found no fewer than 10 probably or possibly related to COVID-19 vaccination.
- The memo references heart inflammation in children roughly ages 7 to 16 and describes the finding as a significant disclosure for the agency.
- Key details are absent from the document, including the children’s preexisting conditions and the vaccine manufacturers involved, and the analysis has not undergone peer review.
- Prasad said vaccine safety surveillance will be strengthened, and reporting indicates the CDC’s vaccine advisory committee plans to examine the evidence next week.
- Reaction has split officials and experts, with FDA commissioner Marty Makary emphasizing vaccine benefits for older and high-risk adults, while legal scholar Dorit Reiss criticized reliance on unpublished findings as policy shifts under Health Secretary Robert F. Kennedy Jr. limit access to COVID-19 shots.