Overview
- The leaked memo by FDA vaccine chief Vinay Prasad cites a review of 96 pediatric VAERS reports to assert that no fewer than 10 child deaths were caused by COVID-19 vaccination, but it provides no case-level evidence.
- Twelve former FDA commissioners, spanning Republican and Democratic administrations, publicly criticized the memo’s methods and warned the proposed policy changes threaten timely access to updated vaccines.
- The memo outlines requiring randomized outcome trials for vaccine updates, revisiting the annual flu-shot framework, and scrutinizing co-administration, moves experts say could raise costs and delay availability.
- Former leaders note FDA and CDC scientists had previously reviewed the reported deaths and reached different conclusions, stressing that VAERS alone cannot establish causality.
- The analysis and underlying data have not been released or peer reviewed, advisory bodies are meeting under heightened scrutiny, and the proposed changes remain under discussion rather than in effect.