Overview
- HHS confirmed the FDA is conducting a broad safety review across age groups after initial attention to pediatric reports.
- The FDA has not released case-level data or peer-reviewed analyses underpinning the claim that about 10 children died after vaccination.
- Three senior House Energy and Commerce Democrats requested deidentified case files, methods and documentation by December 19.
- Twelve former FDA commissioners warned that proposed shifts to require larger randomized trials and other changes could undermine evidence-based vaccine policy.
- Pfizer and Moderna reiterated that extensive monitoring has revealed no new undisclosed safety issues, and experts note VAERS reports alone do not establish causation.