Overview
- An FDA spokesperson said the agency is conducting a thorough investigation across multiple age groups into deaths potentially related to Covid-19 vaccines.
- HHS said the FDA is also taking a closer look at safety data for RSV shots for infants.
- The review follows a memo from FDA official Vinay Prasad citing an initial analysis of 96 deaths and attributing 10 child deaths to vaccination, without releasing methods or case details.
- Prasad has outlined plans to tighten vaccine approval standards, including requiring outcome trials in some cases, stricter rules for use in pregnancy, and a revision of the annual flu framework.
- Former FDA leaders and outside experts have criticized the memo and proposed regulatory shifts, while Pfizer and Moderna emphasize extensive safety monitoring and rare serious adverse events.