FDA opens safety review of injectable drugs for RSV in kids
AP News••business
Key Points:
- The FDA has initiated a safety review of two injectable drugs from Merck and Sanofi designed to protect infants and toddlers from RSV, a virus causing significant pediatric hospitalizations annually in the U.S.
- These drugs, which are lab-made antibodies rather than vaccines, were approved recently for young children, and the FDA's review is described as routine with potential label updates based on evidence.
- Merck and Sanofi report no new safety concerns, with Merck's Enflonsia protecting babies during their first RSV season and Sanofi's Beyfortus having been administered to over 6 million infants globally without identified safety issues.
- The review occurs amid broader changes in U.S. health policy under Health Secretary Robert F. Kennedy Jr., including revised
