FDA opens safety review of injectable RSV drugs approved for babies and toddlers

AP News  – Tuesday, December 9, 2025
By Matthrew Perrone

WASHINGTON (AP) — Food and Drug Administration officials have opened a safety review of two injectable drugs used to protect babies and toddlers from RSV, the respiratory virus that sends thousands of American children to the hospital each year.

The long-acting drugs from Merck and Sanofi are not vaccines, but the government review comes as health officials and advisers under Health Secretary Robert F. Kennedy Jr. roll back recommendations on routine childhood vaccinations.

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