FDA Approves First RSV Vaccine for Infants Through Maternal Immunization Program
β’ The FDA approved the first RSV vaccine for infants via maternal immunization on March 18, 2026, allowing pregnant women to receive vaccination in the third trimester to confer passive immunity to newborns. β’ The approval is based on a Phase 3 trial showing 82% efficacy in preventing severe RSV disease in infants under six months, with passive immunity lasting approximately three months post-birth. β’ RSV causes approximately 100,000 hospitalizations and 300-400 deaths annually among US infants, making this vaccine potentially transformative for preventing severe respiratory illness in the most vulnerable population.
Read original Β· fda.gov
