FDA Approves First RSV Antibody Treatment to Protect Infants and Toddlers

The U.S. Food and Drug Administration has approved Beyfortus, a preventive antibody treatment developed by Sanofi and AstraZeneca, to protect healthy babies and some vulnerable toddlers against respiratory syncytial virus (RSV), the leading cause of hospitalization among young children in the country. Beyfortus, which is not a vaccine but works similarly, provides temporary protection for a single winter respiratory virus season by blocking the virus from entering cells. It can be given at birth or administered in a pediatrician's office before a baby's first winter respiratory virus season. The approval marks the first time broad protection against RSV will be offered to all healthy babies, as previous treatments were limited to high-risk infants.