FDA Approves RSV Protection for Infants and Toddlers

The FDA has approved a shot developed by AstraZeneca and Sanofi called nirsevimab, which protects infants and toddlers against respiratory syncytial virus (RSV), the leading cause of hospitalization among babies in the U.S. This is the first shot approved to protect all infants against RSV, regardless of their health condition. Nirsevimab is administered as a single injection, providing a major advantage over the current monthly administration of palivizumab throughout the RSV season. The shot was found to be up to 75% effective at preventing lower respiratory tract infections and 78% effective at preventing hospitalization. The FDA did not identify any safety concerns, and the shot is expected to be discussed by CDC advisors in August for recommendations on administration and coverage under the Vaccines for Children program.