Overview

• The CDC’s Advisory Committee on Immunization Practices voted 5-2 to recommend a single dose of Enflonsia for infants under eight months during their first RSV season.
• Clinical trials demonstrated that Enflonsia cut medically attended RSV lower respiratory infections by over 60% and reduced hospitalizations by more than 84%.
• Enflonsia is the second monoclonal antibody approved for infant RSV prevention, joining Sanofi/AstraZeneca’s Beyfortus after FDA authorization in early June.
• The panel also agreed unanimously to include Enflonsia in the Vaccines for Children program, extending coverage to uninsured and Medicaid-enrolled infants.
• With no CDC director in place, Health Secretary Kennedy’s sign-off is needed before providers can place orders in July and prepare for fall deliveries.