Merck reports ACIP recommends Enflonsia in infants younger than 8 months

Merck (MRK) announced the U.S. Centers for Disease Control and Prevention Advisory Committee on Immunization Practices voted to recommend Enflonsia as an option for the prevention of respiratory syncytial virus lower respiratory tract disease in infants younger than 8 months of age who are born during or entering their first RSV season. “The ACIP also voted to include Enflonsia in the Vaccines for Children Program – an important step in ensuring broad access to this preventive option for infants,” the company stated. The U.S. Food and Drug Administration approved Enflonsia earlier this month based on clinical data from the Phase 2b/3 CLEVER and Phase 3 SMART trials. Merck plans to make Enflonsia available for ordering by physicians and health care administrators in July 2025, with shipments to be delivered before the start of the 2025-2026 RSV season. The ACIP’s recommendation for Enflonsia is provisional and will be official once reviewed and finalized by the CDC Director or the Health and Human Services Secretary, in the absence of a CDC Director, Merck noted.