- The CDC's ACIP recommends Merck's ENFLONSIA™ (clesrovimab-cfor) for preventing RSV in infants.
- The recommendation includes ENFLONSIA in the Vaccines for Children Program, aiming to increase access.
- Merck plans to start ENFLONSIA shipments before the 2025-2026 RSV season.
The U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended the use of Merck's (MRK, Financial) ENFLONSIA™ (clesrovimab-cfor) for preventing respiratory syncytial virus (RSV) lower respiratory tract disease in infants under 8 months old who are born during or entering their first RSV season. This recommendation includes the addition of ENFLONSIA to the Vaccines for Children Program, marking a significant step in increasing access to this preventive measure for infants.
ENFLONSIA is the first and only RSV preventive option for administration to infants that uses the same dose regardless of weight. The long-acting monoclonal antibody (mAb) is designed to offer direct and durable protection for up to five months, covering a typical RSV season. Merck plans to make ENFLONSIA available for ordering in July 2025, with shipments to be fulfilled before the start of the 2025-2026 RSV season.
The U.S. Food and Drug Administration (FDA) had earlier approved ENFLONSIA, following promising results from the Phase 2b/3 CLEVER and Phase 3 SMART trials. The ACIP's recommendation is still provisional and will become official upon review and finalization by the CDC Director or the Health and Human Services Secretary.
Respiratory syncytial virus (RSV) poses a significant risk to infants, being a leading cause of hospitalization for this age group in the U.S. ENFLONSIA provides a much-needed preventive option, addressing an unmet need for both healthy and high-risk infants during the RSV season, which typically stretches from autumn through spring.
