Merck’s RSV antibody Enflonsia gets ACIP backing for infant use
US pharma major Merck & Co (NYSE: MRK) has secured a key endorsement for its newly approved respiratory syncytial virus (RSV) prevention product, Enflonsia (clesrovimab), as a majority of an influential advisory panel voted to recommend its use in newborns ahead of the 2025-2026 RSV season.
The CDC’s Advisory Committee on Immunization Practices (ACIP) voted 5 to 2 in favor of recommending a single dose of Enflonsia for infants under 8 months old who are entering their first RSV season and are not already protected through maternal immunization. The same panel also voted to include the monoclonal antibody in the federally funded Vaccines for Children Program, potentially broadening access.
Enflonsia is not a vaccine, but rather a long-acting monoclonal antibody designed to deliver immediate and lasting protection throughout a typical five-month RSV season. Administered in a fixed dose, it is meant to protect against lower respiratory tract disease in both healthy and high-risk infants.
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