Another Option for RSV Prevention in Babies Is Approved

Clinical Takeaway

: A second long-acting monoclonal antibody, clesrovimab, protects young infants against RSV.

Context

In 2023, the single-dose monoclonal antibody nirsevimab (Beyfortus) was approved for use in young infants during their first respiratory syncytial virus (RSV) season. Now, a second long-acting anti-RSV monoclonal antibody, clesrovimab (Enflonsia), has been approved by the FDA and recommended by the Advisory Committee on Immunization Practices (ACIP) as a single dose for infants younger than 8 months prior to their first RSV season who are not protected through maternal vaccination. A randomized, placebo-controlled trial was reviewed by the ACIP panel.

Key Results

Efficacy of clesrovimab was 60% against lower respiratory tract infection (LRTI) and 90% against RSV-related hospitalization.
No differences in serious adverse events between c…

Reviewing Author

Deborah Lehman, MD

Disclosures

Nothing to disclose