Efficacy of Nirsevimab at Preventing RSV-Related Hospitalization in Young Infants

Infants who received nirsevimab were less likely to be hospitalized for RSV-related lower respiratory tract infection and less likely to have very severe disease due to RSV.

Recently, the monoclonal antibody nirsevimab (Beyfortus; administered as a single intramuscular dose) was approved in the U.S. for prevention of RSV disease in young infants (NEJM JW Infect Dis Aug 2 2023 and U.S. Food and Drug Administration 2023 Jul 17). Now, investigators in France, Germany, and the U.K. (all countries where nirsevimab had been approved 1 year prior) have conducted the phase 3b, open-label, manufacturer-supported HARMONIE trial, in which 8058 infants aged <12 months and born at ≥29 weeks' gestation were randomized 1:1 to receive a single dose of nirsevimab (before or during RSV season) or standard care (i.e., no prophylaxis). Incidence of hospitalization and severe RSV disease were assessed in both groups. Key findings a…

Reviewing Author

Deborah Lehman, MD

Disclosures

Nothing to disclose

Deborah Lehman, MD

Disclosures

Nothing to disclose

Efficacy of Nirsevimab at Preventing RSV-Related Hospitalization in Young Infants

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Reviewing Author