Use of Nirsevimab for the Prevention of Respiratory Syncytial Virus Disease Among Infants and Young Children: Recommendations of the Advisory Committee on Immunization Practices - United States, 2023
- PMID: 37616235
- PMCID: PMC10468217
- DOI: 10.15585/mmwr.mm7234a4
Use of Nirsevimab for the Prevention of Respiratory Syncytial Virus Disease Among Infants and Young Children: Recommendations of the Advisory Committee on Immunization Practices - United States, 2023
Abstract
Respiratory syncytial virus (RSV) is the leading cause of hospitalization among U.S. infants. In July 2023, the Food and Drug Administration approved nirsevimab, a long-acting monoclonal antibody, for passive immunization to prevent RSV-associated lower respiratory tract infection among infants and young children. Since October 2021, the Advisory Committee on Immunization Practices (ACIP) Maternal and Pediatric RSV Work Group has reviewed evidence on the safety and efficacy of nirsevimab among infants and young children. On August 3, 2023, ACIP recommended nirsevimab for all infants aged <8 months who are born during or entering their first RSV season and for infants and children aged 8-19 months who are at increased risk for severe RSV disease and are entering their second RSV season. On the basis of pre-COVID-19 pandemic patterns, nirsevimab could be administered in most of the continental United States from October through the end of March. Nirsevimab can prevent severe RSV disease among infants and young children at increased risk for severe RSV disease.
Conflict of interest statement
All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Oliver Brooks reports advocacy work with the Immunize LA Families Coalition; no payments were received as part of this work. No other potential conflicts of interest were disclosed.
References
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- Food and Drug Administration. Beyfortus (nirsevimab-alip) product label. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761328s000lbl.pdf
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- CDC. ACIP evidence to recommendations for use of nirsevimab in children 8–19 months of age with increased risk of severe disease entering their second RSV season. Atlanta, GA: US Department of Health and Human Services, CDC; 2023. https://www.cdc.gov/vaccines/acip/recs/grade/nirsevimab-season2-rsv-infa...
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