Nirsevimabe

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Nirsevimab, sold under the brand name Beyfortus, is a human recombinant monoclonal antibody with activity against respiratory syncytial virus (RSV). It is a respiratory syncytial virus (RSV) F protein‑directed fusion inhibitor that is designed to bind to the fusion protein on the surface of the RSV virus. The most common side effects are rash, fever and injection site reactions (such as redness, swelling and pain where the injection is given). It was developed by AstraZeneca and Sanofi. Nirsevimab was approved for medical use in both the European Union and the United Kingdom in November 2022, in Canada in April 2023, and in the United States in July 2023. In the European Union, nirsevimab is indicated for the prevention of respiratory syncytial virus RSV lower respiratory tract disease in neonates and infants during their first RSV season. In the United States, nirsevimab is indicated for the prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season and children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. Alternatively, in October 2023 the CDC recommended maternal RSVpreF vaccination during pregnancy, though administration of both is not needed in most infants. No major hypersensitivity reactions have been reported, and adverse events of grade 3 or higher were only reported in 8% (77 of 968) of participants in the Nirsevimab arm versus 12.5% (12 of 479) in the placebo arm in clinical trial NCT02878330. Nirsevimab binds to the prefusion conformation of the RSV fusion (F) protein, i.e. it binds to the site at which the virus would attach to a cell; effectively rendering it useless.