The European Commission has approved ‘Beyfortus’ (nirsevimab) for the prevention of lower respiratory tract infection caused by respiratory syncytial virus (RSV) in newborns and infants during their first RSV season.
RSV is a common and highly contagious seasonal virus that infects almost all children during the first two years of life. It is the most common cause of lower respiratory tract infection in infants, including bronchiolitis and pneumonia.
Beyfortus’, which has been co-developed by Sanofi and AstraZeneca, is the first choice of single-dose RSV protection for a broad infant population, including those born healthy, term or premature, or with specific health conditions.
Despite the overwhelming burden of RSV-associated infections, the pharmaceutical industry had been unable to offer reliable protection against RSV for six straight decades.
Nirsevimab is a recombinant human monoclonal antibody (IgG1) that neutralizes respiratory syncytial virus (RSV).
Nirsevimab, which works on the principle of passive vaccination, is characterized by a long half-life, so a single dose should be sufficient for the entire RSV season, which usually lasts 5 months in autumn-winter.
More information in:
https://www.nejm.org/doi/full/10.1056/NEJMoa2110275
https://www.ema.europa.eu/en/documents/product-information/beyfortus-epar-product-information_es.pdf