Nirsevimab protects infants against RSV-linked hospitalization

Nirsevimab is efficacious for preventing hospitalization for respiratory syncytial virus (RSV)-associated lower respiratory tract infection among infants, according to a study published in the Dec. 28 issue of the New England Journal of Medicine.

Simon B. Drysdale, Ph.D., from the Centre for Neonatal and Paediatric Infections at the University of London, and colleagues conducted a pragmatic trial involving infants aged 12 months or younger, born at gestational age of at least 29 weeks who were entering their first RSV season in France, Germany, or the United Kingdom. The infants were randomly assigned to receive a single intramuscular injection of nirsevimab (4,037 infants) or standard care (no intervention; 4,021 infants) before or during the RSV season.

The researchers found that 0.3 and 1.5 percent of infants in the nirsevimab and standard-care groups, respectively, were hospitalized for RSV-associated lower respiratory tract infection, corresponding to 83.2 percent efficacy for nirsevimab. Very severe RSV-associated lower respiratory tract infection occurred in 0.1 and 0.5 percent of infants in the nirsevimab and standard-care groups, respectively, corresponding to 75.7 percent efficacy. In France, Germany, and the United Kingdom, the efficacy of nirsevimab against hospitalization for RSV-associated lower respiratory tract infection was 89.6, 74.2, and 83.4 percent, respectively. Overall, 2.1 percent of the nirsevimab group had treatment-related adverse events.

"These findings suggest that nirsevimab has the potential to reduce the burden of hospitalization for RSV-associated lower respiratory tract infection among infants," the authors write.

The study was funded by Sanofi and AstraZeneca, which manufacture nirsevimab.

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