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Nirsevimab in the prevention of respiratory syncytial virus lower respiratory tract disease: a profile of its use

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Abstract

Nirsevimab (Beyfortus™), a long-acting monoclonal antibody targeting the respiratory syncytial virus (RSV) fusion (F) protein, is the first prophylactic monoclonal antibody against RSV to be licensed for use in all infants in their first RSV season, and thus presents a highly valuable tool in the fight against RSV disease in children. Additionally, in the USA and Canada, nirsevimab is licensed for use in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. Data from randomized, double-blind, placebo-controlled clinical trials show that a single intramuscular dose of nirsevimab is efficacious in reducing the incidence of medically attended RSV lower respiratory tract (LRT) disease in healthy term and preterm infants through at least 150 days in their first RSV season. Pharmacokinetic data also support the efficacy of nirsevimab in infants at higher risk of severe RSV disease, including in the second RSV season with a second nirsevimab dose. Nirsevimab has an extended serum half-life, resulting in a duration of protection from a single dose which can cover a full typical RSV season. Nirsevimab is well tolerated, with low rates of reactogenicity, and can be administered concomitantly with childhood vaccines.

Plain Language Summary

Respiratory syncytial virus (RSV) is a significant cause of infant morbidity and mortality worldwide, and prevention strategies involving vaccines or monoclonal antibodies against RSV have been global health priorities. The monoclonal antibody palivizumab has been licensed for 25 years; however, its use in children is restricted to a small subset of infants at increased risk of severe RSV disease, and five monthly doses are necessary to cover the RSV season. Nirsevimab (Beyfortus™) is a long-acting monoclonal antibody designed to provide protection against RSV through the RSV season from a single dose. Based on clinical trial data, nirsevimab, administered as a single intramuscular injection, reduces the incidence of medically attended RSV lower respiratory tract disease in infants through the RSV season. Nirsevimab is well tolerated, with low rates of adverse reactions. As the first monoclonal antibody for the prevention of RSV disease to be licensed for use in all infants in their first RSV season, nirsevimab represents an important advance in the fight against RSV.

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Acknowledgements

The manuscript was reviewed by: S. Hegde, Department of Pathology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India; F. Rustemi, Department of Pharmacy, Albanian University, Tirana, Albania. During the peer review process, AstraZeneca and Sanofi, the marketing authorisation holders of nirsevimab, were also offered an opportunity to provide a scientific accuracy review of their data. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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    Matt Shirley

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M. Shirley is a salaried employee of Adis International Ltd/Springer Nature and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.

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Shirley, M. Nirsevimab in the prevention of respiratory syncytial virus lower respiratory tract disease: a profile of its use. Drugs Ther Perspect 39, 413–420 (2023). https://doi.org/10.1007/s40267-023-01039-4

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