Efficacy and safety of nirsevimab for preventing respiratory syncytial virus infection in infants: an updated systematic review and meta-analysis encompassing 11,001 participants
Year: 2025
Type: review
Study designs: Systematic Review, Meta-Analysis
Abstract: Background Respiratory syncytial virus (RSV) is recognized as the leading cause of lower respiratory tract infections (LRTI) and a major contributor to newborn hospitalizations. Recent clinical trials have demonstrated the effectiveness of nirsevimab in preventing RSV infections among infants. This meta-analysis evaluated the efficacy and safety of nirsevimab in healthy infants born at varying gestational ages during their first RSV season.Methods Adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we searched electronic databases—PubMed, SCOPUS, Cochrane Library, and Web of Science—to identify relevant studies published up to March 2025.Results We included three studies with 11,001 participants. Nirsevimab was significantly associated with decreased hospitalization for LRTI due to RSV (risk ratio [RR]: 0.21; 95% confidence interval [CI] 0.13, 0.33; P = 0.00001), hospitalization for respiratory illness due to any cause (RR: 0.46; 95% CI 0.36, 0.59; P = 0.00001), and medically attended RSV-associated LRTI (RR: 0.25; 95% CI 0.18, 0.36; P = 0.00001) compared to placebo. Comparable results were found in composite safety outcomes and adverse events; however, nirsevimab significantly reduced the incidence of bronchiolitis (RR: 0.70; 95% CI 0.56, 0.88; P = 0.002).Conclusion Nirsevimab shows promise in preventing RSV infections and hospitalizations, warranting further study on its practicality and cost-effectiveness.
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W4409505745