Efficacy and safety of a single dose of nirsevimab against respiratory syncytial virus infection in infants: a meta-analysis and time-to-event analysis.

Document Type

Article

Publication Date

12-30-2025

Abstract

Respiratory syncytial virus (RSV) is one of the causes of lower respiratory tract infections (LRTIs) and related hospitalizations in neonates and infants. Clinical trials have shown that a single dose of nirsevimab can prevent this infection and its related complications. We systematically searched PubMed, Embase, Web of Science (WOS), Scopus, and Cochrane Central on 25 November 2024 and updated on 18 April 2025, without automated filters or language restrictions. Studies reported the outcomes after nirsevimab in infants were retrieved. A random effects model was applied for analysis. A total of 425,362 infants were pooled from 26 studies (6 randomized controlled trials and 20 observational cohorts studies). The immunization with nirsevimab reduced the incidence of RSV-LRTIs by 63% (risk ratio [RR]: 0.37; 95% CI [0.29; 0.47], p-value <  0.001, I

Publication Title

Ital J Pediatr

Volume

52

Issue

1

First Page

15

Last Page

15

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