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Efficacy and safety of a single dose of nirsevimab against respiratory syncytial virus infection in infants: a meta-analysis and time-to-event analysis
Journal article   Open access   Peer reviewed

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

Mohamed Saad Sayed, Mena Ayman Elgendy, Nada Gamil, Hossam Hassan Abdullah, Alaa Alhwary, Rahma Abdulfattah Ibrahim, Sama Hesham Samir, Nada S Jibril, Hebatullah Abdulazeem and Mohammed Alsabri
Italian journal of pediatrics, v 52(1), 15
30 Dec 2025
DOI: https://doi.org/10.1186/s13052-025-02184-4
PMID: 41469925
Featured in Collection :   UN Sustainable Development Goals @ Drexel
url
https://doi.org/10.1186/s13052-025-02184-4View
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Abstract

Antibodies, Monoclonal, Humanized - administration & dosage Antibodies, Monoclonal, Humanized - adverse effects Antibodies, Monoclonal, Humanized - therapeutic use Antiviral Agents - administration & dosage Antiviral Agents - therapeutic use Hospitalization - statistics & numerical data Humans Infant Infant, Newborn Respiratory Syncytial Virus Infections - drug therapy Respiratory Syncytial Virus Infections - prevention & control Treatment Outcome
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  = 91.77%), hospitalization by 73% (RR: 0.27; 95% CI [0.20; 0.37], p-value < 0.001, I  = 97.46%). Nirsevimab also reduced the incidence of all-cause LRTIs and hospitalization, bronchiolitis, ICU admission, emergency unit visits, and all-cause mortality. The high heterogeneity was raised from pooling the real-world data across different clinical settings such as different geographical locations. There was no statistical significance regarding safety outcomes; serious, GIT adverse events, adverse events of special interest, and adverse events > grade 3 between the two groups. The time to event analysis showed that nirsevimab significantly reduced the RSV-LRTIs (Hazard Ratio (HR): 0.25; 95% CI [0.16; 0.37]) and hospitalization (HR: 0.14; 95% CI [0.08; 0.25]). The immunization with a single dose of nirsevimab significantly reduced the RSV-LRTIs and hospitalization in infants who were at risk for RSV infection without any identified safety concerns. The long-term safety concerns are still unclear across the current studies.

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Collaboration types
Domestic collaboration
International collaboration
Web of Science research areas
Pediatrics
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