Nirsevimab Against Hospitalizations and Emergency Department Visits for Lower Respiratory Tract Infection in Infants: A Meta-Analysis
Abstract
Importance
Nirsevimab, a long-acting monoclonal antibody available since 2023, has demonstrated effectiveness in preventing lower respiratory tract infection (LRTI) caused by respiratory syncytial virus (RSV) in clinical trials and postlicensure settings. However, its broader real-world associations with respiratory-related outcomes in infants remain unclear, and characterizing these associations is essential to inform pediatric immunization policy.
Objective
To evaluate the real-world association of nirsevimab with LRTI-related hospitalizations and emergency department (ED) visits in infants.
Data Sources
MEDLINE, Embase, Web of Science, Scopus, Global Health, and medRxiv databases were systematically searched for observational studies published between January 1, 2023, and June 20, 2025. Data analysis was performed between January 1, 2025, and June 20, 2025.
Study Selection
Postlicensure observational studies reporting original data on the effectiveness of nirsevimab immunization programs in infants and children aged 24 months or younger in routine clinical settings were eligible for inclusion.
Data Extraction and Synthesis
Two reviewers independently extracted data and assessed study quality using the Critical Appraisal Checklist of the Joanna Briggs Institute. Random-effects meta-analysis was conducted to estimate pooled odds ratios (ORs) and 95% confidence intervals.
Main Outcomes and Measures
Primary outcomes were all-cause LRTI-related hospitalization, all-cause…
How strong is the evidence?
Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 236 participants or records.
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