Internal Medicine Research

Real-World Effectiveness of Nirsevimab in Preventing RSV-Related Hospitalizations in Infants: A Systematic Review and Meta-Analysis

Article Impact Level: HIGH
Data Quality: STRONG
Summary of The Lancet Child & Adolescent Health, 9(6), 393–403. https://doi.org/10.1016/S2352-4642(25)00093-8
Dr. Dewan Sumsuzzman et al.

Points

  • A meta-analysis of 32 studies across five countries found that nirsevimab significantly reduces RSV-related hospitalizations, ICU admissions, and lower respiratory tract infection incidence in infants under 12 months.
  • The odds ratios showed marked protection from severe outcomes with nirsevimab use, including an 83 percent lower risk of hospitalization and a 75 percent lower risk of RSV-related LRTIs.
  • Despite its impact on hospitalization rates, no significant difference was observed in the length of hospital stay between infants who received nirsevimab and those who did not.
  • The results validate clinical trial data, confirming nirsevimab’s effectiveness in real-world conditions and reinforcing its utility in preventing serious RSV infections.
  • These findings support the integration of nirsevimab into global infant immunization programs to reduce RSV-related disease burden and improve pediatric respiratory health outcomes.

Summary

A recent systematic review and meta-analysis assessed the real-world effectiveness of nirsevimab, a monoclonal antibody approved in 2023 for preventing lower respiratory tract infections (LRTI) caused by respiratory syncytial virus (RSV) in infants. The review included 32 cohort and case-control studies from five countries (France, Italy, Luxembourg, Spain, and the USA), focusing on infants aged 0-12 months. The primary outcomes assessed were RSV-related hospitalizations, intensive care unit (ICU) admissions, and RSV-related LRTI incidence. Results from the pooled analyses revealed that nirsevimab was associated with a significantly lower risk of RSV-related hospitalizations (odds ratio [OR] 0.17, 95% CI 0.12-0.23), ICU admissions (OR 0.19, 95% CI 0.12-0.29), and LRTI incidence (OR 0.25, 95% CI 0.19-0.33), all with moderate to high heterogeneity (I2 ranging from 35% to 85%).

The study also evaluated the length of hospital stay but found no significant difference between the nirsevimab and control groups (weighted mean difference [WMD] 0.01, 95% CI -0.63 to 0.65, I2 = 62.3%). Despite the absence of significant findings for hospital length of stay, the overall results highlight the effectiveness of nirsevimab in reducing severe RSV-related outcomes in real-world settings, corroborating the clinical trial data. These findings suggest that nirsevimab can effectively reduce the healthcare burden associated with RSV, including reducing the need for hospitalization and ICU admission.

This study supports the continued use of nirsevimab in infant immunization programs, demonstrating its effectiveness in preventing RSV-related hospitalizations and severe outcomes across diverse populations. The findings emphasize the value of incorporating nirsevimab into routine clinical practice, particularly in reducing the incidence of RSV-related diseases in infants, and offer further evidence for integrating nirsevimab into immunization programs globally.

Link to the article: https://pubmed.ncbi.nlm.nih.gov/40319903/


References

Sumsuzzman, D. M., Wang, Z., Langley, J. M., & Moghadas, S. M. (2025). Real-world effectiveness of nirsevimab against respiratory syncytial virus disease in infants: A systematic review and meta-analysis. The Lancet Child & Adolescent Health, 9(6), 393–403. https://doi.org/10.1016/S2352-4642(25)00093-8

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