SYSTEMATIC REVIEW article
Front. Public Health
Sec. Infectious Diseases: Epidemiology and Prevention
Volume 13 - 2025 | doi: 10.3389/fpubh.2025.1641085
Nirsevimab for Preventing Respiratory Syncytial Virus Lower Respiratory Tract Infections in Infants: A systematic review and meta-analysis
Provisionally accepted
Samira Soudani1*
Lorenzo Bertizzolo2Mehdi Ghemmouri1Mary Chappell3Rachael Mccool3
Katie Reddish3Paul Miller3Erin Barker3
Harriet Fewster3- 1Sanofi, Global Health Economics and Value Assessment, Lyon, France
- 2Sanofi, Global Medical, Lyon, France
- 3York Health Economics Consortium Ltd, Heslington, United Kingdom
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Background: Respiratory syncytial virus (RSV) causes lower respiratory tract infections (LRTIs) in infants, leading to substantial morbidity and mortality. Nirsevimab, a long-lasting monoclonal antibody, has been demonstrated to reduce RSV-related outcomes in randomised controlled trials (RCTs) and real-world settings. The object was to review the existing real-world evidence (RWE) on the effectiveness of nirsevimab in preventing RSV-LRTIs. Methods: Searches of six databases in addition to trial registries, HTA/ regulatory agency webpages and conference abstracts were conducted in November 2024. Observational studies evaluating nirsevimab prophylaxis in infants during their first RSV season or high-risk infants in their second season were included. For outcomes evaluated by more than 1 study, feasibility assessment was conducted and, where appropriate, studies were combined in meta-analyses. Results: Sixteen studies reporting effectiveness outcomes were included. The studies were conducted across 4 countries (Spain, Italy, US and France), and included 141,550 infants. Nirsevimab showed significant effectiveness for preventing RSV-LRTI hospitalisation (reduction in risk from hazard ratios and odds ratios of 84.5%; 95% CI 73.6 to 90.9%; I2 0% and 73.7%; 95% CI 42.3 to 88.0%; I2 0%, respectively), intensive care unit (ICU) admission (85.9%; 95% CI 13.2 to 97.7%) and ventilatory support (87.1%; 95% CI 70.2 to 94.4%). Nirsevimab was also effective in preventing RSV-LRTI visits in primary care (75.8%; 95% CI 40.4 to 92.7%) and emergency departments (87.9%; 70.3 to 95.1%). Conclusions: Real-world evidence confirms the effectiveness of nirsevimab against RSV-LRTIs and underlines the public health impact of the intervention in preventing RSV-related health outcomes. There is no clear evidence that effectiveness differs for infants born in season (at birth immunisation)
Keywords: nirsevimab1, observational studies as topic2, Systematic Review3, meta analysis4, RSV5
Received: 04 Jun 2025; Accepted: 30 Sep 2025.
Copyright: © 2025 Soudani, Bertizzolo, Ghemmouri, Chappell, Mccool, Reddish, Miller, Barker and Fewster. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Samira Soudani, samira.soudani@sanofi.com
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.