ArticleThe Lancet regional health. Europe2025
Effectiveness of nirsevimab against hospitalisation for RSV-bronchiolitis during high RSV-B circulation in the second year of nationwide implementation in France: a test-negative case-control study.
Article in The Lancet regional health. Europe, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.
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Who cites it
5 citing papers in PubMed, 1 synthesis or guideline pooled it.
- RSV prophylactics for pediatric populations: A product review and meta-analysis of real-world effectiveness.Human vaccines & immunotherapeutics · 2026Pooled it
- Respiratory Syncytial Virus-Related Hospitalizations Among Infants Receiving Nirsevimab.JAMA network open · 2026Article
- Article
- Genomic evolution and minority variant dynamics of RSV during the first season of nirsevimab implementation in Italy (2024-5).Virus evolution · 2026Article
- A new milestone in the fight against RSV disease in infants: continuous vigilance is needed.The Lancet regional health. Europe · 2025Article
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Authors and funding
47 authors.
Funding
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Abstract
Background: Nirsevimab was first introduced in September 2023, showing strong real-world effectiveness in preventing hospitalised RSV-bronchiolitis. RSV-A circulation predominated during 2023-2024, whereas RSV-B was frequent in 2024-2025. Recent reports indicated resistance to nirsevimab in RSV-B strains in France. We aimed to assess the effectiveness of large-scale nirsevimab implementation against hospitalised RSV-bronchiolitis during high RSV-B circulation. Methods: A test-negative case-control study was conducted using a national hospital-based surveillance system. All children <12 months hospitalised for bronchiolitis and tested for RSV in 12 French hospitals from October 10, 2024 to March 15, 2025, were included. Cases were RSV-positive bronchiolitis; controls were RSV-negative bronchiolitis. Effectiveness was assessed by a multivariable logistic regression model adjusted for confounders (sex, gestational age at birth, birth weight, risk factors for severe bronchiolitis, month of diagnosis, and medical centre). A range of sensitivity analyses was conducted. Findings: 1270 patients were included; among which 830 (65.3%) were RSV-positive and 440 (34.7%) were RSV-negative bronchiolitis. The male-to-female sex ratio was 1.35, and the median age was 3 months (IQR: 1.5-5.6). Among cases, 182 (22.0%) received nirsevimab, compared to 282 (64.1%) for controls. Adjusted effectiveness against RSV-bronchiolitis was 84.9% (95% CI, 80.0-88.6). Subgroup analyses by age and severity (intensive care unit admission, respiratory support) showed consistent results, along with sensitivity analyses. Interpretation: Despite high RSV-B circulation, which has recently been identified to carry mutations potentially inducing resistance to nirsevimab, the effectiveness of the second national nirsevimab campaign against hospitalisation for RSV-bronchiolitis remained high. Funding: The study received financial support from Sanofi, AstraZeneca, and the 2023 ATIP-Avenir grant from the National Institute of Health and Medical Research (Inserm).
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