ArticleEuro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin2026
Two-season effectiveness of a single nirsevimab dose against RSV hospitalisation in healthy term-born infants: a population-based case-control study, Spain, October 2023 to March 2025.
Article in Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.
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Who cites it
4 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
- Clinical and epidemiological profile of infants with severe bronchiolitis before and after the COVID-19 pandemic.Jornal de pediatria · 2026Article
- Detection of nirsevimab-resistant RSV-B variants in children carrying the F:N201T substitution through genomic surveillance, Spain, 2025/26 season.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2026Article
- Long-acting monoclonal antibodies and the evolving landscape of infant respiratory syncytial virus prevention.Pediatric investigation · 2026Article
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Authors and funding
37 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUNDIn autumn 2023, Spain recommended nirsevimab to all infants born after 1 April 2023, as catch-up or at-birth immunisation.AIMWe estimated effectiveness of a single nirsevimab dose against respiratory syncytial virus (RSV) hospitalisations throughout two seasons in healthy term-born infants.METHODSCases were children born 1 April 2023 through 31 March 2024 after 35 gestation weeks without major comorbidities and hospitalised for RSV infection between 2023 immunisation campaign onset and 31 March 2025. We selected four healthy population-density controls per case, matched by province and birth date. Using target trial emulation, causal per-protocol effectiveness was estimated for catch-up (within 30 days of 2023 campaign onset) and at-birth immunisation (within 14 days of life) through cloning, censoring and inverse-probability-weighted conditional logistic regression.RESULTSWe included 235/905 cases/controls for catch-up and 334/1,292 cases/controls for at-birth immunisation (first season), and 188/713 cases/controls for catch-up and 328/1,269 cases/controls for at-birth immunisation (second season). Two-season effectiveness was 64% (95% confidence interval (CI): 52-72) and 67% (95% CI: 59-74) for catch-up and at-birth immunisation, respectively, compared with 78% (95% CI: 70-84) and 84% (95% CI: 79-88) during first season and -8% (95% CI: -88 to 38) and 20% (95% CI: -21 to 46) during second season.CONCLUSIONNirsevimab was an effective long-term population-level intervention, decreasing RSV hospitalisations by two-thirds during the first two seasons of life. Effectiveness during second season was low or null, although it may be underestimated due to unavoidable survivor bias. The RSV hospitalisation rate among immunised children did not rebound in the second season.
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