1. Effectiveness of catch-up and at-birth nirsevimab immunisation against RSV hospital admission in the first year of life: a population-based case-control study, Spain, 2023/24 season.
- Author
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Núñez O, Olmedo C, Moreno-Perez D, Lorusso N, Fernández Martínez S, Pastor Villalba PE, Gutierrez Á, Alonso Garcia M, Latasa P, Sancho R, Mendioroz J, Martinez-Marcos M, Muñoz Platón E, García Rivera MV, Pérez-Martinez O, Álvarez-Gil R, Rivas Wagner E, López Gonzalez-Coviella N, Zornoza M, Barranco MI, Pacheco MDC, Álvarez Río V, Fiol Jaume M, Morey Arance R, Adiego Sancho B, Mendez Diaz M, Batalla N, Andreu C, Castilla J, García Cenoz M, Fernández Ibáñez A, Huerta Huerta M, Ibáñez Pérez AC, Berradre Sáenz B, Lamas J, Hermoso L, Casado Cobo S, Galán Cuesta M, Montenegro S, Domínguez M, Jarrín I, Limia A, Pastor-Barriuso R, and Monge S
- Subjects
- Humans, Case-Control Studies, Infant, Female, Male, Spain, Infant, Newborn, Palivizumab therapeutic use, Palivizumab administration & dosage, Antiviral Agents therapeutic use, Seasons, Vaccination statistics & numerical data, Respiratory Syncytial Virus Infections prevention & control, Hospitalization statistics & numerical data, Respiratory Syncytial Virus, Human immunology
- Abstract
BackgroundRespiratory syncytial virus (RSV) causes substantial morbidity in infants < 1 year. In October 2023, Spain recommended the monoclonal antibody nirsevimab to all children born since 1 April 2023, at birth or as catch-up if born before October 2023.AimWe estimated nirsevimab effectiveness in preventing RSV hospitalisations during the 2023/24 season.MethodsWe conducted a nationwide population-based matched case-control study. Cases were children hospitalised for lower respiratory tract infection who were RSV PCR-positive. For each case, we selected four population density controls born in the same province and date (±2 days). We defined at-birth immunisation as receiving nirsevimab during the first 2 weeks of life, and catch-up immunisation within 30 days from campaign onset. Causal intention-to-treat (ITT) and per-protocol (PP) effectiveness was estimated using inverse-probability-of-immunisation weighted conditional logistic regression.ResultsWe included 406 cases and 1,623 controls in catch-up and 546 cases and 2,182 controls in at-birth immunisation studies. Effectiveness in preventing RSV hospitalisations for catch-up immunisation was 71% (95% confidence interval (CI): 65-76) by ITT and 80% (95% CI: 75-84) PP. Effectiveness for at-birth immunisation was 78% (95% CI: 73-82) by ITT and 83% (95% CI: 79-87) PP. Effectiveness was similar for ICU admission, need of mechanical ventilation, and RSV viral subgroups A and B. Children born pre-term or with birthweight < 2,500 g showed lower PP effectiveness of 60-70%.ConclusionsPopulation-level nirsevimab immunoprophylaxis in children in their first RSV season was very effective in preventing RSV hospitalisations, ICU admission and mechanical ventilation, with reduced but still high effectiveness for pre-term and low-birthweight children.
- Published
- 2025
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