1887
Rapid communication Open Access
Like 0

Abstract

We measured effectiveness of nirsevimab against laboratory-confirmed respiratory syncytial virus (RSV) infection in a test-negative case-control study among children aged < 24 months hospitalised for severe acute respiratory infection in three European countries. The overall effectiveness in the 2024/25 season among 2,201 children was 79% (95% CI: 58 to 89) and 85%, 78% and 69% at < 30, 30–89 and 90–215 days since immunisation. Immunisation was effective for preventing RSV-related hospitalisation in children, but effectiveness by time since immunisation needs monitoring in future seasons.

Loading

Article metrics loading...

/content/10.2807/1560-7917.ES.2025.30.45.2500816
2025-11-13
2026-04-20
/content/10.2807/1560-7917.ES.2025.30.45.2500816
Loading
Loading full text...

Full text loading...

/deliver/fulltext/eurosurveillance/30/45/eurosurv-30-45-1.html?itemId=/content/10.2807/1560-7917.ES.2025.30.45.2500816&mimeType=html&fmt=ahah

References

  1. European Medicines Agency (EMA). Beyfortus (nirsevimab). Amsterdam; EMA: Jul 2024. Available from: https://www.ema.europa.eu/en/documents/overview/beyfortus-epar-medicine-overview_en.pdf
  2. World Health Organization (WHO). WHO position paper on immunization to protect infants against respiratory syncytial virus disease, May 2025. Wkly Epidemiol Rec. 2025;22(100):193-218.
  3. European Centre for Disease Prevention and Control (ECDC). Operational considerations for respiratory virus surveillance in Europe. Stockholm: ECDC; 18 Jul 2022. Available from: https://www.ecdc.europa.eu/en/publications-data/operational-considerations-respiratory-virus-surveillance-europe
  4. Ministerio de Sanidad (Sanidad). Recomendaciones de inmunización pasiva para prevención de enfermedad grave por VRS en la población infantil. [Passive immunization recommendations for the prevention of severe RSV disease in children]. Madrid: Sanidad; Nov 2024. Spanish. Available from: https://www.sanidad.gob.es/areas/promocionPrevencion/vacunaciones/comoTrabajamos/docs/VRS_infantil.pdf
  5. Direção Geral da Saúde (DGS). Imunização Sazonal contra o Vírus Sincicial Respiratório em Idade Pediátrica: Outono-Inverno 2024-2025. [Seasonal immunisation against respiratory syncytial virus in paediatric population: Autumn-Winter 2024-2025]. Lisboa: DGS; 12 Aug 2024. Portuguese. Available from: https://www.spp.pt/UserFiles/file/DOCUMENTOS%20OFICIAIS/Norma%2005_2024_atualizada%20a%2011_10_2024.pdf
  6. Superior Health Council (SHC). Preventive strategies against RSV disease in children. Brussels: SHC; Dec 2023. Available from: https://www.health.belgium.be/sites/default/files/uploads/fields/fpshealth_theme_file/20231222_shc-9760_advice_rsv_children_vweb.pdf
  7. Munro APS, Martinón-Torres F, Drysdale SB, Faust SN. The disease burden of respiratory syncytial virus in Infants. Curr Opin Infect Dis. 2023;36(5):379-84.  https://doi.org/10.1097/QCO.0000000000000952  PMID: 37610444 
  8. Eiland LS. Respiratory syncytial virus: diagnosis, treatment and prevention. J Pediatr Pharmacol Ther. 2009;14(2):75-85.  https://doi.org/10.5863/1551-6776-14.2.75  PMID: 23055894 
  9. Li Y, Wang X, Broberg EK, Campbell H, Nair H, European RSV Surveillance Network. Seasonality of respiratory syncytial virus and its association with meteorological factors in 13 European countries, week 40 2010 to week 39 2019. Euro Surveill. 2022;27(16):2100619.  https://doi.org/10.2807/1560-7917.ES.2022.27.16.2100619  PMID: 35451364 
  10. Kutsaya A, Teros-Jaakkola T, Kakkola L, Toivonen L, Peltola V, Waris M, et al. Prospective clinical and serological follow-up in early childhood reveals a high rate of subclinical RSV infection and a relatively high reinfection rate within the first 3 years of life. Epidemiol Infect. 2016;144(8):1622-33.  https://doi.org/10.1017/S0950268815003143  PMID: 26732801 
  11. Li Y, Wang X, Blau DM, Caballero MT, Feikin DR, Gill CJ, et al. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in children younger than 5 years in 2019: a systematic analysis. Lancet. 2022;399(10340):2047-64.  https://doi.org/10.1016/S0140-6736(22)00478-0  PMID: 35598608 
  12. Simões EAF, Madhi SA, Muller WJ, Atanasova V, Bosheva M, Cabañas F, et al. Efficacy of nirsevimab against respiratory syncytial virus lower respiratory tract infections in preterm and term infants, and pharmacokinetic extrapolation to infants with congenital heart disease and chronic lung disease: a pooled analysis of randomised controlled trials. Lancet Child Adolesc Health. 2023;7(3):180-9.  https://doi.org/10.1016/S2352-4642(22)00321-2  PMID: 36634694 
  13. Sumsuzzman DM, Wang Z, Langley JM, Moghadas SM. Real-world effectiveness of nirsevimab against respiratory syncytial virus disease in infants: a systematic review and meta-analysis. Lancet Child Adolesc Health. 2025;9(6):393-403.  https://doi.org/10.1016/S2352-4642(25)00093-8  PMID: 40319903 
  14. Lee B, Trusinska D, Ferdous S, Pei R, Kwok HHY, Schwarze J, et al. Real-world effectiveness and safety of nirsevimab, RSV maternal vaccine and RSV vaccines for older adults: a living systematic review and meta-analysis. Thorax. 2025;80(11):838-48.  https://doi.org/10.1136/thorax-2025-223376  PMID: 40930981 
  15. Attaianese F, Trapani S, Agostiniani R, Ambrosino N, Bertolucci G, Biasci P, et al. Effectiveness of a targeted infant RSV immunization strategy (2024-2025): A multicenter matched case-control study in a high-surveillance setting. J Infect. 2025;91(3):106600.  https://doi.org/10.1016/j.jinf.2025.106600  PMID: 40848988 
  16. Xu H, Aparicio C, Wats A, Araujo BL, Pitzer VE, Warren JL, et al. Estimated effectiveness of nirsevimab against respiratory syncytial virus. JAMA Netw Open. 2025;8(3):e250380.  https://doi.org/10.1001/jamanetworkopen.2025.0380  PMID: 40063022 
  17. European Medicines Agency (EMA). Beyfortus: EPAR - Product Information Annex I Summary of product characteristics. Amsterdam; EMA: 25 Apr 2025. Available from: https://www.ema.europa.eu/en/documents/product-information/beyfortus-epar-product-information_en.pdf
  18. Munro APS, Drysdale SB, Cathie K, Flamein F, Knuf M, Collins AM, et al. 180-day efficacy of nirsevimab against hospitalisation for respiratory syncytial virus lower respiratory tract infections in infants (HARMONIE): a randomised, controlled, phase 3b trial. Lancet Child Adolesc Health. 2025;9(6):404-12.  https://doi.org/10.1016/S2352-4642(25)00102-6  PMID: 40379431 
/content/10.2807/1560-7917.ES.2025.30.45.2500816
Loading

Data & Media loading...

Supplementary data

Submit comment
Close
Comment moderation successfully completed
This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error