1887
Rapid communication Open Access
Like 0

Abstract

The monoclonal antibody nirsevimab was at least 70% effective in preventing hospitalisations in infants with lower respiratory tract infections (LRTI) positive for respiratory syncytial virus (RSV) in Spain (Oct 2023–Jan 2024), where a universal immunisation programme began late September (coverage range: 79–99%). High protection was confirmed by two methodological designs (screening and test-negative) in a multicentre active surveillance in nine hospitals in three regions. No protection against RSV-negative LRTI-hospitalisations was shown. These interim results could guide public-health decision-making.

Loading

Article metrics loading...

/content/10.2807/1560-7917.ES.2024.29.6.2400046
2024-02-08
2024-02-28
http://instance.metastore.ingenta.com/content/10.2807/1560-7917.ES.2024.29.6.2400046
Loading
Loading full text...

Full text loading...

/deliver/fulltext/eurosurveillance/29/6/eurosurv-29-6_1.html?itemId=/content/10.2807/1560-7917.ES.2024.29.6.2400046&mimeType=html&fmt=ahah

References

  1. Griffin MP, Yuan Y, Takas T, Domachowske JB, Madhi SA, Manzoni P, et al. Single-dose nirsevimab for prevention of RSV in preterm infants. N Engl J Med. 2020;383(5):415-25.  https://doi.org/10.1056/NEJMoa1913556  PMID: 32726528 
  2. Hammitt LL, Dagan R, Yuan Y, Baca Cots M, Bosheva M, Madhi SA, et al. Nirsevimab for prevention of RSV in healthy late-preterm and term infants. N Engl J Med. 2022;386(9):837-46.  https://doi.org/10.1056/NEJMoa2110275  PMID: 35235726 
  3. 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 
  4. Drysdale SB, Cathie K, Flamein F, Knuf M, Collins AM, Hill HC, et al. Nirsevimab for prevention of hospitalizations due to RSV in infants. N Engl J Med. 2023;389(26):2425-35.  https://doi.org/10.1056/NEJMoa2309189  PMID: 38157500 
  5. Ernst C, Bejko D, Gaasch L, Hannelas E, Kahn I, Pierron C, et al. Impact of nirsevimab prophylaxis on paediatric respiratory syncytial virus (RSV)-related hospitalisations during the initial 2023/24 season in Luxembourg. Euro Surveill. 2024;29(4):2400033.  https://doi.org/10.2807/1560-7917.ES.2024.29.4.2400033  PMID: 38275017 
  6. Martinón-Torres F, Mirás-Carballal S, Durán-Parrondo C. Early lessons from the implementation of universal respiratory syncytial virus prophylaxis in infants with long-acting monoclonal antibodies, Galicia, Spain, September and October 2023. Euro Surveill. 2023;28(49):2300606.  https://doi.org/10.2807/1560-7917.ES.2023.28.49.2300606  PMID: 38062942 
  7. Mira-Iglesias A, Demont C, López-Labrador FX, Mengual-Chuliá B, García-Rubio J, Carballido-Fernández M, et al. Role of age and birth month in infants hospitalized with RSV-confirmed disease in the Valencia Region, Spain. Influenza Other Respir Viruses. 2022;16(2):328-39.  https://doi.org/10.1111/irv.12937  PMID: 34821055 
  8. European Centre for Disease Prevention and Control (ECDC). Core protocol for ECDC studies of COVID-19 vaccine effectiveness against hospitalisation with Severe Acute Respiratory Infection laboratory-confirmed with SARSCoV-2, version 1.0. Stockholm: ECDC; 2021. Available from: https://www.ecdc.europa.eu/sites/default/files/documents/Core-protocol-for-ECDC-studies-of-COVID-19-vaccine-effectiveness-against-hospitalisation-with-SARI.pdf
  9. Jackson ML, Nelson JC. The test-negative design for estimating influenza vaccine effectiveness. Vaccine. 2013;31(17):2165-8.  https://doi.org/10.1016/j.vaccine.2013.02.053  PMID: 23499601 
  10. Sullivan SG, Feng S, Cowling BJ. Potential of the test-negative design for measuring influenza vaccine effectiveness: a systematic review. Expert Rev Vaccines. 2014;13(12):1571-91.  https://doi.org/10.1586/14760584.2014.966695  PMID: 25348015 
  11. Ladhani SN, Andrews N, Parikh SR, Campbell H, White J, Edelstein M, et al. Vaccination of Infants with Meningococcal Group B Vaccine (4CMenB) in England. N Engl J Med. 2020;382(4):309-17.  https://doi.org/10.1056/NEJMoa1901229  PMID: 31971676 
  12. Parikh SR, Andrews NJ, Beebeejaun K, Campbell H, Ribeiro S, Ward C, et al. Effectiveness and impact of a reduced infant schedule of 4CMenB vaccine against group B meningococcal disease in England: a national observational cohort study. Lancet. 2016;388(10061):2775-82.  https://doi.org/10.1016/S0140-6736(16)31921-3  PMID: 28100432 
  13. Wildenbeest JG, Billard MN, Zuurbier RP, Korsten K, Langedijk AC, van de Ven PM, et al. The burden of respiratory syncytial virus in healthy term-born infants in Europe: a prospective birth cohort study. Lancet Respir Med. 2023;11(4):341-53.  https://doi.org/10.1016/S2213-2600(22)00414-3  PMID: 36372082 
  14. Muñoz-Quiles C, López-Lacort M, Úbeda-Sansano I, Alemán-Sánchez S, Pérez-Vilar S, Puig-Barberà J, et al. Population-based Analysis of Bronchiolitis Epidemiology in Valencia, Spain. Pediatr Infect Dis J. 2016;35(3):275-80.  https://doi.org/10.1097/INF.0000000000000993  PMID: 26658376 
/content/10.2807/1560-7917.ES.2024.29.6.2400046
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