Effectiveness of immunoprophylaxis with Nirsevimab in the province of Vibo Valentia, Italy
Keywords:
bronchiolitis; Niservimab; Italy.Abstract
Introduction: Respiratory syncytial virus represents a challenge for the Italian health system by causing more than 50% of influenza-like illnesses in children under two years of age during the 2022-2023 winter season, in which it was responsible for 73.5% of hospitalizations due to bronchiolitis.
Objective: To determine the effectiveness and safety of the first immunoprophylaxis campaign with Nirsevimab for the prevention of bronchiolitis, carried out in Vibo Valentia province, Italy.
Methods: A prospective and comparative study was carried out, which included 239 newborns, who received, before discharge, a single dose of 50 mg of Nirsevimab with follow-up during the first six months of life. Two groups of patients (with and without receiving immunoprophylaxis) were constituted.
Results: Immunization coverage of 75.3 % was achieved; No serious adverse effects were reported. Hospitalization due to bronchiolitis due to respiratory syncytial virus was reduced by 77.8% compared to the previous winter season. This virus was the causative agent in 37.5% of the non-immunoprophylacized and in 12.5% of the immunoprophylactic patients. The demand for high-flow ventilation and the ventilation time in immunoprophylaxed patients who developed the disease, on average, 30 days later compared to non-immunoprophylaxed patients, were reduced. There were no differences in hospital stay between the two groups. No admission to intensive care was required.
Conclusions: Immunoprophylaxis with Nirsevimab was effective and safe.
Downloads
References
1. Löwensteyn YN, Willemsen JE, Mazur NI, Scheltema NM, van Haas-tregt NCJ, Buuren A, et al. Mortalidad hospitalaria nosocomial relacionada con el VRS en niños < 5 años: una serie de casos globales. Pediatr Infect Dis J. 2023 [acceso 11/05/2025];42(1):1-7. Disponible en: https://pubmed.ncbi.nlm.nih.gov/36476518/
2. Giardina F. Bronchioliti, epidemia in corso in Italia. Quali sono i sintomi e come intervenire. In Salute News. 2023 [acceso 12/06/2025];2. Disponible en: https://www.insalutenews.it/in-salute/bronchioliti-epidemia-in-corso-in-italia-quali-sono-i-sintomi-e-come-intervenire/
3. UPDATE - 2022 Italian guidelines on the management of bronchiolitis in infants. Ital J Pediatr. 2023 [acceso 21/06/2025];19. Disponible en: https://ijponline.biomedcentral.com/articles/10.1186/s13052-022-01392-6
4. Vierucci F, Carmignani A, Baldaccini T, Vaccaro A. La Bronchiolite. Il Pediatra. 2025 [acceso 21/07/2025];(3):7-8. Disponible en: https://www.ilpediatranews.it/
5. Portocaro F, Cutrera R, Vittucci C, Villani A. Bronchiolitis guidelines: what about the Italian situation in a primary care setting? Ital J Pediatr. 2023 [acceso 21/05/2025];49(1):123. Disponible en: https://ijponline.biomedcentral.com/articles/10.1186/s13052-023-01527-3
6. Società Italiana di Medicina di Emergenza e Urgenza Pediatrica. Linee guida per la bronchiolite: qual è la situazione italiana in ambito di cure primarie? 2023 [acceso 22/05/2025]. Disponible en: https://simeup.it/linee-guida-per-la-bronchiolite-qual-e-la-situazione-italiana-in-ambito-di-cure-primarie/
7. Pierangeli A, Nenna R, Fracella M, Scagnolari C, Oliveto G, Sorrentino L et al. Genetici diversity and its impact on disease severity in respiratory syncytial virus subtype-A and -B bronchiolitis before and after pandemic restrictions in Rome. J Infect. 2023;87(4):305-14. DOI: https://doi.org/10.1016/j.jinf.2023.07.008
8. Gang Z, Sushan C, Zhao G, Junming Y, Jim Zhen. Current state and challenges in respiratory syncytial virus drug discovery and development. Antiviral Research. 2024 [acceso 24/04/2025];221. Disponible en: https://www.sciencedirect.com/science/article/abs/pii/S0166354223002693
9. Sanofi-Aztra Zenecc. Guida alla somministrazione di Nirsevimab Bayfortus. 2024 [acceso 26/06/2025]. Disponible en: https://pro.campus.sanofi/dam/Portal/Italy/prodotti/beyfortus/Guida-alla-somministrazione-nirsevimab.pdf
10. Agenzia Italiana dallo Farmaco. Niservimab. Riassunto delle caratteristiche del prodotto. 2025 [acceso 21/09/2025]. Disponible en: https://ec.europa.eu/health/documents/community-register/2024/20240801163318/anx_163318_it.pdf
11. Ruckwardt TJ, Morabito KM, Graham BS. Immunological Lessons from Respiratory Syncytial Virus Vaccine Development. Immunity. 2019 [acceso 21/02/2024];51(3):429-42. Disponible en: https://pubmed.ncbi.nlm.nih.gov/31533056/
12. Jones JM, Fleming-Dutra KE, Prill MM, Roper LE, Brooks O, Sánchez PJ, et al. Uso de nirsevimab para la prevención de la enfermedad por el virus respiratorio sincitial en lactantes y niños pequeños: recomendaciones del Comité Asesor sobre Prácticas de Inmunización – Estados Unidos, 2023. MMWR Morb Mortal Wkly Rep. 2023 [acceso 29/06/2025];72(34):920-5. Disponible en: https://www.cdc.gov/mmwr/volumes/72/wr/mm7234a4.htm
13. Moline HL, Tannis A, Toepfer AP, Williams JV, Boom JA, Englund JA, et al. Nirsevimab highly effective at preventing RSV hospitalization in infants, report shows. Morb Mortal Wkly Rep. 2024 [acceso 21/07/2025]. Disponible en: https://www.cdc.gov/mmwr/volumes/73/wr/mm7309a4.htm
14. Drysdale S, Cathie K, Flamein F, Knuf M, Collins AM, Hill HC, et al. Nirsevimab protects infants against hospitalization from RSV. N Engl J Med. 2023 [acceso 21/07/2025];89. Disponible en: https://www.nejm.org/doi/full/10.1056/NEJMoa2309189
15. Centros para el Control y Prevención de Enfermedades. Declaración para los medios de comunicación. Estudio de los CDC muestra la efectividad de la inmunización contra el virus respiratorio sincitial en los bebés. 2024 [acceso 04/07/2025]. Disponible en: https://www.cdc.gov/spanish/mediosdecomunicacion/comunicados/d_inmunizacion-virus-respiratorio_030724.html
16. Jabagi MJ, Cohen J, Bertrand M, Chalumeau M, Zureik M. Efficacia di nirsevimab nel prevenire l'ospedalizzazione legata al virus respiratorio sinciziale nei neonati. NEJM. 2025 [acceso 03/07/2025];4(3). Disponible en: http://www.sefap.it/web/index.php?class=Comp&className=Content&op=show¶m=CID,4417,preview,0
17. López-Lacort M, Muñoz-Quiles C, Mira-Iglesias A, López-Labrador FX, Garcés-Sánchez M, Escribano-López B, et al. Nirsevimab Effectiveness Against Severe Respiratory Syncytial Virus Infection in the Primary Care Setting. Pediatrics. 2025 [acceso 06/07/2025];155(1). Disponible en: https://pubmed.ncbi.nlm.nih.gov/39363387/
18. Ares-Gómez S, Mallah N, Santiago-Pérez MI, Pardo-Seco J, Pérez-Martínez O, Otero-Barrós MT, et al. Effectiveness and impact of universal prophylaxis with nirsevimab in infants against hospitalisation for respiratory syncytial virus in Galicia, Spain: initial results of a population-based longitudinal study. The Lancet Infectious Diseases. 2024 [acceso 21/07/2025];24(8):817-28. Disponible en: https://www.thelancet.com/article/S1473-3099(24)00215-9/abstract.
19. Nirsevimab para la prevención de infecciones por VRS (Virus Respiratorio Sincitial) en recién nacidos: aprobación del Comité Directivo del Calendario de Vacunación para la Vida y de la Sociedad Italiana de Neonatología. 2023 [acceso 29/07/2025]. Disponible en: https://vaccinarsinpuglia.org/notizie/2023/03/nirsevimab-para-la-prevencion-de-infecciones-por-virus-respiratorio-sincitial-en-recien-nacidos-aprobado-por-la-junta-del-calendario-de-vacunacion-para-la-vida-y-la-sociedad-italiana-de-neonatología
20. Consolati A, Farinelli MP, Serravalle P, Rollandin C, Apprato L, Bongiorno S. Il nirsevimab nella prevenzione della bronchiolite da virus respiratorio sinciziale. Medico e Bambino. 2024;43(4):239-42. DOI: https://doi.org/10.53126/MEB43239
21. Profilaxis contra VRS con anticuerpos monoclonales: datos italianos presentados en ESPID. Quotidiano Sanità (Dakota del Sur). 2025 [acceso 21/07/2025]. Disponible en: https://www.quotidianosanita.it/ciencia-y-farmacia/
22. Scarpelli G, Mondello I, Bonanno E, Bragho S. Immunoprofilassi anti VRS con Nirsevimab in Calabria. Incoriaggioanti i dati preliminari. SININFORMA. 2025 [acceso 21/07/2025];113. Disponible en: https://www.sin-neonatologia.it/area-stampa/sin-informa/
23. Agenzia Europea dei Medicinali. Bayfortus. Riassunto delle caratteristiche del prodotto. 2022 [acceso 23/07/2025]. Disponible en: https://www.ema.europa.eu/en/homepage
24. Estrella-Porter P, Blanco-Calvo C, Lameiras-Azevedo AS, Juaneda J, Fernández-Martínez S, Gómez-Pajares F, et al. Effectiveness of nirsevimab introduction against respiratory syncytial virus in the Valencian Community: A preliminary assessment. Vaccine. 2024 [acceso 29/07/2025];42(22). Disponible en: https://pubmed.ncbi.nlm.nih.gov/38834430/
25. Centros para el Control y Prevención de Enfermedades. Early Estimate of Nirsevimab Effectiveness for Prevention of Respiratory Syncytial Virus–Associated Hospitalization Among Infants Entering Their First Respiratory Syncytial Virus Season — New Vaccine Surveillance Network, October 2023–February 2024. Morbidity and Mortality Weekly Report. 2024 [acceso 30/08/2025]. Disponible en: https://www.cdc.gov/mmwr/volumes/73/wr/mm7309a4.htm?s_cid=mm7309a4_w
26. Assad Z, Romain AS, Aupiais C, Shum M, Schrimpf C, Lorrot M, et al. Nirsevimab and Hospitalization for RSV Bronchiolitis. N Engl J Med. 2024 [acceso 30/08/2025];391:144-54. Disponible en: https://www.nejm.org/doi/full/10.1056/NEJMoa2314885#tab-citations
27. Mazagatos C, Mendioroz J, Rumayor MB, Gallardo García V, Álvarez Río V, Cebollada Gracia AD, et al. Estimated Impact of Nirsevimab on the Incidence of Respiratory Syncytial Virus Infections Requiring Hospital Admission in Children < 1 Year. Weeks 40, 2023, to 8, 2024, Spain. Influenza Other Respir Viruses. 2024 [acceso 14/09/2025];18(5). Disponible en: https://pubmed.ncbi.nlm.nih.gov/38716791/
28. Cavaco Afonso AF, Côrte Pestana FJ, Rodrigues MC, Gomes Andrade AS, Alves J, Gomes Jacinto TC, et al. Effectiveness of nirsevimab against respiratory syncytial virus-related hospitalisation in Madeira, Portugal: 2023-24 season. Authorea. 2025 [acceso 13/09/2025];25. Disponible en: https://www.authorea.com/users/884477/articles/1262820-effectiveness-of-nirsevimab-against-respiratory-syncytial-virus-related-hospitalisation-in-madeira-portugal-2023-24-season
29. Mira-Iglesias A, Demont C, López-Labrador FX, Mengual-Chuliá B, García-Rubio J, Carballido-Fernández M. Role of age and birth month in infants hospitalized withRSV-confirmed disease in the Valencia Region. Influenza Other Respir Viruses. 2022;16(2):328-39. DOI: https://doi.org/10.1111/irv.12873
30. 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 [acceso 13/09/2025];29(4). Disponible en: https://pubmed.ncbi.nlm.nih.gov/38275017/
31. Silva PAN, Ito CRM, Moreira ALE, Santos MO, Barbosa LCG, Wastowski IJ, et al. Influenza and other respiratory viruses in children: prevalence and clinical features. Eur J Clin Microbiol Infect Dis. 2022 [acceso 14/09/2025];41(12):1445-9. Disponible en: https://pubmed.ncbi.nlm.nih.gov/36287292/
32. Agüera M, Soler-Garcia A, Alejandre C, Moussalam-Merino S, Sala-Castellví P, Pons G, et al. Nirsevimab immunization's real-world effectiveness in preventing severe bronchiolitis: A test-negative case-control study. Pediatr Allergy Immunol. 2024 [acceso 17/09/2025];35(6):e14175. Disponible en: https://pubmed.ncbi.nlm.nih.gov/38899631
33. Barbas Del Buey JF, Íñigo Martínez J, Gutiérrez Rodríguez MÁ, Alonso García M, Sánchez-Gómez A, Lasheras Carbajo MD, et al. The effectiveness of nirsevimab in reducing the burden of disease due to respiratory syncytial virus (RSV) infection over time in the Madrid region (Spain): a prospective population-based cohort study. Front Public Health. 2024 [acceso 12/09/2025]; 12:1441786. Disponibile en: https://pubmed.ncbi.nlm.nih.gov/39220460/
34. Wadia U, Moore HC, Richmond PC, Levy A, Bell L, Pienaar C, et al. Effectiveness of nirsevimab in preventing RSV-hospitalisation among young children in Western Australia 2024. J Infect. 2025;90(4):106466. DOI: https://doi.org/10.1016/j.jinf.2025.106466
35. Coma E, Martinez-Marcos M, Hermosilla E, Mendioroz J, Reñé A, Fina F, et al. Effectiveness of nirsevimab immunoprophylaxis against respiratory syncytial virus-related outcomes in hospital and primary care settings: a retrospective cohort study in infants in Catalonia (Spain). Arch Dis Child. 2024 [acceso 08/09/2025];0:1-6. Disponible en: https://adc.bmj.com/content/archdischild/early/2024/06/09/archdischild-2024-327153.full.pdf
36. Maldonado W. Campaña de Invierno 2024. Nirsevimab redujo a cero las muertes de menores de un año por Virus Respiratorio Sincicial. Universidad de Chile. 2024 [acceso 20/09/2025]. Disponible en: https://uchile.cl/noticias/220229/nirsevimab-redujo-a-cero-las-muertes-de-menores-de-un-ano-por-vrs
37. Ruiz-González LA, Piñera-Castro HJ, Smith-Groba J. Impacto del bloqueo estadounidense sobre el sistema cubano de salud en la última década. Rev Cubana Med Milit. 2023 [acceso 24/09/2025];52(1):e02302469. Disponible en: https://revmedmilitar.sld.cu/index.php/mil/article/view/2469
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2026 Roberto Tomás Álvarez Fumero, Salvatore Bragho
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Avisos de derechos de autor propuestos por Creative Commons
1. Política propuesta para revistas que ofrecen acceso abierto
Aquellos autores/as que tengan publicaciones con esta revista, aceptan los términos siguientes:
- Los autores/as conservarán sus derechos de autor y garantizarán a la revista el derecho de primera publicación de su obra, el cuál estará simultáneamente sujeto a la Licencia de reconocimiento de Creative Commons que permite a terceros compartir la obra siempre que se indique su autor y su primera publicación esta revista.
- Los autores/as podrán adoptar otros acuerdos de licencia no exclusiva de distribución de la versión de la obra publicada (p. ej.: depositarla en un archivo telemático institucional o publicarla en un volumen monográfico) siempre que se indique la publicación inicial en esta revista.
- Se permite y recomienda a los autores/as difundir su obra a través de Internet (p. ej.: en archivos telemáticos institucionales o en su página web) antes y durante el proceso de envío, lo cual puede producir intercambios interesantes y aumentar las citas de la obra publicada. (Véase El efecto del acceso abierto).
