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Abstract

Background

Respiratory syncytial virus (RSV) is a leading cause of hospitalisation in children worldwide. Recent regulatory approval of monoclonal antibody (mAb) nirsevimab for infants and the RSVpreF vaccine for pregnant women offers promising approaches to mitigate RSV-associated morbidity.

Aim

To evaluate potential impacts of routine prophylactic campaigns (mAbs targeting infants or maternal vaccination) introduced in the 2024/25 season on hospitalisations from RSV lower respiratory tract infections in Lombardy, Italy.

Methods

We used a catalytic model informed by data from pre-COVID-19 pandemic (before 2020) and post-pandemic periods (until 2022) to quantify the number of cases and hospitalisations that could be averted by seasonal nirsevimab administration to infants and RSVpreF maternal vaccination, considering changes in susceptibility caused by reduced RSV circulation during the pandemic.

Results

As a marked proportion of RSV hospitalisations occurs in infants aged ≤ 1 year, seasonal mAb administration to 80% of newborns (uptake levels observed in Spain) was estimated to avert 50.2% (95% CI: 43.5–55.8) of hospitalisations in the total population. Coverage levels close to those observed for childhood vaccines (95%) could result in an additional average 18% reduction in hospitalisations. Vaccination of 65% of pregnant women, resembling the diphtheria–tetanus–pertussis vaccine coverage in Lombardy for this population, was estimated to avert 30.5% (95% CI: 19.6–39.7) of hospitalisations. At influenza vaccine coverage (12%), less than 8% of hospitalisations could be averted by maternal immunisation.

Conclusion

Routine nirsevimab administration to infants demonstrates clear potential to reduce RSV-associated hospitalisations. Maternal immunisation can help in achieving high protection in at-risk populations.

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This work is licensed under a Creative Commons Attribution 4.0 International License.
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2025-04-10
2025-04-14
/content/10.2807/1560-7917.ES.2025.30.14.2400637
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References

  1. Bénet T, Sánchez Picot V, Messaoudi M, Chou M, Eap T, Wang J, et al. Microorganisms associated with pneumonia in children <5 years of age in developing and emerging countries: The GABRIEL pneumonia multicenter, prospective, case-control study. Clin Infect Dis. 2017;65(4):604-12.  https://doi.org/10.1093/cid/cix378  PMID: 28605562 
  2. 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 
  3. Venkatesan P. Nirsevimab: a promising therapy for RSV. Lancet Microbe. 2022;3(5):e335.  https://doi.org/10.1016/S2666-5247(22)00097-0  PMID: 35544094 
  4. European Medicines Agency (EMA). New medicine to protect babies and infants from respiratory syncytial virus (RSV) infection. Amsterdam: EMA. [Accessed: 10 Jan 2024]. Available from: https://www.ema.europa.eu/en/news/new-medicine-protect-babies-and-infants-respiratory-syncytial-virus-rsv-infection
  5. European Medicines Agency (EMA). First RSV vaccine to protect infants up to 6 months of age and older adults. Amsterdam: EMA. [Accessed: 20 Feb 2024]. Available from: https://www.ema.europa.eu/en/news/first-rsv-vaccine-protect-infants-6-months-age-and-older-adults
  6. Food and Drug Administration (FDA). FDA approves new drug to prevent RSV in babies and toddlers. [Accessed: 10 Jan 2024]. Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-prevent-rsv-babies-and-toddlers
  7. Food and Drug Administration. FDA approves first vaccine for pregnant individuals to prevent RSV in infants. [Accessed: 20 Feb 2024]. Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-first-vaccine-pregnant-individuals-prevent-rsv-infants
  8. European Medicines Agency (EMA). Beyfortus - product information. Amsterdam: EMA. [Accessed: 16 Jan 2025]. Available from: https://www.ema.europa.eu/en/documents/product-information/beyfortus-epar-product-information_en.pdf
  9. Jones JM, Fleming-Dutra KE, Prill MM, Roper LE, Brooks O, Sánchez PJ, et al. Use of nirsevimab for the prevention of respiratory syncytial virus disease among infants and young children: recommendations of the advisory committee on immunization practices - United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72(34):920-5.  https://doi.org/10.15585/mmwr.mm7234a4  PMID: 37616235 
  10. Wilkins D, Yuan Y, Chang Y, Aksyuk AA, Núñez BS, Wählby-Hamrén U, et al. Durability of neutralizing RSV antibodies following nirsevimab administration and elicitation of the natural immune response to RSV infection in infants. Nat Med. 2023;29(5):1172-9.  https://doi.org/10.1038/s41591-023-02316-5  PMID: 37095249 
  11. Dagan R, Hammitt LL, Seoane Nuñez B, Baca Cots M, Bosheva M, Madhi SA, et al. Infants receiving a single dose of nirsevimab to prevent rsv do not have evidence of enhanced disease in their second RSV Season. J Pediatric Infect Dis Soc. 2024;13(2):144-7.  https://doi.org/10.1093/jpids/piad113  PMID: 38219024 
  12. Kampmann B, Madhi SA, Munjal I, Simões EAF, Pahud BA, Llapur C, et al. Bivalent prefusion F vaccine in pregnancy to prevent RSV illness in infants. N Engl J Med. 2023;388(16):1451-64.  https://doi.org/10.1056/NEJMoa2216480  PMID: 37018474 
  13. Fleming-Dutra KE, Jones JM, Roper LE, Prill MM, Ortega-Sanchez IR, Moulia DL, et al. Use of the Pfizer respiratory syncytial virus vaccine during pregnancy for the prevention of respiratory syncytial virus-associated lower respiratory tract disease in infants: recommendations of the advisory committee on immunization practices - United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72(41):1115-22.  https://doi.org/10.15585/mmwr.mm7241e1  PMID: 37824423 
  14. Lombardy Region (Regione Lombardia). Deliberazione della Giunta Regionale (DGR) XII/1827 del 31/01/2024. [Resolution of the Regional Council XII/1827 of 31/01/2024]. Milan: Regione Lombardia; 2024. Italian. Available from: https://www.regione.lombardia.it/wps/wcm/connect/34a23e27-2976-4f41-b622-9de2d56e7f63/DGR+1827_2024+regole_ssr_2024.pdf?MOD=AJPERES&CACHEID=ROOTWORKSPACE-34a23e27-2976-4f41-b622-9de2d56e7f63-oRAnmpl
  15. Ang HJ, Menegale F, Preziosi G, Pariani E, Migliari M, Pellegrinelli L, et al. Reconstructing the impact of COVID-19 on the immunity gap and transmission of respiratory syncytial virus in Lombardy, Italy. EBioMedicine. 2023;95:104745.  https://doi.org/10.1016/j.ebiom.2023.104745  PMID: 37566927 
  16. Paynter S, Yakob L, Simões EAF, Lucero MG, Tallo V, Nohynek H, et al. Using mathematical transmission modelling to investigate drivers of respiratory syncytial virus seasonality in children in the Philippines. PLoS One. 2014;9(2):e90094.  https://doi.org/10.1371/journal.pone.0090094  PMID: 24587222 
  17. Poletti P, Merler S, Ajelli M, Manfredi P, Munywoki PK, Nokes D, et al. Evaluating vaccination strategies for reducing infant respiratory syncytial virus infection in low-income settings. BMC Med. 2015;13(1):49.  https://doi.org/10.1186/s12916-015-0283-x  PMID: 25857701 
  18. Muller WJ, Madhi SA, Seoane Nuñez B, Baca Cots M, Bosheva M, Dagan R, et al. Nirsevimab for prevention of RSV in term and late-preterm infants. N Engl J Med. 2023;388(16):1533-4.  https://doi.org/10.1056/NEJMc2214773  PMID: 37018470 
  19. 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 
  20. 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 
  21. Italian Ministry of Health. Assistenza ospedaliera e dati SDO. [Hospital discharge records]. Rome: Italian Ministry of Health. [Accessed: 4 Sep 2024]. Italian. Available from: https://www.salute.gov.it/portale/assistenzaOspedaliera/homeAssistenzaOspedaliera.jsp
  22. Italian National Institute of Statistics (Istat). Lombardia population. Resident population on 1st January; 2022. Rome: Istituto Nazionale di Statistica (ISTAT). [Accessed: 23 Jul 2024]. Available from: http://dati.istat.it/?lang=en
  23. Italian National Institute of Health (Istituto Superiore di Sanità). RespiVirNet - Sistema di Sorveglianza Integrata epidemiologica e virologica [Integrated epidemiological and virological surveillance system]. Rome: Italian National Institute of Health. [Accessed: 2 Sep 2024]. Available from: https://www.epicentro.iss.it/influenza/respivirnet
  24. 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;12:1441786.  https://doi.org/10.3389/fpubh.2024.1441786  PMID: 39220460 
  25. 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. Lancet Infect Dis. 2024;24(8):817-28.  https://doi.org/10.1016/S1473-3099(24)00215-9  PMID: 38701823 
  26. Kieffer A, Beuvelet M, Sardesai A, Musci R, Milev S, Roiz J, et al. Expected impact of universal immunization with nirsevimab against rsv-related outcomes and costs among all US infants in their first RSV season: a static model. J Infect Dis. 2022;226(Suppl 2):S282-92.  https://doi.org/10.1093/infdis/jiac216  PMID: 35968866 
  27. Ren S, Chen Q, Zhang Y, Yi L, Qian C, Lu Y, et al. Modeling the optimal seasonal monoclonal antibody administration strategy for respiratory syncytial virus (RSV) prevention based on age-season specific hospitalization rate of RSV in Suzhou, China, 2016-2022. Vaccine. 2024;42(2):352-61.  https://doi.org/10.1016/j.vaccine.2023.11.054  PMID: 38057209 
  28. Voirin N, Virlogeux V, Demont C, Kieffer A. Potential impact of nirsevimab on RSV transmission and medically attended lower respiratory tract illness caused by rsv: a disease transmission model. Infect Dis Ther. 2022;11(1):277-92.  https://doi.org/10.1007/s40121-021-00566-9  PMID: 34813073 
  29. Alharbi A, Yousef A, Zubani A, Alzahrani M, Al-Hindi M, Alharbi S, et al. Respiratory syncytial virus (RSV) burden in infants in the Kingdom of Saudi Arabia and the impact of all-infant RSV protection: a modeling study. Adv Ther. 2024;41(4):1419-35.  https://doi.org/10.1007/s12325-024-02798-w  PMID: 38356106 
  30. Hodgson D, Koltai M, Krauer F, Flasche S, Jit M, Atkins KE. Optimal Respiratory Syncytial Virus intervention programmes using Nirsevimab in England and Wales. Vaccine. 2022;40(49):7151-7.  https://doi.org/10.1016/j.vaccine.2022.10.041  PMID: 36328884 
  31. Zheng Z, Weinberger DM, Pitzer VE. Predicted effectiveness of vaccines and extended half-life monoclonal antibodies against RSV hospitalizations in children. NPJ Vaccines. 2022;7(1):127.  https://doi.org/10.1038/s41541-022-00550-5  PMID: 36302926 
  32. Do LAH, Le NTN, Mahmud S, Mulholland K, Pecenka C, Clark A. Impact and cost-effectiveness of strategies to prevent respiratory syncytial virus (RSV) disease in Vietnam: A modelling study. Vaccine. 2023;41(46):6782-90.  https://doi.org/10.1016/j.vaccine.2023.09.003  PMID: 37690873 
  33. Li Y, Hodgson D, Wang X, Atkins KE, Feikin DR, Nair H. Respiratory syncytial virus seasonality and prevention strategy planning for passive immunisation of infants in low-income and middle-income countries: a modelling study. Lancet Infect Dis. 2021;21(9):1303-12.  https://doi.org/10.1016/S1473-3099(20)30703-9  PMID: 33965062 
  34. Cromer D, van Hoek AJ, Newall AT, Pollard AJ, Jit M. Burden of paediatric respiratory syncytial virus disease and potential effect of different immunisation strategies: a modelling and cost-effectiveness analysis for England. Lancet Public Health. 2017;2(8):e367-74.  https://doi.org/10.1016/S2468-2667(17)30103-2  PMID: 28804787 
  35. Shoukat A, Abdollahi E, Galvani AP, Halperin SA, Langley JM, Moghadas SM. Cost-effectiveness analysis of nirsevimab and maternal RSVpreF vaccine strategies for prevention of Respiratory Syncytial Virus disease among infants in Canada: a simulation study. Lancet Reg Health Am. 2023;28:100629. https://doi.org/10.1016/j.lana.2023.100629  PMID: 38026446 
  36. Laufer RS, Baral R, Buchwald AG, Campbell JD, Coulibaly F, Diallo F, et al. Optimizing next-generation RSV prevention in Mali: A cost-effectiveness analysis of pediatric vaccination, maternal vaccination, and extended half-life monoclonal antibody immunoprophylaxis. PLOS Glob Public Health. 2023;3(5):e0001432.  https://doi.org/10.1371/journal.pgph.0001432  PMID: 37145993 
  37. Álvarez Aldean J, Rivero Calle I, Rodríguez Fernández R, Aceituno Mata S, Bellmunt A, Prades M, et al. Cost-effectiveness analysis of maternal immunization with RSVpreF vaccine for the prevention of respiratory syncytial virus among infants in Spain. Infect Dis Ther. 2024;13(6):1315-31.  https://doi.org/10.1007/s40121-024-00975-6  PMID: 38733493 
  38. 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 
  39. Sanofi. Sanofi BeyfortusTM (nirsevimab-alip) statement. Paris: Sanofi. [Accessed: 22 Apr 2024]. Available from: https://www.news.sanofi.us/Sanofi-Beyfortus-Statement
  40. Karafillakis E, Paterson P, Larson HJ. ‘My primary purpose is to protect the unborn child’: Understanding pregnant women’s perceptions of maternal vaccination and vaccine trials in Europe. Vaccine. 2021;39(39):5673-9.  https://doi.org/10.1016/j.vaccine.2021.07.099  PMID: 34419304 
  41. Azzari C, Baraldi E, Bonanni P, Bozzola E, Coscia A, Lanari M, et al. Epidemiology and prevention of respiratory syncytial virus infections in children in Italy. Ital J Pediatr. 2021;47(1):198.  https://doi.org/10.1186/s13052-021-01148-8  PMID: 34600591 
  42. Sanz-Muñoz I, Castrodeza-Sanz J, Eiros JM. Potential effects on elderly people from nirsevimab use in infants. Open Respir Arch. 2024;6(2):100320.  https://doi.org/10.1016/j.opresp.2024.100320  PMID: 38617129 
  43. Lombardy Region (Regione Lombardia). Fornitura farmaco BEYFORTUS e servizi connessi - SANOFI - ARIA_2024_008.9. [BEYFORTUS supply and related services]. Milan: Regione Lombardia. [Accessed: 23 Jan 2025]. Italian. Available from: https://www.sintel.regione.lombardia.it/eprocdata/conventionDetail.xhtml?id=189499965
  44. Sicily Region (Regione Sicilia). Procedura di gara per la fornitura dei vaccini esclusivi anti virus respiratorio sinciziale per donne in gravidanza e dell’anticorpo monoclonale umano. [Tender procedure for the supply of exclusive vaccines against respiratory syncytial virus for pregnant women and the human monoclonal antibody]. Palermo: Regione Sicilia. [Accessed: 23 Jan 2025]. Italian. Available from: https://appalti.regione.sicilia.it/PortaleAppalti/it/ppgare_bandi_lista.wp?actionPath=/ExtStr2/do/FrontEnd/Bandi/view.action&currentFrame=7&codice=G00649&_csrf=OIHLKASFXWSVIDFWMEH9CQ1X1F4D295T
Impact of routine prophylaxis with monoclonal antibodies and maternal immunisation to prevent respiratory syncytial virus hospitalisations, Lombardy region, Italy, 2024/25 season
<p class="citation"> <span>Citation style for this article:</span> <span class="meta-value authors"> <a href="/search?value1=Francesco+Menegale&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Menegale Francesco</a>, <a href="/search?value1=Luigi+Vezzosi&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Vezzosi Luigi</a>, <a href="/search?value1=Marcello+Tirani&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Tirani Marcello</a>, <a href="/search?value1=Simona+Scarioni&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Scarioni Simona</a>, <a href="/search?value1=Stefano+Odelli&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Odelli Stefano</a>, <a href="/search?value1=Federica+Morani&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Morani Federica</a>, <a href="/search?value1=Catia+Borriello&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Borriello Catia</a>, <a href="/search?value1=Elena+Pariani&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Pariani Elena</a>, <a href="/search?value1=Ilaria+Dorigatti&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Dorigatti Ilaria</a>, <a href="/search?value1=Danilo+Cereda&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Cereda Danilo</a>, <a href="/search?value1=Stefano+Merler&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Merler Stefano</a>, <a href="/search?value1=Piero+Poletti&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Poletti Piero</a></span>. Impact of routine prophylaxis with monoclonal antibodies and maternal immunisation to prevent respiratory syncytial virus hospitalisations, Lombardy region, Italy, 2024/25 season. <a href="/content/ecdc">Euro Surveill.</a> 2025;30(14):pii=2400637. <a href="https://doi.org/10.2807/1560-7917.ES.2025.30.14.2400637" title="doi link" target="_blank">https://doi.org/10.2807/1560-7917.ES.2025.30.14.2400637</a> <span class="ES_Article_citation"> <span class="generated">Received</span>: 25 Sept 2024;&nbsp;&nbsp; <span class="generated">Accepted</span>: 12 Feb 2025 </span> </p>
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