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Vaccine effectiveness of a bivalent respiratory syncytial virus (RSV) pre-F vaccine against RSV-associated hospital admission among adults aged 75–79 years in England: a multicentre, test-negative, case–control study

Lookup NU author(s): Dr Brendan PayneORCiD, Dr John Steer

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


Abstract

© 2025Background: A respiratory syncytial virus (RSV) vaccination programme for older adults using bivalent pre-F vaccine was introduced in England from Sept 1, 2024. Although vaccine effectiveness has been reported against all-cause RSV-associated respiratory hospital admissions, data are scarce on vaccine effectiveness against different presentations of RSV-associated illness, such as exacerbation of chronic illness. Methods: This multicentre, test-negative, case–control study used data from a national, hospital-based, acute respiratory infection sentinel surveillance (HARISS) system across 14 hospitals in England. Eligibility criteria were vaccine-eligible adults aged 75–79 years admitted to hospital with acute respiratory infection (ARI) for ≥24 h and tested with molecular diagnostic assays within 48 h of admission. Cases were RSV positive, and controls were negative for RSV, influenza, and SARS-CoV-2. Vaccination status and data on sex were obtained from the National Immunisation Information System. The primary outcome was hospital admission due to RSV-associated ARI, which was tested for using nasopharyngeal or combined nose and throat swabs. Clinical data were collected using a structured questionnaire. Findings: Between Oct 1, 2024, and March 31, 2025, 1006 older adults were admitted to hospital with ARI; 173 were RSV positive (cases) and 833 were RSV negative (controls). 526 (52·3%) of 1006 individuals were female and 480 (47·7%) were male. Mean age was 77·8 years (SD 1·4) in individuals who were RSV positive and 77·6 years (SD 1·3) in those who were negative for RSV, influenza, and SARS-CoV-2. Vaccine effectiveness was 82·3% (95% CI 70·6–90·0) against hospitalisation for any RSV-associated ARI and 86·7% (75·4–93·6) in those with severe disease including oxygen supplementation. Vaccine effectiveness was 88·6% (75·6–95·6) among individuals admitted due to lower respiratory tract infection, including pneumonia, 77·4% (42·4–92·8) due to exacerbation of chronic lung disease, and 78·8% (47·8–93·0) due to exacerbation of chronic heart disease, lung disease, and/or frailty. In individuals with immunosuppression, vaccine effectiveness was 72·8% (39·5–89·3). Interpretation: This study provides evidence that the RSV pre-F vaccine is highly effective against RSV-associated hospital admissions, including exacerbations of chronic disease, and in adults with immunosuppression. Funding: UK Health Security Agency.


Publication metadata

Author(s): Symes R, Whitaker HJ, Ahmad S, Arnold D, Banerjee S, Evans CM, Gore R, Hart J, Heaney K, Kon OM, Melhuish A, Ortale Zogaib M, Pelosi E, Rahman NM, Woltmann G, McKeever T, Zambon M, Watson CH, Lim WS, Lopez Bernal J, HARISS network, Payne B, Steer J

Publication type: Article

Publication status: Published

Journal: The Lancet Infectious Diseases

Year: 2025

Pages: epub ahead of print

Online publication date: 27/10/2025

Acceptance date: 02/04/2025

Date deposited: 26/11/2025

ISSN (print): 1473-3099

ISSN (electronic): 1474-4457

Publisher: Elsevier Ltd

URL: https://doi.org/10.1016/S1473-3099(25)00546-8

DOI: 10.1016/S1473-3099(25)00546-8

Data Access Statement: Original data are confidential, and no additional data are available.

PubMed id: 41167207


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Funding

Funder referenceFunder name
UK Health Security Agency

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