Abstract
Background
Respiratory syncytial virus (RSV) causes substantial morbidity and mortality in older adults. In 2023, the RSVpreF vaccine was licenced and recommended for adults through the UK’s national immunisation programmes. Real-world evidence on vaccine effectiveness (VE) across different populations and healthcare settings is limited.
Methods
We conducted a retrospective, multi-nation, test-negative design analysis to evaluate RSVpreF VE against hospitalisation in adults aged 74–79 years across England, Wales, Scotland, and Northern Ireland during the 2024–25 RSV season. Laboratory testing, admission, and vaccination data were linked at the individual patient level. Eligible cases were hospitalised individuals with laboratory-confirmed RSV, and controls were RSV-negative hospitalised patients; SARS-CoV-2- and influenza-positive controls were excluded in the primary analysis. Nation specific VE estimates were derived using multivariable logistic regression, adjusted for epidemiological week of specimen collection, and combined using fixed-effects meta-analysis with inverse-variance weighting. Sensitivity analyses included redefinition of controls and leave-one-nation-out analyses.
Findings
A total of 11,117 adults were included (6528 in England, 942 in NI, 1462 in Scotland, 2185 in Wales). Overall, 3896 (35.0%) had received RSVpreF. Across nations, 826 RSV-positive cases were identified, of whom 726 (87.9%) were unvaccinated. Adjusted VE against RSV-related hospitalisation was 74% (95% confidence interval [CI] 68–80) in England, 77% (30–95) in NI, 81% (60–91) in Scotland, and 82% (43–94) in Wales. Pooled fixed-effects VE was 75% (69–80; I 2 = 0%). VE estimates from sensitivity analyses were robust to the inclusion of vaccine-preventable respiratory infection controls and adjustment for vaccination status. Leave-one-nation-out sensitivity analysis showed that excluding England increased pooled VE to 81% (66–89), whereas exclusion of NI, Scotland, or Wales had minimal impact (75%, 68–80 to 69–80).
Interpretation RSVpreF vaccination provides high real-world protection against RSV-related hospitalisation in adults across the UK.
Respiratory syncytial virus (RSV) causes substantial morbidity and mortality in older adults. In 2023, the RSVpreF vaccine was licenced and recommended for adults through the UK’s national immunisation programmes. Real-world evidence on vaccine effectiveness (VE) across different populations and healthcare settings is limited.
Methods
We conducted a retrospective, multi-nation, test-negative design analysis to evaluate RSVpreF VE against hospitalisation in adults aged 74–79 years across England, Wales, Scotland, and Northern Ireland during the 2024–25 RSV season. Laboratory testing, admission, and vaccination data were linked at the individual patient level. Eligible cases were hospitalised individuals with laboratory-confirmed RSV, and controls were RSV-negative hospitalised patients; SARS-CoV-2- and influenza-positive controls were excluded in the primary analysis. Nation specific VE estimates were derived using multivariable logistic regression, adjusted for epidemiological week of specimen collection, and combined using fixed-effects meta-analysis with inverse-variance weighting. Sensitivity analyses included redefinition of controls and leave-one-nation-out analyses.
Findings
A total of 11,117 adults were included (6528 in England, 942 in NI, 1462 in Scotland, 2185 in Wales). Overall, 3896 (35.0%) had received RSVpreF. Across nations, 826 RSV-positive cases were identified, of whom 726 (87.9%) were unvaccinated. Adjusted VE against RSV-related hospitalisation was 74% (95% confidence interval [CI] 68–80) in England, 77% (30–95) in NI, 81% (60–91) in Scotland, and 82% (43–94) in Wales. Pooled fixed-effects VE was 75% (69–80; I 2 = 0%). VE estimates from sensitivity analyses were robust to the inclusion of vaccine-preventable respiratory infection controls and adjustment for vaccination status. Leave-one-nation-out sensitivity analysis showed that excluding England increased pooled VE to 81% (66–89), whereas exclusion of NI, Scotland, or Wales had minimal impact (75%, 68–80 to 69–80).
Interpretation RSVpreF vaccination provides high real-world protection against RSV-related hospitalisation in adults across the UK.
| Original language | English |
|---|---|
| Article number | 101620 |
| Pages (from-to) | 1-10 |
| Number of pages | 10 |
| Journal | The Lancet Regional Health - Europe |
| Volume | 64 |
| Early online date | 31 Mar 2026 |
| DOIs | |
| Publication status | Published (in print/issue) - 1 May 2026 |
Bibliographical note
Crown Copyright © 2026 Published by Elsevier Ltd. This is an open access article under the Open Government License (OGL) (http://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/).Data Availability Statement
England: This work is carried out under Regulation 3 of The Health Service (Control of Patient Information) Regulations; Secretary of State for Health, 2002) using patient identification information without individual patient consent as part of the UKHSA legal requirement for public health surveillance and monitoring of vaccines. As such, authors cannot make the underlying dataset publicly available for ethical and legal reasons. However, all the data used for this analysis is included as aggregated data in the manuscript Table 1. Applications for relevant anonymised data should be submitted to the UKHSA Office for Data Release at https://www.gov.uk/government/publications/accessing-ukhsa-protected-data.Northern Ireland: Health and Social Care data are available for use by approved researchers and internal HSC analysts by application to the Business Services Organisation Honest Broker Service Trusted Research Environment. This work was conducted on pseudonymised data as part of routine infectious disease surveillance under information governance agreements with data controllers.
Scotland: This work was carried out in Scotland on pseudonymised data as part of routine infectious disease surveillance by members of the Vaccine Effectiveness team in Public Health Scotland. Due to the terms of data access, individual-level data used in this analysis cannot be shared publicly.
Wales: This work was carried out in Wales by the specialists in the Vaccine Preventable Disease Programme and Communicable Disease Surveillance Centre of the Public Health Wales NHS Trust, using patient identification information without individual patient consent, in line with the core function in article 3(2a) of the trust's establishment order (to provide to or in relation to the health service in Wales and manage a range of public health, health protection, healthcare improvement, health advisory, child protection and microbiological laboratory services and services relating to the surveillance, prevention and control of communicable diseases). All data are held on NHS Wales secure servers and processed in accordance to Public Health Wales Information Governance policies.
Funding
This study received no specific funding.
UN SDGs
This output contributes to the following UN Sustainable Development Goals (SDGs)
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SDG 3 Good Health and Well-being
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