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

Rebecca Symes¹, Heather J Whitaker², Shazaad Ahmad³, David Arnold⁴, Suryabrata Banerjee⁵, Cariad M Evans⁶, Robin Gore⁷, Jennifer Hart⁸, Katy Heaney⁹, Onn Min Kon¹⁰, Anne Melhuish¹¹, Munira Ortale Zogaib¹², Emanuela Pelosi¹³, Najib M Rahman¹⁴, Gerrit Woltmann¹⁵, Tricia McKeever¹⁶, Maria Zambon¹⁷, Conall H Watson¹⁸, Wei Shen Lim¹⁹, Jamie Lopez Bernal¹⁸; HARISS network collaborators

Collaborators, Affiliations

Collaborators

HARISS network collaborators:
Matthew Donati²⁰, Elisabeth North⁴, Hongyi Zhang²¹, Chloe Myers²¹, Bethan Phillips⁹, Ajit Lalvani²², Paul Randell²³, Joan Nanan²⁴, Fiona McGill¹¹, Christopher W Holmes²⁵, Claire L McMurray²⁵, Samantha Steadman²⁶, Leanne Small²⁶, Tim William Felton²⁷, Nicholas Machin²⁸, Brendan Payne¹², Nikhil Premchand²⁹, John Steer²⁹, Louise Berry³⁰, Louise Lansbury¹⁶, Tine Panduro³¹, Melissa Dobson³¹, Monique Andersson³², Marc Lipman³³, Lise Ridge³⁴, Thomas Swaine⁸, Adam Hinchcliffe⁸, Charlotte Si Yuan Lim⁸, Aimee Serisier⁸, Tamsin McKinnon⁸, Simon Tazzyman³⁵, Thushan de Silva³⁶, Tristan W Clark³⁷, Christopher Rawlinson³⁸, Alec Cobbold³⁸

Affiliations

¹ Immunisation and Vaccine-Preventable Diseases Division, UK Health Security Agency, London, UK; School of Medicine, University of Nottingham, Nottingham, UK. Electronic address: rebecca.symes@ukhsa.gov.uk.
² Modelling Division, UK Health Security Agency, London, UK.
³ Department of Virology, Manchester Medical Microbiology Partnership, Manchester University NHS Foundation Trust, Manchester, UK; Division of Evolution and Genomic Sciences, School of Biological Sciences, University of Manchester, Manchester, UK.
⁴ Academic Respiratory Unit, North Bristol NHS Trust, Bristol, UK.
⁵ Northumbria Healthcare NHS Foundation Trust, Newcastle Upon Tyne, UK.
⁶ Department of Virology, Sheffield Teaching Hospitals NHS Trust, Sheffield, UK.
⁷ Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
⁸ Department of Virology, Royal Free Hospital, Royal Free London NHS Foundation Trust, London, UK.
⁹ Frimley Health NHS Foundation Trust, Frimley, UK.
¹⁰ National Heart and Lung Institute, Imperial College London and Imperial College Healthcare NHS Trust, London, UK; NIHR Imperial Biomedical Research Centre, London, UK.
¹¹ Leeds Teaching Hospitals NHS Trust, Leeds, UK.
¹² The Newcastle-upon-Tyne Hospitals NHS Foundation Trust, Newcastle, UK.
¹³ University Hospital Southampton, NHS Foundation Trust, Southampton, UK.
¹⁴ Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK; Chinese Academy of Medical Science, Oxford Institute, Oxford, UK.
¹⁵ University Hospitals Leicester NHS Trust, Leicester, UK; NIHR Leicester Biomedical Research Centre, Leicester, UK.
¹⁶ School of Medicine, University of Nottingham, Nottingham, UK; NIHR Nottingham Biomedical Research Centre, Nottingham, UK.
¹⁷ Public Health Microbiology, United Kingdom Health Security Agency, London, UK.
¹⁸ Immunisation and Vaccine-Preventable Diseases Division, UK Health Security Agency, London, UK; NIHR Health Protection Unit in Respiratory Infections, Imperial College, London, UK.
¹⁹ School of Medicine, University of Nottingham, Nottingham, UK; NIHR Nottingham Biomedical Research Centre, Nottingham, UK; Department of Respiratory Medicine, Nottingham University Hospitals NHS Trust, Nottingham, UK.
²⁰ UK Health Security Agency, South West Regional Laboratory and Severn Infection Sciences, Bristol, UK.
²¹ UKHSA Clinical Microbiology and Public Health Laboratory, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge, UK.
²² NIHR Health Protection Research Unit in Respiratory Infections, National Heart and Lung Institute, Imperial College London, London, UK.
²³ Imperial College Healthcare NHS Trust, London, UK.
²⁴ National Heart and Lung Institute, Imperial College London and Imperial College Healthcare NHS Trust, London, UK.
²⁵ Division of Microbiology and Infection, University of Leicester, Leicester, UK; University Hospitals of Leicester NHS Trust, Leicester, UK.
²⁶ University Hospitals of Leicester NHS Trust, Leicester, UK.
²⁷ The University of Manchester, Manchester, UK; NIHR Manchester Biomedical Research Centre, Manchester, UK; Manchester University NHS Foundation Trust, Manchester, UK.
²⁸ Virology Department, Manchester Medical Microbiology Partnership, Manchester University NHS Foundation Trust and UK Health Security Agency, UK.
²⁹ Northumbria Healthcare NHS Foundation Trust, Newcastle, UK.
³⁰ Department of Microbiology, Nottingham University Hospitals NHS Trust, Nottingham, UK.
³¹ Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK; Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK.
³² Nuffield Department of Clinical Laboratory Sciences, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.
³³ UCL Respiratory, Division of Medicine UCL & Respiratory Medicine, Royal Free Hospital, Royal Free London NHS Foundation Trust, London, UK.
³⁴ Respiratory Medicine, Royal Free Hospital, Royal Free London NHS Foundation Trust, London, UK.
³⁵ South Yorkshire and Bassetlaw Pathology Network, Sheffield Teaching Hospitals NHS Trust, Sheffield, UK.
³⁶ Division of Clinical Medicine, School of Medicine and Population Health, The University of Sheffield, Sheffield, UK.
³⁷ School of Clinical and Experimental Sciences, University of Southampton and Department of Infection, University Hospitals Southampton NHS Foundation Trust, UK.
³⁸ Immunisation and Vaccine-Preventable Diseases Division, UK Health Security Agency, London, UK.

PMID: 41167207
DOI: 10.1016/S1473-3099(25)00546-8

Free article

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

Rebecca Symes et al. Lancet Infect Dis. 2025.

Free article

. 2025 Oct 27:S1473-3099(25)00546-8.

doi: 10.1016/S1473-3099(25)00546-8. Online ahead of print.

Authors

Collaborators

HARISS network collaborators:
Matthew Donati²⁰, Elisabeth North⁴, Hongyi Zhang²¹, Chloe Myers²¹, Bethan Phillips⁹, Ajit Lalvani²², Paul Randell²³, Joan Nanan²⁴, Fiona McGill¹¹, Christopher W Holmes²⁵, Claire L McMurray²⁵, Samantha Steadman²⁶, Leanne Small²⁶, Tim William Felton²⁷, Nicholas Machin²⁸, Brendan Payne¹², Nikhil Premchand²⁹, John Steer²⁹, Louise Berry³⁰, Louise Lansbury¹⁶, Tine Panduro³¹, Melissa Dobson³¹, Monique Andersson³², Marc Lipman³³, Lise Ridge³⁴, Thomas Swaine⁸, Adam Hinchcliffe⁸, Charlotte Si Yuan Lim⁸, Aimee Serisier⁸, Tamsin McKinnon⁸, Simon Tazzyman³⁵, Thushan de Silva³⁶, Tristan W Clark³⁷, Christopher Rawlinson³⁸, Alec Cobbold³⁸

Affiliations

¹ Immunisation and Vaccine-Preventable Diseases Division, UK Health Security Agency, London, UK; School of Medicine, University of Nottingham, Nottingham, UK. Electronic address: rebecca.symes@ukhsa.gov.uk.
² Modelling Division, UK Health Security Agency, London, UK.
³ Department of Virology, Manchester Medical Microbiology Partnership, Manchester University NHS Foundation Trust, Manchester, UK; Division of Evolution and Genomic Sciences, School of Biological Sciences, University of Manchester, Manchester, UK.
⁴ Academic Respiratory Unit, North Bristol NHS Trust, Bristol, UK.
⁵ Northumbria Healthcare NHS Foundation Trust, Newcastle Upon Tyne, UK.
⁶ Department of Virology, Sheffield Teaching Hospitals NHS Trust, Sheffield, UK.
⁷ Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
⁸ Department of Virology, Royal Free Hospital, Royal Free London NHS Foundation Trust, London, UK.
⁹ Frimley Health NHS Foundation Trust, Frimley, UK.
¹⁰ National Heart and Lung Institute, Imperial College London and Imperial College Healthcare NHS Trust, London, UK; NIHR Imperial Biomedical Research Centre, London, UK.
¹¹ Leeds Teaching Hospitals NHS Trust, Leeds, UK.
¹² The Newcastle-upon-Tyne Hospitals NHS Foundation Trust, Newcastle, UK.
¹³ University Hospital Southampton, NHS Foundation Trust, Southampton, UK.
¹⁴ Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK; Chinese Academy of Medical Science, Oxford Institute, Oxford, UK.
¹⁵ University Hospitals Leicester NHS Trust, Leicester, UK; NIHR Leicester Biomedical Research Centre, Leicester, UK.
¹⁶ School of Medicine, University of Nottingham, Nottingham, UK; NIHR Nottingham Biomedical Research Centre, Nottingham, UK.
¹⁷ Public Health Microbiology, United Kingdom Health Security Agency, London, UK.
¹⁸ Immunisation and Vaccine-Preventable Diseases Division, UK Health Security Agency, London, UK; NIHR Health Protection Unit in Respiratory Infections, Imperial College, London, UK.
¹⁹ School of Medicine, University of Nottingham, Nottingham, UK; NIHR Nottingham Biomedical Research Centre, Nottingham, UK; Department of Respiratory Medicine, Nottingham University Hospitals NHS Trust, Nottingham, UK.
²⁰ UK Health Security Agency, South West Regional Laboratory and Severn Infection Sciences, Bristol, UK.
²¹ UKHSA Clinical Microbiology and Public Health Laboratory, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge, UK.
²² NIHR Health Protection Research Unit in Respiratory Infections, National Heart and Lung Institute, Imperial College London, London, UK.
²³ Imperial College Healthcare NHS Trust, London, UK.
²⁴ National Heart and Lung Institute, Imperial College London and Imperial College Healthcare NHS Trust, London, UK.
²⁵ Division of Microbiology and Infection, University of Leicester, Leicester, UK; University Hospitals of Leicester NHS Trust, Leicester, UK.
²⁶ University Hospitals of Leicester NHS Trust, Leicester, UK.
²⁷ The University of Manchester, Manchester, UK; NIHR Manchester Biomedical Research Centre, Manchester, UK; Manchester University NHS Foundation Trust, Manchester, UK.
²⁸ Virology Department, Manchester Medical Microbiology Partnership, Manchester University NHS Foundation Trust and UK Health Security Agency, UK.
²⁹ Northumbria Healthcare NHS Foundation Trust, Newcastle, UK.
³⁰ Department of Microbiology, Nottingham University Hospitals NHS Trust, Nottingham, UK.
³¹ Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK; Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK.
³² Nuffield Department of Clinical Laboratory Sciences, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.
³³ UCL Respiratory, Division of Medicine UCL & Respiratory Medicine, Royal Free Hospital, Royal Free London NHS Foundation Trust, London, UK.
³⁴ Respiratory Medicine, Royal Free Hospital, Royal Free London NHS Foundation Trust, London, UK.
³⁵ South Yorkshire and Bassetlaw Pathology Network, Sheffield Teaching Hospitals NHS Trust, Sheffield, UK.
³⁶ Division of Clinical Medicine, School of Medicine and Population Health, The University of Sheffield, Sheffield, UK.
³⁷ School of Clinical and Experimental Sciences, University of Southampton and Department of Infection, University Hospitals Southampton NHS Foundation Trust, UK.
³⁸ Immunisation and Vaccine-Preventable Diseases Division, UK Health Security Agency, London, UK.

PMID: 41167207
DOI: 10.1016/S1473-3099(25)00546-8

Abstract

Background: 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.

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Conflict of interest statement

Declaration of interests DA reports grants from the NIHR Advanced Fellowship in Pleural Infection and the University of Bristol. RG reports speaker fees and/or conference attendance (unrelated to paper topic matter) from AstraZeneca UK, Sanofi UK, and GSK UK; support for attending meetings or travel from Sanofi UK; and an unpaid presidential role for the British Society for Allergy and Clinical Immunology. MZ reports being a Chair of International Society for Influenza and other Respiratory Virus Diseases and membership of the New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG), the Scientific Advisory Group for Emergencies (SAGE), and Joint Committee on Vaccination and Immunisation expert or working groups. CHW reports being an invited speaker at independently organised scientific and medical conferences, which are sponsored by vaccine makers. WSL reports institutional funding from UK Health Security Agency (WSL's institution is a lead coordinating institution of HARISS); unrestricted investigator-initiated institutional research funding from Pfizer, for an unrelated multicentre study in pneumonia in which WSL is the chief investigator (study ended Dec 31, 2023); being an unpaid Deputy Chair of Joint Committee on Vaccination and Immunisation; and an unpaid leadership role in the NIHR Respiratory Translational Collaboration, Acute Respiratory Infection National Research Strategy Group. TC reports grants or contracts from NIHR, Biomerieux/Biofire, Inflammatix, and SenseBio; consulting fees from Biomerieux/Biofire, Cepheid, Janssen, Sanofi, Synairgen, Harvey Medical, and IP Pragmatics; payment or honoraria from Cepheid, Qiagen, Biomerieux/Biofire, Janssen, and Medscape; support for attending meetings or travel from Cepheid, Roche diagnostics, Roche, Qiagen, and Janssen; participation on a data safety monitoring or advisory board for Roche, Shionogi, Roche Diagnostics, GSK, Seqirus, Sanofi, Cepheid, and Janssen; stock or stock options with Synairgen; and receipt of equipment, materials, drugs, medical writing, gifts, or other services from Biomerieux/Biofire, Qiagen, Lex diagnostics, and Abbott. MD reports subsidised attendance at a UK Clinical Virology Network scientific conference, which is a charity with partial financial support from companies active in respiratory virus diagnostics. No direct payments were received. The UKHSA Immunisation and Vaccine-Preventable Diseases Division undertakes post-marketing surveillance and analysis for vaccine makers, including Pfizer for RSV, for which it makes cost-recovery charges.

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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

Collaborators

Affiliations

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

Authors

Collaborators

Affiliations

Abstract

Conflict of interest statement

LinkOut - more resources

Full Text Sources

Miscellaneous