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. 2025 Aug 30:e2515896.
doi: 10.1001/jama.2025.15896. Online ahead of print.

RSV Vaccine Effectiveness Against Hospitalization Among US Adults Aged 60 Years or Older During 2 Seasons

Diya Surie  1 , Wesley H Self  2   3 , Katharine A Yuengling  1 , Adam S Lauring  4   5 , Yuwei Zhu  6 , Basmah Safdar  7 , Adit A Ginde  8 , Samantha J Simon  8 , Ithan D Peltan  9   10 , Samuel M Brown  9   10 , Manjusha Gaglani  11   12 , Shekhar Ghamande  13 , Cristie Columbus  14 , Nicholas M Mohr  15 , Kevin W Gibbs  16 , David N Hager  17 , Matthew Prekker  18 , Michelle N Gong  19 , Amira Mohamed  19 , Nicholas J Johnson  20 , Jay S Steingrub  21 , Akram Khan  22 , Abhijit Duggal  23 , Alexandra J Gordon  24 , Nida Qadir  25 , Steven Y Chang  25 , Christopher Mallow  26 , Jamie R Felzer  27 , Jennie H Kwon  28 , Matthew C Exline  29 , Ivana A Vaughn  30 , Mayur Ramesh  31 , Leigh Papalambros  4   5 , Jarrod M Mosier  32 , Estelle S Harris  33 , Adrienne Baughman  2 , Sydney A Cornelison  6 , Paul W Blair  3 , Cassandra A Johnson  6 , Nathaniel M Lewis  34 , Sascha Ellington  34 , Carlos G Grijalva  35 , H Keipp Talbot  36 , Jonathan D Casey  36 , Natasha Halasa  37 , James D Chappell  37 , Rachel E Rutkowski  1 , Kevin C Ma  1 , Fatimah S Dawood  1 ; Investigating Respiratory Viruses in the Acutely Ill (IVY) Network
Collaborators, Affiliations

RSV Vaccine Effectiveness Against Hospitalization Among US Adults Aged 60 Years or Older During 2 Seasons

Diya Surie et al. JAMA. .

Abstract

Importance: Respiratory syncytial virus (RSV) vaccines for adults aged 60 years or older became available in 2023. One dose is recommended for all adults aged 75 years or older and those aged 60 to 74 years at increased risk of severe RSV; however, duration of protection is unknown.

Objective: To evaluate RSV vaccine effectiveness against RSV-associated hospitalization among adults aged 60 years or older during 2 RSV seasons.

Design, setting, and participants: A total of 6958 adults aged 60 years or older were included in this test-negative, case-control study if they were hospitalized with acute respiratory illness at any of 26 hospitals in 20 US states during the October 1, 2023, to March 31, 2024, or October 1, 2024, to April 30, 2025, RSV seasons and had respiratory virus testing within 10 days of illness onset. Case patients tested positive for RSV only; control patients tested negative for RSV, SARS-CoV-2, and influenza. Demographic and clinical data were obtained through patient interview and electronic health records.

Exposures: Receipt of 1 RSV vaccine dose at least 14 days before illness onset.

Main outcomes and measures: Multivariable logistic regression was used to compare the odds of RSV vaccination among hospitalized cases and controls. Models were adjusted for age, sex, race and ethnicity, geographic region, and calendar month and year. Vaccine effectiveness was estimated as (1 - adjusted odds ratio) × 100%. Analyses were stratified by timing of RSV vaccine receipt (same vs prior season) relative to illness onset.

Results: Of 6958 adults aged 60 years or older, 821 (11.8%) were RSV cases and 6137 (88.2%) were controls. A total of 1438 patients were Black (20.1%) and 4314 were White (62.0%); 3534 were female (50.8%). Median age was 72 years (IQR, 66-80 years) and 1829 adults (26.3%) were immunocompromised. A total of 63 cases (7.7%) and 966 controls (15.7%) were vaccinated. Estimated vaccine effectiveness against RSV-associated hospitalization was 58% (95% CI, 45%-68%) during 2 seasons and 69% (95% CI, 52%-81%) for same-season vaccination vs 48% (95% CI, 27%-63%; P = .06) for prior-season vaccination. Estimated vaccine effectiveness during 2 seasons was significantly lower among immunocompromised adults (30%; 95% CI, -9% to 55%) than immunocompetent adults (67%; 95% CI, 53%-77%; P = .02) and among those with cardiovascular disease (56%; 95% CI, 32%-72%) vs without (80%; 95% CI, 62%-90%; P = .03).

Conclusions and relevance: Respiratory syncytial virus vaccines prevented RSV-associated hospitalization during 2 seasons, although effectiveness was lower in patients with immunocompromise and cardiovascular disease than in those without these conditions. Ongoing monitoring is needed to determine the optimal RSV revaccination interval.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Lauring reported receiving consulting fees and research support from Roche outside the submitted work. Dr Peltan reported support from the National Institute of General Medical Sciences; funding from the National Heart, Lung, and Blood Institute (NHLBI); and payments to his institution from Bluejay Diagnostics, Regeneron, and Novartis outside the submitted work. Dr Gong reported funding from NHLBI for serving as a coinvestigator for the HART trial; participating as a data and safety monitoring board member for Best and PALMS; serving as a scientific advisor for Regeneron for a sepsis-induced hypotension trial, Philips Healthcare for hemodynamic monitoring and artificial intelligence tools, and Novartis for acute respiratory distress syndrome future trials; serving on the American Thoracic Society executive committee; serving as the steering committee chair for the ARDS, Pneumonia, and Sepsis (APS) Consortium, funded by NHLBI; and serving as the section editor for UpToDate for Wolters Kluwer outside the submitted work. Mr Khan reported receiving grants from Dompé Pharmaceuticals, Direct Biologics, and 4DMedical outside the submitted work. Dr Vaughn reported receiving grants through her institution for other unrelated research projects from eMAX Health, Boehringer Ingelheim, Eli Lilly, Evidera PPD, and Pfizer outside the submitted work. Dr Grijalva reported consulting for GSK and Merck and receiving research support from the Centers for Disease Control and Prevention (CDC), National Institutes of Health, Agency for Healthcare Research and Quality, and Syneos Health outside the submitted work. Dr Talbot reported receiving CDC funding outside the submitted work. Dr Casey reported serving as a medical monitor for Reprieve Cardiovascular, Inc, outside the submitted work. Dr Halasa reported grant funding from Merck and onetime consulting with CSL Seqirus outside the submitted work. Dr Chappell reported research support from Merck and QuidelOrtho for studies of RSV epidemiology and diagnostic detection among pediatric patients in Jordan outside the submitted work.

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