RSV Vaccine Linked to 75.6% Lower Hospitalization Risk in Adults ≥60, Real-World Study Finds

GSK’s adjuvanted recombinant respiratory syncytial virus (RSV) vaccine, Arexvy, was associated with significant reductions in RSV-related hospitalization and certain cardiovascular and respiratory complications among adults aged 60 years and older, according to new real-world data presented at the 9th Conference of the Respiratory Syncytial Virus Foundation (ReSViNET) 2026 in Rome, Italy.¹

Although RSV is primarily known for its high disease burden among infants and pediatric patients, it is increasingly recognized as the central cause for a substantial amount of respiratory illness in older adults. Despite being largely mild to moderate, RSV can result in hospitalization, serious complications such as heart attack, stroke, severe flare-ups of asthma and chronic obstructive pulmonary disease (COPD), and even death.²

“These new data are a significant step in our understanding of how to help prevent such RSV-related health outcomes. I look forward to more data investigating this association further,” Deepak L. Bhatt, MD, MPH, MBA, Director of Mount Sinai Fuster Heart Hospital and the Dr. Valentin Fuster Professor of Cardiovascular Medicine at the Icahn School of Medicine at Mount Sinai in New York, said in a press release.¹

In a retrospective cohort study using US administrative claims data from the Optum Research Database (August 2022–May 2024), investigators evaluated vaccine effectiveness (VE) in more than 2.5 million adults aged ≥60 years. The analysis included 520 440 vaccinated individuals matched 1:4 to 2 081 760 unvaccinated individuals.¹

At a median follow-up of 5.6 months (maximum 9.7 months) post-vaccination, the vaccine was associated with 75.6% VE against RSV-related hospitalization (unvaccinated group, n=1419/2 081 760; vaccinated group, n=95/520 440; 95% CI, 69.8%–80.2%).¹

Exploratory analyses among adults aged ≥60 years with existing cardiovascular disease showed an observed 63.1% VE against major adverse cardiovascular events (MACE)—defined as myocardial infarction, ischemic stroke, heart failure–related hospitalization, or unstable angina–related hospitalization—during RSV-related hospitalization (unvaccinated group, n=212/699 177; vaccinated group, n=21/170 803; 95% CI, 41.8%–76.6%).¹

Among adults aged ≥60 years with underlying chronic obstructive pulmonary disease (COPD) or asthma, VE against severe exacerbations during RSV-related hospitalization was 74.4% for COPD (unvaccinated group, n=265/286 406; vaccinated group, n=20/76 209; 95% CI, 59.3%–83.9%) and 61.6% for asthma (unvaccinated group, n=57/190 590; vaccinated group, n=7/53 636; 95% CI, 9.1%–83.7%).¹

In a separate nationwide Danish cohort study of adults aged ≥60 years with COPD, vaccination was associated with 100% VE against RSV-related hospitalization (unvaccinated group, n=115/89 376; vaccinated group, n=0/7448; 95% CI, 71.1%–100%).¹

The press release notes that observational studies cannot establish causality between RSV vaccination and reduced RSV-related risks, but the findings contribute to a growing body of real-world evidence.

The vaccine is approved for the prevention of RSV–lower respiratory tract disease in adults aged ≥60 years in more than 65 countries, and for certain at-risk populations aged 50–59 years in more than 55 countries, including the US and Japan. In the European Economic Area, it is approved for adults aged ≥18 years.¹

RSV is estimated to cause between 6000 and 10 000 deaths annually in older adults in the United States and between 110 000 and 180 000 hospitalizations among individuals aged ≥50 years.¹

References:

1. GSK’s Arexvy associated with reductions in certain RSV-related risks including heart attack, stroke and severe flare-ups of COPD and asthma, real world study shows. News release. GSK. February 17, 2026. Accessed February 18, 2026. https://www.gsk.com/en-gb/media/press-releases/gsk-s-arexvy-associated-with-reductions-in-certain-rsv-related-risks-including-heart-attack-stroke-and-severe-flare-ups-of-copd-and-asthma-real-world-study-shows/
2. Savic M, Penders Y, Shi T, Branche A, Pirçon J. Respiratory syncytial virus disease burden in adults aged 60 years and older in high‐income countries: A systematic literature review and meta‐analysis. Influenza and Other Respiratory Viruses. 2023;17:e13031. doi:10.1111/irv.13031