AREXVY Vaccine Reduces Hospitalization, Major Adverse Cardiovascular Events in RSV

On February 18, 2026, GSK announced new efficacy data for Respiratory Syncytial Virus Vaccine, Adjuvanted (AREXVY), noting an observed reaction in major adverse cardiovascular events and RSV-related hospitalizations in adults ≥60 years.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

AREXVY is composed of recombinant RSV glycoprotein F, stabilized in the prefusion conformation, combined with GSK’s proprietary adjuvant AS01E. The vaccine is currently indicated for the prevention of lower respiratory tract disease (LRTD) due to RSV in patients aged ≥60 years and for those ages 50-59 who are at an increased risk for LRTD caused by RSV.1

“In the real-world data being presented at RSVVW’26, it is observed that RSV vaccination could help reduce the risk of certain serious RSV-related outcomes, potentially including major adverse cardiovascular events such as heart attack and stroke, as well as severe flare-ups of COPD and asthma,” Deepak Bhatt, MD, MPH, 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, said in a statement. “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.”1

This retrospective cohort study, conducted across the US, included >2.5 million patients, of whom 520,440 were vaccinated. These patients were exact matched in a 1:4 ratio to 2,081,760 patients who did not receive the vaccine. The vaccinated group received treatment between August 2023 and May 2024.1

During the study, the vaccine was associated with 75.6% effectiveness against RSV-related hospitalization at a median follow-up period of 5.6 months post-vaccination (unvaccinated group, n = 1419/2,081,760; vaccinated group, n = 95/520,440; 95% CI, 69.8-80.2%). Additional exploratory endpoints indicated 63.1% vaccine effectiveness against major adverse cardiovascular events, including heart attack and stroke, during hospitalization among patients aged ≥60 years (unvaccinated, n = 212/699,177; vaccinated, n = 21/170,803; 95% CI, 41.8-76.6%).1

The vaccine also showed 74.4% and 61.6% effectiveness against severe COPD and asthma flare-ups, respectively (COPD unvaccinated, n = 265/286,406; vaccinated, n = 20/76,209; 95% CI, 59.3-83.9%. Asthma unvaccinated, n = 57/190,590; vaccinated, n = 7/53,636; 95% CI, 9.1-83.7%).1

Another nationwide cohort study was conducted in Denmark among patients with COPD aged ≥60 years. During this study, the vaccine displayed an effectiveness of 100% in preventing RSV-related hospitalizations (unvaccinated, n = 115/89,376; vaccinated, n = 0/7448; 95% CI, 71.1-100%).1

“These data underscore the value of our RSV vaccine in its observed association with helping to prevent RSV-related hospitalization and reducing the risk of acute events of certain chronic conditions associated with this potentially serious disease,” Christian Felter, GSK Global Medical Lead, RSV, said in a statement. “We are proud of our contribution at the forefront of generating innovative research in RSV to inform the clinical community and improve outcomes for patients.”1

Full data from both the US and Denmark studies will be presented at RSVVW’26, the 9th Conference of the Respiratory Syncytial Virus Foundation (ReSViNET) in Rome, Italy, from February 17-20.1

References

1. GSK. 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. BusinessWire. February 18, 2026. Accessed February 18, 2026. https://www.businesswire.com/news/home/20260217706893/en/GSKs-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. 2022;17(1). doi:10.1111/irv.13031