At a Glance
- GSK demonstrates strong real-world vaccine effectiveness against RSV hospitalizations in older adults.
- Exploratory data links vaccination to reduced cardiovascular events during RSV-related hospital stays.
- Benefits observed for preventing severe COPD and asthma flare-ups tied to RSV in high-risk patients.
- Danish nationwide study shows complete protection against RSV hospitalizations in COPD patients ≥60.
- Builds evidence supporting GSK’s RSV vaccine for preventing lower respiratory tract disease and related burdens.
Written By: Nikita Jha, BPharm
Reviewed By: Pharmacally Editorial Team
GSK plc unveiled compelling real-world effectiveness data for its adjuvanted recombinant RSV vaccine at RSVVW’26, the 9th Conference of the Respiratory Syncytial Virus Foundation (ReSViNET) in Rome, Italy. With 19 abstracts presented and 3 supported, GSK reinforces its leadership in RSV prevention research.
A large US retrospective cohort study tracked over 2.5 million adults aged ≥60 years, matching 520,440 vaccinated individuals 1:4 to 2,081,760 unvaccinated controls. Vaccinations occurred from August 1, 2023, to May 31, 2024, with a median follow-up of 5.6 months (max 9.7 months). The vaccine linked to 75.6% vaccine effectiveness (VE) against RSV-related hospitalizations (95% CI: 69.8–80.2%; vaccinated: 95/520,440; unvaccinated: 1,419/2,081,760).
Exploratory endpoints highlighted broader benefits during RSV hospitalizations:
- 63.1% VE against major adverse cardiovascular events (MACE), like heart attacks and strokes (95% CI: 41.8–76.6%; vaccinated: 21/170,803; unvaccinated: 212/699,177).
- 74.4% VE against severe COPD flare-ups (95% CI: 59.3–83.9%; vaccinated: 20/76,209; unvaccinated: 265/286,406).
- 61.6% VE against severe asthma flare-ups (95% CI: 9.1–83.7%; vaccinated: 7/53,636; unvaccinated: 57/190,590).
In a separate Danish nationwide cohort of COPD patients aged ≥60, the vaccine showed 100% VE against RSV hospitalizations (95% CI: 71.1–100%; vaccinated: 0/7,448; unvaccinated: 115/89,376).
While observational studies limit causal claims, these findings build evidence for risk reductions in RSV lower respiratory tract disease (LRTD) the vaccine’s indication plus cardiovascular and respiratory comorbidities, easing winter hospitalization burdens.
Deepak L. Bhatt, MD, MPH, MBA, Director of Mount Sinai Fuster Heart Hospital, noted: “These real-world data suggest RSV vaccination could reduce risks of serious outcomes like MACE, COPD, and asthma flare-ups. This advances our understanding of RSV prevention.”
Christian Felter, GSK Global Medical Lead for RSV, added: “Our vaccine’s observed links to lower hospitalization and acute events in chronic conditions highlight its value. We’re committed to innovative RSV research for better patient outcomes.”
Both studies’ US as well as Danish analyses feature at RSVVW’26, signaling growing momentum for GSK’s RSV vaccine in older adults.
GSK RSV Vaccine Background
GSK’s Arexvy, a recombinant RSVPreF3 antigen combined with AS01E adjuvant, prevents RSV lower respiratory tract disease in adults aged 60 years and older across more than 65 countries. It is also approved for at-risk individuals aged 50 to 59 in over 55 countries, including the US and Japan, and for all adults aged 18 and older in Europe.
RSV Burden in Adults
RSV impacts 64 million people globally each year and causes 110,000 to 180,000 hospitalizations and 6,000 to 10,000 deaths annually in US adults aged 50 and older with comorbidities like COPD, asthma, or heart failure. Adults experience higher complications and costs than children; these studies highlight the vaccine’s potential to reduce admissions and exacerbations in high-risk seniors.
Reference
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, 17 February 2026, 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 | GSK