RSV Vaccine Demonstrates Cardioprotective Effects, Reduces MACE and Hospitalizations, With Deepak Bhatt, MD, MPH

A study conducted by GSK, investigating its Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted (Arexvy), has highlighted the vaccine’s efficacy in reducing major adverse cardiovascular events (MACEs) and RSV-related hospitalizations in adults ≥60 years.1

Arexvy is comprised of recombinant RSV glycoprotein F stabilized in the prefusion conformation, combined with GSK’s proprietary adjuvant AS01E. The vaccine has already received approval for the prevention of lower respiratory tract disease due to RSV in the same patient population, as well as for those aged 50-59 years who are at greater risk of the disease.2

“First of all, preventing a bad infection can secondarily prevent bad side effects of the infection, and we this all the time even outside of RSV when patients come in and they’re vulnerable, or they’re over the age of 60, and they may have underlying cardiac disease,” Deepak Bhatt, MD, MPH, director of the Mount Sinai Fuster Heart Hospital and the Dr. Valentin Fuster Professor of Cardiovascular Medicine at the Icahn School of Medicine at Mount Sinai, told HCPLive in an exclusive interview. “The other possibility is a little more speculative; perhaps the infection itself is triggering inflammation that is triggering the heart attack.”

Presented at RSVVW’26, the 9th Conference of the Respiratory Syncytial Virus Foundation in Rome, this retrospective cohort study aimed to estimate the vaccine effectiveness of Arexvy against MACE and severe exacerbations of chronic obstructive pulmonary disease (COPD) and asthma. The team collected claims data from the Optum Research Database, including patients aged ≥60 years identified between August 2023 and May 2024. For vaccinated patients, the index date was the date of vaccination.3

Investigators then matched each vaccinated patient to 4 unvaccinated patients on age, sex, insurance type, and state of residence. Baseline characteristics were measured during the 12 months pre-index, while the follow-up period began 14 days post-index. Each outcome, including MACE and flare-ups of COPD or asthma, was measured overall and regarding RSV-related outcomes.3

Ultimately, the trial enrolled a total of 520,440 vaccinated patients, who were then exact matched in a 1:4 to 2,081,760 unvaccinated patients. Mean age across all patients was 74.3 years (standard deviation [SD], 6.7). 869,980 patients had existing cardiovascular disease, 362,615 had existing COPD, and 244,226 had existing asthma.3

Among adults with existing cardiovascular disease, the vaccine’s effectiveness against MACE was 20.4% (95% CI, 18-22.9%). Effectiveness against RSV-related MACE was 63.1% (41.8-76.6%), while effectiveness against severe COPD and asthma exacerbations overall was 8.6% (4.2-12.7%) and 19.4% (5.7-31.1%), respectively. For RSV-related severe COPD and asthma exacerbations, effectiveness estimates were 74.4% (59.3-83.9%) and 61.6% (9.1-83.7%), respectively.3

Ultimately, investigators determined that these data highlight a substantial benefit of adjuvanted RSVPreF3 vaccination in preventing RSV-related MACE, as well as severe asthma and COPD exacerbations among patients ≥60 years.3

“I think this is going to be an area of future investigation for other vaccines as well,” Bhatt said. “For instance, vaccinating for shingles, beyond just reducing the risk of developing recurrent shingles, can potentially have cardiovascular benefits. This is something that would need to be studied in randomized clinical trials, of course, but certainly there are emerging observational data supporting that.”

Editor’s Note: Bhatt reports disclosures with GSK, Merck, Cereno Scientific, Angiowave, Boehringer Ingelheim, Novo Nordisk, and others.

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. February 17, 2025. Accessed February 26, 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. Livingston R. Arexvy Vaccine Reduces Hospitalization, Major Adverse Cardiovascular Events in RSV. HCPLive. February 18, 2026. Accessed February 26, 2026. https://www.hcplive.com/view/arexvy-vaccine-reduces-hospitalization-major-adverse-cardiovascular-events-in-rsv

3. Singer D, Steffens A, La E, et al. Effectiveness of adjuvanted RSVPreF3 vaccine in preventing major adverse cardiovascular events, severe asthma exacerbations, and severe COPD exacerbations among US adults aged 60 years and older. Poster presented at the ReSViNET 2026; February 17, 2026. Accessed February 26, 2026. https://www.rtihs.org/publications/effectiveness-adjuvanted-rsvpref3-vaccine-preventing-major-adverse-cardiovascular