A multi-institutional collaboration led by the Center for Translational Cardiology and Pragmatic Randomized Trials at Copenhagen University Hospital-Herlev and Gentofte, University of Copenhagen, reports that RSVpreF vaccination reduced all-cause cardiorespiratory hospitalizations in adults aged 60 years or older.
Respiratory syncytial virus is linked to elevated cardiovascular risk in older adults, including those with preexisting cardiovascular disease. Previous studies have examined RSV-associated pulmonary illness and observed cardiac complications during RSV hospitalizations.
An RSV vaccine, RSVpreF, has gained approval for preventing lower respiratory tract illness, though Phase III trials did not assess cardiovascular outcomes.
In the study, “Bivalent RSV Prefusion F Protein–Based Vaccine for Preventing Cardiovascular Hospitalizations in Older Adults: A Prespecified Analysis of the DAN-RSV Trial,” published in JAMA, researchers conducted a prespecified secondary analysis to investigate vaccine effectiveness of RSVpreF compared with no vaccine against cardiovascular outcomes among adults aged 60 years or older.
A total of 131,276 participants in Denmark were randomized 1:1 to RSVpreF (n = 65,642) or no vaccine (n = 65,634) during the 2024–2025 winter season. Mean age was 69.4 years, 50.3% were male, and 21.8% had preexisting cardiovascular disease.
All-cause cardiorespiratory hospitalization occurred in 26.3 vs. 29.2 events per 1,000 participant-years for RSVpreF vs. control, yielding an absolute rate reduction of 2.90 per 1,000 participant-years (95% CI, 0.10–5.71), vaccine effectiveness 9.9% (95% CI, 0.3%–18.7%), P = .04.
Cardiovascular hospitalization rates were 16.4 vs. 17.7 events per 1,000 participant-years (vaccine effectiveness 7.4% [95% CI, −5.5% to 18.8%]; P = .24), and stroke hospitalization rates were 3.0 vs. 3.8 per 1,000 participant-years (vaccine effectiveness 19.4% [95% CI, −8.6% to 40.4%]; P = .14). Myocardial infarction, heart failure hospitalization, and atrial fibrillation showed no statistically significant between-group differences.
Authors conclude that RSVpreF vaccination was associated with fewer all-cause cardiorespiratory hospitalizations in adults aged 60 years or older, with no statistically significant reduction observed in any specific cardiovascular outcomes.
Findings suggest potential downstream cardiorespiratory benefits of RSV immunization and support broader consideration of vaccination in older adults, including those with cardiovascular disease, to reduce severe cardiorespiratory complications.