A major study led by the Center for Translational Cardiology and Pragmatic Randomized Trials at Copenhagen University Hospital-Herlev and Gentofte has found that the RSVpreF vaccine may help reduce cardiorespiratory hospitalizations in older adults.
Respiratory syncytial virus (RSV) is known to increase cardiovascular risks, especially among individuals aged 60 years and older.
Past studies have linked RSV infections with pulmonary illness and heart complications, particularly during hospitalizations.
However, clinical trials for RSV vaccines have not previously evaluated their effect on cardiovascular outcomes.
This new research, published in JAMA, provides insight into the potential cardiovascular benefits of RSV immunization.
Titled “Bivalent RSV Prefusion F Protein–Based Vaccine for Preventing Cardiovascular Hospitalizations in Older Adults: A Prespecified Analysis of the DAN-RSV Trial,” the study reports findings from a large randomized controlled trial involving 131,276 participants in Denmark.
Adults aged 60 or older were randomly assigned to receive the RSVpreF vaccine or no vaccine during the 2024–2025 winter season.
The participants had an average age of 69.4 years, with 50.3% male and 21.8% having preexisting cardiovascular disease.
Researchers found that the vaccine group experienced 26.3 all-cause cardiorespiratory hospitalizations per 1,000 participant-years, compared to 29.2 in the control group.
This represents a vaccine effectiveness of 9.9% and an absolute reduction of 2.9 hospitalizations per 1,000 participant-years (P = .04).
Although RSVpreF showed a statistically significant reduction in overall cardiorespiratory hospitalizations, the data did not show significant reductions in specific cardiovascular outcomes such as:
Cardiovascular hospitalization: 16.4 vs. 17.7 per 1,000 participant-years (7.4% effectiveness, P = .24); Stroke: 3.0 vs. 3.8 per 1,000 participant-years (19.4% effectiveness, P = .14); Myocardial infarction, heart failure, and atrial fibrillation: no significant differences.
Despite the lack of significant reductions in these individual cardiovascular events, the authors believe the vaccine may still offer meaningful health benefits.
By lowering the risk of cardiorespiratory hospitalization overall, RSV immunization could help reduce the burden of severe illness in older adults, especially those with existing cardiovascular disease.
The findings support consideration of RSV vaccination as part of public health strategies aimed at protecting vulnerable older populations.
The study is published in JAMA.
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