Bivalent Respiratory Syncytial Virus (RSV) Prefusion F Protein–Based Vaccine for Preventing Cardiovascular Hospitalizations in Older Adults: A Prespecified Analysis of the DAN-RSV Trial
Authors' conclusion
In adults aged 60 years or older, all-cause cardiorespiratory hospitalization was significantly lower with RSVpreF than with no vaccine.
Study context
- Population
- Adults aged ≥60 years regardless of comorbidity, Denmark, 2024–2025 winter season28,662 (21.8%) with preexisting cardiovascular disease (CVD)
- Participants
- 131,276 adults
- Comparison
- RSVpreF vs no vaccine
- RSVpreFn = 65,642
- No vaccinen = 65,634reference
- Primary endpoint
- Hospitalization for any cardiorespiratory disease (prespecified secondary outcome of the trial)
- Follow-up
- From 14 days after booked study visit through May 31, 2025
Methodological detailsprespecified, pragmatic, open-label, individually randomized
- Prespecified
- Pragmatic
- Open-label
- Individually randomized
Primary result
As reported in the abstract
All-cause cardiorespiratory hospitalization
Absolute rate reduction
2.90 per 1000 PY
95% CI 0.10–5.71
All-cause cardiorespiratory hospitalization
Vaccine effectiveness
9.9%
95% CI 0.3%–18.7%P = 0.04
vaccine effectiveness = 1 - IRR
Secondary outcomes
All-cause CV hospitalization (exploratory)
vaccine effectiveness 7.4% (−5.5% to 18.8%) · P = 0.24
Stroke (exploratory)
vaccine effectiveness 19.4% (−8.6% to 40.4%) · P = 0.14
| Outcome | Vaccine effectiveness (95% CI) |
|---|---|
| All-cause cardiorespiratory hospitalization, by baseline CVD (subgroup)CVD at baseline | 5.0% (−11.2% to 16.7%) |
| All-cause cardiorespiratory hospitalization, by baseline CVD (subgroup)No CVD at baseline | 15.2% (2.2%–27.1%) |
- All-cause cardiorespiratory hospitalization, by baseline CVD (subgroup): P = .27 for interaction
MI, HF hospitalization, AF (exploratory)
- No statistically significant between-group differences
Original publication
Bivalent RSV Prefusion F Protein–Based Vaccine for Preventing Cardiovascular Hospitalizations in Older Adults: A Prespecified Analysis of the DAN-RSV Trial. JAMA. Published 28 October 2025. doi:10.
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