What happened
RSVpreF cuts RSV-related respiratory hospitalizations ~70% versus no vaccine in expanded ESC 2026 follow-up.
“Similar to what we have seen with the influenza vaccines, people with a chronic cardiovascular disease are at increased risk of hospitalizations with worsening of their preexisting disease or triggering of new coronary events with respiratory viruses such as flu, RSV, and COVID-19. Preventing these acute infections during the winter season may help keep them out of hospital.”
News Coverage ↗
“The findings suggest potential downstream cardiorespiratory benefits of RSV immunization. The results support broader consideration of RSV vaccination in older adults, including among those with CVD, as part of a strategy to reduce severe cardiorespiratory complications.”
Quoted in News Coverage ↗
Relative protection is high but RSV was rare, and all-cause deaths were numerically higher with the vaccine.
X post ↗
Strong real-world randomized evidence, but the optimal revaccination interval remains unknown.
X post ↗
RSV vaccination is an underutilised, cheap way to protect patients with cardiovascular disease.
X post ↗
A striking effect in a huge pragmatic trial, raising the question of RSV vaccination as cardiovascular prevention.
X post ↗“RSV has traditionally been underrecognized by clinicians as a cause of cardiopulmonary hospitalizations.”
Editorial ↗Open questions from this trial that would benefit from expert input.
Answers are grounded in this paper and cite their sources.
Why the trial, tables, limitations, PICO, abstract, media & sources
RSV infection in older adults triggers both respiratory and cardiovascular hospitalisations, but whether RSV vaccination prevents these cardiorespiratory events had not been demonstrated in a randomised trial powered for clinical outcomes.
Does the bivalent RSV prefusion F vaccine reduce RSV-related respiratory tract disease hospitalization in adults?
| Outcome | RSVpreF | No vaccine |
|---|---|---|
| RSV respiratory hospitalization, adults >=60 (2025 primary) Per 1000 participant-years; 83.3% vaccine effectiveness (2025 NEJM primary) | RSVpreF 0.11 | No vaccine 0.66 |
| RSV respiratory hospitalization, expanded cohort Per 1000 person-years; ~70% effectiveness in ESC 2026 expanded follow-up incl. broader adult cohort | RSVpreF 0.16 | No vaccine 0.55 |
Does the bivalent RSV prefusion F vaccine reduce RSV-related respiratory tract disease hospitalization in adults?
The bivalent RSV prefusion F vaccine significantly reduces the incidence of RSV-related respiratory tract disease hospitalization in adults compared to no vaccine.
Experts read the expanded DAN-RSV results as strong randomized evidence that RSV vaccination keeps older adults out of hospital, and cardiologists are urging wider use in heart patients, though one voice points to very low event rates and deaths that were not lower with the vaccine.
Most voices treat the result as a clear win for RSV vaccination in older adults. Cardiologists frame it as an underused, cheap way to protect people with heart disease, who are at higher risk when they catch respiratory viruses. Still open: how often to revaccinate, and whether the protection reaches hard outcomes like death and cardiovascular events.
Several clinicians agree that people with cardiovascular disease are at higher risk of hospitalization from RSV and similar respiratory viruses. They see vaccination as a way to protect this group.
3 takes classified by contention axis so far — the map appears as more land.
Alania notes that the best revaccination interval is still unknown. Schaltz-Buchholzer flags that all-cause deaths were numerically higher with the vaccine. Whether RSV vaccination also works as cardiovascular prevention was posed as a question rather than answered.
Supports RSVpreF vaccination in older adults with CVD; extends efficacy data to cardiorespiratory hospitalization prevention.
BACKGROUND: Respiratory syncytial virus (RSV) is an important cause of severe respiratory disease in adults, with the highest burden among older adults and individuals with chronic health conditions. The bivalent RSV prefusion F (RSVpreF) vaccine has been shown to prevent RSV-associated respiratory illness, but data from randomized trials regarding its effect on hospitalization outcomes are limited. METHODS: In this pragmatic, individually randomized, open-label trial conducted in Denmark and Spain, adults were assigned in a 1:1 ratio to receive RSVpreF or no vaccine. During the first year of enrollment, participants who were 60 years of age or older in Denmark were enrolled; during the second year, eligibility was expanded to participants 18 years of age or older in Denmark and Spain. The results of the first year of enrollment have been reported previously; because fewer RSV-related hospitalization events than anticipated occurred in the first year, demographic and geographic enrollment was expanded. The primary endpoint was RSV-related respiratory tract disease (RTD) hospitalization in the intention-to-treat population. Secondary endpoints included RSV-related lower RTD and all-cause RTD hospitalization. RESULTS: Of 513,358 participants who underwent random assignment during the 2024-2025 and 2025-2026 winter seasons, the incidence rate of RSV-related RTD hospitalization was 0.16 events per 1000 person-years in the RSVpreF group and 0.55 events per 1000 person-years in the control group, corresponding to an estimated vaccine effectiveness of 70.3% (95% confidence interval [CI], 49.7-83.2). The incidence of RSV-related lower RTD hospitalization was 0.11 and 0.39 events per 1000 person-years in the RSVpreF vaccine and no-vaccine groups, respectively, corresponding to an estimated vaccine effectiveness of 71.1% (95% CI, 45.4-85.7) and the incidence of all-cause RTD hospitalization was 11.16 and 12.01 events per 1000 person-years in the RSVpreF vaccine and no-vaccine groups, respectively, corresponding to an estimated vaccine effectiveness of 7.1% (95% CI, -0.3-13.9). The incidence of serious adverse events was 2.0% in the RSVpreF vaccine group and 2.2% in the no-vaccine group. CONCLUSIONS: In a randomized trial that included expanded demographic and geographic enrollment during a second RSV season, the RSVpreF vaccine was associated with a lower incidence of RSV-related respiratory tract disease hospitalization as compared to no vaccine. (Funded by Pfizer; ClinicalTrials.gov number, NCT06684743.).
Lassen et al. (2026) conducted an RCT in Respiratory syncytial virus (RSV) respiratory disease (n=513,358). Bivalent RSV prefusion F (RSVpreF) vaccine vs. No vaccine was evaluated on RSV-related respiratory tract disease (RTD) hospitalization in the intention-to-treat population (vaccine effectiveness 70.3%, 95% CI 49.7-83.2). The bivalent RSVpreF vaccine reduced RSV-related respiratory tract disease hospitalization compared to no vaccine.
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