A Danish nationalist registry proceedings shows nan RSVpreF vaccine is highly effective astatine preventing terrible RSV unwellness and related hospitalizations successful older adults, offering real-world support for broader immunization strategies.

Study: RSV Prefusion F Vaccine for Prevention of Hospitalization successful Older Adults. Image Credit: CI Photos / Shutterstock
In a caller study published in The New England Journal of Medicine, researchers investigated the efficacy of nan caller bivalent RSV prefusion F protein-based vaccine (RSVpreF) successful preventing terrible symptomatic Respiratory Syncytial Virus (RSV) infections, peculiarly successful older adults (60 years and older).
The study leveraged an extended (131,000 participants), open-label, pragmatic randomized proceedings conducted successful Denmark during nan 2024–2025 wintertime season. Participants aged 60 and supra were chiefly recruited via integer invitations done nan nationalist registry infrastructure. The proceedings was designed to bespeak real-world conditions, utilizing wide eligibility criteria and integrating administrative wellness registries for recruitment, randomization (1:1 – vaccine vs. nary trial-administered vaccine), and result tracking.
Findings revealed that nan vaccine was 83.3% effective astatine preventing rigorously defined RSV-related hospitalizations (based connected ICD-10 codes aliases affirmative tests wrong 7 days of admission) and 91.7% effective against RSV-related little respiratory tract illness hospitalizations, confirming its domiciled successful protecting older populations wrong a real-world proceedings framework.
Background
Respiratory Syncytial Virus (RSV) is simply a negative-sense, single-stranded RNA microorganism that, while communal crossed property groups, tin origin terrible respiratory unwellness successful infants and older adults, often starring to hospitalization of nan latter. Reports item an estimated 470,000 hospitalizations and 33,000 deaths successful adults aged 60 aliases much annually successful industrialized nations. Despite this burden, regular RSV testing remains limited, perchance underestimating existent incidence.
About nan Study
Titled A Pragmatic Randomized Trial to Evaluate Bivalent RSV Prefusion F Protein–based Vaccine Effectiveness for Preventing RSV Hospitalizations successful Adults Aged 60 Years aliases Above (DAN-RSV), nan proceedings randomly assigned 131,276 adults successful a 1:1 ratio to person either nan RSVpreF vaccine aliases nary trial-administered vaccine (control group). Notably, 1.2% of controls sought RSV vaccination extracurricular nan trial. The study's superior endpoint was hospitalization for RSV-related respiratory tract disease, defined utilizing nationalist registry information done ICD-10 codes aliases a affirmative RSV trial wrong 7 days earlier aliases aft admission. Key secondary endpoints included hospitalization for RSV-related little respiratory tract illness and hospitalization for respiratory tract illness from immoderate cause, tested hierarchically aft nan superior endpoint.
Study Findings
The study’s findings demonstrated important efficacy, pinch only 3 hospitalizations for RSV-related respiratory tract illness successful nan 65,642 participants who received nan vaccine, compared to 18 hospitalizations successful nan 65,634 participants successful nan power group. Fewer events occurred than expected, partially owed to reduced RSV testing successful Denmark pursuing nan COVID-19 pandemic.
These findings construe to a vaccine effectiveness of 83.3% (95% Confidence Interval [CI], 42.9–96.9), exceeding nan prespecified occurrence criterion of 20% (p = 0.007). The vaccine besides showed use against broader outcomes: 91.7% efficacy against RSV-related little respiratory tract hospitalization (1 vs. 12 events; 95% CI, 43.7–99.8; p=0.009); a 15.2% simplification successful immoderate respiratory tract illness hospitalization (284 vs. 335; 95% CI, 0.5–27.9; p=0.04), though this secondary endpoint was not adjusted for multiplicity aft hierarchical testing; and a 9.9% simplification successful cardiorespiratory hospitalizations (exploratory). The greater absolute simplification successful hospitalizations for respiratory illness from immoderate origin (compared to confirmed RSV cases) suggests that nan vaccine prevented galore hospitalizations wherever RSV infection went undiagnosed owed to constricted testing.
The incidence of superior adverse events was akin betwixt nan 2 groups wrong 6 weeks of vaccination. Five vaccine-related SAEs occurred (including pericarditis and Bell’s palsy), and a non-significant mortality imbalance emerged by season’s extremity (146 vs. 120 deaths).
Conclusions
The study provides robust grounds from a pragmatic proceedings that RSVpreF importantly reduces RSV-related hospitalizations successful adults aged 60 and older. By leveraging a large-scale, open-label creation and nationalist registries, nan study addresses limitations of earlier trials. While imaginable healthy-volunteer bias and undertesting of RSV stay caveats, nan vaccine demonstrated protection against terrible outcomes pinch a manageable information profile.
Journal reference:
- Lassen, M. C. H., Johansen, N. D., Christensen, S. H., Aliabadi, N., Skaarup, K. G., Modin, D., Claggett, B. L., Larsen, C. S., Larsen, L., Wiese, L., Dalager-Pedersen, M., Lindholm, M. G., Jensen, A. M. R., Dons, M., Bernholm, K. F., Davidovski, F. S., Duus, L. S., Ottosen, C. I., Nielsen, A. B., … Biering-Sørensen, T. (2025). RSV Prefusion F Vaccine for Prevention of Hospitalization successful Older Adults. New England Journal of Medicine. DOI – 10.1056/nejmoa2509810. https://www.nejm.org/doi/full/10.1056/NEJMoa2509810

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