Real-world effectiveness of adjuvanted RSVPreF3 vaccination in the prevention of RSV-related hospitalization among US adults aged ≥60 years
The immune-boosted RSVPreF3 vaccine was linked to far fewer RSV-related hospitalizations.
*Retrospective matched cohort study; Level 3 (OCEBM).
Citation
Singer D, Steffens A, La EM, et al. Real-world effectiveness of adjuvanted RSVPreF3 vaccination in the prevention of RSV-related hospitalization among US adults aged ≥60 years. Chest. 2026. doi:10.1016/j.chest.2026.07.5002
Background
Respiratory syncytial virus can cause serious lung illness in older adults, especially those with chronic medical conditions. This study tested whether vaccination worked in routine US care, not just in trials.
Patients
Adults aged ≥60 years in a large US insurance claims database. Exclusions included prior RSV vaccination, recent RSV diagnosis, missing key data, or less than 14 days of follow-up.
Intervention
One dose of adjuvanted RSVPreF3 vaccine.
Control
Matched adults without RSV vaccination.
Outcome
Primary outcome: RSV-related hospitalization. Secondary outcomes included severe hospitalization, emergency visits, and death during RSV-related hospitalization.
Follow-up Period
Median 5.6 months; maximum 9.7 months.
Results
The analysis included 520,440 vaccinated and 2,081,760 unvaccinated adults. Effectiveness remained significant in high-risk groups, including lung disease, heart disease, diabetes, kidney disease, and weakened immunity.
| Outcome | Vaccine effectiveness | People vaccinated to prevent 1 event |
|---|---|---|
| RSV-related hospitalization (primary) | 75.6% (69.8–80.2) | About 2,004 |
| RSV-related hospitalization or emergency visit | 76.4% (72.2–79.9) | About 1,140 |
| Severe RSV-related hospitalization | 79.1% (71.0–84.9) | About 3,973 |
| Death during RSV-related hospitalization | 66.8% (14.6–87.1) | About 67,100 |
RSVPreF3: respiratory syncytial virus prefusion F3 vaccine. Estimates used weighted matched groups. The control was no RSV vaccination, not another RSV vaccine.
Limitations
Claims data may misclassify vaccination, diagnoses, and medical conditions. RSV cases were not laboratory-confirmed. Residual differences in health behavior may remain; negative control outcomes suggested some possible bias. Findings may not apply to uninsured adults. Follow-up covered only one RSV season. Relative benefits were large, but absolute event rates were low.
Funding
Sponsored by GSK; employees and contractors involved, creating potential bias.
Clinical Application
Offer RSV vaccination to eligible older or high-risk adults; evidence supports hospitalization reduction but not multi-season durability.
Discussion
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In this retrospective cohort study, adjuvanted RSVPreF3 vaccination was associated with lower RSV-related hospitalization among adults ≥60 years (VE 75.6%, 95% CI 69.8–80.2). Given the nonrandomized claims-based design, how valid and applicable are these findings for changing vaccination practice? The authors report vaccine effectiveness of 75.6% against RSV-related hospitalization, calculated as (1 − hazard ratio) × 100%. Which interpretation is most appropriate?