Singer D, Steffens A, La E, Horn EK, Theiss-Nyland K, Fonseca MJ, Gerber S, Kawai A, Buikema A, Johnson MG, Song R, Hague S, Layton JB. Effectiveness of adjuvanted RSVPreF3 vaccine in preventing major adverse cardiovascular events, severe asthma exacerbations, and severe COPD exacerbations among US adults aged 60 years and older. Poster presented at the ReSViNET 2026; February 17, 2026. Rome, Italy.

OBJECTIVE: This study assessed the effectiveness of adjuvanted RSVPreF3 vaccination in preventing overall and respiratory syncytial virus (RSV)-related major adverse cardiovascular events (MACE), severe chronic obstructive pulmonary disease (COPD) exacerbations, and severe asthma exacerbations among United States (US) adults aged ≥60 years at risk of these events.

BACKGROUND: Previous studies have reported vaccine effectiveness (VE) of adjuvanted RSVPreF3 against RSV-related hospitalizations among adults aged ≥60 years. Additional evidence is needed on VE against other related outcomes, including MACE and COPD and asthma exacerbations.

METHODS: This retrospective cohort study estimated VE of adjuvanted RSVPreF3 against MACE and severe exacerbations of COPD and asthma using claims data from the Optum Research Database (ORD; August 2022–May 2024). The study included adults aged ≥60 years identified between August 2023–May 2024. For vaccinated patients, the assigned index date was the date of adjuvanted RSVPreF3 vaccination. Each vaccinated patient was matched to four unvaccinated patients on age, sex, insurance type, and state of residence who were assigned the same index date as the vaccinated patient. Baseline characteristics were measured during the 12 months pre-index (wherein continuous enrollment was required). The follow-up period began 14 days post-index. Each outcome, based on International Classification of Diseases, Tenth Revision, Clinical Modification diagnosis codes, was assessed overall (during any hospitalization) and as RSV-related (during RSV-related hospitalization). Censoring occurred at disenrollment, death, RSV vaccination, or end of the analysis period. Propensity score-based weighting was used to balance baseline characteristics between the vaccinated and unvaccinated groups. Cox proportional hazards regression models compared risk of outcomes between weighted vaccinated and unvaccinated groups. VE was calculated as (1 − hazard ratio) x 100%.

RESULTS: The analysis included 520,440 vaccinated and 2,081,760 unvaccinated patients (mean [standard deviation] age: 74.3 [6.7] years; 56.9% female). A total of 869,980 (33.4%) had existing cardiovascular disease (CVD), 362,615 (13.9%) had existing COPD, and 244,226 (9.4%) had existing asthma. Among adults with existing CVD, adjuvanted RSVPreF3 VE against MACE overall was 20.4% (95% confidence interval [CI]: 18.0–22.9%). VE against RSV-related MACE was 63.1% (41.8–76.6%). VE against severe COPD and asthma exacerbations (among adults with each respective condition at baseline) overall was 8.6% (4.2–12.7%) and 19.4% (5.7–31.1%), respectively. For RSV-related severe COPD and asthma exacerbations, VE estimates were 74.4% (59.3–83.9%) and 61.6% (9.1–83.7%), respectively.

CONCLUSIONS: Findings suggest a considerable benefit of adjuvanted RSVPreF3 vaccination in preventing RSV-related MACE and severe asthma and COPD exacerbations among adults aged ≥60 years.