Effectiveness of the adjuvanted RSVPreF3 vaccine in preventing major adverse cardiovascular events and severe exacerbations of chronic obstructive pulmonary disease and asthma among US adults aged ≥60 years.

Singer, David; Steffens, Andrea; La, Elizabeth M; Buikema, Ami R; Horn, Emily K; Theiss-Nyland, Katherine; Fonseca, Maria João; Gerber, Susan I et al. · Chest · 2026

retrospective_cohort · Level III

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Abstract

Observational studies have demonstrated real-world vaccine effectiveness (VE) of adjuvanted respiratory syncytial virus (RSV) prefusion F3 (RSVPreF3) vaccination against RSV-related hospitalizations among older adults. What is the VE of adjuvanted RSVPreF3 vaccination against major adverse cardiovascular events (MACE), severe chronic obstructive pulmonary disease (COPD) exacerbations, and severe asthma exacerbations among United States (US) adults aged ≥60 years with underlying cardiovascular disease (CVD), COPD, and asthma, respectively? A retrospective cohort study using Optum Research Database claims data assessed adjuvanted RSVPreF3 VE against MACE and against severe exacerbations of COPD and asthma (overall and RSV-related) among populations with baseline CVD, COPD, and asthma, respectively. Between August 2023-May 2024, vaccinated and unvaccinated adults aged ≥60 years were matched 1:4 on age, sex, insurance, and US state. Index date for vaccinated and matched unvaccinated patients was the same, assigned as vaccination date, with baseline characteristics assessed during 12 months pre-index and balanced via propensity score-based weighting. Outcomes were assessed 14 days post-index to disenrollment, death, receipt of any RSV vaccination, or end of analysis period (May 31, 2024). Cox proportional hazards regression estimated hazard ratios within baseline disease populations, with VE calculated as (1 - hazard ratio) x 100%. At baseline, 170,803 vaccinated and 699,177 unvaccinated individuals had CVD, 76,209 vaccinated and 286,406 unvaccinated had COPD, and 53,636 vaccinated and 190,590 unvaccinated had asthma. Among individuals with CVD, estimated VE was 65.0% (95% confidence interval: 45.4-77.6%) against RSV-related MACE including mortality and 63.1% (41.8-76.6%) against RSV-related MACE not including mortality. Among individuals with COPD, VE was 74.4% (59.3-83.9%) against RSV-related severe COPD exacerbations. In individuals with asthma, VE against RSV-related severe asthma exacerbations was 61.6% (9.1-83.7%). Adjuvanted RSVPreF3 vaccination may offer considerable protection against RSV-related MACE and severe COPD and asthma exacerbation events in individuals with underlying CVD, COPD, and asthma. Not applicable.