Singer et al. 2026. Real-world effectiveness of adjuvanted RSVPreF3 vaccination in the prevention of RSV-related hospitalization among US adults aged ≥60 years. https://doi.org/10.1016/j.chest.2026.07.5002

Primary outcome: RSV-related hospitalization; vaccine effectiveness (VE) 75.6% (95% CI: 69.8–80.2%).

• Effectiveness was consistent across adults regardless of underlying conditions, including asthma, COPD, cardiovascular disease, and diabetes, as well as across age groups (60–74, 75+, and 80+ years).
• Additional outcomes included severe RSV-related hospitalization events involving ICU admission, mechanical ventilation, ECMO, or death.

Fonseca et al. 2026. Adjuvanted-RSVPreF3 vaccine uptake and effectiveness in individuals with COPD: a nationwide Danish cohort study. https://www.tandfonline.com/doi/10.1080/14760584.2026.2641671?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed 

Primary endpoint (Uptake): Only 5.9% of 126,249 Danish adults ≥60 years with COPD received RSVPreF3 during the 2024/25 RSV season

• Effectiveness: RSVPreF3 demonstrated 100% effectiveness (95% CI: 71.1–100.0) against RSV hospitalization in adults with COPD.

Papi et al. 2026. Adjuvanted RSVPreF3 vaccine impact over 3 RSV seasons in older adults with comorbidities. https://www.medrxiv.org/content/10.64898/2026.04.09.26348324v1.full

Pivotal Efficacy Trial Follow-Up Among Individuals 60Co-Morbidities: A single dose of adjuvanted RSVPreF3 provided sustained protection over 3 RSV seasons in adults ≥60 years with comorbidities, with RSV-LRTD efficacy of 75.1% in COPD, 65.8% in asthma, 69.8% in diabetes, and 74.1% in obesity.

• RSVPreF3 also reduced RSV-related complications, including COPD and asthma exacerbations, with fewer breakthrough cases requiring systemic corticosteroids or antibiotics.

Singer et al. 2026. Effectiveness of the Adjuvanted Respiratory Syncytial Virus Prefusion F3 Vaccine in Preventing Major Adverse Cardiovascular Events and Severe Exacerbations of COPD and Asthma Among US Adults ≥ 60 Years of Age. https://www.sciencedirect.com/science/article/pii/S0012369226061829?via%3Dihub 

Selected Exploratory Cardiopulmonary Outcomes

• RSV-related major adverse cardiovascular events (MACE) excluding mortality: VE 63.1% (95% CI: 41.8–76.6%).
• RSV-related severe COPD exacerbations: VE 74.4% (95% CI: 59.3–83.9%).
• RSV-related severe asthma exacerbations: VE 61.6% (95% CI: 9.1–83.7%).

Hasan et. 2026. Effectiveness of respiratory syncytial virus vaccination in solid organ transplant recipients in the United States. https://www.amjtransplant.org/article/S1600-6135(26)02580-3/fulltext

Retrospective real-world target trial emulation (Epic Cosmos): 63,108 US solid organ transplant recipients aged ≥60 years. 

• RSV vaccination was associated with lower risks of RSV infection (HR 0.70, 95% CI 0.56–0.88), RSV-related hospitalisation (HR 0.61, 95% CI 0.43–0.86), and all-cause mortality (HR 0.45, 95% CI 0.41–0.50).

Ku et al. 2026. Real-world Effectiveness of Adjuvanted RSVPreF3 Vaccine in Preventing RSV-associated Lower Respiratory Tract Disease Hospitalization in Adults ≥60 Years of Age: Early Results From a Test-negative Design Analysis. https://academic.oup.com/ofid/article/13/5/ofag279/8667331

• Kaiser Observational Study (Test-Negative Design): In a real-world test-negative study of adults ≥60 years, a single dose of adjuvanted RSVPreF3 (AREXVY) demonstrated 82.3% vaccine effectiveness (95% CI 61.5–91.9) against laboratory-confirmed RSV-associated lower respiratory tract disease (LRTD) hospitalization. 
• High-risk subgroups: Vaccine effectiveness was consistently high across high-risk populations, including immunocompromised individuals and those with comorbidities, with VE estimates ranging from 81.0% to 92.1%.

Efficacy and Safety of Respiratory Syncytial Virus (RSV) Prefusion F Protein Vaccine (RSVPreF3 OA) in Older Adults Over 2 RSV Seasons - Clinical Infectious Diseases, ciae010, https://doi.org/10.1093/cid/ciae010

• The adjuvanted RSV prefusion F protein–based vaccine (RSVPreF3 OA) was efficacious against RSV-related lower respiratory tract disease (RSV-LRTD) in ≥60-years-olds over 1 RSV season. We evaluated efficacy and safety of 1 RSVPreF3 OA dose and of 2 RSVPreF3 OA doses given 1 year apart against RSV-LRTD over 2 RSV seasons post–dose 1.

Methods: In this phase 3, blinded trial, ≥60-year-olds were randomized (1:1) to receive RSVPreF3 OA or placebo pre–season 1. RSVPreF3 OA recipients were re-randomized (1:1) to receive a second RSVPreF3 OA dose (RSV revaccination group) or placebo (RSV_1dose group) pre–season 2; participants who received placebo pre–season 1 received placebo pre–season 2 (placebo group). Efficacy of both vaccine regimens against RSV-LRTD was evaluated over 2 seasons combined (confirmatory secondary objective, success criterion: lower limits of 2-sided CIs around efficacy estimates >20%).

Results: The efficacy analysis comprised 24 967 participants (RSV_1dose: 6227; RSV revaccination: 6242; placebo: 12 498). Median efficacy follow-up was 17.8 months. Efficacy over 2 seasons of 1 RSVPreF3 OA dose was 67.2% (97.5% CI: 48.2–80.0%) against RSV-LRTD and 78.8% (95% CI: 52.6–92.0%) against severe RSV-LRTD. Efficacy over 2 seasons of a first dose followed by revaccination was 67.1% (97.5% CI: 48.1–80.0%) against RSV-LRTD and 78.8% (95% CI: 52.5–92.0%) against severe RSV-LRTD. Reactogenicity/safety of the revaccination dose were similar to dose 1.

Conclusions: One RSVPreF3 OA dose was efficacious against RSV-LRTD over 2 RSV seasons in ≥60-year-olds. Revaccination 1 year post–dose 1 was well tolerated but did not seem to provide additional efficacy benefit in the overall study population.

Clinical Trials Registration: ClinicalTrials.gov: NCT04886596.

For more information: https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciae010/7585312