Real-world evidence on RSV vaccine uptake, effectiveness, and safety in older adults: a systematic review and...

Vaccines to prevent respiratory syncytial virus (RSV)-associated lower respiratory tract disease in older adults have become available in recent years. We investigated RSV vaccine uptake, effectiveness, and safety signals in older adults reported in post-licensure real-world studies.

For this systematic review and meta-analysis, we conducted 11 monthly searches (between November 5, 2024, and November 10, 2025) in Ovid Medline, Embase, and Global Health databases. Meta-analyses, using random-effects modelling, were performed for uptake, effectiveness, and safety signals. PROSPERO registration: CRD42025643585.

A total of 3900 studies were identified, of which 36 were included, published between December 22, 2023, and October 28, 2025, and covering over 121.8 million individuals across the United States, United Kingdom, Italy, Australia, Czech Republic, Switzerland, France, Canada, and Israel. In the United States, RSV vaccine uptake among adults aged ≥60 years during the 2023/24 RSV season was 18.0% (95% confidence interval (CI): 12.2-25.7; ten studies), varying by clinical and socio-demographic subgroups. Among adults aged ≥60 years, pooled estimates of vaccine effectiveness were 75.3% (95% CI: 73.7-76.9; three studies) against any laboratory-confirmed RSV-positive infection, 76.4% (95% CI: 74.2-78.5; four studies) against RSV-related emergency department or urgent care visits, 74.8% (95% CI: 66.8-82.9; six studies) against RSV-related hospital admissions, and 79.8% (95% CI: 68.1-91.5; four studies) against severe RSV-associated disease. Following vaccination, Guillain-Barré syndrome (GBS) was reported in two studies with between 5.2 and 6.5 cases per one million doses for RSVPreF3+AS01 (Arexvy, GSK) vaccines and between 9.0 and 18.2 cases per one million doses for RSVpreF (Abrysvo, Pfizer) vaccines.

RSV vaccine uptake in older adults was low globally with substantial disparities between sociodemographic and clinical subgroups. Our study showed a favourable safety profile and high effectiveness of the RSV vaccines, highlighting the value of wide implementation of these vaccines.

There was no funding for the study.