Real-World Effectiveness of RSVpreF and RSVpreF3 Vaccines in Preventing Hospitalisation and Emergency Department Visits Associated with Respiratory Syncytial Virus in Older Adults: A Meta-Analysis.

Abstract

Respiratory syncytial virus (RSV) vaccines were first recommended for older adults during the 2023-24 season in countries that authorised their use. Although early observational studies complemented trial findings, real-world evidence on vaccine effectiveness against severe RSV disease remains limited. We assessed the effectiveness of RSVpreF and RSVpreF3 vaccines in preventing RSV-related hospitalisations and emergency department (ED) visits among older adults. We searched MEDLINE, Embase, Web of Science, Scopus, Global Health, and medRxiv for observational studies published between January 1, 2023 and December 30, 2025, reporting real-world effectiveness of RSV vaccines in adults aged 60 years or older. Pooled analyses used inverse-variance random-effects models to estimate effectiveness against RSV-related hospitalisations and ED visits. Subgroup analyses assessed differences in effectiveness by age, immune status, and vaccine type. This study is registered with PROSPERO (CRD420251021777). From 4925 records screened, 8 cohort and case-control studies were included. Vaccination was associated with lower odds of RSV-related hospitalisation (odds ratio [OR]: 0.23; 95% Confidence Interval [CI]: 0.20-0.27; I²=6.5%) and ED visits (OR: 0.23; 95% CI: 0.21-0.27; I²=0.0%). Effectiveness against RSV-related hospitalisation was lower in immunocompromised adults (OR: 0.31; 95% CI: 0.27-0.34; I²=0.0%) than in immunocompetent individuals (OR: 0.20; 95% CI: 0.11-0.35; I²=0.0%). Effectiveness did not differ by age group (60-74 vs ≥75 years) or vaccine product. Vaccination provided substantial protection against RSV-related healthcare utilisation among older adults. Continued surveillance and real-world evidence are needed to inform immunisation policy and improve protection in immunocompromised individuals.