Accepted for/Published in: JMIR Public Health and Surveillance
Date Submitted: Mar 21, 2025
Date Accepted: Oct 20, 2025
Safety and Efficacy of RSV Vaccine in Older adults: A Systematic Review and meta-Analysis of Randomized Controlled Trials
ABSTRACT
Background:
It is significant to evaluate the efficacy and the safety of new respiratory syncytial virus (RSV) preF vaccination in preventing lower respiratory tract infection (LRTI) and RSV associated respiratory illness (RSV-ARI) among older populations.
Objective:
We evaluated the safety and efficacy of the novel respiratory syncytial virus (RSV) preF vaccine in preventing lower respiratory tract infections (LRTIs) and RSV-associated acute respiratory illnesses (RSV-ARIs) in older adults.
Methods:
We conducted a systematic review of RCTs from five databases—PubMed, Embase, Cochrane Library, Web of Science, and Cochrane Central Register of Randomized Controlled Trials—up to July 31 2024. For categorical variables, we used risk ratio (RR); for continuous variables, weighted mean difference (WMD) or standardized mean difference (SMD). We extracted key study characteristics and assessed quality using the Newcastle–Ottawa Scale (NOS). Sensitivity analysis evaluated individual study impacts on pooled effects, and publication bias was examined with Egger and Begg tests.
Results:
Meta-analysis of five studies (101,825 older adults) showed reduced LRTI incidence in the vaccinated group, with heterogeneity resolved after excluding one study. Analysis of four studies (99,931 participants) confirmed lower RSV-ARI incidence with no heterogeneity. Safety analysis (14 studies, 76,695 participants) showed higher adverse events (AEs) in the vaccinated group, mainly injection-site reactions and vaccine-related AEs, but no significant difference in serious adverse events (SAEs). Subgroup analyses identified potential sources of AE heterogeneity, and sensitivity analyses confirmed efficacy but suggested instability in injection-site reactions.
Conclusions:
This meta-analysis showed a statistically significant difference in the incidence of LRTI and RSV-ARI between the vaccine and placebo groups in older adults. However, no significant difference was observed in overall adverse events (AE) or serious adverse events (SAE).
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.