mRNA Vaccines for Solid Tumors: Review and Analysis

Abstract

Background: Personalized messenger RNA (mRNA) cancer vaccines represent a novel class of immunotherapeutic designed to elicit patient-specific anti-tumor responses. Despite promising immunogenicity and safety profiles in early-phase trials, comprehensive evidence on their survival benefit remains limited. Methods: A systematic review and meta-analysis, adhering to PRISMA 2020 guidelines, was conducted to assess the impact of personalized mRNA cancer vaccines on overall survival (OS) in patients with solid tumors. Literature from 2010 to 2025 was screened across major databases. Four studies meeting predefined eligibility criteria were included. Hazard ratios (HRs) and 95% confidence intervals (CIs) were synthesized using a random-effects model to account for inter-study variability. Results: The meta-analysis yielded a pooled HR of 0.64 (95% CI: 0.40–1.00), indicating a 36% reduction in mortality risk for patients treated with personalized mRNA vaccines compared to conventional therapies or placebo. Heterogeneity across studies was moderate, and all included trials demonstrated HRs favoring vaccine intervention. Conclusion: Personalized mRNA cancer vaccines are associated with a statistically and clinically meaningful improvement in overall survival among patients with solid tumors. These findings underscore the therapeutic promise of individualized mRNA immunotherapy and support the advancement of large-scale randomized phase III trials to validate efficacy across broader patient populations.