SYSTEMATIC REVIEW article
Front. Immunol.
Sec. Vaccines and Molecular Therapeutics
Volume 16 - 2025 | doi: 10.3389/fimmu.2025.1624007
This article is part of the Research TopicImmunological Regulation to Enteroviruses and Respiratory Viruses: Infection and Vaccination ResponsesView all 7 articles
Evaluating the Efficacy, Safety, and Immunogenicity of FDA-Approved RSV Vaccines: A Systematic Review of Arexvy, Abrysvo, and mResvia
Provisionally accepted
- 1Faculty of Medicine, Umm Al-Qura University, Makkah, Saudi Arabia
- 2King Abdulaziz University, Jeddah, Saudi Arabia
- 3Special Infectious Agents Unit, King Fahd Medical Research Center, King Abdulaziz University, Jeddah, Saudi Arabia, Jeddah, Saudi Arabia
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Background: Respiratory Syncytial Virus (RSV) poses a major health threat to older adults, pregnant women, and high-risk populations. We systematically evaluated the efficacy, immunogenicity, and safety of three FDA-approved RSV vaccines: Arexvy, Abrysvo, and mResvia. Methods: Following PRISMA 2020 guidelines, we searched PubMed, ClinicalTrials.gov, FDA, and Vaccine Adverse Event Reporting System (VAERS) up to March 2025. Of 1,250 identified records, 24 studies (14 RCTs, 7 observational, 3 post-marketing) met inclusion criteria. Risk of bias was assessed using the Cochrane RoB tool and Newcastle-Ottawa Scale. PROSPERO registration: CRD420250651132. Results: Included studies enrolled over 50,000 participants across North America, Europe, Asia, and Latin America. Arexvy reduced RSV-related hospitalizations in older adults by 60-65% (95% CI: 56-66%); Abrysvo showed 58-63% efficacy in older adults and 68-72% protection against infant RSV hospitalization via maternal immunization. mResvia demonstrated 55-58% efficacy against RSV illness. All vaccines induced 5-7-fold increases in neutralizing antibody titers, with responses sustained for up to 12 months. Safety profiles were favorable: local injection site pain occurred in ~23-29%, systemic symptoms in 7-11%, and serious adverse events in <1%. No new safety concerns were identified in post-marketing surveillance. Conclusion: FDA-approved RSV vaccines provide robust protection against RSV in high-risk populations, with sustained immunogenicity and acceptable safety. While findings are promising, generalizability to underserved regions remains limited, and long-term effectiveness data are still emerging. Continued real-world monitoring and head-to-head comparisons are needed to inform global immunization strategies.
Keywords: RSV, Arexvy, Abrysvo, mResvia, vaccine efficacy, Immunogenicity, Safety, Systematic review
Received: 07 May 2025; Accepted: 09 Jul 2025.
Copyright: © 2025 Qashqari and Alandijany. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Fadi Qashqari, Faculty of Medicine, Umm Al-Qura University, Makkah, Saudi Arabia
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.