Evaluating the efficacy, safety, and immunogenicity of FDA-approved RSV vaccines: a systematic review of Arexvy, Abrysvo, and mResvia
BackgroundRespiratory 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.MethodsFollowing PRISMA 2020 guide...
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| Main Authors: | , |
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| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2025-08-01
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| Series: | Frontiers in Immunology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fimmu.2025.1624007/full |
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| Summary: | BackgroundRespiratory 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.MethodsFollowing 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.ResultsIncluded 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.ConclusionFDA-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.Clinical Trial Registrationhttps://www.crd.york.ac.uk/PROSPERO/view/, identifier CRD420250651132. |
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| ISSN: | 1664-3224 |