What type of study is this?

This is a Systematic Review study (also classified as: RCT, Observational).

August 18, 2025Open Access

Evaluating the efficacy, safety, and immunogenicity of FDA-approved RSV vaccines: a systematic review of Arexvy, Abrysvo, and mResvia

TAThamir A. AlandijanyKing Abdulaziz University FQFadi S. QashqariUmm al-Qura University

Key Points

FDA-approved RSV vaccines showed 60-65% efficacy in reducing hospitalizations among older adults; immunogenic responses were sustained for up to 12 months.
Out of 1,250 records reviewed, 24 studies (14 RCTs) assessed safety and efficacy, reporting minimal adverse events and no new safety concerns.
Arexvy and Abrysvo demonstrated significant protective effects, including 68-72% efficacy against infant RSV hospitalizations through maternal immunization.
Robust protection against RSV in high-risk populations indicates important implications for global immunization strategies, though more real-world monitoring is necessary.

Abstract

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. Clinical Trial Registration https://www.crd.york.ac.uk/PROSPERO/view/ , identifier CRD420250651132.

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