Alandijany Thamir A, Qashqari Fadi S
Special Infectious Agents Unit, King Fahd Medical Research Center, King Abdulaziz University, Jeddah, Saudi Arabia.
Department of Medical Laboratory Sciences, Faculty of Applied Medical Sciences, King Abdulaziz University, Jeddah, Saudi Arabia.
Front Immunol. 2025 Aug 18;16:1624007. doi: 10.3389/fimmu.2025.1624007. eCollection 2025.
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.
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.
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.
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.
https://www.crd.york.ac.uk/PROSPERO/view/, identifier CRD420250651132.
呼吸道合胞病毒（RSV）对老年人、孕妇和高危人群构成重大健康威胁。我们系统评估了三种获美国食品药品监督管理局（FDA）批准的RSV疫苗：Arexvy、Abrysvo和mResvia的疗效、免疫原性和安全性。
遵循PRISMA 2020指南，我们检索了截至2025年3月的PubMed、ClinicalTrials.gov、FDA和疫苗不良事件报告系统（VAERS）。在1250条识别记录中，24项研究（14项随机对照试验、7项观察性研究、3项上市后研究）符合纳入标准。使用Cochrane偏倚风险工具和纽卡斯尔-渥太华量表评估偏倚风险。PROSPERO注册号：CRD420250651132。
纳入研究在北美、欧洲、亚洲和拉丁美洲招募了超过50000名参与者。Arexvy使老年人中与RSV相关的住院率降低了60%-65%（95%置信区间：56%-66%）；Abrysvo在老年人中显示出58%-63%的疗效，通过母体免疫对婴儿RSV住院的保护率为68%-72%。mResvia对RSV疾病的疗效为55%-58%。所有疫苗均使中和抗体滴度提高了5-7倍，反应持续长达12个月。安全性良好：约23%-29%的人出现局部注射部位疼痛，7%-11%的人出现全身症状，严重不良事件的发生率<1%。上市后监测未发现新的安全问题。
FDA批准的RSV疫苗为高危人群提供了强有力的RSV防护，具有持续的免疫原性和可接受的安全性。虽然研究结果很有前景，但在服务不足地区的推广性仍然有限，长期有效性数据仍在不断涌现。需要持续的真实世界监测和直接比较，以为全球免疫策略提供信息。
https://www.crd.york.ac.uk/PROSPERO/view/，标识符CRD420250651132。
