Li Yihao, Xia Huilin, Zhang Hong, Lu Yuan, Zhou Hang, Yu Rongbin, Huang Peng
Department of Epidemiology, Key Laboratory of Public Health Safety and Emergency Prevention and Control Technology of Higher Education Institutions in Jiangsu Province, National Vaccine Innovation Platform, Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing, China.
Hum Vaccin Immunother. 2025 Dec;21(1):2525603. doi: 10.1080/21645515.2025.2525603. Epub 2025 Jul 11.
This post-marketing safety study evaluated the co-administration of recombinant zoster vaccine (RZV, Shingrix) and influenza vaccines (HD-IIV/aIIV/RIV) in adults aged ≥ 65 years using U.S. VAERS data (2018-2024). Among 791 adverse event (AE) reports analyzed via empirical Bayesian data mining and clinical review, 55 (6.9%) were serious, with non-serious AEs dominated by injection site reactions (65%), pyrexia (15.2%), and chills (13.4%). Serious AEs included asthenia (8.1%), pyrexia (8.1%), and Guillain-Barré syndrome (GBS, 6.4%); clinical review confirmed 7 Brighton-criteria GBS cases and one Bell's palsy. Data mining detected no new safety signals, and comparative analysis revealed that co-administration safety aligned with clinical trial profiles and monotherapy (influenza/RZV alone), showing no elevated risks. These findings support co-administration safety in older adults, advocating for community pharmacy-based delivery to optimize coverage. Limitations include VAERS' passive surveillance nature (underreporting, lack of denominator data), necessitating cautious interpretation and ongoing monitoring.
这项上市后安全性研究利用美国疫苗不良事件报告系统（VAERS）的数据（2018 - 2024年），评估了≥65岁成年人中重组带状疱疹疫苗（RZV，Shingrix）和流感疫苗（HD-IIV/aIIV/RIV）的联合接种情况。在通过经验贝叶斯数据挖掘和临床审查分析的791份不良事件（AE）报告中，55份（6.9%）为严重不良事件，非严重不良事件以注射部位反应（65%）、发热（15.2%）和寒战（13.4%）为主。严重不良事件包括乏力（8.1%）、发热（8.1%）和吉兰 - 巴雷综合征（GBS，6.4%）；临床审查确认了7例符合布莱顿标准的GBS病例和1例贝尔麻痹。数据挖掘未发现新的安全信号，比较分析表明联合接种安全性与临床试验情况及单药治疗（单独接种流感疫苗/RZV）一致，未显示风险升高。这些发现支持老年人联合接种的安全性，提倡通过社区药房给药以优化疫苗接种覆盖率。局限性包括VAERS的被动监测性质（报告不足、缺乏分母数据），需要谨慎解读并持续监测。
