Wang Jing, Du Jian, Liu Yan, Xu Yuyang, Han Jiayin, Zhang Xuechao
Department of Infectious Disease Control and Prevention, Hangzhou Center for Diseases Control and Prevention (Hangzhou Health Supervision Institution), Hangzhou 310021, China.
Department of Expanded Program on Immunization, Hangzhou Center for Disease Control and Prevention, Hangzhou 310021, China.
Vaccines (Basel). 2024 Dec 6;12(12):1376. doi: 10.3390/vaccines12121376.
This study aimed to evaluate the safety profile of the recombinant zoster vaccine (RZV) after its marketing in China.
We present a descriptive analysis and safety signal assessment of adverse events following immunization (AEFI) associated with RZV between September 2020 and December 2023. The descriptive data collected includes demographic characteristics and the classification of characteristics of AEFI cases, while vaccine safety signal assessment was evaluated using the reporting odds ratio (ROR).
In total, we documented 275 AEFI cases following RZV vaccination, with a reporting rate of 76.22/10,000 doses administered. Notably, only one case was classified as serious, and the reporting rates were significantly higher among females, individuals aged 50-59 years, and those residing in rural areas. Furthermore, the reporting rate for the first dose exceeded that for the second dose. Among the reported AEFI cases, 98.91% were attributed to vaccine product-related reactions, and 97.45% were initially reported by either the vaccine recipient or their guardians. The interval between vaccination and symptom onset was predominant within 3 d after vaccination. The disproportionality analysis identified five positive signals-fever (37.5-38.5 °C), injection site reactions greater than 5 cm, pain, Henoch Schönlein purpura (HSP), and swelling-which suggests a stronger association with the RZV than the expected threshold.
In summary, RZV demonstrated a favorable safety profile. However, continued monitoring and research on the long-term safety implications of RZV are needed.
本研究旨在评估重组带状疱疹疫苗（RZV）在中国上市后的安全性。
我们对2020年9月至2023年12月期间与RZV相关的免疫接种后不良事件（AEFI）进行了描述性分析和安全信号评估。收集的描述性数据包括人口统计学特征和AEFI病例的特征分类，同时使用报告比值比（ROR）评估疫苗安全信号。
总共记录了275例RZV接种后的AEFI病例，报告率为每10000剂接种76.22例。值得注意的是，只有1例被分类为严重病例，女性、50 - 59岁的个体以及农村地区居民的报告率显著更高。此外，第一剂的报告率超过了第二剂。在报告的AEFI病例中，98.91%归因于疫苗产品相关反应，97.45%最初由疫苗接种者或其监护人报告。接种疫苗与症状出现之间的间隔主要在接种后3天内。不成比例分析确定了五个阳性信号——发热（37.5 - 38.5°C）、注射部位反应大于5厘米、疼痛、过敏性紫癜（HSP）和肿胀——这表明与RZV的关联比预期阈值更强。
总之，RZV显示出良好的安全性。然而，需要对RZV的长期安全性影响进行持续监测和研究。
