2017 年至 2023 年中国江苏省水痘疫苗接种后不良事件监测。
Surveillance of adverse events following varicella vaccine immunization in Jiangsu province, China from 2017 to 2023.
机构信息
Department of Expanded Program on Immunization, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Jiangsu Health Development Research Center, Nanjing, China.
出版信息
BMC Infect Dis. 2024 Sep 16;24(1):983. doi: 10.1186/s12879-024-09903-y.
UNLABELLED
To assess the safety of varicella vaccine (VarV) by conducting post-marketing surveillance on adverse events following immunization (AEFI) in Jiangsu Province, China.
METHODS
We utilized the AEFI Information System of mainland China to monitor and categorize adverse reactions associated with VarV.
RESULTS
The incidence rate of AEFI was significantly higher after the first dose (48.79/100,000 doses) compared to the second dose (45.18/100,000 doses) (χ = 4.63, P = 0.031). Regional variations in AEFI incidence were observed within Jiangsu Province. Common reactions comprised 90.96% of AEFIs, while rare reactions and coincidental events accounted for 6.59% and 0.51%, respectively. Notably, there were no adverse events linked to vaccine quality, program errors, psychogenic reactions, or fatalities. Over 96% of AEFIs occurred within three days of VarV administration, with redness at the injection site (2.6 cm to 5 cm in diameter) being the most frequently observed symptom.
CONCLUSION
VarV demonstrates a commendable safety profile. Although there was a slight increase in AEFI incidence between 2022 and 2023, common vaccine reactions were predominantly observed, and the rates of rare reactions remained very low.
目的
通过对江苏省疫苗接种后不良反应（AEFI）进行上市后监测，评估水痘疫苗（VarV）的安全性。
方法
利用中国大陆 AEFI 信息系统对 VarV 相关不良反应进行监测和分类。
结果
与第二剂（45.18/100000 剂）相比，第一剂 VarV 的 AEFI 发生率明显更高（48.79/100000 剂）（χ=4.63，P=0.031）。江苏省内存在 AEFI 发生率的区域差异。常见反应占 AEFIs 的 90.96%，罕见反应和偶合事件分别占 6.59%和 0.51%。值得注意的是，没有与疫苗质量、计划错误、精神反应或死亡相关的不良事件。超过 96%的 AEFIs发生在 VarV 给药后 3 天内，注射部位发红（直径 2.6-5cm）是最常见的症状。
结论
VarV 具有良好的安全性。尽管 2022 年至 2023 年之间 AEFI 发生率略有增加，但主要观察到常见疫苗反应，罕见反应发生率仍非常低。
Zotero 插件