Institute of Immunization and Prevention, Zhejiang Center for Disease Control and Prevention, Hangzhou, China.
Hum Vaccin Immunother. 2022 Dec 31;18(1):2035141. doi: 10.1080/21645515.2022.2035141. Epub 2022 Mar 3.
To evaluate the safety of 13-valent pneumococcal conjugate vaccine (PCV13) after its licensure.
Review and describe the AEFI reported to national adverse event following immunization surveillance system (NAEFISS) in Zhejiang province from 2017 to 2020. Reporting rates of AEFI were calculated by age, city, severity of AEFI, categories of AEFI, and reaction categories. The data mining algorithm used in this study was reporting odds ratio (ROR). A value of ROR-1.96SE >1 (standard error [SE]) was considered as the positive signal.
NAEFISS received 3332 AEFI cases following PCV13, with a reporting rate of 17.58/10000 doses. Of the reported AEFI, 652 were serious AEFI cases and the reporting rate was 3.44 for serious AEFI. The reporting rate of fever was the highest among all the clinical diagnosis (7.39/10000 doses). The positive signals were obtained for injection site reaction (ROR-1.96SE: 1.55), hypotonic hyporesponsive episode (HHE) (ROR-1.96SE: 1.62) and febrile seizure (ROR-1.96SE: 1.52).
The present results supported previous observations that the PCV13 administered as the four-dose schedule was generally well tolerated in Chinese infants as we did not identify any new/unexpected safety concern from the NAEFISS during a four-year time period.
评估 13 价肺炎球菌结合疫苗（PCV13）获得许可后的安全性。
回顾并描述 2017 年至 2020 年期间浙江省国家疫苗不良反应监测系统（NAEFISS）报告的不良事件。通过年龄、城市、AEFI 严重程度、AEFI 类别和反应类别计算 AEFI 的报告率。本研究使用的数据挖掘算法是报告比值比（ROR）。ROR-1.96SE>1（标准误差[SE]）的值被认为是阳性信号。
NAEFISS 收到 3332 例 PCV13 后发生的 AEFI，报告率为 17.58/10000 剂。在报告的 AEFI 中，有 652 例为严重 AEFI 病例，严重 AEFI 的报告率为 3.44/10000 剂。所有临床诊断中，发热的报告率最高（7.39/10000 剂）。接种部位反应（ROR-1.96SE：1.55）、低张性低反应发作（HHE）（ROR-1.96SE：1.62）和热性惊厥（ROR-1.96SE：1.52）获得阳性信号。
本研究结果支持先前的观察结果，即按照四剂方案接种 PCV13 通常在我国婴儿中具有良好的耐受性，我们在四年时间内未从 NAEFISS 中发现任何新的/意外的安全性问题。
