[The surveillance analysis of the adverse events following immunization of the domestic 13-valent pneumococcal polysaccharide conjugate vaccine in Zhejiang Province]

To evaluate the safety of the domestic 13-valent pneumococcal polysaccharide conjugate vaccine-tetanus toxoid protein (PCV13-TT) after its licensure. The adverse event following immunization (AEFI) and the vaccination data of PCV13-TT in Zhejiang province from July 2020 to October 2021 were collected from national adverse event following immunization surveillance system and Zhejiang provincial immunization information system. Descriptive epidemiological method was used for this analysis. From July 2020 to October 2021, 302 317 doses of PCV13-TT were administered in children under 6 years old in Zhejiang Province and 636 AEFI case reports were received, with a reporting rate of 21.04 per 10 000 doses. Of these AEFI cases, 97.17% were mild vaccine product-related reaction (20.54 per 10 000 doses) and 95.44% occurred in the 0-1 d after vaccination (20.08 per 10 000 doses). The most common clinical diagnoses of AEFI included fever (224 cases), redness (204 cases), and induration (190 cases), while allergic rash (11 cases) was the most common diagnosis among the abnormal reactions. In conclusion,the present results bolstered that the domestic PCV13-TT was generally well tolerated in children under 6 years old in Zhejiang Province.评价国产13价肺炎球菌多糖结合疫苗（PCV13-TT）上市后使用的安全性。采用横断面描述性研究方法，由浙江省疾病预防控制中心收集国家疑似预防接种异常反应（AEFI）信息管理系统中2020年7月至2021年10月期间浙江省PCV13-TT的AEFI报告数据；从浙江省疫苗管理和预防接种信息综合管理系统中统计同期PCV13-TT的接种数据。采用描述流行病学方法对PCV13-TT的AEFI报告发生情况进行描述性分析。结果显示，2020年7月至2021年10月期间，浙江省5岁及以下儿童中PCV13-TT共接种302 317剂次，报告AEFI共636例（报告发生率为21.04/万剂次），97.17%为一般反应（20.54/万剂次），95.44%发生在接种后0~1 d内（20.08/万剂次）。一般反应中最常见的为发热（224例）、局部红肿（204例）及硬结（190例），异常反应中报告最多的是过敏性皮疹（11例）。综上，浙江地区PCV13-TT上市后在5岁及以下儿童中接种具有较好的安全性。.