2016-2020年中国23价肺炎球菌多糖疫苗疑似预防接种异常反应监测

Surveillance of adverse events following immunization with 23-valent pneumococcal polysaccharide vaccine in China,2016-2020

目的 分析中国23价肺炎球菌多糖疫苗(23-valent pneumococcal polysaccharide vaccine, PPV23)疑似预防接种异常反应(Adverse events following immunization, AEFI)报告特征。方法 通过中国疾病预防控制信息系统收集2016-2020年PPV23接种信息和AEFI个案信息,描述性分析AEFI发生特征和报告发生率。结果 2016-2020年中国报告PPV23 AEFI 31 998例,报告发生率为115.27/10万剂。在AEFI中一般反应、异常反应分别占94.32%、3.35%,报告发生率分别为108.73/10万剂、3.87/10万剂。一般反应中发热、局部红肿、局部硬结报告发生率分别为84.74/10万剂、49.58/10万剂、20.23/10万剂;异常反应中过敏性皮疹报告发生率为2.18/10万剂,其他异常反应报告发生率均<1/10万剂。结论 2016-2020年中国PPV23 AEFI多为一般反应,异常反应极其罕见;需继续加强PPV23 AEFI监测。

Objective To analyze adverse events following immunization(AEFI)with 23-valent pneumococcal polysaccharide vaccine(PPV23)in China.Methods We obtained data on PPV23 AEFIs and vaccination during 2016-2020 from the China Disease Prevention and Control Information System and analyzed characteristics and incidences of reported AEFIs.Results A total of 31998 PPV23 AEFIs were reported during 2016-2020 in China,for an incidence of 115.27 per 100000 doses administered.Common and rare adverse reactions accounted for 94.32%and 3.35%of all AEFIs with incidences of 108.73 and 3.87 per 100000 doses,respectively.Incidences per 100000 doses of common adverse reactions of fever,local redness/swelling,and local induration were 84.74,49.58,and 20.23,while incidences of rare adverse reactions of allergic rashes and other rare reactions were 2.18 and less than 1.Conclusions Most PPV23 AEFIs were common and mild and severe reactions were rare during 2016-2020 in China.We should continue to strengthen PPV23 AEFI surveillance.