EV71疫苗疑似预防接种异常反应监测结果

Surveillance results of adverse events following immunization of enterovirus 71 inactvated vaccine

目的分析6月龄~3岁儿童接种武汉生物制品研究所肠道病毒71型灭活疫苗(EV71疫苗)的疑似预防接种异常反应(AEFI)发生情况,评价该疫苗的安全性.方法按照《全国疑似预防接种异常反应监测方案》要求,采用主动监测和被动监测结合的方式收集浙江省2017年9月—2018年10月接种EV71疫苗的6月龄~3岁儿童AEFI报告病例资料,采用描述流行病学方法分析人群特征、地区分布、接种剂次及接种后发生AEFI相关情况.结果监测接种儿童107503人,其中主动监测27173人,被动监测80330人.接种EV71疫苗后发生AEFI 288例,AEFI报告发生率为267.90/10万人;其中一般反应266例,报告发生率为247.43/10万剂;异常反应14例,报告发生率为13.02/10万剂;偶合症8例,报告发生率为7.44/10万剂;无严重AEFI病例.288例AEFI病例中,被动监测145例,报告发生率为180.51/10万剂;主动监测143例,报告发生率为526.26/10万剂.男童150例,女童138例,男女比为1.09:1.浙江省各市均有AEFI病例报告,报告病例数居前三位的是金华市、台州市和杭州市,占全省报告病例数的50.69%.接种第1剂次后发生AEFI 202例,占70.14%;AEFI在接种日发生163例,占56.60%.266例一般反应主要表现为发热、红肿和硬结;14例异常反应临床损害均较轻,其中8例为过敏性皮疹,未发现其他严重异常反应.结论 6月龄~3岁儿童接种该疫苗后AEFI报告发生率为267.90/10万剂,无严重AEFI病例,该EV71疫苗安全性良好.

Objective To evaluate the safety of enterovirus 71(EV71) inactivated vaccines produced by Wuhan Institute of Bio Products through learning the incidence of adverse events following immunization(AEFI) in children aged 6 months to 3 years old after vaccination. Methods According to the national requirement for vaccine safety monitoring program,data of AEFI cases after inoculated EV71 vaccines from September 2017 to October 2018 in Zhejiang Province was collected by combining active and passive monitoring. Demographic characteristics,space distribution,dose and incidence of AEFI were analyzed. Results A total of 107 503 children were included in this study,of which 27 173 were actively monitored and 80 330 were passively monitored. The monitoring results showed that 288 cases of AEFI occurred after inoculated EV71 vaccines,the reported incidence rate was 267.90/100 000. Of 288 cases,266 cases had common reactions(247.43/100 000),14 cases had abnormal reactions(13.02/100 000) and 8 cases had complications(7.44/100 000);145 cases were passively monitored(180.51/100 000) and143 cases were actively monitored(526.26/100 000);150 cases were males and 138 cases were females,with the males to females ratio of 1.09∶1. The AEFI of EV71 vaccines were reported in all the cities of Zhejiang Province,with Jinhua,Taizhou and Hangzhou ranking the top three and accounting for 50.69% of all the reported cases. About 202 cases of AEFI(70.14%)occurred after the first dose of EV71 vaccines,and 163 cases(56.60%) occurred on the day of inoculation.Most of common reactions were fever,swelling and sclerosis. The harm of the reported abnormal reactions was mild,with 8 cases of anaphylactic rash and no other serious abnormal reactions were found. Conclusion The reported incidence rate of AEFI of the domestic EV71 vaccine in children aged from 6 months to 3 years is 267.90/100 000,without serious abnormal reactions,suggesting that the EV71 vaccine is safe.