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| Surveillance results of adverse events following immunization of enterovirus 71 inactvated vaccine |
| PAN Xue-jiao*，FU Jian，SHEN Ling-zhi，LYU Hua-kun，XIAO Yan-hui，CHEN Hai-ping，SHI Xuan-wen
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| *Zhejiang Provincial Center for Disease Control and Prevention，Hangzhou，Zhejiang 310051，China |
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Abstract 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）and 143 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.
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Published: 01 November 2019
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[1] 中华人民共和国国家卫生健康委员会.2017年全国法定传染病疫情概况[EB/OL].（2018-02-26） [2019-08-17]. http：// www.nhc.gov.cn/jkj/s3578/201802/de926bdb046749abb7b0a8e23d 929104.shtml.
[2] 吴晨，吴昊澄，丁哲渊，等.2008—2015年浙江省手足口病流行特征分析[J].疾病监测，2016，31（10）：831-834.
[3] LI R，LIU L，MO Z，et al.An inactivated enterovirus 71 vaccine in healthy children[J].N Engl J Med，2014，370（9）：829- 837.
[4] ZHU F，XU W，XIA J，et al.Efficacy，safety，and immunogenicity of an enterovirus 71 vaccine in China[J].N Engl J Med，2014，370（9）：818-828.
[5] HU Y M，WANG X，WANG J Z，et al.Immunogenicity，safety，and lot consistency of a novel inactivated enterovirus 71 vaccine in Chinese children aged 6 to 59 months[J].Clin Vaccine Immunol，2013，（12）：1805-1811.
[6] 中华人民共和国卫生部，国家食品药品监督管理局.全国疑似预防接种异常反应监测方案[S].2010.
[7] 白云骅，李丽，张军楠，等.肠道病毒71型灭活疫苗上市后安全性主动监测[J].中国公共卫生，2017，33（4）：65-67.
[8] 杜进发，钟革，陆伟才，等.2016—2017年广西肠道病毒71型灭活疫苗疑似预防接种异常反应监测结果分析[J].应用预防医学，2018，24（5）：384-386.
[9] 汪志国，汤奋扬，高君，等.肠道病毒71型灭活疫苗上市后安全性监测与评价[J].江苏预防医学，2018，29（6）：626- 629.
[10］辛秀梅，张金凤，热孜万，等.新疆疑似预防接种异常反应主动监测项目结果分析[J].中国妇幼保健，2012，27（24）：3747-3749.
[11］沈金花，陆红梅，黄卓英，等.上海市松江区乙型肝炎疫苗安全性主动与被动监测[J].职业与健康，2012，28（24）：3125-3127.
[12］王亚丽，董锋，王丹，等.美国疫苗上市后安全性监测给我们的启示[J].中国药事，2015，29（9）：908-911.
[13］黄巍，周晓红，席胜，等.两种EV71型灭活疫苗安全性比较[J].预防医学，2018，30（4）：356-358.
[14］刘世科，陈伟，王帆，等.婴幼儿接种EV71疫苗的安全性观察[J].预防医学，2019，31（5）：505-507.
[15］戚小华，李倩，凌罗亚，等.浙江省2010—2012年麻疹成分疫苗疑似预防接种异常反应监测分析[J].国际流行病学传染病学杂志，2013，40（5）：317-320.
[16］孙肖瑜，魏晶娇，李万仓，等.温州市EV71灭活疫苗的疑似预防接种异常反应分析[J].预防医学，2018，30（6）：629- 630. |
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