肠道病毒71型灭活疫苗上市后安全性主动监测

Post-marketing assessment on safety of inactived enterovirus type 71 vaccine by proactive monitoring

目的初步评价肠道病毒71型(EV71)灭活疫苗(EV71疫苗)上市后常规接种的安全性,比较疑似预防接种不良反应(AEFI)主动及被动监测的差异。方法 2016年8—11月在北京市朝阳区对3 162名儿童开展EV71疫苗上市后安全性监测,其中对770名受种儿童采用手机应用(APP)信息化平台进行主动监测AEFI,对2 392名受种儿童通过家长上报方式进行被动监测AEFI。结果主动监测组AEFI总发生率为42.33%(326/770),以全身反应为主,未见罕见和极罕见不良反应;被动监测组AEFI总发生率为0.67%(16/2 392),明显低于主动监测组(χ~2=51 274.285,P<0.001),主要表现为一般反应。结论该EV71疫苗安全性良好;主动监测能够更敏感地获得疫苗接种后不良反应,可为疫苗的安全性评价提供可靠的数据支持。

Objective To evaluate the post-marketing safety of routine inoculation of inactivated enterovirus type 71 （EV71） vaccine and to compare the differences in adverse event following immunization （AEFI） between proactive and passive monitoring.Methods A post-marketing safety assessment was conducted among 3 162 children having EV71 vaccine inoculation in Chaoyang district of Beijing between August and November 2016.Of the children,770 were under an active monitoring on AEFI via mobile application information platform and 2 392 under a passive monitoring via their parents＇ feedback report.Results In the active monitoring group,the overall incidence of AEFI of EV71 vaccine was 42.33% （326/770）,with systemic reaction being the main AEFI and rare and very rare adverse reactions were not observed.Whereas,in the passive monitoring group,the overall incidence of AEFI EV71 vaccine was only 0.67% （16/2 392） and significantly lower than that of active monitoring group （χ2=51 274.285,P〈0.001）,with temporal reactions being the main AEFI.Conclusion The EV71 vaccine is of good safety.Proactive monitoring is more conducive for the collection of vaccine safety-related data and safety assessment of the vaccine.