肠道病毒A71型灭活疫苗上市后安全性分析

Post-marketing safety analysis of inactivated enterovirus A71 vaccines

目的评价肠道病毒A71型(EV-A71)疫苗上市后的安全性。方法以2016年4月至2018年3月在浙江省89个县(市、区)预防接种门诊中,所有接种EV-A71灭活疫苗的6~59月龄健康儿童为研究对象,分别通过接种现场30min内观察,3d内和4~30d随访,收集接种者局部和全身不良反应发生情况。比较不同特征研究对象发生不良反应的差异。结果共接种EV-A71疫苗71663剂次,其中男和女童分别接种37331和34332剂次;6~11、12~23和24~59月龄组分别接种13707、32639和25317剂次。在接种后30min、3d内和4~30d不良反应发生率分别为0.33%(239剂次)、1.58%(1133剂次)和0.34%(244剂次)。3d内发生不良反应共1372剂次,发生率为1.91%,其中1级为539剂次,2级为677剂次,3级为156剂次,未发生4级不良反应。局部不良反应中以红、硬结和瘙痒较为常见,发生率分别为0.05%(39剂次),0.02%(16剂次)和0.02%(12剂次),全身不良反应中以发热最为常见,发生率为1.19%(856剂次),其次为腹泻和食欲下降,发生率分别0.15%(104剂次)和0.13%(90剂次)。结论EV-A71疫苗接种后不良反应大多数较轻微,且多数为常见的一般反应,尚未发现罕见不良反应。

Objectives To evaluate the safety of inactivated enterovirus A71(EV-A71) vaccines after large-scale immunization in the community.Methods We selected EV-A71 susceptible people (healthy children) aged 6-59 months in vaccination clinics from 89 counties in Zhejiang Province between April 2016 and March 2018. All local and systematic adverse actions were collected by 30 min on-site inspection, within 3 days and 4-30 days follow-up. Chi-square test and Fisher′s exact test were used to compare the difference of AEs incidence in various characteristics among two groups.Results A total of 71 663 doses of vaccines were included for active safety analysis, which included 37 331 doses in boys and 34 332 doses in girls. Among all the doses, children aged 6 to 11 months, 12 to 23 months and 24 to 59 months were received 13 707, 32 639 and 25 317 doses respectively. The incidence of adverse reactions within 30 min, 3 days and 4-30 days were 0.33%(239 doses), 1.58%(1 133 doses) and 0.34%(244 doses) respectively. Adverse reactions within 3 days were 1 372 doses, with a incidence of 1.91%;among all the cases, 539 doses (0.75%) were grade 1, 677 doses (0.94%) were grade 2 and 156 doses (0.22%) were grade 3, no grade-4 adverse reaction was reported. The common local adverse reactions were redness, swelling and pruritus, with the incidence rates were 0.05%(39 doses), 0.02%(16 doses) and 0.02%(12 doses), respectively, while the most common systemic adverse reaction was pyrexia with an incidence of 1.19%(856 doses), followed by diarrhea and anorexia with the incidence rates were 0.15%(104 doses) and 0.13%(90 doses) respectively.Conclusion Most adverse actions of EV-A71 vaccines were mild and moderate and majority of them were common adverse actions. No new adverse reactions were found in the study.