江苏省口服轮状病毒减毒活疫苗疑似预防接种异常反应监测分析

Surveillance of suspected adverse event following immunization with oral live attenuated rotavirus vaccine in Jiangsu province

目的 分析江苏省口服轮状病毒(rotavirus, RV)减毒活疫苗疑似预防接种异常反应(adverse event following immunization,AEFI)的发生特征,评价RV疫苗预防接种安全性。方法 分别通过中国疾病预防控制信息系统和江苏省预防接种综合服务管理信息系统收集2019-2022年RV疫苗AEFI个案信息和接种数据,进行描述性流行病学分析。结果 2019-2022年江苏省共报告RV疫苗AEFI 344例,报告发生率为25.58/10万剂。一般反应、异常反应、偶合症分别为304例(22.61/10万剂)、31例(2.31/10万剂)和9例(0.67/10万剂)。临床表现主要为发热(14.35/10万剂)、腹泻呕吐(11.23/10万剂)和过敏性皮疹(1.93/10万剂),未发现肠套叠异常反应病例报告。第1、2、3剂次接种后AEFI报告发生率分别为37.16/10万剂、16.94/10万剂和11.43/10万剂,首剂接种报告发生率高于其他剂次,差异有统计学意义(χ^(2)=67.639,P<0.001)。结论 江苏省RV疫苗AEFI报告发生率处在预期范围内,疫苗接种具有良好的安全性。

Objective To analyze the occurrence characteristics of suspected adverse events following immunization(AEFIs)with oral live attenuated rotavirus vaccine(RV)during 2019-2022 in Jiangsu province and assess the safety of RV vaccination.Methods A descriptive epidemiological analysis was conducted by collecting AEFI case information and vaccination data from the China Information System for Disease Control and Prevention Information System and the Jiangsu Province Comprehensive Immunization Service Management Information System during 2019-2022.Results A total of 344 RV AEFI cases were reported during 2019-2022 in Jiangsu province,resulting in an inci-dence of 25.58 cases per 100000 doses administered.Among the AEFIs reported,304 cases(22.61 per 100000 doses)were common adverse reactions,31 cases(2.31 per 100000 doses)were rare adverse reactions,and 9 cases(0.67 per 100000 doses)were coincidental events.The main clinical manifestations included fever(14.35 per 100000 doses),diarrhea and vomiting(11.23 per 100000 doses),and allergic rash(1.93 per 100000 doses).No cases of intussusception were reported as adverse reactions.AEFI incidences for the first,second,and third doses were 37.16,16.94 and 11.43 per 100000 doses,respectively,with the first dose showing a statistically higher incidence compared to subsequent doses(χ^(2)=67.639,P<0.001).Conclusions The reported incidence of AEFIs associated with the RV vaccine in Jiangsu province falls within the expected range,indicating that the vaccine is safe for administration.