3岁及以上人群新型冠状病毒灭活疫苗接种反应临床观察分析  

Clinical observation on adverse reaction after vaccination of inactivated 2019-nCoV vaccine in population aged 3 years and above

作　　者：穆秋玥[1] 冯添 黄飞 罗周 焦宇航 高源雪 管庆虎[1] 陈虎 张锐智[1] Mu Qiuyue;Feng Tian;Huang Fei;Luo Zhou;Jiao Yuhang;Gao Yuanxue;Guan Qinghu;Chen Hu;Zhang Ruizhi(Institute for Immunization Planning,Guizhou Provincial Center for Disease Control and Prevention,Guiyang 550001,China;Department for Immunization Planning,Yanhe County Center for Disease Control and Prevention of Guizhou,Yanhe 565300,China)

机构地区：[1]贵州省疾病预防控制中心免疫规划研究所,贵阳550001 [2]贵州省沿河县疾病预防控制中心免疫规划科,沿河565300

出　　处：《中华流行病学杂志》2023年第11期1738-1743,共6页Chinese Journal of Epidemiology

摘　　要：目的评价贵州省≥3岁人群接种新型冠状病毒(新冠病毒)灭活疫苗的安全性。方法采用开放式设计,于2021年6月至2022年7月在贵州省沿河县招募符合条件的人群,按照(0,28)d免疫程序接种2剂次新冠病毒灭活疫苗,收集每剂次疫苗接种后30 min内和0~28 d的不良反应,分年龄、剂次、患病情况分析不良反应发生率。结果总不良反应发生率为1.51%(294/19458),所有不良反应均发生在接种后7 d内,严重程度为1级或2级,以接种部位疼痛最常见。3~、18~和≥60岁组不良反应发生率分别为1.01%(58/5721)、2.44%(220/9017)和0.34%(16/4720),差异有统计学意义(P<0.001)。第1剂次接种后不良反应发生率(1.20%,233/19458)高于第2剂次(0.37%,61/16368),差异有统计学意义(P<0.001)。≥60岁组中健康人群和患基础疾病人群不良反应发生率分别为0.36%(9/2520)和0.32%(7/2200),差异无统计学意义(P=0.818)。结论≥3岁人群接种新冠病毒灭活疫苗安全性良好,在老年健康人群和患基础疾病人群中接种均具有良好安全性。Objective To evaluate the safety of mass vaccination of inactivated 2019-nCoV vaccine in population aged≥3 years in Guizhou Province.Methods The open-label study was conducted in eligible volunteers in Yanhe County of Guizhou from June 2021 to July in 2022.In the study,two doses of the inactivated 2019-nCoV vaccine were given at(0,28)days according to the immunization schedule.The information about adverse reaction(AR)within 30 minutes and during 0-28 days after vaccination were collected,and the incidence of AR was analyzed by age,doses,and health status.Results The overall incidence of AR was 1.51%(294/19458),all ARs,mainly pain at injection site,occurred within 7 days after the vaccination,the AR grade was 1-2.The incidence of AR was 1.01%in age group 3-years(58/5721),2.44%in age group 18-years(220/9017),and 0.34%in age group≥60 years(16/4720).The differences were significant(P<0.001).The incidence of AR after the first dose vaccination(1.20%,233/19458)was significantly higher than that after the second dose(0.37%,61/16368),the difference was significant(P<0.001).In the elderly aged≥60 years,the incidence of AR was 0.36%(9/2520)in healthy group and 0.32%(7/2200)in group with underlying medical conditions,the differences were not significant(P=0.818).Conclusion The domestic inactivated 2019-nCoV vaccine showed good safety in mass vaccination in population aged≥3 years,including the elderly in both healthy group and group with underlying medical conditions.

关 键 词：新型冠状病毒灭活疫苗 安全性 不良反应 

分 类 号：R186[医药卫生—流行病学]