文章摘要
穆秋玥,冯添,黄飞,罗周,焦宇航,高源雪,管庆虎,陈虎,张锐智.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[J].中华流行病学杂志,2023,44(11):1738-1743
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
收稿日期:2023-03-28  出版日期:2023-11-17
DOI:10.3760/cma.j.cn112338-20230328-00189
中文关键词: 新型冠状病毒灭活疫苗  安全性  不良反应
英文关键词: Inactivated 2019-nCoV vaccine  Safety  Adverse reaction
基金项目:
作者单位E-mail
穆秋玥 贵州省疾病预防控制中心免疫规划研究所, 贵阳 550001  
冯添 贵州省疾病预防控制中心免疫规划研究所, 贵阳 550001  
黄飞 贵州省沿河县疾病预防控制中心免疫规划科, 沿河 565300  
罗周 贵州省沿河县疾病预防控制中心免疫规划科, 沿河 565300  
焦宇航 贵州省疾病预防控制中心免疫规划研究所, 贵阳 550001  
高源雪 贵州省疾病预防控制中心免疫规划研究所, 贵阳 550001  
管庆虎 贵州省疾病预防控制中心免疫规划研究所, 贵阳 550001  
陈虎 贵州省疾病预防控制中心免疫规划研究所, 贵阳 550001  
张锐智 贵州省疾病预防控制中心免疫规划研究所, 贵阳 550001 919987774@qq.com 
摘要点击次数: 2282
全文下载次数: 547
中文摘要:
      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%(294/19 458),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%(58/5 721)、2.44%(220/9 017)和0.34%(16/4 720),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%,233/19 458)高于第2剂次(0.37%,61/16 368),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%(9/2 520)和0.32%(7/2 200),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。
英文摘要:
      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% (294/19 458), 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 (58/5 721), 2.44% in age group 18- years (220/9 017), and 0.34% in age group ≥ 60 years (16/4 720). The differences were significant (P<0.001). The incidence of AR after the first dose vaccination (1.20%, 233/19 458) was significantly higher than that after the second dose (0.37%, 61/16 368), the difference was significant (P<0.001). In the elderly aged ≥ 60 years, the incidence of AR was 0.36% (9/2 520) in healthy group and 0.32% (7/2 200) 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.
查看全文   Html全文     查看/发表评论  下载PDF阅读器
关闭