| 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 |
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| 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. |
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