Clinical observation on adverse reaction after vaccination of inactivated 2019-nCoV vaccine in population aged 3 years and above
10.3760/cma.j.cn112338-20230328-00189
- VernacularTitle: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
- Author:
Qiuyue MU
1
;
Tian FENG
;
Fei HUANG
;
Zhou LUO
;
Yuhang JIAO
;
Yuanxue GAO
;
Qinghu GUAN
;
Hu CHEN
;
Ruizhi ZHANG
Author Information
1. 贵州省疾病预防控制中心免疫规划研究所,贵阳 550001
- Keywords:
Inactivated 2019-nCoV vaccine;
Safety;
Adverse reaction
- From:
Chinese Journal of Epidemiology
2023;44(11):1738-1743
- CountryChina
- Language:Chinese
-
Abstract:
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.