Yang Z N, Zhao Y Y, Li L, Gao H D, Cai Q, Sun X X, Zhang F S, Su J F, Zhang Y N, Shu X, Wang X W, Yang Y K, Zhang Y T, Zhou S, Yang X M
China National Biotech Group Company Limited, Beijing 100024, China.
Zhonghua Liu Xing Bing Xue Za Zhi. 2021 Jun 10;42(6):977-982. doi: 10.3760/cma.j.cn112338-20210325-00249.
To evaluate the safety of two inactivated COVID-19 vaccines in a large-scale emergency use. Based on the "Vaccination Information Collection System", the incidence data of adverse reactions in the population vaccinated with the inactivated COVID-19 vaccines developed by Beijing Institute of Biological Products Co., Ltd and Wuhan Institute of Biological Products Co., Ltd, respectively, in emergency use were collected, and the relevant information were analyzed with descriptive epidemiological and statistical methods. By December 1, 2020, the vaccination information of 519 543 individuals had been collected. The overall incidence rate of adverse reactions was 1.06%, the incidence rate of systemic adverse reactions was 0.69% and the incidence rate of local adverse reactions was 0.37%. The main systemic adverse reactions included fatigue, headache, fever, cough and loss of appetite with the incidence rates of 0.21%, 0.14%, 0.06%, 0.05% and 0.05%, respectively; the main local adverse reactions were injection site pain and injection site swelling with the incidence rates of 0.24% and 0.05%, respectively. The two inactivated COVID-19 vaccines by Beijing Institute of Biological Products Co., Ltd and Wuhan Institute of Biological Products Co., Ltd showed that in the large-scale emergency use, the incidence rate of general reactions was low and no serious adverse reactions were observed after the vaccinations, demonstrating that the vaccines have good safety.
评估两种新型冠状病毒灭活疫苗在大规模紧急使用中的安全性。基于“预防接种信息收集系统”，收集北京生物制品研究所有限责任公司和武汉生物制品研究所有限责任公司研制的新型冠状病毒灭活疫苗在紧急使用中接种人群的不良反应发生数据，并采用描述性流行病学和统计学方法进行相关信息分析。截至2020年12月1日，共收集519543人的接种信息。不良反应总发生率为1.06%，全身不良反应发生率为0.69%，局部不良反应发生率为0.37%。主要全身不良反应包括乏力、头痛、发热、咳嗽和食欲不振，发生率分别为0.21%、0.14%、0.06%、0.05%和0.05%；主要局部不良反应为接种部位疼痛和接种部位肿胀，发生率分别为0.24%和0.05%。北京生物制品研究所有限责任公司和武汉生物制品研究所有限责任公司的两种新型冠状病毒灭活疫苗在大规模紧急使用中显示，一般反应发生率低，接种后未观察到严重不良反应，表明疫苗具有良好的安全性。
