| 杨中楠,赵韵芽,李璐,高汇迪,蔡琪,孙晓霞,张福生,苏锦锋,张轶楠,舒祥,王雪薇,杨云凯,张云涛,周颂,杨晓明.新型冠状病毒灭活疫苗（Vero细胞）大规模紧急使用安全性评价[J].Chinese journal of Epidemiology,2021,42(6):977-982 |
| 新型冠状病毒灭活疫苗（Vero细胞）大规模紧急使用安全性评价 |
| Evaluation of safety of two inactivated COVID-19 vaccines in a large-scale emergency use |
| Received:March 25, 2021 |
| DOI：10.3760/cma.j.cn112338-20210325-00249 |
| KeyWord: 新型冠状病毒灭活疫苗 紧急使用 安全性 |
| English Key Word: Inactivated COVID-19 vaccine Emergency use Safety |
| FundProject: |
| Author Name | Affiliation | E-mail | | Yang Zhongnan | China National Biotech Group Company Limited, Beijing 100024, China | | | Zhao Yunya | China National Biotech Group Company Limited, Beijing 100024, China | | | Li Lu | China National Biotech Group Company Limited, Beijing 100024, China | | | Gao Huidi | China National Biotech Group Company Limited, Beijing 100024, China | | | Cai Qi | China National Biotech Group Company Limited, Beijing 100024, China | | | Sun Xiaoxia | China National Biotech Group Company Limited, Beijing 100024, China | | | Zhang Fusheng | China National Biotech Group Company Limited, Beijing 100024, China | | | Su Jinfeng | China National Biotech Group Company Limited, Beijing 100024, China | | | Zhang Yinan | China National Biotech Group Company Limited, Beijing 100024, China | | | Shu Xiang | China National Biotech Group Company Limited, Beijing 100024, China | | | Wang Xuewei | China National Biotech Group Company Limited, Beijing 100024, China | | | Yang Yunkai | China National Biotech Group Company Limited, Beijing 100024, China | | | Zhang Yuntao | China National Biotech Group Company Limited, Beijing 100024, China | | | Zhou Song | China National Biotech Group Company Limited, Beijing 100024, China | | | Yang Xiaoming | China National Biotech Group Company Limited, Beijing 100024, China | yangxiaoming@sinopharm.com |
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| Abstract: |
| 目的 评价新型冠状病毒灭活疫苗大规模紧急使用的安全性。方法 通过“疫苗接种信息采集系统”，收集在紧急使用中新型冠状病毒灭活疫苗（北京生物制品研究所、武汉生物制品研究所）接种人群的不良反应发生情况，采用流行病学与统计学方法分析相关信息。结果 截至2020年12月1日，共采集519 543人次接种信息，总不良反应发生率为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%。全身不良反应以疲劳（0.21%）、头痛（0.14%）、发热（0.06%）、咳嗽（0.05%）、食欲不振（0.05%）为主要表现；局部不良反应以接种部位疼痛（0.24%）、接种部位肿胀（0.05%）为主要表现。结论 大规模新型冠状病毒灭活疫苗（Vero细胞）（北京生物制品研究所、武汉生物制品研究所）进行紧急使用后，一般反应的发生率较低，未见严重不良反应，疫苗具有良好的安全性。 |
| English Abstract: |
| Objective To evaluate the safety of two inactivated COVID-19 vaccines in a large-scale emergency use. Methods 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. Results 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. Conclusion 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. |
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