合肥市新型冠状病毒灭活疫苗(Vero细胞)紧急接种期间安全性  

Safety analysis of inactivated SARS-CoV-2 vaccine(Vero cells)during emergency vaccination in Hefei

作　　者：朱立炜 陈国杰 姜凌 马春雨 ZHU Li-wei;CHEN Guo-jie;JIANG Ling;MA Chun-yu(Hefei First People's Hospital,Hefei 230031,China;Binhu Hospital of Hefei,Hefei 230601,China;Baohe District Center for Disease Control and Prevention,Hefei 230051,China;Luyang District Center for Disease Control and Prevention,Hefei 230061,China)

机构地区：[1]合肥市第一人民医院,合肥230031 [2]合肥市滨湖医院,合肥230601 [3]合肥市包河区疾病预防控制中心,合肥230051 [4]合肥市庐阳区疾病预防控制中心,合肥230061

出　　处：《中华疾病控制杂志》2021年第7期802-805,共4页Chinese Journal of Disease Control & Prevention

摘　　要：目的探讨合肥市新型冠状病毒灭活疫苗(Vero细胞)(简称新冠疫苗)在紧急接种期间的安全性,为该疫苗后期在全人群中的推广接种提供参考。方法在合肥市抽取19家预防接种门诊作为免疫安全性主动监测点,于2020年12月15日―2021年2月10日对合肥市接种新冠疫苗的18~59岁重点人群进行观察,对疫苗接种后不良反应发生率、不良反应类型及严重程度进行描述性分析。结果有效观察18574人,累积接种新冠疫苗33433剂次,接种发生一般不良反应713例次,发生率2.13%,第1剂次不良反应发生率为2.57%,高于第2剂次不良反应发生率1.58%(χ^(2)=38.92,P<0.001),2家公司生产灭活疫苗一般反应发生率的差异无统计学意义(χ^(2)=3.08,P=0.082);在注射部位红肿、注射部位硬结、发热等不良事件中,1、2和3级不良事件发生率分别为0.65%、1.42%和0.06%,未发现≥4级及罕见和极罕见不良事件。结论国产新型冠状病毒灭活疫苗(Vero细胞)具有较高的安全性。Objective To study the safety of inactivated SARS-CoV-2 vaccine(Vero cells)(SARS-CoV-2 vaccine)in Hefei during the emergency vaccination period,and to provide reference for the promotion and vaccination of this vaccine in the whole population in the later period.Methods A total of 19 vaccination clinics in Hefei were selected as active monitoring sites for immunization safety.Focus groups aged 18-59 years who were vaccinated with SARS-CoV-2 vaccine in Hefei from 15 December 2020 to 10 February 2021 were observed.The incidence,types and severity of adverse reactions after vaccination were descriptively analyzed.Results A total of 18574 people were effectively observed,and 33433 doses of SARS-CoV-2 vaccine were inoculated.713 cases of general adverse reactions occurred,with an incidence of 2.13%.The incidence of adverse reactions in the first dose was 2.57%,which was higher than that in the second dose(1.58%,χ^(2)=38.92,P<0.001).There was no statistical significance in the incidence of general adverse reactions of inactivated vaccine produced by the two companies(χ^(2)=3.08,P=0.082).Among the adverse events such as redness and swelling at the injection site,induration at the injection site,and fever,the incidence of grade 1,2 and 3 adverse events were 0.65%,1.42%,and 0.06%,but there were no≥grade 4,rare and extremely rare adverse events.Conclusion Domestic inactivated SARS-CoV-2 vaccine(Vero cells)is great safe.

关 键 词：新型冠状病毒 灭活疫苗 安全性 

分 类 号：R186[医药卫生—流行病学]