新型冠状病毒疫苗Ⅲ期临床试验及真实世界研究  

Evaluation of SARS-CoV-2 Vaccine Based on PhaseⅢClinical Trials and Real-world Studies

作　　者：麦迪娜·金格斯 郑碧芸 尹平[1] MAIDINA Jingesi;ZHENG Biyun;YIN Ping(School of Public Health,Tongji Medical College,Huangzhong University of Science and Technology,Wuhan 430030,China)

机构地区：[1]华中科技大学同济医学院公共卫生学院,武汉430030

出　　处：《医药导报》2021年第9期1159-1168,共10页Herald of Medicine

摘　　要：新型冠状病毒肺炎(COVID-19)已形成世界大流行,对人类的生命健康造成严重威胁。为应对这场全球公共卫生危机,疫苗的研究开发、接种工作正在积极推进。当前,全球已有19种疫苗进入世界卫生组织紧急使用评估列表,其有效性和安全性也引起社会各界的广泛关注。该文基于Ⅲ期临床试验数据和真实世界研究数据,从灭活疫苗、mRNA疫苗、病毒载体疫苗、蛋白亚单位疫苗等4类疫苗类型出发,综合评价紧急使用评估列表中8款疫苗的有效性和安全性,以期为疫苗的临床应用和医药专业人员开展新型冠状病毒疫苗临床安全性监察提供参考。Coronavirus disease 2019(COVID-19)has become a worldwide pandemic,which poses a serious threat to all human beings.In response to this global public health crisis,the development and vaccination of vaccines are underway.Currently,19 vaccines have been included in the World Health Organization(WHO)emergency use assessment list,their effectiveness and safety have also attracted widespread attention.Based on data from phase III clinical trials and real-world studies,this paper presents a comprehensive evaluation of the efficacy and safety of eight vaccines on the emergency use evaluation list,which including inactivated vaccines,mRNA vaccines,viral vector vaccines and protein subunit vaccines.Hopefully this paper provides a reference for the clinical application and clinical safety monitoring of vaccines.

关 键 词：新型冠状病毒疫苗 新型冠状病毒肺炎 Ⅲ期临床试验 真实世界研究 安全性 有效性 

分 类 号：R186[医药卫生—流行病学] R978.7[医药卫生—公共卫生与预防医学]