邓涛,年悬悬,张家友,黄仕和,杨晓明
DENG Tao,NIAN Xuan-xuan,ZHANG Jia-you,HUANG Shi-he,YANG Xiao-ming

• 1:武汉生物制品研究所有限责任公司
• 2:国家联合疫苗工程技术研究中心
• 3:中国生物技术股份有限公司

摘要(Abstract)：

新型冠状病毒肺炎(Coronavirus Disease 2019,COVID-19)是由重症急性呼吸综合征冠状病毒2(severe acute respiratory syndrome coronavirus 2,SARS-CoV-2)感染引起的呼吸道传染病。COVID-19在全球范围的大流行造成了严重的公共卫生危机,已成为导致死亡的主要原因之一。为减轻COVID-19对公共健康和社会经济的影响,全球疫苗研发机构均在积极开发疫苗,目前上市的COVID-19疫苗包括灭活疫苗、病毒载体疫苗、mRNA疫苗和重组蛋白疫苗等多种类型。传统经典的灭活疫苗由于其生产工艺成熟、安全性良好、免疫原性稳定、可及性强,受到众多疫苗企业的青睐。目前已有多款COVID-19灭活疫苗获得紧急使用或批准附条件上市。本文就COVID-19灭活疫苗研发的毒种与细胞基质选择、生产工艺、临床前研究、对突变株的保护作用作一综述,并着重探讨COVID-19灭活疫苗的临床研究进展及其面临的挑战。
Coronavirus Disease 2019(COVID-19) is a respiratory infectious disease caused by severe acute respiratory syndrome coronavirus 2(SARS-CoV-2). The global pandemic of COVID-19 has caused an unprecedented public health crisis and become one of the main causes of death. In order to reduce the impact of COVID-19 on public health,economy and society,vaccine research and development institutions all over the world are actively developing vaccines. Currently,there are four types of COVID-19 vaccines on the market,including inactivated vaccine,viral vector vaccine,mRNA vaccine and recombinant protein vaccine. Traditional and classic inactivated vaccine is favored by many vaccine enterprises due to mature production process,good safety,stable immunogenicity and strong accessibility. At present,a number of inactivated COVID-19 vaccines have been approved for emergency use or conditional marketing. In this paper,the selection of virus seed and cell matrix,production technology,preclinical research,and protective effect on mutant of inactivated COVID-19 vaccine are summarized,and the clinical research progress and challenges of the vaccine are discussed.

关键词(KeyWords)： 新型冠状病毒肺炎;重症急性呼吸综合征冠状病毒2;灭活疫苗;临床试验;安全性;有效性
Coronavirus Disease 2019(COVID-19);Severe acute respiratory syndrome coronavirus 2(SARS-CoV-2);Inactivated vaccine;Clinical trial;Safety;Efficacy

Abstract:

Keywords:

基金项目(Foundation): 国家重点研发计划“2019-nCoV灭活疫苗”项目（2020YFC0842100）

作者(Author): 邓涛,年悬悬,张家友,黄仕和,杨晓明
DENG Tao,NIAN Xuan-xuan,ZHANG Jia-you,HUANG Shi-he,YANG Xiao-ming

DOI: 10.13200/j.cnki.cjb.003388

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