文章摘要
高帆,李长贵,梁争论,徐苗.我国新型冠状病毒疫苗研发进展及思考[J].中国药事,2020,34(4):375-380
我国新型冠状病毒疫苗研发进展及思考
Research Progress and Consideration in the Novel Coronavirus Vaccine in China
投稿时间:2020-03-28  
DOI:10.16153/j.1002-7777.2020.04.001
中文关键词: 新型冠状病毒(SARS-CoV-2)  冠状病毒  疫苗
英文关键词: Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2)  coronavirus  vaccine
基金项目:
作者单位E-mail
高帆 中国食品药品检定研究院, 北京 102629  
李长贵 中国食品药品检定研究院, 北京 102629  
梁争论 中国食品药品检定研究院, 北京 102629 lzhenglun@126.com 
徐苗 中国食品药品检定研究院, 北京 102629 xumiaobj@126.com 
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中文摘要:
      新型冠状病毒(SARS-CoV-2)是继SARS冠状病毒(SARS-CoV)和中东呼吸综合征冠状病毒(MERS-CoV)之后又一严重危害人类的病毒。SARS-CoV-2引起的疾病被世界卫生组织命名为COVID-19,具有较高的传染性和病死率。为控制疫情蔓延,我国正应急开展多种技术路线的COVID-19疫苗研发,包括灭活疫苗、重组蛋白疫苗、病毒载体疫苗和核酸疫苗(DNA和mRNA)等,在加快疫苗研发进程的同时把握应急研发进度和科学性之间的平衡,并行解决相关科学问题,在满足安全性的前提下保证疫苗的有效性和质量可控。目前我国研发的腺病毒载体疫苗已率先进入Ⅰ期临床试验,多家企业进入注册检验和滚动提交审评资料阶段。本文对COVID-19疫苗研究进展进行综述,并提出现阶段对此种新疫苗研发的考虑。
英文摘要:
      Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is a novel virus threatening human health besides SARS coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERSCoV). The disease caused by SARS-CoV-2, with high infectivity and mortality, named as Coronavirus Disease 2019 (COVID-19) by World Health Organization. In order to control the spread of the COVID-19 epidemic, a variety of technical routes for COVID-19 vaccine research and development (R&D) are being carried out urgently in China, including inactivated vaccines, recombinant protein vaccines, viral vector vaccines and nucleic acid vaccines (DNA and mRNA). While accelerating the vaccine R&D process, we should get the right balance between the emergency R&D and scientificity, solve relevant scientific problems simultaneously, and guarantee the effectiveness and quality control of COVID-19 vaccine under the premise of ensuring safety. At present, the adenovirus vector vaccine developed in China has taken the lead in phase I clinical trials, and many Chinese manufacturers have entered the stage of registration test and rolling submission of review data. In this paper, the research progress in COVID-19 vaccine was reviewed, and the consideration of R&D for this new vaccine was put forward at the present stage.
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