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

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。

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.