摘要
应对新型冠状病毒肺炎(COVID-19)疫情防控的迫切需求,核酸疫苗以其快速高效的优点得到了疫苗研发领域的高度重视,特别是信使核糖核酸(mRNA)疫苗的研发进程显著加快,首次获批上市并在人体中使用。本文从核酸疫苗及相关技术概念、研发轨迹与发展趋势等方面总结梳理核酸疫苗的研发态势,辨识核酸疫苗特征,分析COVID-19疫情对mRNA疫苗研究的促进作用,梳理核酸疫苗拓展应用的主要领域,针对可能存在的技术性、安全性问题开展深入讨论。研究建议,从改良目的基因表达、完善递送系统、提高免疫应答、增强mRNA稳定性及易存性等方面着手,着力开展核酸疫苗的关键技术开发;严格监管核酸疫苗的安全性和有效性;引导利益相关方对具有安全性风险、可能对肿瘤与传染病防控带来颠覆性影响的mRNA疫苗技术开展改进研究,注重技术研发的前瞻布局并促进应用转化。
Considering the urgent needs of coronavirus disease 2019(COVID-19)epidemic prevention and control,nucleic acid vaccine has attracted great attention in the vaccine research and development(R&D)field owing to its high efficiency and good efficacy.Particularly,the R&D process of messenger RNA(mRNA)vaccine has significantly accelerated,and the mRNA vaccine was approved for the first time to be marketed and used in humans.This article first summarizes the R&D status of nucleic acid vaccines from the aspects of related technical concept,R&D path,and development trend,and identifies the characteristics of nucleic acid vaccines.Subsequently,it analyzes the impact of COVID-19 outbreak on the mRNA vaccine research,summarizes the main fields of application of nucleic acid vaccines,and studies the possible technical and safety problems.Furthermore,we suggest that the key technologies of nucleic acid vaccines should be developed by improving the target gene expression,delivery system,immune response,and mRNA stability and storage.Moreover,the safety and efficacy of nucleic acid vaccines should be strictly monitored;stakeholders should conduct research on mRNA vaccine technologies that have safety risks and potentially disruptive effects on cancer and infectious disease prevention and control;and a forward-looking technological layout and technical transformation should be emphasized.
作者
李爱花
杨雪梅
孙轶楠
苑亚坤
杨俊涛
Li Aihua;Yang Xuemei;Sun Yinan;Yuan Yakun;Yang Juntao(Institute of Medical Information,Chinese Academy of Medical Sciences,Beijing 100020,China;Chinese Academy of Medical Sciences,Beijing 100005,China)
出处
《中国工程科学》
CSCD
北大核心
2021年第4期153-161,共9页
Strategic Study of CAE
基金
中国工程院咨询项目“工程科技颠覆性技术战略研究(二期)”(2019-ZD-27)。
