全球新型冠状病毒疫苗及治疗药物研发现状与趋势  

Global research and development of COVID-19 vaccine and therapeutics:status and trend

作　　者：郑楠 赵明[1] 田晓鑫[1] 陈頔[1] 张亚同[1] 金鹏飞[1] ZHENG Nan;ZHAO Ming;TIAN Xiao-xin;CHEN Di;ZHANG Ya-tong;JIN Peng-fei(Department of Pharmacy,Bejing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Science,Beijing Key Laboratory of Asssment of Clinical Drugs Risk and Individual Application(Beijing Hospital),Beijing 100730,China)

机构地区：[1]北京医院药学部国家老年医学中心,中国医学科学院老年医学研究院,北京市药物临床风险与个体化应用评价重点实验室(北京医院),北京100730

出　　处：《中国新药杂志》2022年第1期69-76,共8页Chinese Journal of New Drugs

基　　金：国家重点研发计划(2020YFC2008304)。

摘　　要：截至2021年5月,我国已附条件上市及获批紧急使用了6款新型冠状病毒疫苗(以下简称新冠疫苗)产品,其中包括4款新冠灭活疫苗产品、1款新冠腺病毒疫苗产品以及1款新冠重组疫苗产品。6款疫苗产品均在全球范围内进行了不同阶段的临床试验,临床研究结果在一定程度上证明了疫苗的安全性及预防新型冠状病毒肺炎(COVID-19)疫情的有效性。针对上述产品,本文深入总结了不同新冠疫苗产品的特点以及支持产品获批关键性证据的临床试验结果。此外,面对目前全球COVID-19疫情的严峻形势,分析了全球新冠疫苗及新冠治疗药物研发状况及挑战。As of May 2021, 6 new vaccines against coronavirus disease 2019(COVID-19) have been conditionally approved and urgently used in China, including products of 4 new inactivated vaccines, 1 new adenovirus vaccine and 1 new recombinant vaccine. All the six vaccine products have been under different stages of clinical trials in global scale, and the results of the clinical trials have demonstrated the safety of the vaccines and the efficacy against COVID-19. Focusing on the above products, this paper deeply summarizes the characteristics of different new vaccine products and the clinical trial results as the key evidence supporting the approval of the products. In addition, facing the current severe situation of COVID-19, the status and challenges regarding the research and development of new vaccines and therapeutics are analyzed.

关 键 词：灭活疫苗 腺病毒疫苗 重组疫苗 新冠疫苗临床试验 

分 类 号：R978.7[医药卫生—药品]