新型冠状病毒专题

新型冠状病毒肺炎疫苗临床研究进展

  • 靳卫平 申硕
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  • 武汉生物制品研究所有限责任公司病毒性疫苗研究一室, 430207;国家联合疫苗工程技术研究中心,武汉 430207

网络出版日期: 2025-08-16

基金资助

国家重点研发计划(2020YFC0842100、2020YFC0860600);2020年中央引导地方科技发展专项(Z135050009017)

The advance of COVID-19 vaccine development and clinical trials

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  • Research division 1 of Viral Vaccines,Wuhan Institute of Biological Products Co., Ltd., Wuhan 430207, China;National Engineering Technology Research Center of Combined Vaccines, Wuhan 430207, China

Online published: 2025-08-16

Supported by

National Program on Key Research Project of China (2020YFC0842100、2020YFC0860600); Joined Central/Hubei Governments Science and Technology Development Special Project (Z135050009017)

摘要

至2021年2月,新型冠状病毒引起的新型冠状病毒肺炎疫情全球大流行已造成1亿以上的报告病例和超过200万的致死病例。随着临床治疗、病理学、流行病学和病毒分子生物学研究取得进展,疫苗研发也获得了重大突破。目前已有多款疫苗完成初步的临床安全性和效力评估,并获得紧急使用或有条件上市批准。此文对研究进展较快的多种类型新型冠状病毒肺炎疫苗的临床研究结果进行分析,总结疫苗安全性、免疫原性和初步保护效力的临床研究结果,对疫苗面临的挑战和应对策略进行讨论和展望,重点描述和总结新型技术平台的mRNA疫苗及灭活疫苗的技术指标和特点。

本文引用格式

靳卫平 申硕 . 新型冠状病毒肺炎疫苗临床研究进展[J]. 国际生物制品学杂志, 2021 , 44(2) : 61 -68 . DOI: 10.3760/cma.j.cn311962-20210219-00006

Abstract

As of February of 2021, the COVID-19 globe pandemic caused by 2019 novel coronavirus infection has resulted in over 100 million reported cases and 2 million fatal cases worldwide. With the advance in studies on clinical treatment, pathology, epidemiology, and basic molecular biology of the pathogen, vaccine development has made great breakthroughs. Several COVID-19 vaccines have been granted emergency use or conditional license. This review analyzes the safety, immunogenicity and primary efficacy of more advanced candidate vaccines based on their clinical study results. The challenges and strategies of different kinds of vaccines are discussed, focusing on mRNA vaccine using novel technology platform and traditional inactivated vaccines.
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