新冠肺炎疫苗的研究现状及面临的挑战

doi:10.13560/j.cnki.biotech.bull.1985.2021-1042

摘要/Abstract

摘要：

2019年底爆发的新型冠状病毒肺炎（COVID-19）造成了全球范围内的社会和经济混乱,严重威胁着人类生命健康。随着世界各国在新冠肺炎疫苗开发上的不断努力,现已有多款疫苗获批紧急授权使用或注册上市。本文将对新冠肺炎大流行情况下国内外目前投入使用的11款疫苗的临床试验结果、安全性、有效性进行概述,并对当前疫苗研制及应用过程中面临的挑战进行简要分析。

关键词: 新冠肺炎, 上市/授权疫苗, 研发过程, 保护效力, 挑战

Abstract:

The outbreak of COVID-19 at the end of 2019 has caused social and economic chaos around the world,which is a serious threat to human life and health. With the continuous efforts of countries around the world in the development of COVID-19 vaccine,a number of vaccines have been approved for emergency use or registered on the market. This article summarizes the clinical trial results,safety and effectiveness of 11 vaccines currently used at home and abroad under COVID-19 pandemic,as well as briefly analyzes the challenges faced in the development and application of the current vaccine.

Key words: COVID-19, licensed vaccines, development process, protective efficacy, challenges

温亚亚, 宋丽, 汪巧菊, 潘志明, 焦新安. 新冠肺炎疫苗的研究现状及面临的挑战[J]. 生物技术通报, 2022, 38(7): 136-145.

WEN Ya-ya, SONG Li, WANG Qiao-ju, PAN Zhi-ming, JIAO Xin-an. Research Status and Challenges of COVID-19 Vaccine[J]. Biotechnology Bulletin, 2022, 38(7): 136-145.

图/表 3

参考文献 72

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疫苗名称 Vaccine	类型 Type	研发单位 Developer	上市时间 Time to market	总体保护率 Overall protective efficacy/%	中/重症保护率 Efficacy against moderate to severe diease/%	不良反应 Adverse reactions
BBIBP-CorV	灭活苗	北京生物制品研究所中国疾病预防控制中心	2020.12.30	79.34	100	注射部位疼痛红肿、疲劳、发热等,症状轻微。无与疫苗相关的严重不良事件
新冠肺炎灭活疫苗	灭活苗	武汉生物制品研究所武汉病毒研究所	2021.02.25	72.51	100
Ad5-nCoV	Ad5腺病毒载体疫苗	康希诺生物军事医学科学院	2021.02.25	57.50	91.70
CoronaVac	灭活苗	北京科兴中维	2021.02.05	67.00	89.00
ZF2001	二聚体亚单位 S疫苗	中国科学院微生物研究所、智飞生物	2021.03.10	81.43	100

疫苗名称 Vaccine	类型 Type	研发单位 Developer	上市时间 Time to market	总体保护率 Overall protective efficacy/%	中/重症保护率 Efficacy against moderate to severe diease/%	不良反应 Adverse reactions
BBIBP-CorV	灭活苗	北京生物制品研究所中国疾病预防控制中心	2020.12.30	79.34	100	注射部位疼痛红肿、疲劳、发热等,症状轻微。无与疫苗相关的严重不良事件
新冠肺炎灭活疫苗	灭活苗	武汉生物制品研究所武汉病毒研究所	2021.02.25	72.51	100
Ad5-nCoV	Ad5腺病毒载体疫苗	康希诺生物军事医学科学院	2021.02.25	57.50	91.70
CoronaVac	灭活苗	北京科兴中维	2021.02.05	67.00	89.00
ZF2001	二聚体亚单位 S疫苗	中国科学院微生物研究所、智飞生物	2021.03.10	81.43	100

疫苗名称 Vaccine	类型 Type	抗原 Target antigen	研发单位 Developer	上市时间 Time to market	总体保护率 Overall protective efficacy/%	中/重症保护率 Efficacy against moderate to severe diease/%	不良反应 Adverse reactions
BNT162b2	mRNA 疫苗	3LNP-mRNAs	美国辉瑞德国BioTech 上海复星医药	2020.12.11	95.0	/	接种疫苗后心肌炎和心包炎风险增加
mRNA-1273	mRNA 疫苗	S-2P	美国Moderna 美国国家过敏和传染病研究所	2020.12.18	94.1	100	接种疫苗后心肌炎和心包炎风险增加
Sputnik V	非复制型腺病毒载体疫苗	rAd26-S +rAd5-S	俄罗斯加马列亚流行病与微生物学国家研究中心	2020.08.11	91.6	100	注射部位疼痛红肿、疲劳、发热、肌肉疼痛等
Covaxin	灭活苗	/	印度巴拉特生物技术	2021.01.03	80.6	/	注射部位疼痛红肿、疲劳、发热、肌肉疼痛等
ChAdOx1 nCoV-19	非复制型腺病毒载体疫苗	ChAdOx-S	英国牛津大学阿斯利康公司	2020.12.30	76.0	100	两种疫苗接种后均出现罕见血栓案例。强生疫苗接种后格林-巴利综合征风险增加
Ad26.COV2.S	非复制型腺病毒载体疫苗	Ad26-S	美国强生公司	2021.02.27	/	66.1 / 85.4	两种疫苗接种后均出现罕见血栓案例。强生疫苗接种后格林-巴利综合征风险增加

疫苗名称 Vaccine	类型 Type	抗原 Target antigen	研发单位 Developer	上市时间 Time to market	总体保护率 Overall protective efficacy/%	中/重症保护率 Efficacy against moderate to severe diease/%	不良反应 Adverse reactions
BNT162b2	mRNA 疫苗	3LNP-mRNAs	美国辉瑞德国BioTech 上海复星医药	2020.12.11	95.0	/	接种疫苗后心肌炎和心包炎风险增加
mRNA-1273	mRNA 疫苗	S-2P	美国Moderna 美国国家过敏和传染病研究所	2020.12.18	94.1	100	接种疫苗后心肌炎和心包炎风险增加
Sputnik V	非复制型腺病毒载体疫苗	rAd26-S +rAd5-S	俄罗斯加马列亚流行病与微生物学国家研究中心	2020.08.11	91.6	100	注射部位疼痛红肿、疲劳、发热、肌肉疼痛等
Covaxin	灭活苗	/	印度巴拉特生物技术	2021.01.03	80.6	/	注射部位疼痛红肿、疲劳、发热、肌肉疼痛等
ChAdOx1 nCoV-19	非复制型腺病毒载体疫苗	ChAdOx-S	英国牛津大学阿斯利康公司	2020.12.30	76.0	100	两种疫苗接种后均出现罕见血栓案例。强生疫苗接种后格林-巴利综合征风险增加
Ad26.COV2.S	非复制型腺病毒载体疫苗	Ad26-S	美国强生公司	2021.02.27	/	66.1 / 85.4	两种疫苗接种后均出现罕见血栓案例。强生疫苗接种后格林-巴利综合征风险增加