关注新型冠状病毒疫苗上市后的热点问题

叶鹏凌; 王鸣

关注新型冠状病毒疫苗上市后的热点问题

叶鹏凌^{1, 2,},
王鸣^{2, 3, ,}

1.
深圳赛诺菲巴斯德生物制品有限公司，北京 100022
2.
广州市预防医学会，广东广州 510440
3.
广州市疾病预防控制中心，广东广州 510440

详细信息

作者简介:
叶鹏凌，男，福建省漳州市人，医学硕士，高级医学联络官，主要从事疫苗医学事务工作，Email：jack.pengling@gmail.com

通讯作者:
王鸣，Tel：020–36055853，Email：wangming@gzcdc.org.cn

中图分类号: R211；R51；R373；R186
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出版历程
- 收稿日期: 2021-02-18
- 网络出版日期: 2021-09-24

Hot issues after marketing of COVID-19 vaccine

Ye Pengling^{1, 2
,},
Wang Ming^{2, 3
, ,}

1.
Shenzhen Sanofi Pasteur Biological Products Co., Ltd, Beijing 100022, China
2.
Guangzhou Municipal Preventive Medical Association, Guangzhou 510440, Guangdong, China
3.
Guangzhou Municipal Center for Disease Control and Prevention, Guangzhou 510440, Guangdong, China

More Information

Corresponding author: Wang Ming, Email: wangming@gzcdc.org.cn

摘要

摘要: 新型冠状病毒肺炎（COVID-19）疫情发生至今仍呈全球蔓延态势，提示自然状态下疫情仍将持续。虽然对新型冠状病毒（SARS-CoV-2）感染的治疗已取得一定进展，但仍不足以遏制疫情的发展。因此，人类将控制COVID-19疫情的希望寄托在疫苗的研发上。目前，多个COVID-19疫苗产品在完成Ⅲ期临床试验后应用于人群的免疫接种。大众对不同种类新冠疫苗的安全性、免疫原性、保护效力、免疫程序及病毒变异应对等问题十分关注。由于各研发机构采用不同的评价指标发布疫苗研发与应用的相关信息，媒体又从不同视角和口径进行解读，令大众和行内专家学者感到迷惑，对疫苗应用的效果产生疑虑。本综述收集、分析已公开的研究数据，就COVID-19疫苗研发现状及上市后应用的一些热点问题进行探讨。
- 新型冠状病毒 /
- 全球化蔓延 /
- 新型冠状病毒疫苗 /
- 人群免疫 /
- 研究热点
Abstract: The pandemic of COVID-19 continues to spread worldwide, suggesting that the epidemic would continue in natural state. Although some progress has been achieved in the treatment of COVID-19, it is far from containing the spread of the epidemic. Therefore, human beings have pinned their hopes of controlling the COVID-19 epidemic on the development of vaccines. Currently, several COVID-19 vaccine products have been applied to immunize the population after completion of phase Ⅲ clinical trials. The safety, immunogenicity, efficacy, immunization procedures and response to virus mutations of different COVID-19 vaccines are the great concern of the public. The public and experts in the field are confused about the efficacy of vaccines due to the different evaluation indicators used by research and development institutions in publishing vaccine development and application information and the interpretation by media from different perspectives and calibers. This paper summarizes the published research data and discusses the hot issues in development and post-marketing application of COVID-19 vaccine.
- Coronavirusdiseases2019 /
- Worldwide spread /
- Coronavirusdiseases2019 vaccine /
- Population/herd immunity /
- Research hot issues

HTML全文

表 1 不同技术路线研发新型冠状病毒肺炎疫苗的优劣势对比^［2］

Table 1. Advantages and disadvantages of different technical routes COVID-19 vaccine development

疫苗	抗原生产	优　点	缺　点
减毒活疫苗	体外	免疫原性强，效力时间长	研发速度缓慢，筛选难度较高
灭活疫苗	体外	技术相对成熟，安全性较高	研发和生产需要的硬件条件较高，免疫原性较低，常需与佐剂配合使用
重组蛋白疫苗	体外	免疫原性强，产品质量相对稳定	对抗原蛋白的纯度和稳定性要求较高
病毒载体疫苗	体外/体内	可呈递多种抗原，效率较高	广泛存在的预存免疫可能会影响免疫效果，有一定生物学风险
mRNA疫苗	体内	可呈递多种抗原，体内不长期留存	相对传统疫苗，疫苗疑似不良反应较多，如无合适载体则容易降解
DNA疫苗	体内	稳定，可呈递多种抗原，免疫时间持久	长时间留存有安全隐患

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