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美国批准用于紧急使用的COVID-19疫苗综述。

Review of COVID-19 Vaccines Approved in the United States of America for Emergency Use.

作者信息

Vasireddy Deepa, Atluri Paavani, Malayala Srikrishna Varun, Vanaparthy Rachana, Mohan Gisha

机构信息

Department of Pediatrics, Pediatric Group of Acadiana, Lafayette, LA, USA.

Bay Area Hospital, Coos Bay, OR, USA.

出版信息

J Clin Med Res. 2021 Apr;13(4):204-213. doi: 10.14740/jocmr4490. Epub 2021 Apr 27.

Abstract

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel coronavirus causing a global pandemic. Coronaviruses are a large family of single-stranded ribonucleic acid (RNA) viruses. The virus has four essential structural proteins which include the spike (S) glycoprotein, matrix (M) protein, nucleocapsid (N) protein and small envelope (E) protein. Different technologies are being used for vaccine development to battle the pandemic. There are messenger ribonucleic acid (mRNA)-based vaccines, deoxyribonucleic acid (DNA) vaccines, inactivated viral vaccines, live attenuated vaccines, protein subunit-based vaccines, viral vector-based vaccines and virus-like particle-based vaccines. Vaccine development has five stages. In the clinical developmental stage, vaccine development can be sped up by combining phase 1 and 2. The vaccines can also be approved more swiftly on an emergent basis and released sooner for usage. The United States Food and Drug Administration (USFDA) has approved Pfizer-BioNTech, Moderna and Janssen coronavirus disease 2019 (COVID-19) vaccines for emergency use. There are other vaccines that have been approved around the world. The mRNA vaccines have been created using a novel technology and they contain a synthetically created RNA sequence of virus fragments encoding the S-protein which is injected. These vaccines have a relatively low cost of production and faster manufacturing time but can have comparatively lower immunogenicity and more than one dose of vaccine may be required. In the case of viral vector-based vaccines, genes encoding the SARS-CoV-2 S protein are isolated and following gene sequencings are introduced into the adenovirus vector. These vaccines have a relatively fast manufacturing time but the efficacy of the vaccine is variable based on the host's immune response to the viral vector. At the time of this paper, there were 81 vaccines in clinical development stage and 182 vaccines in preclinical development stage. Vaccines are an essential tool in our battle against COVID-19. Some of the COVID-19 vaccines have completed their phase III trials while many other potential vaccines are still in developmental stages. It used to take close to a decade for a vaccine to be developed and undergo rigorous testing until its production and availability to the public, but over the past year, we have seen multiple vaccines in different phases of testing against SARS-CoV-2 virus.

摘要

严重急性呼吸综合征冠状病毒2(SARS-CoV-2)是一种引发全球大流行的新型冠状病毒。冠状病毒是一大类单链核糖核酸(RNA)病毒。该病毒有四种重要的结构蛋白,包括刺突(S)糖蛋白、基质(M)蛋白、核衣壳(N)蛋白和小包膜(E)蛋白。为抗击这一疫情,人们正在使用不同技术来研发疫苗。有基于信使核糖核酸(mRNA)的疫苗、脱氧核糖核酸(DNA)疫苗、灭活病毒疫苗、减毒活疫苗、基于蛋白亚单位的疫苗、基于病毒载体的疫苗和基于病毒样颗粒的疫苗。疫苗研发有五个阶段。在临床研发阶段,可以通过将1期和2期合并来加快疫苗研发。疫苗也可以在紧急情况下更快获得批准并更快投入使用。美国食品药品监督管理局(USFDA)已批准辉瑞-生物科技公司、莫德纳公司和杨森公司的2019冠状病毒病(COVID-19)疫苗用于紧急使用。世界其他地区也有其他疫苗获得批准。mRNA疫苗是利用一种新技术研制的,它们含有一段人工合成的编码所注射S蛋白的病毒片段RNA序列。这些疫苗生产成本相对较低,生产时间较快,但免疫原性可能相对较低,可能需要接种多剂疫苗。对于基于病毒载体的疫苗,会分离出编码SARS-CoV-2 S蛋白的基因,并在基因测序后将其引入腺病毒载体。这些疫苗生产时间相对较快,但疫苗的疗效会因宿主对病毒载体的免疫反应而有所不同。在撰写本文时,有81种疫苗处于临床研发阶段,182种疫苗处于临床前研发阶段。疫苗是我们抗击COVID-19的重要工具。一些COVID-19疫苗已经完成了III期试验,而许多其他潜在疫苗仍处于研发阶段。过去,一种疫苗从研发到经过严格测试直至生产并可供公众使用通常需要近十年时间,但在过去一年里,我们看到了多种针对SARS-CoV-2病毒处于不同测试阶段的疫苗。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/687f/8110223/abd0335d3b35/jocmr-13-204-g001.jpg

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