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[欧盟获批的新冠疫苗概述——从技术、临床试验到注册]

[Overview of COVID-19 vaccines licensed in the EU-from technology via clinical trial to registration].

作者信息

Hildt Eberhard

机构信息

Abteilung Virologie, Paul-Ehrlich-Institut, Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel, Paul-Ehrlich-Straße 51-59, 63225, Langen, Deutschland.

出版信息

Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2022 Dec;65(12):1237-1243. doi: 10.1007/s00103-022-03600-4. Epub 2022 Oct 18.

Abstract

Currently (as of July 2022), six different COVID-19 vaccines are licensed in the EU. These include two mRNA-based vaccines (BNT162b2, Comirnaty® and mRNA-1273, Spikevax®), two adenoviral vector-based vaccines (AZD1222, Vaxzevria® and Ad26.COV2.S, Jcovden®), the subunit vaccine Nuvaxovid® (NVX-CoV2373), and the inactivated virus vaccine VLA2001. Although these vaccines are based on different technologies, they all share the use of the spike protein of SARS-CoV‑2 as antigen.This overview describes the characteristics of their composition, their efficacy, and the impact of various factors on efficacy. Another aspect of this overview is the description of the approval process and the identification of factors that have contributed to the unprecedented speed in the development and approval of vaccines against a pandemic pathogen.

摘要

目前(截至2022年7月),欧盟已批准六种不同的新冠疫苗。其中包括两种基于信使核糖核酸的疫苗(BNT162b2,商品名Comirnaty®;以及mRNA-1273,商品名Spikevax®),两种基于腺病毒载体的疫苗(AZD1222,商品名Vaxzevria®;以及Ad26.COV2.S,商品名Jcovden®),亚单位疫苗Nuvaxovid®(NVX-CoV2373),以及灭活病毒疫苗VLA2001。尽管这些疫苗基于不同技术,但它们都使用严重急性呼吸综合征冠状病毒2(SARS-CoV-2)的刺突蛋白作为抗原。本概述介绍了这些疫苗的成分特点、功效以及各种因素对功效的影响。本概述的另一个方面是描述审批过程,并确定促成针对大流行病原体的疫苗以前所未有的速度研发和获批的因素。

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