vaccine manufacturing

疫苗生产
  • 文章类型: Journal Article
    预防性疫苗被认为是控制疫情爆发和预防大流行的最具成本效益和最有效的手段之一。然而,获得许可和制造人类使用疫苗的要求很复杂,昂贵的,而且耗时。2013-2016年埃博拉病毒病(EVD)疫情是迄今为止最大的埃博拉病毒病疫情,也是历史上第三次国际关注的突发公共卫生事件。所以为了防止大流行,来自公共和私营部门的众多合作伙伴共同努力和资源,尽快开发了一种研究性扎伊尔埃博拉病毒(EBOV)候选疫苗(rVSVΔG-ZEBOV-GP)。经过五年的开发,rVSVΔG-ZEBOV-GP疫苗于2019年12月被欧洲药品管理局(EMA)和美国食品和药物管理局(FDA)批准为ERVEBOTM。这篇综述描述了这种EBOV疫苗的开发计划,总结了人们对安全的了解,免疫原性,和功效,描述了程序中正在进行的工作,并重点介绍了适用于大流行疫苗开发的经验教训。
    Preventative vaccines are considered one of the most cost-effective and efficient means to contain outbreaks and prevent pandemics. However, the requirements to gain licensure and manufacture a vaccine for human use are complex, costly, and time-consuming. The 2013-2016 Ebola virus disease (EVD) outbreak was the largest EVD outbreak to date and the third Public Health Emergency of International Concern in history, so to prevent a pandemic, numerous partners from the public and private sectors combined efforts and resources to develop an investigational Zaire ebolavirus (EBOV) vaccine candidate (rVSVΔG-ZEBOV-GP) as quickly as possible. The rVSVΔG-ZEBOV-GP vaccine was approved as ERVEBOTM by the European Medicines Authority (EMA) and the United States Food and Drug Administration (FDA) in December 2019 after five years of development. This review describes the development program of this EBOV vaccine, summarizes what is known about safety, immunogenicity, and efficacy, describes ongoing work in the program, and highlights learnings applicable to the development of pandemic vaccines.
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