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ACCELLERATED PROCESS DEVELOPMENT AND STOCKPILE FOR MERS, LASSA AND NIPAH VIRAL VACCINES

机译:MERS,LASSA和NIPAH病毒疫苗的加速流程开发和样本

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CEPI (the Coalition for Epidemic Preparedness Innovation) was launched in January 2017. The global need for CEPI emerged after the devastating Ebola crisis in 2014/15 that caused over 11,000 deaths and had an economic impact of at least $2.8 billion in the worst-affected countries alonei. The collective response to Ebola had fallen short, and it was evident we needed a better system to produce proven vaccines against known epidemic threats. A year ago at Davos, the governments of India and Norway and Guinea; the Bill & Melinda Gates Foundation, Wellcome and the World Economic Forum backed the creation of CEPI, an innovative partnership of public, private, philanthropic and civil society organizations, to provide a global insurance policy to defend against future epidemics. Through a call for proposal to vaccine developers, CEPI launched a portfolio of projects covering the development of MERS, Lassa and Nipah viral vaccines, based on WHO blueprint list of pathogens and in addition, a number of platform technologies are currently evaluated for the development of rapid response against unknown pathogens. In this paper, we introduce the CEPI process development, the vaccine technologies and stockpile strategies for MERS, Lassa and Nipah candidates in the CEPI portfolio. The cell lines, process and scale up portfolio strategies will be reviewed for emergency settings vs conventional vaccine process development. The emergency stockpile development strategy will be presented in this paper. In addition, we also highlight the critical areas of dialogue with regulatory authorities for the enhancement of use of experimental vaccine candidates in emergency settings for efficacy trials.
机译:CEPI(流行病防范创新联盟)于2017年1月成立。在2014/15年度埃博拉灾难性灾难之后,全球对CEPI的需求出现了,这场危机造成11,000多人死亡,并在受影响最严重的国家产生至少28亿美元的经济影响。国家(地区)i。对埃博拉病毒的集体反应未能兑现,很明显,我们需要一个更好的系统来生产针对已知流行病威胁的经验证的疫苗。一年前,在达沃斯,印度,挪威和几内亚等国政府;比尔和梅琳达·盖茨基金会,惠康基金会和世界经济论坛支持CEPI的创立,CEPI是公共,私人,慈善和民间社会组织的创新合作伙伴关系,旨在提供全球保险政策以抵御未来的流行病。通过向疫苗开发者征集建议,CEPI根据世卫组织病原体蓝图清单启动了一个涵盖MERS,Lassa和Nipah病毒疫苗开发的项目组合,此外,目前正在评估多种平台技术以开发疫苗。对未知病原体的快速反应。在本文中,我们介绍了CEPI产品组合中的MERS,Lassa和Nipah候选人的CEPI流程开发,疫苗技术和储备策略。与常规疫苗工艺开发相比,将针对紧急情况审查细胞系,工艺和扩大组合策略。本文将提出应急储备发展战略。此外,我们还强调了与监管机构进行对话的关键领域,以增强在紧急情况下进行功效试验所需的实验性疫苗的使用。

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