美国卫生与公众服务部
华盛顿哥伦比亚特区（Washington, D.C.）
2020年2月18日
[摘译]
为加速开发抗击2019新型冠状病毒的疫苗，美国卫生与公众服务部（U.S. Department of Health and Human Services）主管防备及应对的助理部长办公室（Office of the Assistant Secretary for
Preparedness and Response）已与赛诺菲（Sanofi）所属的全球性疫苗公司赛诺菲巴斯德（Sanofi Pasteur）进行接触。
隶属于主管防备及应对的助理部长办公室的生物医学高级研究与开发局（Biomedical Advanced Research and Development Authority）将提供专业技能以及重新调拨的经费来支持疫苗的研发。赛诺菲将利用其无鸡蛋成分的基因重组技术平台来生产一种应对2019新型冠状病毒的重组候选疫苗。
这种技术能对病毒蛋白做出精确的基因匹配。这种蛋白的DNA将与一种对人体无害的病毒的DNA组合，并用于快速生产大量的刺激免疫系统来抵御病毒的抗原。这些抗原将从这些细胞中经过分离和采集，并经过纯化，以产生用于进一步研发的疫苗工作原液。
生物医学高级研究与开发局局长瑞克·布莱特（Rick A. Bright）博士表示：“灵活性和可扩展性是快速应对一种新发传染病的基石。利用这种已经得到验证的技术。我们能够立即转而应对这种新型全球健康威胁。我们的目标是研发一种获得许可的疫苗，以提供长期的健康保障，抵御这种最新的病毒，并预防今后的冠状病毒爆发。”
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与赛诺菲的这种扩大合作是生物医学高级研究与开发局过去几周来着重于研发一种应对新型冠状病毒的候选疫苗的第二个项目。目前还没有针对新型冠状病毒感染的获得批准的疫苗、治疗或诊断方法；不过，美国食品和药物管理局（U.S. Food and Drug Administration）已发布了一项紧急使用授权（EUA），使疾病控制与预防中心（Centers for Disease Control and Prevention）研发的一种诊断测试能够得到紧急应用。
生物医学高级研究与开发局还正在与整个政府的有关部门合作，其中包括卫生与公众服务部内的部门以及国防部（Department of Defense）。这支团队正在审核来自公共和私营部门的潜在的疫苗、治疗和诊断方法，特别是研发中的用于中东呼吸系统综合症（Middle East Respiratory Syndrome）和严重急性呼吸系统综合症（Severe Acute Respiratory Syndrome）的产品，以找到有希望得到研发和许可的候选产品，来发现、抵御或治疗新型冠状病毒感染。
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U.S. Department of Health and Human Services
Washington, D.C.
February 18, 2020
Racing to develop a vaccine against the 2019 COVID-19, the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response has engaged Sanofi Pasteur, the vaccines global business unit of Sanofi.
The Biomedical Advanced Research and Development Authority (BARDA), a component of ASPR, will provide expertise and reallocated funds to support the vaccine’s development. Sanofi will use its egg-free, recombinant DNA platform to produce a recombinant COVID-19 vaccine candidate.
The technology produces an exact genetic match to proteins of the virus. The protein’s DNA will be combined with DNA from a virus harmless to humans, and used to rapidly produce large quantities of antigen which stimulate the immune system to protect against the virus. The antigens will be separated and collected from these cells and purified to create working stocks of vaccine for advanced development.
“Flexibility and scalability are cornerstones of rapid response to an emerging infectious disease,” said BARDA Director Rick A. Bright, Ph.D. “Using this proven technology, we can pivot immediately to address this new global health threat. Our goal is a licensed vaccine to provide long-term health security against this latest virus and prevent future coronavirus outbreaks.”
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This expanded collaboration with Sanofi is BARDA’s second program to focus on developing a COVID-19 vaccine candidate in the past few weeks. There is currently no approved vaccine, treatment, or diagnostic for COVID-19 infections; however, the U.S. Food and Drug Administration has issued an emergency use authorization (EUA) to enable emergency use of a diagnostic test developed by the Centers for Disease Control and Prevention.
BARDA also is working with counterparts across the government, including within HHS and with the Department of Defense. The team is reviewing potential vaccines, treatments and diagnostics from across the public and private sectors, particularly products in development for Middle East Respiratory Syndrome (MERS) or Severe Acute Respiratory Syndrome (SARS), to identify promising candidates for development and licensure to detect, protect against or treat COVID-19 infections.
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