辉瑞公司将在数天之内申请新冠疫苗的紧急使用授权

    Drug-makers Pfizer and BioNTech said they are "within days" of seeking emergency use authorization for their COVID-19 vaccine from the U.S. Food and Drug Administration (FDA).
    制药商辉瑞公司和BioNTech公司表示,他们将在“数天之内”向美国食品和药品管理局申请新冠疫苗的紧急使用授权。

    Pfizer, an American company, and its German partner BioNTech said final results from the large Phase 3 study show the vaccine to be 95 percent effective against COVID-19.
    美国辉瑞公司及其德国合作伙伴BioNTech公司表示,3期大型研究的最终结果表明,该疫苗对新冠肺炎的有效率在95%以上。

    The drug-makers said there were 170 confirmed cases of COVID-19 in the study of 43,000 volunteers. Among the confirmed cases, eight received the experimental vaccine and 162 received a placebo – a shot with an inactive substance.
    这些制药商表示,在参与研究的4.3万名志愿者中,有170例新冠肺炎确诊病例。在这些确诊病例中,有8人接种了实验性疫苗,162接种了安慰剂,也就是注射了一种非活性物质。

    The FDA only requires that a vaccine be at least 50 percent effective to be considered for emergency use. The agency also wants the drug-makers to present two months of safety data from the trials, which Pfizer said it had done.
    美国食品和药品管理局要求疫苗有效率至少50%才能考虑用于紧急用途。该机构还希望制药商提供两个月的试验安全性数据,辉瑞表示它已经照做。

    Pfizer and BioNTech added that there were no serious safety concerns. They reported that the shot was also more than 94 percent effective in adults over the age of 65, a high-risk group.
    辉瑞和BioNTech公司还称其疫苗没有严重的安全隐患。他们报告称,在65岁以上年龄的高危人群中,这种疫苗的有效率也超过了94%。

    Andrew Hill is a researcher at the University of Liverpool's department of pharmacology. He told Reuters, "The 94 percent protection for older people is key. This is the evidence we needed to ensure that the most vulnerable people are protected."
    安德鲁·希尔是利物浦大学药理学系的研究员。他对路透社表示,“对老年人94%有效是关键。这是我们确保最脆弱人群得到保护所需要的证据。”

    Moderna, another American drug-maker, reported this week that early results showed its experimental vaccine to be 94.5 percent effective against COVID-19.
    另一家美国制药商莫德纳公司本周报告称,早期结果表明其实验性疫苗对新冠肺炎的有效率为94.5%。

    Neither company has published the results in scientific papers. But they are ready to share the information with the FDA and other regulatory agencies around the world.
    两家公司均未在科学论文中发表该结果。但是他们准备与美国食品和药品管理局以及全球其它监管机构共享信息。

    Both vaccine candidates use a new technology known as messenger RNA, or mRNA. To make an mRNA vaccine, scientists create a genetic material that directs the human body to produce antibodies that can recognize and destroy the new coronavirus. The new technology lets drug-makers develop and manufacture new treatments faster than traditional vaccines.
    这两种候选疫苗都采用了一种名为信使核糖核酸(mRNA)的新技术。为了生产这些信使核糖核酸疫苗,科学家创造了一种遗传物质,指导人体产生可以识别和破坏新冠病毒的抗体。这项新技术使得制药商能够开发和生产出比传统疫苗更快的新疫苗。

    Dr. Ugur Sahin is the chief executive co-founder of BioNTech. He said, "These achievements highlight the potential of mRNA as a new drug class."
    乌古尔·沙辛博士是BioNTech公司的首席执行官兼联合创始人。他说:“这些成就突出了信使核糖核酸作为一种新的药物类别的潜力。”

    He added, "We will continue to work with our partners and governments around the world to prepare for global distribution in 2020 and beyond."
    他还说:“我们将继续与世界各地的合作伙伴以及政府合作,为2020年及以后的全球分发做准备。”

    What's next?
    下一步怎么办?

    The two drug-makers said they could have as many as 70 million shots ready by the end of this year with the FDA's emergency approval.
    这两家制药商表示,如果获得美国食品和药品管理局的紧急批准,他们可以在今年年底前准备好高达7000万针疫苗。

    Both vaccines require two shots. That means 35 million people could receive them by the end of 2020. Health officials expect the first treatments to be given to health care workers and other high-risk groups.
    这两种疫苗都需要注射两次。这意味着到2020年底,将会有3500万人接受注射。卫生官员预期首批疫苗将提供给医护人员以及其他高危人群注射。

    Pfizer and BioNTech also reported they could produce up to 1.3 billion treatments in 2021. Moderna said it could have 1 billion available next year.
    辉瑞和BioNTech公司还报告称,他们能在2021年生产出高达13亿针疫苗。莫德纳公司表示他们明年能准备好10亿针疫苗。

    Pfizer is also developing temperature-controlled containers to ship its vaccine at minus-70 degrees Celsius. These containers can also be used for storage by refilling with dry ice.
    辉瑞公司还开发了可控温容器,以便在零下70摄氏度温度下运输其疫苗。这些容器也可以通过重新装满干冰用于储存。

    Moderna says its vaccine can be kept at temperatures of 2 to 8 degrees Celsius for 30 days. They can be stored for up to 6 months at minus-20 degrees Celsius.
    莫德纳公司表示,其疫苗可以在2到8摄氏度温度下保存30天。它们可以在零下20度温度下最多储存6个月。

    The two vaccine announcements have raised hopes as the health crisis worsens in many parts of the world. The virus has now infected nearly 56 million people and killed more than 1.3 million worldwide.
    随着这种健康危机在全球大部分地区恶化,这两种疫苗的发布燃起了人们的希望。新冠病毒现在已经感染了全球近5600万人口,并且导致130万人死亡。

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