VOA慢速英语:Experimental Ebola Treatments Bypassing Usual Regulatory Hurdles

Researchers are hurrying to develop effective treatments and vaccines for Ebola. The disease has killed more than 4,500 people. Most of the victims lived in one of three West African countries - Guinea, Liberia or Sierra Leone.
研究人员正在加紧研制有效埃博拉的方法和疫苗。该病已经造成超过4500人死亡。多数受害者生活在几内亚、利比里亚和塞拉利昂这三个西非国家中的一个。

In the United States, the government's process for approving new drugs can often take years. But treatments for Ebola are moving quickly through the approval process.
在美国，政府审批新药的流程往往需要几年时间。但埃博拉疗法正在快速通过审批程序。

Before US government officials approve a new drug, researchers must perform detailed scientific tests, what are called clinical trials. The tests must be done on humanbeings to show that the experimental treatment is both safe and effective. These drug trials usually involve thousands of people and can take many years to complete.
在美国政府官员批准一种新药之前，研究人员必须进行细致的科学测试，即所谓的临床试验。这些试验必须是对人类进行，以表明这种实验性疗法既安全又有效。这些药物试验通常需要涉及成千上万的人，并耗费多年时间才能完成。

But there are exceptions. Thomas Geisbert is a microbiologist at the University of Texas medical branch in Galveston. He says the U.S. Food and Drug Administration can make an exception through what he calls its "animal rule." This enables researchers to get fast approval when faced with a deadly disease like the Ebola virus.
但也有例外。Thomas Geisbert是得克萨斯大学加尔维斯顿医学分部的一位微生物学家。他说，美国食品和药物管理局能够通过他所谓的“动物法则”破例。这使得研究人员能够在面对埃博拉病毒这种致命疾病时快速得到审批。

Mr Geisbert helped develop what is known as the VSV Ebola vaccine, this vaccine recently moved to human clinical trials at the Walter Reed Army Institute of Research in Maryland. The tests involve 20 healthy volunteers.
Geisbert先生帮助开发了所谓的VSV埃博拉疫苗。这种疫苗最近在马里兰州的沃尔特•里德陆军研究所转入了人体临床试验。试验涉及了20位健康的志愿者。

Mr Geisbert says that the animal rule requires only that scientists demonstrate that a treatment is effective in an animal model of human disease. This time, he says, the human model of disease was monkeys.
Geisbert先生称，动物规则仅要求科学家证明某种疗法对人类疾病的动物模型有效。他说，这次的疾病的人体模型是猴子。

"In conjunction with that, you do a conventional phase one trial. That's just a study where you put a vaccine or treatment into a healthy human volunteer just to make sure that you know in normal, healthy people that your vaccine or drug does not cause any disease or serious adverse event," Geisbert said.
Geisbert说，“与此相应我们进行第一阶段传统试验。这只是一次研究，我们把疫苗或疗法应用到健康人类志愿者身上，只是为了确保在健康的普通人身上，我们的疫苗或药物不会导致任何疾病或严重的不良反应。”

Another experimental drug called zMapp went straight from the laboratory to Ebola patients. The Food and Drug Administration also bypassed human safety trials to treat a handful of patients in the United States.
另一种被称为zMapp的实验性药物直接从实验室投入到治疗埃博拉病人。美国食品和药物管理局还绕过了人体安全性试验来治疗美国的少数患者。

Many researchers are hard at work to develop effective treatments and vaccines for Ebola. Canadian researchers made the VSV vaccine, which is now being tested in Maryland. The British drug company GlaxoSmithKline has made another promising but experimental vaccine.
许多研究人员都在努力研制有效的埃博拉疗法和疫苗。加拿大研究人员研制出了VSV疫苗，目前正在马里兰州进行试验。英国葛兰素史克制药公司研制出了另一种很有希望的实验性疫苗。

The safety of that vaccine is currently being tested in Mali. The West African nation shares a border with Guinea, where the virus has infected many people. As of now, no Ebola cases have been reported in Mali.
这种疫苗的安全性目前正在马里进行试验。这个西非国家毗邻很多人感染这种病毒的几内亚。但截至目前，马里没有任何埃博拉病例报告。

Researchers say, the promising vaccine will move into a more advanced human testing early next year. They will use these tests to show if the vaccine is safe for human use.
研究人员称，这种很有希望的疫苗将在明年年初转入更高级别的人体试验。他们将借助这些试验以表明，这种疫苗对人类应用是否安全。