Developed by the American drug-maker Pfizer and Germany's BioNTech, it is the world's first COVID-19 vaccine to complete a rigorous and scientific vaccine development process. China and Russia approved COVID-19 vaccines without waiting for results from large trials known as Phase 3 trials.
这种疫苗由美国制药商辉瑞和德国生物科技公司BioNTech联合开发,它是世界上首个完成严格而科学的疫苗开发过程的新冠疫苗。中国和俄罗斯没等3期大型试验结果出来就批准了新冠疫苗。
Britain's Medicine and Healthcare Products Regulatory Agency (MHRA) said it used a "rolling review" to study as information became available from Pfizer during the trials. The process permitted the agency to approve the vaccine in a short amount of time.
英国药品和保健产品管理局表示,由于辉瑞公司试验期间的信息已经公布,因此它采用“滚动审查”进行研究。这一过程使得该机构得以在短时间内批准该疫苗。
The approval came just 12 days after Pfizer and BioNTech said they were requesting emergency use approval from regulatory agencies around the world. Final results from the large Phase 3 study found the vaccine to be 95 percent effective against COVID-19.
在辉瑞和BioNTech表示他们正向全球监管机构申请紧急使用授权仅仅12天之后,就在英国获得了批准。3期大型试验的最终结果发现,该疫苗对新冠肺炎的有效率为95%。
Dr. June Raine, the chief executive of MHRA said, "The safety of the public will always come first." She added, "And I emphasize again that this recommendation has only been given by the MHRA following the most rigorous scientific assessment of every piece of data."
英国药品和保健产品管理局首席执行官琼·蕾妮博士表示:“公众安全始终是第一位。”她还表示:“我再次强调,只有在对每条数据进行最严格的科学评估之后,英国药品和保健产品管理局才会给出这种建议。”
British Health Secretary Matt Hancock told the British Broadcasting Corporation that "help is on its way." He added, "When this vaccine is rolled out, things will get better. We will start that process next week."
英国卫生部长马特·汉考克对英国广播公司表示,“救星就要到了。”他还表示:“当这种疫苗推出时,情况就会好起来。我们将在下周开始接种过程。”
The U.S. Food and Drug Administration (FDA) will meet on December 10 to consider Pfizer's emergency use request. The agency will meet again on December 17 to look at American drug-maker Moderna's emergency use request for its vaccine.
美国食品和药品管理局将于12月10日开会审议辉瑞公司提交的紧急使用申请。该机构将于12月17日再次开会,研究美国莫德纳公司对其疫苗的紧急使用申请。
Speaking on the U.S. television news program Good Morning America Wednesday, Dr. Moncef Slaoui said he "would expect the FDA to reach a similar conclusion" that British officials had reached. In other words, he expects the FDA to approve Pfizer's request. Slaoui is head of the U.S. Operation Warp Speed program.
蒙塞福·斯劳伊博士周三在美国电视新闻节目《早安美国》上发表讲话时表示,他希望美国食品和药品管理局能够得出跟英国官员已经得出的类似结论。换句话说,他希望美国食品和药品管理局批准辉瑞公司的申请。斯劳伊是“美国曲速行动”的负责人。
The European Medicines Agency said it has received emergency use requests from both Pfizer and Moderna. The agency added its decision "could be issued within weeks."
欧洲药品管理局表示,它已经收到了辉瑞和莫德纳公司的申请。该机构还表示将在数周之内发布其决定。
British regulators are also considering another vaccine, developed by AstraZeneca and the University of Oxford.
英国监管机构还在审查另一种由阿斯利康公司和牛津大学联合开发的疫苗。
Who is first in line for the vaccine?
谁能优先接种疫苗?
Britain said it would start vaccinating high-risk groups using 800,000 shots from Pfizer's manufacturing center in Belgium early next week. The treatment requires two shots, which means about 400,000 Britons will receive the treatment this year. Pfizer has agreed to supply Britain with 40 million shots of vaccine through 2021.
英国表示将在下周初开始使用来自辉瑞公司比利时制造中心的80万支疫苗为高危人群接种。这种疫苗需要打两针,这意味着今年大约有40万英国人能够得到接种。辉瑞公司已经同意在2021年前向英国提供4000万支疫苗。
"Age is by far the single most important factor in terms of risk from COVID-19," said Wei Shen Lim, head of Britain's COVID-19 vaccine committee.
英国新冠疫苗委员会主席Wei Shen Lim表示:“就新冠肺炎的风险而言,年龄是迄今为止最重要的因素。”
In the United States, a government advisory group said Tuesday that health care workers and older people in nursing homes should be the first to receive the vaccine treatments. The U.S. is expected to receive 40 million shots of vaccine from Pfizer and Moderna by the end of this year, enough to vaccinate 20 million people.
美国一家政府咨询小组周二表示,养老院的医护人员和老年人应该首批接种疫苗。到今年年底,美国有望从辉瑞和莫德纳公司获得4000万支疫苗,足够为2000万人接种。
The speed of the rollout will depend on how quickly Pfizer and BioNTech can manufacture the vaccine. The drug-makers said they are adding another manufacturing center in Germany, in addition to two already in Germany, one in Belgium and one in the U.S.
疫苗接种速度将取决于辉瑞和BioNTech公司生产疫苗的速度。这些制药商表示,除了在德国现有两个,比利时和美国各一个制造中心,他们还将在德国新增另一个制造中心。
The Pfizer-BioNTech vaccine must be stored and shipped at extremely cold temperatures of around minus 70 degrees Celsius. Pfizer said it has developed shipping containers that use dry ice to keep the vaccines cold. The containers are also equipped with GPS sensors to follow their movements.
辉瑞和BioNTech公司联合推出的疫苗必须在大约零下70摄氏度的极低温下存储和运输。辉瑞公司称其已经开发出使用干冰让疫苗保持低温的运输容器。这些容器还配备了GPS传感器以跟踪其移动。