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疫苗“争夺战”打响,英国最先批准辉瑞新冠疫苗

发布者: 千缘 | 发布时间: 2020-12-6 01:18| 查看数: 100| 评论数: 0|



Britain has approved Pfizer's COVID-19 vaccine for emergency use.

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.

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.

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.

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."

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."

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.

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.

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."

British regulators are also considering another vaccine, developed by AstraZeneca and the University of Oxford.

Who is first in line for the vaccine?

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.

"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.

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.

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.

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.

I'm Jonathan Evans.

rigorous

[ˈrɪɡərəs]

adj.谨慎的;细致的;彻底的;严格的

rollout

[ˈroʊˌlaʊt]

n.首次展示


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