Pfizer Vaccine Approved in Britain, Next up US, Europe
2020-12-03
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1Britain has approved Pfizer's COVID-19 vaccine for emergency use.
2Developed 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.
3China and Russia approved COVID-19 vaccines without waiting for results from large trials known as Phase 3 trials.
4Britain'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.
5The process permitted the agency to approve the vaccine in a short amount of time.
6The approval came just 12 days after Pfizer and BioNTech said they were requesting emergency use approval from regulatory agencies around the world.
7Final results from the large Phase 3 study found the vaccine to be 95 percent effective against COVID-19.
8Dr. June Raine, the chief executive of MHRA said, "The safety of the public will always come first."
9She 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."
10British Health Secretary Matt Hancock told the British Broadcasting Corporation that "help is on its way."
11He added, "When this vaccine is rolled out, things will get better. We will start that process next week."
12The U.S. Food and Drug Administration (FDA) will meet on December 10 to consider Pfizer's emergency use request.
13The agency will meet again on December 17 to look at American drug-maker Moderna's emergency use request for its vaccine.
14Speaking on the U.S. television news program Good Morning America Wednesday,
15Dr. Moncef Slaoui said he "would expect the FDA to reach a similar conclusion" that British officials had reached.
16In other words, he expects the FDA to approve Pfizer's request.
17Slaoui is head of the U.S. Operation Warp Speed program.
18The European Medicines Agency said it has received emergency use requests from both Pfizer and Moderna.
19The agency added its decision "could be issued within weeks."
20British regulators are also considering another vaccine, developed by AstraZeneca and the University of Oxford.
21Britain said it would start vaccinating high-risk groups using 800,000 shots from Pfizer's manufacturing center in Belgium early next week.
22The treatment requires two shots, which means about 400,000 Britons will receive the treatment this year.
23Pfizer has agreed to supply Britain with 40 million shots of vaccine through 2021.
24"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.
25In 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.
26The 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.
27The speed of the rollout will depend on how quickly Pfizer and BioNTech can manufacture the vaccine.
28The 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.
29The Pfizer-BioNTech vaccine must be stored and shipped at extremely cold temperatures of around minus 70 degrees Celsius.
30Pfizer said it has developed shipping containers that use dry ice to keep the vaccines cold.
31The containers are also equipped with GPS sensors to follow their movements.
32I'm Jonathan Evans.
1Britain has approved Pfizer's COVID-19 vaccine for emergency use. 2Developed 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. 3Britain'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. 4The 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. 5Dr. 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." 6British 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." 7The 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. 8Speaking 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. 9The 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." 10British regulators are also considering another vaccine, developed by AstraZeneca and the University of Oxford. 11Who is first in line for the vaccine? 12Britain 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. 13"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. 14In 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. 15The 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. 16The 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. 17I'm Jonathan Evans. 18Hai Do wrote this story for Learning English. Ashley Thompson was the editor. 19___________________________________________________________ 20Words in This Story 21rigorous - adj. very strict and demanding 22review - n. an act of carefully examining something 23emphasize - v. to give special attention to something 24assessment - n. the act of making a judgment about something 25conclusion - n. a final decision 26factor - n. something that helps produce or influence a result