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Pfizer Vaccine Approved in Britain, Next up US, Europe
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. China and Russia approved COVID-19 vaccines without waiting for results from large trials known as Phase 3 trials.
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.”
A technician inspects vials of coronavirus disease (COVID-19) vaccine candidate BNT162b2 at a Pfizer manufacturing site in manufacturing site in St. Louis, Missouri, U.S. in an undated photograph. (Pfizer/Handout via REUTERS)
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.
Vials of coronavirus disease (COVID-19) vaccine candidate BNT162b2 are inspected at a Pfizer manufacturing site in Kalamazoo, Michigan, U.S. in an undated photograph. (Pfizer/Handout via REUTERS)
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.
Hai Do wrote this story for Learning English. Ashley Thompson was the editor.
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Words in This Story
rigorous - adj. very strict and demanding
review - n. an act of carefully examining something
emphasize - v. to give special attention to something
assessment - n. the act of making a judgment about something
conclusion - n. a final decision
factor - n. something that helps produce or influence a result