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Pfizer/BioNTech file for emergency approval for virus vaccine

Pfizer/BioNTech file for emergency approval for virus vaccine

AFP
Washington
Pfizer confirmed on Friday and that it and partner BioNTech have applied for emergency use authorization for their coronavirus vaccine, becoming the first to do so in the US or Europe as the pandemic rages around the world.
The vaccine has been developed with breathtaking speed -- just 10 months after the genetic code of the novel coronavirus was first sequenced.
“Yes. We have submitted,” a Pfizer spokesman told AFP, confirming the filing to the US Food and Drug Administration.
The announcement had been expected for several days, after the companies said that a completed study of trials of the product showed it was 95 percent effective in protecting people from infection. The announcement also confirms what BioNTech’s CEO told AFP Thursday.
“Filing in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” Pfizer CEO Albert Bourla said in an earlier statement.
The vaccine has been under evaluation for weeks in the European Union, Australia, Canada, Japan and the United Kingdom, the companies said.
“The companies will be ready to distribute the vaccine candidate within hours after authorization,” their statement said.
The Food and Drug Administration has not said how long it will take to study the vaccine data, but the government expects to give the green light for the vaccine in the first two weeks of December.
The European Union could also move quickly on the Pfizer-BioNTech vaccine, perhaps as soon as the second half of December, according to European Commission president Ursula von der Leyen.
Hot on the heels of these companies is a vaccine developed by another biotech firm, Moderna, which says its product is also about 95 percent effective.
The speed with which these vaccines have been developed as the pandemic wreaks havoc around the world has no precedent. Over the past decade, the vaccines authorized in the US have taken an average of eight years to develop.

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