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Pfizer to Request Emergency Use Authorization from FDA for Coronavirus Vaccine

A person walks past the Pfizer Headquarters building in Manhattan, N.Y., November 9, 2020. (Carlo Allegri/Reuters)

Pfizer has announced that it will file a request on Friday with the U.S. Food and Drug Administration for emergency use authorization of its coronavirus vaccine.

The request comes after a Phase 3 clinical study showed Pfizer’s vaccine to be 95 percent effective in preventing the disease associated with the coronavirus.

“Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally,” Pfizer CEO and chairman Dr. Albert Bourla said in a statement Friday. “Filing in the U.S. 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.”

The drugmaker said it will be ready to distribute the vaccine within hours after authorization and plans to produce up to 50 million doses around the world by the end of the year and up to 1.3 billion doses by the end of next year.

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