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FDA chief says approval of Pfizer's COVID-19 vaccine imminent

By
Don Jacobson
UPS executive Wesley Wheeler holds a sample vial that will transport the Pfizer-BioNTech COVID-19 vaccine, at a logistics hearing Thursday on Capitol Hill in Washington, D.C. Photo by Samuel Corum/UPI/Pool
UPS executive Wesley Wheeler holds a sample vial that will transport the Pfizer-BioNTech COVID-19 vaccine, at a logistics hearing Thursday on Capitol Hill in Washington, D.C. Photo by Samuel Corum/UPI/Pool | License Photo

Dec. 11 (UPI) -- The Food and Drug Administration said Friday it will soon grant emergency use authorization for the COVID-19 vaccine developed by Pfizer and BioNTech, a key step toward distribution nationwide.

The FDA has informed the companies it will "rapidly work toward finalization and issuance of an emergency use authorization," FDA Commissioner Dr. Stephen Hahn said in a statement Friday.

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The FDA's vaccines committee voted to recommend approval for the Pfizer-BioNTech vaccine on Thursday. The agency isn't required to follow the recommendation, but it almost always does.

The vaccine developed by Pfizer and BioNTech has proven in late-stage clinical testing to be about 95% effective in blocking the novel coronavirus that causes COVID-19. Britain and Canada have approved the vaccine for emergency use and Britain began inoculating citizens on Tuesday.

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Hahn added Friday that he's informed the Centers for Disease Control and Prevention and the Trump administration's Operation Warp Speed that FDA approval for the vaccine is imminent, "so they can execute their plans for timely vaccine distribution."

Once the FDA grants authorization, a CDC advisory committee will determine if it's appropriate to begin inoculations. The CDC Advisory Committee on Immunization Practices will meet Friday and Sunday and officials told CNN the panel is expected to vote at Sunday's meeting.

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Once CDC Director Dr. Robert Redfield approves the panel's move, officials can begin distributing the vaccine.

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Operation Warp Speed officials have said initial shipments of the Pfizer-BioNTech vaccine will begin within 24 hours of final authorization.

Health and Human Services Administrator Alex Azar also said Friday that the first Americans could begin receiving initial does of the vaccine on Monday or Tuesday.

Some 20 million people could be vaccinated by the end of the month with another 50 million inoculated in January, he told ABC's Good Morning America.

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There are other coronavirus vaccines also in development. Moderna, AstraZeneca and Novavax are among the other companies developing a vaccine to resist COVID-19.

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