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news 8/23/2021, 10:12am

FDA issues full approval to Pfizer COVID-19 vaccine

By Staff Reports
FDA issues full approval to Pfizer COVID-19 vaccine

Prepared doses of the Pfizer COVID-19 vaccine sit on a table April 7, 2021, at IU Health Ball Memorial Hospital. Jaden Whiteman, DN File

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The United States Food and Drug Administration (FDA) issued full approval of the Pfizer-BioNTech COVID-19 vaccine Aug. 23, moving it up from its emergency-use authorization the vaccine has had since Dec. 11, 2020. The Pfizer vaccine is fully authorized for use for citizens ages 16 and older, and still under emergency-use authorization for those older than 12, according to an FDA press release.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic," said Acting FDA Commissioner Janet Woodcock, M.D. in the release. "While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product."

Pfizer’s vaccine was first granted emergency authorization on Dec. 11, 2020. In the following eight months, 51.5 percent of the U.S. population has received the vaccine, good for more than 170 million people in total, according to Centers for Disease Control and Prevention data.


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