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FDA Grants Full Approval for Pfizer COVID-19 Vaccine

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Pfizer-BioNTech  (PFE) - Get Pfizer Inc. Report COVID-19 vaccine has become the first vaccine to win the U.S. Food and Drug Administration's (FDA) full approval, meaning it's the first COVID-19 vaccine to be fully licensed for use in the U.S. 

On Monday, the U.S. Food and Drug Administration made the announcement of the approval of Pfizer's vaccine for the prevention of COVID-19 disease in individuals 16 years of age and older.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. 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,” said Acting FDA Commissioner Janet Woodcock in a statement.

 “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S,” Woodcock continued.

However, the agency says that the vaccine continues to be available under emergency use authorization, including for individuals 12 through 15 years of age.

Pfizer’s vaccine has been available for emergency use since Dec. 11. 2020.

Earlier, the Biden administration offered booster shots of Pfizer and Moderna for all Americans beginning the week of Sept. 20.

Related: COVID-19 Vaccine Booster Shots For All Americans Starting September 20 

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