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A vial of the Pfizer-BioNTech coronavirus disease (COVID-19) vaccine. Courtesy of REUTERS/Dado Ruvic

First COVID vaccine gets full FDA authorization

FDA gives full approval to Pfizer-BioNTech COVID-19 vaccine

August 23, 2021

The FDA gave full approval for the Pfizer-BioNTech COVID-19 vaccine on August 23rd. The Pfizer vaccine is the first COVID vaccine to receive this approval. It is the only vaccine approved for those between the ages of 12 and 18. The vaccine was granted emergency use approval in December 2020 in the United States.

The Pfizer-BioNTech COVID-19 vaccine has now been fully approved for those of 16 years of age and older. It requires two shots three weeks apart to be fully effective. The vaccine is still under emergency use authorization for children 12 to 15.

Acting FDA Commissioner Janet Woodcock said in an official statement, “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.”

According to Our World in Data, 52% of the U.S. population is vaccinated against COVID-19. Many of the vaccine-hesitant have cited the lack of full FDA approval of any COVID vaccine as their reason for not receiving a vaccine.

With the new approval, many more Americans may choose to receive a COVID vaccine. After fully authorizing the Pfizer vaccine, the FDA may soon allow for children under 12 to receive the vaccine. This also opens up the possibility for vaccines to be mandated in places of work, schools, and government properties.


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