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News > World

FDA Grants Full Approval to Pfizer’s COVID-19 Vaccine

  • Vaccination center in Marin County, California, U.S., Aug. 23, 2021.

    Vaccination center in Marin County, California, U.S., Aug. 23, 2021. | Photo: Twitter/ @maringov

Published 24 August 2021
Opinion

"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.

The U.S. Food and Drug Administration (FDA) on Monday granted full approval to the Pfizer/BioNTech COVID-19 vaccine for people age 16 and older.

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"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.

"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.," he added.

“Pfizer said the U.S. is the first country to grant full approval of its vaccine, in a process that required a 360,000-page application and rigorous inspections. Never before has the FDA has so much evidence to judge a shot's safety,” AP reported, adding that the Pfizer vaccine will now be marketed as "Comirnaty".

The vaccine also continues to be available under emergency use authorization, including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

The Pfizer/BioNTech vaccine has been authorized for emergency use in the United States since mid-December for people age 16 and older. In May, the authorization was extended to those 12 and older.

As of Tuesday, the United States had reported 38,814,596 COVID-19 cases and 646,667 related deaths. So far 51.5 percent of the U.S. population has been fully vaccinated, according to Centers for Disease Control and Prevention data.

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