Updated Aug 23, 2021 - Health

FDA grants full approval to Pfizer's COVID vaccine

A vial of the Pfizer-BionTech COVID-19 vaccine
Photo: Marcos del Mazo/LightRocket via Getty Images

The Food and Drug Administration on Monday granted full approval to the Pfizer-BioNTech coronavirus vaccine for those aged 16 and older.

Why it matters: It's the first COVID-19 vaccine to receive full authorization from the federal government. Experts hope the approval will encourage more unvaccinated people in the U.S. to get the shot, especially as the country experiences a surge in COVID cases largely driven by the Delta variant.

  • The full authorization is expected to usher in a wave of new vaccine mandates by local governments and businesses, per the New York Times.
  • It also comes less than a week after the Biden administration announced that booster shots will be available to many vaccinated people beginning Sept. 20, if the plan is approved by the FDA.

What they're saying: “The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic," acting FDA commissioner Janet Woodcock said in a statement.

  • "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,” Woodcock added.
  • "Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S."

Pfizer CEO Albert Bourla echoed Woodcock, saying the "approval for those aged 16 and over affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed."

  • "I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity," he added.

By the numbers: About 62.4% of adults in the U.S. were fully vaccinated as of Sunday morning, according to the Centers for Disease Control and Prevention.

  • The U.S. has recorded more than 37.7 million confirmed coronavirus cases and over 628,500 deaths since the pandemic began, per Johns Hopkins University data.

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Editor's note: This story has been updated with additional details.

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