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FDA grants full approval to Pfizer's COVID vaccine

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

  • "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.

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