FDA Grants Full Approval to Pfizer's COVID Vaccine

The Pfizer COVID-19 vaccine is the first to receive full approval from the Food and Drug Administration, and experts hope it will reassure people who were hesitant to get vaccinated

Pfizer Covid-19 Vaccination
Pfizer COVID-19 vaccine. Photo: Justin Tallis - Pool / Getty

The Food and Drug Administration has granted full approval to Pfizer's COVID-19 vaccine, making it the first of the three approved U.S. vaccines to receive the designation.

Pfizer's vaccine previously had an emergency use authorization, and while it was heavily tested to ensure it was safe for use, health experts hope that the full approval will further reassure Americans who were hesitant to get vaccinated.

"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," acting FDA Commissioner Janet Woodcock said in a statement.

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The designation also gives colleges, hospitals and companies more leeway to enact vaccine requirements. Soon after the FDA announcement, New York City said they would now require all teachers and school staff to get vaccinated.

Despite the vaccine's proven safety, the lack of full FDA approval had become an argument from unvaccinated people as to why they wouldn't get inoculated, and the hope is that this additional testing and certification will change minds. In a June poll from the Kaiser Family Foundation, 31% of unvaccinated people said that they would be more likely to get vaccinated after the full FDA approval.

"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," Woodcock said. "Today's milestone puts us one step closer to altering the course of this pandemic in the U.S."

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Pfizer's FDA approval is for people aged 16 and up. The vaccine is still under emergency use approval for kids aged 12 to 15 as the FDA continues to fully vet the shot.

Moderna's COVID-19 vaccine is also expected to receive full FDA approval in the coming weeks.

As of Aug. 23, just over 60% of Americans have received at least one dose of a COVID-19 vaccine, and 51.5% are fully vaccinated, according to the Centers for Disease Control. Of the eligible population, those aged 12 and up, 71% have received at least one dose and 60.2% are fully vaccinated.

The majority of COVID-19 vaccine doses administered in the U.S. — nearly 205 million — have been the Pfizer vaccine.

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