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The Federal Drug Administration has given full approval to Pfizer’s COVID-19 vaccine for all adults, making it the first vaccine to get full federal approval in the U.S.
The landmark moment could convince some vaccine-hesitant people to get their shot—and may foreshadow a jump in new vaccine mandates to battle the pandemic.
“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,” acting FDA commissioner Janet Woodcock said in a statement.
The Pfizer-BioNTech COVID-19 Vaccine has now been fully approved for all people 16 years of age and older, and requires two shots three weeks apart. The vaccine remains under emergency use authorization for people aged 12 to 15.
The FDA’s official approval could give more momentum to COVID-19 vaccine mandates as the U.S. attempts to battle a surge in cases driven by the Delta variant as well as vaccine hesitancy. Mandates for FDA-approved vaccines have long been accepted for public schools, universities, workplaces and elsewhere, but vaccines which only had emergency use authorization rarely made the cut for those mandates.
The approval could also convince some people who have remained hesitant about the vaccine because of concerns that it was rushed.
The FDA had come under criticism for not fully approving the vaccine sooner, even though millions of doses have been administered in the U.S. But the agency insisted on a full six months of data from its clinical trials before it would officially grant approval. The two other widespread COVID-19 vaccines, Moderna and Johnson & Johnson, have yet to get full FDA approval, though they’re likely coming soon.
“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,” Woodcock said in her statement.