FDA grants full approval for Pfizer vaccine
The Food and Drug Administration on Monday granted full approval of the Pfizer vaccine, becoming the first COVID-19 vaccine to transition from an emergency authorization status to full FDA approval.
The full approval indicates that Pfizer has shown enough effectiveness and safety data to meet the stringent Biologics License Application requirements, which includes at least six months of safety data from a majority of the volunteers in a large, final stage clinical trial.
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Pfizer's full approval will pave the way for further vaccine mandates in both the public and private sector. Some businesses and state leaders have held off thus far, signaling they'd wait for full approval before imposing tighter requirements.
Federal, state and local health officials have also expressed optimism that full approval will help dissolve some of the lingering hesitancy around taking a shot that until now has been only authorized for emergency use.
Acting FDA Commissioner Janet Woodcock called Monday's announcement a "pivotal moment" made possible by a "rigorous and thorough review" done in record time.
"Working around the clock, FDA staff were able to complete the evaluation of this biologics license application in just over three months," she said. "This is an unprecedented timeline given the volume of review and the meticulous manner in which it was done, but we want to underscore that our efforts to move as quickly as possible have in no way sacrifice scientific standards for the integrity of our process."
President Joe Biden said Monday, "If you're one of the millions of Americans who've said that they will not get the shot until it has full and final approval of the FDA -- it has now happened.
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-ABC News' Sasha Pezenik