Photo: John Angelillo/UPI
The Food and Drug Administration on Monday gave full regulatory approval to the COVID-19 vaccine produced by Pfizer and BioNTech, making it the first coronavirus vaccine in the United States to receive the agency's highest mark of approval.
The FDA, as expected, announced the approval of the shot about eight months after it issued emergency use authorization, a step that allowed people in the United States to begin receiving the vaccine.
"The FDA's approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic," Acting FDA Commissioner Dr. Janet Woodcock said in a statement. "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."
Woodcock noted that the approval means the vaccine meets "rigorous scientific standards" that were also required for emergency authorization in December.
Millions of unvaccinated people in the United States have cited the lack of full FDA approval as a factor in their decision not to receive the shot.
"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 added.
U.S. Surgeon General Dr. Vivek Murthy said Sunday that full FDA approval of Pfizer's vaccine should lead to increased vaccination numbers and more vaccine mandates from businesses and other entities.