On Monday, the Food and Drug Administration (FDA) granted full approval to the Pfizer COVID-19 vaccine, developed with its partner BioNTech, a long-awaited development that public health officials hope will persuade some people who remain hesitant about the vaccine to get the shot.
“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,” said Acting FDA Commissioner Janet Woodcock, M.D.
“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.,” Commissioner Woodcock added.
The vaccine is the first of the pandemic vaccines used in the United States to be granted full approval from the FDA. Up until now, Pfizer, Moderna, and Johnson & Johnson’s COVID-19 vaccines had been granted permission to be used under an Emergency Use Authorization (EUA).
The FDA said the vaccine was now approved for use in people ages 16 and up, the only group for which Pfizer now has the required six months of follow-up safety data. Study of the vaccine in 12- to 15-year-olds began later, and the six-month follow-up is still underway.
The vaccine will continue to be used in 12- to 15-year-olds under the emergency use authorization. Clinical trials are ongoing for use in children 11 and younger.
Monday’s approval “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.”
