The U.S. Food and Drug Administration (FDA) granted full approval to the Pfizer-BioNTech COVID-19 vaccine.
The approval on Monday is the first COVID-19 vaccine fully approved in the U.S.
The FDA said in a press release that the vaccine will now be marketed as Comirnaty “for the prevention of COVID-19 disease in individuals 16 years of age and older.”
The vaccine will continue to be under emergency use authorization for individuals who are between the ages of 12-15, as well “for the administration of a third dose in certain immunocompromised individuals.”
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” acting FDA Commissioner Janet Woodcock, M.D. said in a statement.
Woodcock continued:
“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. 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.”
Pfizer CEO Albert Bourla also expressed hope that “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,” according to The Hill.
The FDA’s announcement comes under four months after Pfizer-BioNTech filed for full approval.
According to the U.S. Centers for Disease Control and Prevention (CDC), 51.5% of the U.S. population is fully vaccinated, as of Sunday.