The U.S. Food and Drug Administration (FDA) has given full approval to the Pfizer-BioNTech COVID-19 vaccine.
This is the first COVID-19 vaccine to get full approval from the FDA, and it's expected to lead to more vaccine mandates.
The vaccine, which was approved on Monday, and will now be marketed as Comirnaty for the prevention of COVID-19 disease in people 16 years of age and older.
Meanwhile, the vaccine is still available under emergency use authorization for people 12- to 15-years-old, as well as the administration of a third dose for those who are immunocompromised (beginning Sept. 20), the FDA says.
This news could help encourage some who have been hesitant to get vaccinated to get the shot.
It's also expected to pave the way for new COVID-19 vaccine mandates and will trigger the University of Minnesota's vaccine mandate.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic," Acting FDA Commissioner Janet Woodcock said in a statement. "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," Woodcock added. "Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
More than 170 million people in the U.S. are fully vaccinated against COVID-19, with more than 92 million of them receiving the Pfizer vaccine, which was the first to get emergency use authorization.
In Minnesota, 57.3% (3.47 million) of the more than 6 million COVID-19 doses administered in Minnesota have been Pfizer.
The two other vaccines that have emergency use authorization in the U.S. are the two-dose Moderna vaccine and the single-dose Johnson & Johnson (Janssen) vaccine. They have not yet gotten full approval from the FDA.