U.S. FDA Grants Full Approval to Pfizer/BioNTech COVID-19 Vaccine

The U.S. Food and Drug Administration (FDA) on Monday granted full approval to the Pfizer/BioNTech COVID-19 vaccine for people aged 16 and older.

 

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock in a statement. “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.,” said Woodcock.

 

According to the statement, 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 also continues to be available under emergency use authorization, including for individuals 12 through 15 years of age and for the administration of the third dose in certain immunocompromised individuals, said the statement.

The vaccine, known as the Pfizer/BioNTech vaccine earlier, has been authorized for emergency use in the United States since mid-December for people aged 16 and older. In May, the authorization was extended to those 12 and older.

As of Sunday, 51.5 percent of the total U.S. population were fully vaccinated, showed Centers for Disease Control and Prevention data.

 

Source: Xinhua