FDA grants full approval to Pfizer-BioNTech COVID-19 vaccine

The U.S. Food and Drug Administration on Monday gave full approval to the COVID-19 vaccine made by Pfizer Inc and German partner BioNTech SE for use in people over the age of 16, in first such approval of a COVID-19 shot.

The vaccine has been authorized for emergency use since December and more than 204 million people in the United States have received it, based on Sunday's data. But none of the three authorized COVID-19 vaccines had previously received full FDA approval.

Public health officials hope it will convince more unvaccinated Americans that Pfizer's shot is safe and effective. Vaccine hesitancy among some Americans has hindered the United States response to the novel coronavirus.

"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," said Janet Woodcock, the U.S. Food and Drug Administration's acting commissioner.

Roughly 51% of Americans have been fully vaccinated so far, even as a recent surge of infections spurred by the contagious Delta variant ravages parts of the country with low vaccination rates.

(Reporting by Michael Erman in New Jersey and Manas Mishra in Bangalore; Editing by Sriraj Kalluvila)