The Food and Drug Administration issued full approval to the Pfizer-BioNTech COVID-19 vaccine on Monday morning, marking the first time a vaccine against the disease caused by the novel coronavirus pandemic has been given the stamp of approval from regulators.
The vaccine, which was granted FDA emergency use authorization in December, will now be marketed under the name Comirnaty for Americans 16-years-old or older.
“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 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.,” she said.
Data from the Centers for Disease Control and Prevention shows that 170 million people in the United States have already been fully vaccinated against COVID-19, and over 201 million people have received at least one dose of vaccine. – READ MORE