August 23, 2021
The US Food and Drug Administration (FDA) has granted a biological license application, more commonly known as "full approval," to the Pfizer-BioNTech COVID-19 vaccine.
It is the first COVID-19 vaccine to be fully licensed in the US. It will be marketed under the trade name Comirnaty.
The approval applies to individuals ages 16 and older. The vaccine is still available for emergency use for those ages 12 through 15.
The FDA's stamp of approval is somewhat anticlimactic, following months of real-world use and millions of doses doled out to the general population. It comes after months of scrutiny by the agency of the clinical trial data.
Still, the approval puts the vaccines on firmer legal footing and is expected to spur a raft of new vaccination requirements by employers, schools, and universities.
Public health advocates have seen full approval as an important tool to increase vaccination rates in the US and had criticized the FDA for taking so long to grant the license. The agency resisted pressure to speed up its process, saying a thorough review was necessary to ensure public confidence.
"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, MD, in an FDA news release.
"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 US," Woodcock said.