On Tuesday, August 23, the U.S Food and Drug Administration (FDA) approved the Pfizer-BioNTech COVID-19 Vaccine, the first fully approved coronavirus vaccine.
According to a release, the vaccine will now be named and marketed as Comirnaty. The Pfizer vaccine is currently available to all individuals 16 and older. In addition, emergency use authorization (EUA) for immunocompromised individuals needing a third dose and for individuals aged 12-15 will still be available.
“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,” Acting FDA Commissioner Janet Woodcock, M.D., said. “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.”
The Pfizer vaccine has been available under EUA since the end of 2020, and the full FDA approval comes at an important time as schools and large-scale events are on the horizon for Fall 2021.