FDA grants full approval to Pfizer-BioNTech’s Covid shot, to be called Comirnaty

The Food and Drug Administration has granted full approval to the Pfizer-BioNTech coronavirus vaccine for those aged 16 and older.

This is the first COVID-19 vaccine to receive full authorization from the federal government. Health officials and experts are hoping the approval will b e a catalyst for more people in the U.S. to vaccinate, especially as the country experiences a surge in COVID-19 cases. The Pfizer-BioNTech COVID-19 Vaccine, will now be marketed as Comirnaty (koe-mir’-na-tee).

The full authorization is also expected to usher in a wave of new vaccine mandates by local governments and businesses.

It also comes less than a week after the Biden administration announced that booster shots will be available to many vaccinated people beginning Sept. 20, if the plan is approved by the FDA.

“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, M.D. “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.”

Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021.

According to the Centers for Disease Control and Prevention, about 62.4% of adults in the U.S. are fully vaccinated.

The United States has recorded more than 37.7 million confirmed coronavirus cases and over 628,500 deaths since the pandemic began, according to Johns Hopkins University data.