The U.S. Food and Drug Administration formally approved the the Pfizer-BioNTech COVID-19 vaccine for the prevention of the coronavirus in people 16 years of age and older. The vaccine will remain available under emergency use authorization (EUA) for individuals 12-15 and for a third dose in “certain immunocompromised individuals.”
The vaccine has been available under EUA for people ages 16 and older since Dec. 11, 2020, and for those 12 and above starting May 10, 2021. The EUA is utilized during public health emergencies to make treatments more accessible after the FDA has determined the benefits of the product outweigh the risks.
“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.”
The FDA’s approval comes after clinical trial results determined that of the 22,000 people who received the vaccine and 22,000 people who received a placebo, the vaccine was 91% likely at preventing a coronavirus infection.
FDA approval for the Moderna vaccine is ongoing, and expected shortly.