Pfizer-BioNTech's COVID-19 vaccine becomes the first to score full FDA approval

Pfizer-BioNTech’s Comirnaty becomes the first vaccine candidate to obtain full approval from the FDA.

Today, the United States’ Food and Drug Administration (FDA) granted full approval to the Pfizer-BioNTech’s COVID-19 vaccine – the first vaccine to be approved by the agency. It will be marketed as Comirnaty, to prevent COVID-19 disease in individuals 16 years of age and older. The greenlight is expected to pave the way for other vaccines. “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.

The Pfizer-BioNTech COVID-19 vaccine has been made available to individuals 16 years of age and older since December last year under Emergency Use Authorization (EUA). In May 2021, the authorization was subsequently expanded to include those aged 12 to 15 years. Though millions of Americans have already received the vaccine, the approval will be expected to boost confidence in the vaccines. “EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product’, read a statement from the FDA.