Updated Aug. 23, 2021 at 12:03 p.m. to include information about the transition from emergency use authorization to formal authorization. 

The Food and Drug Administration formally approved Pfizer’s COVID-19 vaccine this morning. The decision replaces the emergency use authorization the FDA granted the vaccine last December and comes one week following the Centers for Disease Control and Prevention recommendation for booster shots of both Pfizer and Moderna vaccines.

When the FDA typically gives formal approval to a drug or vaccine, it means the agency has determined, based on substantial evidence, that the drug or vaccine is effective for its intended use and benefits of the product outweigh its risks when used according to the product’s approved labeling. This process can take up to several years. 

When the FDA granted emergency use authorization on the COVID-19 vaccine last December, they did so in response to the ongoing pandemic. According to the FDA, under an emergency use authorization and during an emergency, the FDA makes a product available to the public based on the best available evidence at that given time and continues to revise it when more information and data becomes available. 

While nearly 73% of adults in the US have received at least one dose of the Pfizer, Moderna or Johnson & Johnson vaccine, the approval could help those who are hesitant to get vaccinated feel safer.

“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," acting FDA Commissioner Janet Woodcock said in a statement. "Today's milestone puts us one step closer to altering the course of this pandemic in the U.S."

The authorization could also make it easier for organizations, universities and employers to require the COVID-19 vaccine, like Elon University chose to over the summer for students, but not staff and faculty

Moderna’s COVID-19 vaccine has not been fully approved, but its approval is expected in the near future.


Graysen Shirley contributed to the reporting of this story.