The U.S. Food and Drug Administration will decide on full approval of the Pfizer-BioNTech COVID-19 vaccine by January 2022.
Pfizer announced on Friday that the FDA granted their request for primary review for its Biologics License Application, which Pfizer submitted in May. The application process involves submitting nonclinical and clinical data to support the licensure of the COVID-19 vaccine.
Priority review allows the FDA to take action within a six-month window, rather than the typical 10-month time frame. But the decision could come much sooner than January.
"The Prescription Drug User Fee (PDUFA) Goal Date of January 2022 reflects the PDUFA deadline for Priority Review and does not mean approval will not happen before that time," FDA Press Officer Abby Capobianco said. "Quite to the contrary, the review of this BLA has been ongoing, is among the highest priorities of the agency, and the agency intends to complete the review far in advance of the PDUFA Goal Date."
The FDA issued an emergency use authorization (EUA) for Pfizer’s vaccine in December 2020, which allowed the shots to be administered without full approval.
Since that time, Pfizer is one of three FDA-authorized vaccines that have driven America’s case numbers down from the highs seen last winter.
American multinational pharmaceutical corporation, Pfizer Inc. logo seen outside their branch in Seoul. (Photo by Simon Shin/SOPA Images/LightRocket via Getty Images)
The EUA is only valid for the duration of the emergency, which is why getting full approval is the crucial next phase in the U.S. vaccination effort.
Full approval would only apply to recipients 16 and older. Pfizer is still conducting clinical trials on children, hoping the data will convince the FDA to expand its EUA to younger recipients.
So far, the FDA allows anyone 12 and older to receive the Pfizer shots.
This story was reported from Atlanta. The Associated Press contributed to this story.