Pfizer-BioNTech COVID vaccine to be reviewed by USFDA by January

"Quite to the contrary, the review of this BLA (biologics license application) 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 vaccine is among the three being used in the United States under the FDA's emergency use authorization, alongside shots from Johnson & Johnson and Moderna Inc.

If approved, it would be the first shot to get the agency's full approval based on longer-term data on safety and effectiveness, potentially helping ease vaccine hesitancy as the country witnesses new outbreaks in some parts, mainly due to the highly infectious Delta coronavirus variant. 

Over 85 million Americans have been fully vaccinated with Pfizer's vaccine, according to latest government data. 

Pfizer/BioNTech finished submitting their application for a full U.S. approval in May and the agency will review the data under its "priority review" pathway.

The FDA in May expanded the emergency use of the two-shot vaccine to children 12 through 15 years of age.

Read also: Pfizer vaccine may reduce risk of COVID-19 infection in pregnant women: JAMA