Pfizer-BioNTech COVID vaccine to be reviewed by USFDA by January
New Delhi: The U.S. health regulator will review Pfizer and German partner BioNTech SE's application for full approval of their COVID-19 vaccine in people 16 years and older by January, the companies said on Friday.
The target action date does not mean the approval will not happen before January, the U.S. Food and Drug Administration's Acting Commissioner Janet Woodcock said on Twitter.
"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.
The companies said on Friday they intend to submit an application to support approval of the vaccine in this age group once the required data is available six months after the second dose.
Moderna filed for full U.S. approval of its COVID-19 vaccine for adults early in June.
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