Created: May 07, 2021 07:50 AM
(WHEC)— Pfizer and BioNtech are asking the United States Food and Drug Administration for full approval of their coronavirus vaccine.
The vaccine was granted an emergency use authorization back in December for use in adults aged 16 and older. However, six months of data is required for a biologics license application, which is needed for full approval.
The companies say they will submit this data on a rolling basis over the coming weeks.
If granted, it will be the first vaccine to be fully approved in the country.
Last month, the companies asked the FDA to expand their EUA to include adolescents aged 12 to 15.
They are only applying for full approval for people ages 16 and up, but say they will submit a supplemental Biologics License Application once they have six months of data in adolescents.
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