Pfizer seeks full approval of coronavirus vaccine

NEW YORK CITY (NBC) – Pfizer and BioNTech are asking the FDA 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 have asked the FDA to expand their EAU 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 BLA once they have six months of data in adolescents.

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