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5/7, 1:14 PM (Source: TeleTrader)
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Pfizer, BioNTech ask for full vaccine approval in US

Pfizer and BioNTech announced on Friday they have initiated the process of asking for full authorization of their COVID-19 vaccine with the United States Food and Drug Administration (FDA).

The companies asked for a Biologics License Application (BLA) of the jab for people over 16 years of age. "Data to support the BLA will be submitted by the companies to the FDA on a rolling basis over the coming weeks, with a request for Priority Review. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA will be set once the BLA is complete and formally accepted for review by the agency," the companies noted.

In December 2020, the FDA approved the Pfizer/BioNTech vaccine for emergency use after which millions of Americans received the jab.

Breaking the News / NP