Pfizer and BioNTech start process of seeking full FDA approval of their COVID-19 vaccine

Pfizer and BioNTech start process of seeking full FDA approval of their COVID-19 vaccine

Pfizer Inc. and German partner BioNTech SE said Friday they have initiated rolling submission of a Biologics License Application (BLA) with the U.S. Food and Drug Administration for full approval of their COVID-19 vaccine in individuals 16 years of age and older. The vaccine was already granted emergency use authorization last December, a measure used by the FDA in emergency situations. “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 companies said in a joint statement. Since the vaccine was granted an EUA on Dec. 11, the companies have delivered more than 170 million doses across the U.S. Pfizer and BioNTech has also submitted an application to expand the EUA to include individuals aged 12-to-15 years-old, and plan to submit a supplemental BLA to support licensure of the vaccine in that age group once the required 6 months of data after a second dose are available. Pfizer shares rose 0.6% premarket, while BioNTech shares rose 4.3%. Those shares have climbed 106% in the year to date, while the SPDR S&P Biotech ETF has fallen 11% and the S&P 500 has gained 11.9%.

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