Pfizer and BioNTech file Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine with FDA
Following in the steps of US mRNA biotech Moderna (Nasdaq: MRNA), which last week gained a first regulator approval for its bivalent vaccine, now BioNTech (Nasdaq: BNTX) and Pfizer (NYSE: PFE) say they have completed their submission to the US Food and Drug Administration (FDA) today requesting an Emergency Use Authorization of a 30µg booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years and older.
The application is based on guidance from the FDA to include both clinical data from the companies’ bivalent Omicron BA.1-adapted vaccine and pre-clinical and manufacturing data from the bivalent Omicron BA.4/BA.5-adapted vaccine. This is aiming to address the continued evolution of SARS-CoV-2.
The companies have already generated mega-billion dollars-worth of sales with their COVID-19 vaccine Comirnaty.
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