- (PLX AI) - Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 vaccine for individuals 12 years of age and older.
- • The application follows guidance from the FDA to include clinical data from the companies' bivalent Omicron BA.1-adapted vaccine and pre-clinical and manufacturing data from the companies' bivalent Omicron BA.4/BA.5-adapted vaccine to address the continued evolution of SARS-CoV-2
- • Pending authorization, the Omicron BA.4/BA.5-adapted bivalent vaccine will be available to ship immediately
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