Pfizer and BioNTech Submit EUA Application for Omicron-Adapted Bivalent COVID-19 Vaccine

Pfizer-BioNTech have applied for Emergency Use Authorization (EUA) of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine booster dose candidate in individuals 12 years and older.

The EUA application includes clinical data on the companies’ bivalent Omicron BA.1-adapted vaccine, but also pre-clinical data on the companies’ bivalent Omicron BA.4/BA.5-adapted vaccine.

The companies said that, pending authorization, the Omicron BA.4/BA.5-adapted bivalent vaccine will be available to ship immediately.

The bivalent vaccine is also under review in the EU for conditional marketing authorization.