ADC Reviews

Pfizer and BioNTech Submit Emergency Use Authorization Application to FDA for Omicron Bivalent Vaccine

Omicron BA.4BA.5

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a booster dose of an 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.


On August 22, Pfizer and BioNTech announced that they had submitted an emergency use authorization (EUA) application to the FDA for the Omicron BA.4/BA.5 bivalent new crown mRNA vaccine for use in people 12 years of age and older.

Over time, new coronavirus variants have evolved. Currently, Omicron BA.4/BA.5 is the predominant variant circulating in the United States.

The bivalent vaccine submitted for this EUA application contains mRNA encoding the original novel coronavirus spike protein and mRNA encoding the spike protein of the Omicron BA.4/BA.5 variant strain. Studies have shown that the bivalent vaccine produced strong neutralizing antibody responses against the original wild strain, Omicron BA.1, BA.2 and BA.4/BA.5 variants.