Omicron BA.4/BA.5-Adapted Bivalent mRNA COVID-19 Vaccine Seeks Authorization

New York-based Pfizer Inc. and BioNTech SE today announced they had completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older.

The bivalent vaccine contains mRNA encoding the original SARS-CoV-2 spike protein, which is present in the original Pfizer-BioNTech COVID-19 Vaccine, together with mRNA encoding the spike protein of the Omicron BA.4/BA.5 variant.

Albert Bourla, Chairman and CEO of Pfizer, stated in a press release on August 22, 2022, "Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA.4/BA.5 boosters, if authorized, to help protect individuals and families as we prepare for potential fall and winter surges."

This 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 the SARS-CoV-2 coronavirus.

Data from a Phase 2/3 clinical trial of a 30-µg booster dose of their Omicron BA.1-adapted bivalent vaccine candidate elicited a superior immune response against the Omicron BA.1 variant compared to the companies' current COVID-19 vaccine. 

Pending EUA, the Omicron BA.4/BA.5-adapted bivalent vaccine will be available to ship immediately.

The Comirnaty version is the worldwide leader in mRNA vaccine distribution during the COVID-19 pandemic.

As of August 18, 2022, the U.S. NIH OpenData portal, in collaboration with ACTIV and industry partners, had not displayed in vitro therapeutic activity against SARS-CoV-2 variants for this vaccine candidate. 

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