Pfizer and BioNTech Request EUA for Omicron BA.4/BA.5 Adapted Bivalent Vaccine

Pfizer and BioNTech have completed a submission to FDA requesting emergency use authorization (EUA) of a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for people 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—alongside 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.

“The agility of the mRNA platform, together with extensive clinical experience with the Pfizer-BioNTech COVID-19 vaccine, has allowed us to develop, test, and manufacture updated, high-quality vaccines that align to circulating strains with unprecedented speed,” says Albert Bourla, Pfizer’s chairman and CEO. “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."

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