Pfizer and BioNTech submit application to U.S. FDA for emergency use authorization of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine
Pfizer Inc and BioNTech SE 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.
A conditional marketing authorization application has also been initiated with the European Medicines Agency (EMA) for the Omicron BA.4/BA.5-adapted bivalent vaccine and is expected to be completed in the coming days.
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. Pre-clinical data showed a booster dose of Pfizer and BioNTech's Omicron BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against Omicron BA.1, BA.2 and BA.4/BA.5 variants, as well as the original wild-type strain. A clinical study investigating the safety, tolerability and immunogenicity of the Omicron BA.4/BA.5-adapted bivalent vaccine in individuals 12 years of age and older is expected to start this month.
