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.