Pfizer and BioNTech have submitted an application to the U.S. Food and Drug Administration (FDA) requesting the authorization of their bivalent COVID-19 vaccine for use in people 12 years and older.
The new formulation combines the original vaccine with one that specifically targets omicron BA.4 and BA.5 subvariants.
“Given the ongoing evolution of SARS-CoV-2 and its variants, it’s of great importance that vaccines can be rapidly adapted to the major circulating Omicron lineages,” BioNTech CEO and co-founder Dr. Ugur Sahin said. “In less than three months after the FDA provided its guidance for adapted vaccines in the U.S., we are ready to ship the first doses of our Omicron BA.4/BA.5-adapted bivalent vaccine, pending regulatory authorization, to provide people in the U.S. with the possibility to get a booster adapted to the currently most dominant strain of the virus.”
The current vaccines were designed to prevent the version of COVID-19 that first emerged in China. According to Pfizer and BioNTech officials, this new booster will provide broader protection against infection and mild illness.
If approved by the FDA, the omicron BA.4/BA.5-adapted bivalent vaccine will be available to ship immediately.
