FDA authorises Moderna, Pfizer-BioNTech for use as Omicron-targeted booster

The bivalent vaccines, which we will also refer to as «updated boosters,» contain two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2, the FDA said in a statement.

The Moderna COVID-19 Vaccine, Bivalent, is authorised for use as a single booster dose in individuals 18 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent, is authorised for use as a single booster dose in individuals 12 years of age and older.

The monovalent COVID-19 vaccines that are authorised or approved by the FDA and have been administered to millions of people in the United States since December 2020 contain a component from the original strain of SARS-CoV-2.