FDA authorises Moderna, Pfizer-BioNTech for use as Omicron-targeted booster
WASHINGTON. KAZINFORM The U.S. Food and Drug Administration (FDA) amended the emergency use authorisations (EUAs) of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorise bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination, WAM reports.
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.