FDA issues updated EUA for bivalent booster doses to fight omicron; providers to cease administration of monovalent boosters
The Food and Drug Administration yesterday it has amended the emergency use authorizations for Pfizer鈥檚 and Moderna鈥檚 COVID-19 vaccines to account for new, bivalent formulations designed to install immunity against the SARS-CoV-2 omicron variant. FDA will refer to the bivalent doses in literature as 鈥渦pdated doses,鈥 which contain two messenger RNA 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.
According to the FDA, individuals 18 years of age and older are eligible for a single booster dose of the Moderna COVID-19 Vaccine, Bivalent if they are at least two months removed from the completion of their primary vaccination series or have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent booster is authorized as a single booster dose for individuals 12 years of age and older who are at least two months removed from the completion of their completed primary vaccination or have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.
The EUA expressly instructs providers to no longer use the monovalent booster shots; instead, patients are to be rescheduled for on-the-books booster appointments and return after the bivalent boosters鈥 official approval.
In related news, the American Medical Association announced an editorial update to with eight new codes for the Pfizer and Moderna bivalent COVID-19 vaccine booster doses.