The Food and Drug Administration yesterday announced it has amended the emergency use authorizations for Pfizer’s and Moderna’s 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 “updated doses,” 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’ official approval. 
 
In related news, the American Medical Association announced an editorial update to Current Procedural Terminology with eight new codes for the Pfizer and Moderna bivalent COVID-19 vaccine booster doses. 

Related News Articles

Headline
The AHA is offering a new set of social messages and assets for February to encourage the public to get vaccinated and boosted against COVID-19. The new…
Headline
A Food and Drug Administration advisory committee unanimously voted today to recommend harmonizing the composition of all COVID-19 vaccine primary series and…
Headline
In a study released today by the Centers for Disease Control and Prevention, a single bivalent COVID-19 vaccine booster provided additional protection against…
Headline
A Food and Drug Administration advisory committee is scheduled to vote Thursday on whether to simplify current COVID-19 vaccine use so that all primary series…
Headline
Evusheld may not prevent COVID-19 in immunocompromised individuals exposed to the XBB.1.5 omicron subvariant, because the treatment has failed to neutralize…
Headline
In a study reported yesterday in JAMA Internal Medicine, children and adolescents previously diagnosed with multisystem inflammatory syndrome (MIS-C) reported…