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
Pfizer has submitted a request for the Food and Drug Administration to authorize a 10-microgram booster dose of its bivalent COVID-19 vaccine booster for…
Headline
Health care providers who treat uninsured or underinsured patients with commercially procured bebtelovimab, a COVID-19 monoclonal antibody therapy for…
Headline
Moderna Friday submitted its request that the Food and Drug Administration authorize for emergency use its bivalent COVID-19 vaccine for children and…
Headline
AHA will co-host a Sept. 27 Facebook Live event with AdventHealth on the importance of getting children vaccinated and boosted against COVID-19, which will…
Headline
Insured and uninsured Americans can receive the new bivalent Pfizer or Moderna COVID-19 booster and other COVID-19 vaccines at no cost as long as the federal…
Headline
The Biden Administration will make over 170 million doses of the bivalent COVID-19 vaccine booster available to Americans for free at pharmacies, doctor’s…