COVID-19 Bivalent Vaccine Booster Approval

Over the past three years, we have watched COVID-19 evolve and create new, more contagious variants of the virus. In December, we saw the emergence of the Omicron variant which quickly became the dominant variant – and the most contagious to date. As a result, the U.S. Food and Drug Administration (FDA) advised COVID-19 vaccine manufacturers to update their COVID-19 vaccines with an Omicron-specific component. These new “bivalent” vaccines will more effectively fight the Omicron strains of COVID-19.   

Moderna and Pfizer-BioNTech are currently seeking authorization from the FDA for an Emergency Use Authorization for their new bivalent COVID-19 booster. Pending authorization, the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) will meet to make a recommendation on booster dose and timing. We anticipate this to take place during the September 1-2, 2022, ACIP meeting. 

As outlined in the CDC planning guide, the bivalent COVID-19 vaccine will be administered as a single booster dose to those who previously completed a primary series of COVID-19 vaccine. It is anticipated that bivalent COVID-19 vaccine booster doses may initially be authorized for people ages 12 years and older (Pfizer-BioNTech) and for people ages 18 years and older (Moderna), followed by younger pediatric age groups. The bivalent booster is expected to replace existing booster formulas, meaning individuals will not have a choice in which booster to select. 

AHCA/NCAL has been meeting with the CDC and LTC pharmacy partners to ensure LTC remains a top priority for access to this booster.  

Facilities should contact their LTC pharmacies and schedule bivalent booster clinics. AHCA/NCAL will provide another update once the bivalent booster is approved.  

Please contact with questions.