FDA Authorizes Bivalent COVID-19 Booster

September 08, 2022 – Late last month, the U.S. Food and Drug Administration (FDA) amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination.  The bivalent vaccines, or updated booster, contain two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original COVID-19 strain, and one in common between the BA.4 and BA.5 lineages of the Omicron Variant that remains dominant in the United States.  This updated booster provides better protection against COVID-19 caused by the Omicron Variant.

“The bivalent booster is recommended for individuals age 12 (Pfizer-BioNTech) and older who are at least two months out from completing their primary series, or receiving their original booster(s), said Dr. Caryn Slack, MD, MPH, Mono County Health Officer.  “The development of this updated booster follows the influenza platform that has been in place for decades, essentially using a scientific formula to enhance the existing recipe and strengthen the vaccine’s protection against the COVID-19 strain as it has evolved.”

Bivalent COVID-19 Booster Eligibility:

• Individuals 18 years of age and older are eligible for a single booster dose of the Moderna COVID-19 Vaccine, Bivalent if it has been at least two months since they have completed primary vaccination or have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.
• Individuals 12 years of age and older are eligible for a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent if it has been at least two months since they have completed primary vaccination or have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

“The COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of COVID-19,” said FDA Commissioner Robert M. Califf, M.D.  “As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants.”

It remains safe to receive COVID-19 vaccines and flu shots at the same time.  Additional details regarding the FDA’s approval of the bivalent booster can be accessed here.

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