COVID-19 Vaccine Booster Doses – IDH Update

On Aug. 31, the U.S. Food and Drug Administration (FDA) approved emergency use authorizations (EUAs) of the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine bivalent formulations. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) has also recommended the bivalent vaccine. IDOH supports this recommendation.

The Moderna COVID-19 vaccine, bivalent, is authorized for use as a single booster dose in individuals 18 years of age and older. The Pfizer-BioNTech COVID-19 vaccine, bivalent, is authorized for use as a single booster dose in individuals 12 years of age and older.

With this authorization, the FDA has also revised the EUA of the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine to remove the use of the monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines for booster administration for individuals 18 years of age and older and 12 years of age and older. Please immediately discontinue the administration of these booster doses.

At this time, the Pfizer-BioNTech COVID-19 vaccine remains authorized for administration of a single booster dose for individuals 5 through 11 years of age at least five months after completing a primary series of the Pfizer-BioNTech COVID-19 vaccine. These monovalent vaccines also continue to be authorized for use for administration of a primary series for individuals 6 months of age and older as described in the letters of authorization.

The Centers for Disease Control and Prevention (CDC) updated its guidance for COVID-19 vaccination.

• People ages 12 years and older should receive 1 bivalent mRNA booster after completion of a monovalent primary series; it replaces all prior booster recommendations for this age group. The bivalent booster can be administered at least two months after the last COVID vaccine.
• Bivalent Pfizer-BioNTech booster dose is authorized for ages 12 and older at least two months after receiving the second primary dose, regardless of any previous monovalent booster doses given
• Bivalent Moderna booster dose is authorized for ages 18 and older, two months after receiving the second primary dose, regardless of any previous monovalent booster doses given