Younger Age Groups Now Eligible For Bivalent COVID-19 Booster Vaccines
Date: 11/09/22
On October 12, 2022, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorizations (EUAs) for the bivalent Pfizer-BioNTech and Moderna COVID-19 vaccines for use as a single booster dose in younger age groups at no cost. The Centers for Disease Control (CDC) recommends that all children, including children who have already had COVID-19, should get vaccinated.
For the Pfizer-BioNTech booster:
- Children 5 years old and older are authorized for the bivalent Pfizer-BioNTech COVID-19 booster vaccine, at least two months following completion of the primary vaccination series or the most recent monovalent booster vaccine.
- A new formulation is used for the bivalent COVID-19 booster vaccine that is specific to the younger age group.
- Texas Health and Human Services (HHSC) added the following National Drug Codes (NDCs) to the Medicaid and CHIP formulary as a payable pharmacy benefit for children 5 through 11 years of age, effective October 12, 2022:
Drug Name | Dose | NDC |
|---|---|---|
PFIZER COVID BIVAL (5-11YR)EUA | 0.2 mL | 59267-0565-02 |
PFIZER COVID BIVAL (5-11YR)EUA | 0.2 mL | 59267-0565-01 |
For the Moderna booster:
- Children 6 years old and older are authorized for the bivalent Moderna COVID-19 booster vaccine, after at least two months following completion of the primary vaccination series or the most recent monovalent booster vaccine.
- No new formulation for the bivalent COVID-19 booster vaccine, but there is a difference in dosage for children 6 through 11 years old.
- HHSC previously added the following NDCs to the Medicaid and CHIP formulary on August 31, 2022, as a payable pharmacy benefit. Under the amended EUA from the FDA, these NDCs are now authorized for use in children 6 through 11 years of age.
- As a reminder, the same NDCs for the bivalent Moderna COVID-19 booster dose can be used for individuals 12 years of age and older, but the dose is 0.5 mL.
Drug Name | Dose | NDC |
|---|---|---|
MODERNA COVID BIVAL (6Y UP) EUA | 0.25 mL | 80777-0282-05 |
MODERNA COVID BIVAL (6Y UP) EUA | 0.25 mL | 80777-0282-99 |
Pharmacy providers should submit bivalent Pfizer-BioNTech and Moderna COVID-19 booster dose claims using the Submission Clarification Code (SCC) value of “10” (“Meets Plan Limitations”).
To learn more, please review:
- FDA: Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose in Younger Age Groups
- FDA Fact Sheet For Health Care Providers Administering Pfizer-Biontech Bivalent Boosters (PDF)
- FDA Fact Sheet For Health Care Providers Administering Moderna Bivalent Boosters (PDF)
- CDC: Moderna COVID-19 Vaccine: Vaccine Appearance, Preparation, And Administration Summary (PDF)
- CDC: Pfizer-Biontech COVID-19 Vaccine: Appearance, Preparation, And Administration Summary (PDF)