Younger Age Groups Now Eligible For Bivalent COVID-19 Booster Vaccines

Date: November 10, 2022Attention: All Providers               Effective date: October 12, 2022Providers should monitor the Texas Children’s Health Plan (TCHP) Provider Portal regularly for alerts and updates associated to the COVID-19 event.  TCHP reserves the right to update and/or change this information without prior notice due to the evolving nature of the COVID-19 event. Call to action: Texas Children’s Health Plan (TCHP) would like to inform providers of the recent changes to the eligible age groups for booster vaccines. 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.  For more detailed information about the bivalent vaccine EUA approval, changes to monovalent vaccines, product labeling, preparation, and administration, reference the following links. Resources:

• FDA (October 12, 2022): 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)
• gov: Moderna COVID-19 Vaccine: Vaccine Appearance, Preparation, and Administration Summary (PDF)
• gov: Pfizer-BioNTech COVID-19 Vaccine: Appearance, Preparation, and Administration Summary (PDF)

How this impacts providers: Pfizer-BioNTech

• Under the EUA, Children down to five years may receive the bivalent Pfizer-BioNTech COVID-19 booster vaccine when given at least two months after:
  • completion of the primary vaccination series OR
  • the most recent monovalent booster vaccine
• Pfizer-BioNTech developed a new formulation for the bivalent COVID-19 booster vaccine that is specific to the younger age group.
• 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 old effective October 12:

 

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

  Moderna

• Under the EUA, children down to six years may receive the bivalent Moderna COVID-19 booster vaccine after at least two months after:
  • completion of the primary vaccination series OR
  • the most recent monovalent booster vaccine
• Moderna did not develop a new formulation for the bivalent COVID-19 booster vaccine. Rather, a lower dosage of 0.25 ml is indicated 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 also authorized for use in children 6 through 11 years old:

 

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

 

• As a reminder, the same NDCs for the bivalent Moderna COVID-19 booster dose can be used for individuals 12 years and older, but the dose is 0.5 mL.

  If you have any questions, please email Provider Relations at: providerrelations@texaschildrens.org.For access to all provider alerts,log into: www.thecheckup.org or www.texaschildrenshealthplan.org/for-providers.