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

Date: January 13, 2023

Attention: All Providers

Effective date: December 8, 2022

Providers 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 December 8, 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 third dose in the primary series (Pfizer-BioNTech) and a single booster dose (Moderna) in younger age groups. Refer to the reference links below for more information about the bivalent vaccine EUA approval, changes to monovalent vaccines, product labeling, preparation, and administration. 

Resources:

• FDA news release December 8, 2022: Coronavirus (COVID-19) Update: FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of Age | FDA
• 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)
• Moderna COVID-19 Vaccine: Vaccine Appearance, Preparation, and Administration Summary (cdc.gov) (pdf)
• Pfizer-BioNTech COVID-19 Vaccine: Appearance, Preparation, and Administration Summary (cdc.gov) (pdf)

How this impacts providers:

Pfizer-BioNTech

• Children down to 6 months are authorized for the bivalent Pfizer-BioNTech COVID-19 vaccine who have not yet begun their three-dose primary series of the Pfizer-BioNTech COVID-19 vaccine or have not yet received the third dose of their primary series will now receive the updated bivalent Pfizer-BioNTech COVID-19 vaccine as the third dose in their primary series following two doses of the original monovalent Pfizer-BioNTech COVID-19 vaccine.
• Children 6 months through 4 years who have already completed their three-dose primary series with the original monovalent Pfizer-BioNTech COVID-19 vaccine will not be eligible for a booster dose of an updated bivalent vaccine at this time. 
• Pfizer-BioNTech developed a new formulation for the bivalent COVID-19 vaccine 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 6 months through 4 years beginning December 8:

Drug Name	Dose	NDC
PFIZER COVID BIVAL (6MO-4Y) EUA	0.2 mL	59267-0609-01
PFIZER COVID BIVAL (6MO-4Y) EUA	0.2 mL	59267-0609-02

Moderna

Children down to 6 months are authorized for the updated bivalent Moderna COVID-19 booster vaccine after at least two months following completion of the primary monovalent vaccination series.  

•  Moderna developed a new formulation for the bivalent COVID-19 vaccine 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 6 months through 5 years of age effective December 8:

Drug Name	Dose	NDC
MODERNA COVID BIVAL (6MO-5Y) EUA	0.2 mL	80777-0283-02
MODERNA COVID BIVAL (6MO-5Y) EUA	0.2 mL	80777-0283-99

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.