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Pediatric Updates for Moderna and Pfizer-BioNTech COVID-19 Vaccines

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On June 17, 2022, the U.S. Food and Drug Administration (FDA) amended the emergency use authorization of the Moderna COVID-19 vaccine to include children 6 months through 17 years of age and emergency use authorization of the Pfizer-BioNTech COVID-19 vaccine to include children 6 months through 4 years of age. On June 17, 2022, the new Moderna COVID-19 and Pfizer-BioNTech COVID-19 vaccine national drug codes (NDCs) were added to the formulary for Medicaid and the Children’s Health Insurance Program (CHIP) as a payable pharmacy benefit.

The federal Public Readiness and Emergency Preparedness (PREP) Act allows pharmacists to administer COVID-19 vaccines to children 3 years of age or older. The Health and Human Services Commission (HHSC) allows for pharmacy benefit coverage of the Moderna COVID-19 and the Pfizer-BioNTech COVID-19 vaccine in compliance with the expanded use authorized by the FDA. 

Moderna COVID-19 Vaccine

  • The FDA previously authorized the Moderna COVID-19 vaccine for use in adults 18 years of age or older.
  • The FDA amended the emergency use authorization (EUA) to include vaccine use in children 6 months through 17 years of age.
    • For the expanded pediatric age group, the Moderna COVID-19 vaccine is administered as a primary series of two intramuscular doses one month apart. This two-dose schedule is identical to that of older age groups. The vaccine dosage strength varies by age.

Pfizer-BioNTech COVID-19

  • The FDA previously authorized the Pfizer-BioNTech COVID-19 for use in individuals 5 years of age or older.
  • The FDA amended the EUA to include vaccine use in children 6 months through 4 years of age.
    • The Pfizer-BioNTech COVID-19 vaccine is administered as a primary series of three intramuscular doses for the expanded pediatric age group. The initial and second doses are administered three weeks apart, and the third dose is administered at least eight weeks after the second. This three-dose schedule is different from the two-dose schedule for older age groups. The vaccine dosage strength varies by age.

Note: The age group definitions for the Moderna and Pfizer-BioNTech COVID-19 vaccines are not identical.

Updated Vaccine NDCs

The following new vaccine NDCs were added:

Drug Name

Dosage

Pfizer-BioNTech COVID-19 Vaccine (6M-4Y)

3 MCG/0.2 ML

Pfizer-BioNTech COVID-19 Vaccine (6M-4Y)

3 MCG/0.2 ML

Moderna COVID-19 Vaccine (6M-5Y)

25 MCG/0.25 ML

Moderna COVID-19 Vaccine (6M-5Y)

25 MCG/0.25 ML

Moderna COVID-19 Vaccine (6-11Y)

50 MCG/0.5 ML

Moderna COVID-19 Vaccine (6-11Y)

50 MCG/0.5 ML

Email questions or comments to vdp-formulary@hhsc.state.tx.us.