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

July 1, 2022

On June 17, 2022, the U.S. Food and Drug Administration (FDA) authorized emergency use of the Moderna COVID-19 and the Pfizer-BioNTech COVID-19 vaccine for children down to 6 months of age.  The federal Public Readiness and Emergency Preparedness (PREP) Act allows pharmacists to administer COVID-19 vaccines to children three years and older.

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 adults 18 and older.
  • The FDA amended the emergency use authorization (EUA) to include children six months through 17 years.  
    • 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 vaccine

  • The FDA had previously authorized the Pfizer-BioNTech COVID-19 for use in individuals five years and older.
  • The FDA amended the EUA to include the use of the vaccine in children six months through 4 years.
  • 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 than 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.

On June 17, 2022, the following Moderna COVID-19 and Pfizer-BioNTech COVID-19 vaccine national drug codes (NDCs) were added to the formulary for the Medicaid and Children’s Health Insurance Program (CHIP) as a payable pharmacy benefit: 

Drug name Dosage NDC
Pfizer-BioNTech COVID-19 Vaccine (6M-4Y) 3 MCG/0.2 ML 59267-0078-04
Pfizer-BioNTech COVID-19 Vaccine (6M-4Y) 3 MCG/0.2 ML 59267-0078-01
Moderna COVID-19 Vaccine (6M-5Y) 25 MCG/0.25 ML 80777-0279-05
Moderna COVID-19 Vaccine (6M-5Y) 25 MCG/0.25 ML 80777-0279-99
Moderna COVID-19 Vaccine (6-11Y) 50 MCG/0.5 ML 80777-0277-05
Moderna COVID-19 Vaccine (6-11Y) 50 MCG/0.5 ML 80777-0277-99

Refer to the Formulary search for the list of available COVID-19 vaccines.

Pharmacies should follow these guidelines when submitting claims.

  • The initial dose of a COVID vaccine must use the value “02” (Other Override) in the “Submission Clarification Code” field (420-DK) to indicate the first dose of a multi-dose vaccine.
  • The second dose with a value of “06” (Starter Dose) in the “Submission Clarification Code” field (420-DK) indicates the second or final dose of a multi-dose vaccine.
  • The third dose with a value of “07” (Medically Necessary) in the “Submission Clarification Code” field (420-DK) indicates the third dose of a multi-dose vaccine.

Refer to the Claims Billing (B1) Transaction payer sheets for specific transaction, segment, and field requirements.