Are there changes to bivalent COVID-19 vaccines for children?

Yes. Effective December 8, 2022, the AMA created 2 CPT codes for the Pfizer bivalent vaccine product code and its administration to children. Two previously created codes for the Moderna vaccine have also received Emergency Use Authorization (EUA) from the FDA.

Pfizer-BioNTech

The Pfizer monovalent vaccine is no longer authorized for use as the third dose of the three-dose primary series in children 6 months through 4 years of age. The monovalent Pfizer-BioNTech COVID-19 vaccine remains authorized for administration as the first two doses of the three-dose primary series in individuals 6 months through 4 years of age, as a two-dose primary series for individuals 5 years of age and older, and as a third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. For your convenience, we are providing the long descriptors for each codes below.

Pfizer-BioNTech COVID-19 Vaccine, Bivalent Product and Administration, third dose

  • 91317 - Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, bivalent spike protein, preservative free, 3 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation, for intramuscular use

  • 0173A - Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, bivalent spike protein, preservative free, 3 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation, third dose

Moderna

The FDA has amended the emergency use authorizations (EUAs) for the Moderna vaccine codes for children, effective 12/08/2022.

The Moderna COVID-19 vaccine, bivalent is now authorized for administration in children aged  6 months through 5 years  as a single booster dose at least 2 months after completion of primary vaccination with the monovalent Moderna COVID-19 vaccine. The Moderna bivalent version is also authorized for use in individuals 6 years and older as a single booster dose at least two months after completion of either primary vaccination with any authorized or approved COVID-19 vaccine.

Moderna COVID-19 Vaccine, Bivalent Product and Administration – Booster Dose previously announced in November 2022 that are effective 12/8/2022 include:

  • 91316 - Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, bivalent, preservative free, 10 mcg/0.2 mL dosage, for intramuscular use
  • 0164A - Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) (coronavirus disease [COVID-19]) vaccine, mRNALNP, spike protein, bivalent, preservative free, 10 mcg/0.2 mL dosage, booster dose

For additional information, see:

FDA News Release; December 8, 2022

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-updated-bivalent-covid-19-vaccines-children-down-6-months

COVID-19 CPT Vaccine and Immunization Codes, updated December 9, 2022

https://www.ama-assn.org/practice-management/cpt/covid-19-cpt-vaccine-and-immunization-codes

AMA Special Edition CPT Assistant, December 2022

https://www.ama-assn.org/system/files/cpt-assistant-guide-coronavirus-december-2022.pdf