Pfizer-BioNTech COVID-19 Vaccine Booster Dose Age Change and New Formulation

Published on
December 16, 2021

On Dec. 9, 2021, the U.S. Food and Drug Administration (FDA) amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to approve a booster dose for individuals 16 and 17 years of age. Additionally, Pfizer is expected to begin distributing a new formulation of the multiple-dose Pfizer-BioNTech COVID-19 vaccine, which does not require dilution, starting Dec. 13, 2021.

HHSC is updating pharmacy benefit coverage for the Pfizer-BioNTech COVID-19 vaccine.

Age Change for Booster Dose

The Pfizer-BioNTech COVID-19 vaccine and Comirnaty are the only vaccine options currently authorized for a booster dose by the FDA in individuals 16 and 17 years of age. A single booster dose is authorized at least six months after completing the primary vaccination series with the Pfizer-BioNTech COVID-19 vaccine only.

New Formulation

On Oct. 29, 2021, the FDA approved a new tris-sucrose formulation of the Pfizer-BioNTech COVID-19 vaccine, which includes tromethamine, an ingredient used to improve storage conditions for pharmaceutical products. With the addition of tromethamine, the vaccine is more stable at regular refrigerator temperatures for longer periods. The new tris-sucrose formulation of the Pfizer-BioNTech COVID-19 vaccine can be distinguished by a different cap color, which is gray, and is authorized by FDA for use in individuals 12 years of age and older. HHSC expects Pfizer to begin distributing the new tris-sucrose formulation, which does not require dilution and is supplied in a multiple-dose vial, on Dec. 13, 2021.

The new tris-sucrose formulation of the Pfizer-BioNTech COVID-19 vaccine with a gray cap has different storage conditions and will eventually replace the original formulation once the current supply has been exhausted. The new tris-sucrose formulation can be stored unopened in regular refrigerators for up to 10 weeks. The original, purple cap version of the Pfizer-BioNTech COVID-19 vaccine authorized by the FDA for the same age group, requires ultra-cold temperature storage, is supplied in a multiple-dose vial, and must be diluted before use.

Beginning Dec. 13, 2021, Texas Medicaid added coverage for the new tris-sucrose formulation of the Pfizer-BioNTech COVID-19 Vaccine. HHSC will add the national drug codes (NDCs) for each vaccine to the Medicaid, Children’s Health Insurance Program (CHIP), and Healthy Texas Women (HTW) program formularies as a payable pharmacy benefit.

Drug name Dosage NDC
PFIZER COVID-19 (12Y UP) vaccine (EUA) 30 mcg/0.3 mL 59267-1025-01
PFIZER COVID-19 (12Y UP) vaccine (EUA) 30 mcg/0.3 mL 59267-1025-03
PFIZER COVID-19 (12Y UP) vaccine (EUA) 30 mcg/0.3 mL 59267-1025-04