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

Last updated on 12/31/2021

On December 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 persons 16 or 17 years old. Additionally, starting December 13, 2021, Pfizer is expected to begin distributing a new formulation of the multiple-dose Pfizer-BioNTech COVID-19 vaccine that does not require dilution.

The Texas Health and Human Services Commission (HHSC) is updating pharmacy benefit coverage for the Pfizer-BioNTech COVID-19 vaccine.

Age Change for Booster Dose

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

New Formulation

On October 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 its different cap color, which is gray. The FDA has authorized persons 12 years of age and older to receive this new formulation. Additionally, the new formulation of the Pfizer-BioNTech COVID-19 vaccine is FDA approved for booster doses for persons 16 years of age or 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 December 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 after 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 persons 12 years of age or older requires ultra-cold temperature storage, is supplied in a multiple-dose vial, and must be diluted before use.

Beginning December 13, 2021, Texas Medicaid added coverage for the new tris-sucrose formulation of the Pfizer-BioNTech COVID-19 vaccine. HHSC will add 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.

The following table indicates what will appear on the Medicaid, CHIP, and HTW program formularies:

 

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

Email VDP-Formulary@hhsc.state.tx.us with questions or comments.