Pfizer Maroon Cap and Label Discrepancy

Commissioner Lambrew letterhead

Pfizer Maroon Cap and Label Discrepancy

June 23, 2022

On June 17, 2022, the US Food and Drug Administration authorized emergency use of the
Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years of age to provide a 3
-
dose series. The Pfizer-BioNTech COVID-19 Vaccine for use in children 6 months through 4
years of age is supplied in multiple dose vials with maroon caps and labels with a maroon
border. After dilution each multiple dose vial contains ten doses of 0.2 mL each.

You may notice a discrepancy between the vial and carton labels. 

The vial labels may state “Age 2y to < 5y” or “Age 6m to < 5y” and carton labels may
state “For age 2 years to < 5 years” or “For age 6 months to < 5 years”.

Vials with EITHER printed age range CAN be used for individuals 6 months through 4 years of age.

For complete information about the Pfizer-BioNTech COVID-19 Vaccine authorized for use in
children 6 months through 4 years of age supplied in multiple dose vials with maroon caps and
labels with a maroon border and the most recent Fact Sheet, please see
https://www.cvdvaccine.com.

For additional questions, contact the Maine Immunization Program at (207) 287-3746 or email: ImmunizeME.DHHS@maine.gov.

Resources:

Pfizer-BioNTech COVID-19 Vaccine Presentations

Moderna COVID-19 Vaccine Presentations

U.S. COVID-19 Vaccine Product Information

At-A-Glance COVID-19 Vaccination Schedules