
IMPORTANT INFORMATION:
6 MONTHS THROUGH 4 YEARS OF AGE, DILUTE BEFORE USE, MAROON CAP
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
Formulation/Presentation Guide
Refer to the information outlined below to understand the formulations.
12 YEARS OF AGE AND OLDER,
DILUTE BEFORE USE

Purple Cap3
DOSE
30 mcg
DOSE VOLUME
0.3 mL
AMOUNT OF DILUENT NEEDED PER VIAL†
1.8 mL
DOSES PER VIAL
6 doses per vial (after dilution)
REFRIGERATED STORAGE TIME
1 month
Storage Conditions
ULTRA-LOW-TEMPERATURE (ULT) FREEZER [-90°C to -60°C (-130°F to -76°F)]
12 months‡
FREEZER
[-25°C to -15°C (-13°F to 5°F)]
2 weeks
REFRIGERATOR
[2°C to 8°C (35°F to 46°F)]
1 month
ROOM TEMPERATURE
[8°C to 25°C (46°F to 77°F)]
2 hours prior to dilution
(including any thaw time)
AFTER FIRST PUNCTURE
[2°C to 25°C (35°F to 77°F)]
Discard after 6 hours
12 YEARS OF AGE AND OLDER,
DO NOT DILUTE

Gray Cap4
DOSE
30 mcg
DOSE VOLUME
0.3 mL
AMOUNT OF DILUENT NEEDED PER VIAL†
NO DILUTION
DOSES PER VIAL
6 doses per vial
REFRIGERATED STORAGE TIME
10 weeks
Storage Conditions
ULTRA-LOW-TEMPERATURE (ULT) FREEZER [-90°C to -60°C (-130°F to -76°F)]
12 months§
FREEZER
[-25°C to -15°C (-13°F to 5°F)]
DO NOT STORE
REFRIGERATOR
[2°C to 8°C (35°F to 46°F)]
10 weeks
ROOM TEMPERATURE
[8°C to 25°C (46°F to 77°F)]
12 hours prior to first puncture
(including any thaw time)
AFTER FIRST PUNCTURE
[2°C to 25°C (35°F to 77°F)]
Discard after 12 hours
5 THROUGH
11 YEARS OF AGE,
DILUTE BEFORE USE

Orange Cap5
DOSE
10 mcg
DOSE VOLUME
0.2 mL
AMOUNT OF DILUENT NEEDED PER VIAL†
1.3 mL
DOSES PER VIAL
10 doses per vial (after dilution)
REFRIGERATED STORAGE TIME
10 weeks
Storage Conditions
ULTRA-LOW-TEMPERATURE (ULT) FREEZER [-90°C to -60°C (-130°F to -76°F)]
12 months§
FREEZER
[-25°C to -15°C (-13°F to 5°F)]
DO NOT STORE
REFRIGERATOR
[2°C to 8°C (35°F to 46°F)]
10 weeks
ROOM TEMPERATURE
[8°C to 25°C (46°F to 77°F)]
12 hours prior to dilution
(including any thaw time)
AFTER FIRST PUNCTURE
[2°C to 25°C (35°F to 77°F)]
Discard after 12 hours
6 MONTHS THROUGH 4 YEARS OF AGE,
DILUTE BEFORE USE

Maroon Cap6
DOSE
3 mcg
DOSE VOLUME
0.2 mL
AMOUNT OF DILUENT NEEDED PER VIAL†
2.2 mL
DOSES PER VIAL
10 doses per vial (after dilution)
REFRIGERATED STORAGE TIME
10 weeks
Storage Conditions
ULTRA-LOW-TEMPERATURE (ULT) FREEZER [-90°C to -60°C (-130°F to -76°F)]
12 months§
FREEZER
[-25°C to -15°C (-13°F to 5°F)]
DO NOT STORE
REFRIGERATOR
[2°C to 8°C (35°F to 46°F)]
10 weeks
ROOM TEMPERATURE
[8°C to 25°C (46°F to 77°F)]
12 hours prior to dilution
(including any thaw time)
AFTER FIRST PUNCTURE
[2°C to 25°C (35°F to 77°F)]
Discard after 12 hours||
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COMIRNATY® (COVID-19 Vaccine, mRNA). Prescribing Information (12 years of age and older), DILUTE BEFORE USE, Purple Cap.
Pfizer and BioNTech; July 8, 2022. -
COMIRNATY® (COVID-19 Vaccine, mRNA). Prescribing Information (12 years of age and older), DO NOT DILUTE, Gray Cap.
Pfizer and BioNTech; July 8, 2022. - Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (12 years of age and older), DILUTE BEFORE USE, Purple Cap.
Pfizer and BioNTech; July 8, 2022. -
Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (12 years of age and older), DO NOT DILUTE, Gray Cap.
Pfizer and BioNTech; July 8, 2022. - Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap.
Pfizer and BioNTech; June 17, 2022 - Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (6 months through 4 years of age), DILUTE BEFORE USE, Maroon Cap.
Pfizer and BioNTech; June 17, 2022