Emergency Use Authorization1
Select Important Vial Information
To prevent vaccine administration errors, prior to preparation and administration:
- Please verify that vial labels state Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)
- Verify the vial cap color and label for the respective authorized age group
Expiry Information
Expiry information for vaccine vials can be found at https://lotexpiry.cvdvaccine.com/
Important Authorization Update
Monovalent mRNA
Formulation/
Presentation Guide
Refer to the information outlined below for
For individuals 6 months through 4 years of age

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)
6 MONTHS THROUGH 4 YEARS OF AGE, DILUTE BEFORE USE
Maroon Cap1
Dosing Information
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)†
For eligibility, dosing schedule, and other important information, please see EUA Fact Sheet.
STORAGE CONDITIONS
Ultra-low-temperature (ULT) freezer
[-90°C to -60°C (-130°F to -76°F)]
18 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||
For individuals 5 through 11 years of age

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)
5 THROUGH 11 YEARS OF AGE, DILUTE BEFORE USE
Orange Cap1
Dosing Information
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)†
For eligibility, dosing schedule, and other important information, please see EUA Fact Sheet.
STORAGE CONDITIONS
Ultra-low-temperature (ULT) freezer
[-90°C to -60°C (-130°F to -76°F)]
18 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||
For individuals 12 years of age and older

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)
12 YEARS OF AGE AND OLDER, DO NOT DILUTE
Gray Cap1
Dosing Information
Dose
30 mcg
Dose volume
0.3 mL
Amount of diluent needed per vial
NO DILUTION
Doses per vial
Multiple dose vial: 6 doses per vial*
Single dose vial: 1 dose per vial
For eligibility, dosing schedule, and other important information, please see EUA Fact Sheet.
STORAGE CONDITIONS
Ultra-low-temperature (ULT) freezer
[-90°C to -60°C (-130°F to -76°F)]
18 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§
-
Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5). Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (6 months of age and older), Pfizer and BioNTech; April 28, 2023.