Emergency Use Authorization1-5
Emergency uses of Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent have not been approved or licensed by FDA but have been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older as appropriate. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)   (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see EUA Fact Sheets at www.cvdvaccine-us.com
Select Important Vial Information
PFIZER-BIONTECH COVID-19 VACCINE, 6 MONTHS THROUGH 4 YEARS OF AGE, DILUTE BEFORE USE, MAROON CAP
The original monovalent
PFIZER-BIONTECH COVID-19 VACCINE, 12 YEARS OF AGE AND OLDER, DILUTE BEFORE USE, PURPLE CAP
Pfizer-BioNTech COVID-19 Vaccine is no longer supplied in vials with a purple cap in the US. For information related to Pfizer-BioNTech COVID-19 Vaccine, Dilute Before Use, purple cap, please review the EUA Fact Sheet or the full Prescribing Information. Expiry information can be found at: https://lotexpiry.cvdvaccine.com/
Expiry Information
Expiry information for vaccine vials can be found at https://lotexpiry.cvdvaccine.com/
Formulation/
Presentation Guide
Refer to the information outlined below for
For individuals 6 months through 4 years of age


Primary Series
Pfizer-BioNTech COVID-19 Vaccine* and
Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron
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 dilution
(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)
6 MONTHS THROUGH 4 YEARS OF AGE, DILUTE BEFORE USE
Authorized for use in individuals 6 months through 4 years of age to provide a single booster dose at least 2 months after completion
of primary vaccination with 3 doses of the original monovalent Pfizer-BioNTech COVID-19 Vaccine*
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 dilution
(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

Primary Series
Pfizer-BioNTech COVID-19 Vaccine
5 THROUGH 11 YEARS OF AGE, DILUTE BEFORE USE
Orange Cap2
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 dilution
(including any thaw time)
After first puncture
[2°C to 25°C (35°F to 77°F)]
Discard after 12 hours§

Booster Dose
Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)
5 THROUGH 11 YEARS OF AGE, DILUTE BEFORE USE, BIVALENT
Orange Cap3
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 dilution
(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

Primary Series
Pfizer-BioNTech COVID-19 Vaccine
12 YEARS OF AGE AND OLDER, DO NOT DILUTE
Gray Cap4
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*
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‡

Booster Dose
Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)
12 YEARS OF AGE AND OLDER, DO NOT DILUTE, BIVALENT
Gray Cap5
Dosing Information
Dose
30 mcg
Dose volume
0.3 mL
Amount of diluent needed per vial
NO DILUTION
Doses per vial
Single dose vial: 1 dose per vial
Multiple dose vial: 6 doses 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 andPfizer-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 through 4 years of age), DILUTE BEFORE USE, Maroon Cap. Pfizer and BioNTech; March 14, 2023. -
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; December 8, 2022. -
Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers), Bivalent (Original and Omicron BA.4/BA.5) (Booster Dose for 5 through 11 years of age), DILUTE BEFORE USE, Orange Cap. Pfizer and BioNTech; December 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; December 8, 2022. -
Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers), Bivalent (Original and Omicron BA.4/BA.5) (Booster Dose for 12 years of age and older), DO NOT DILUTE, Gray Cap. Pfizer and BioNTech; December 8, 2022.