Vaccine Information: Comirnaty (Page 5 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

Single Dose Vials: COMIRNATY is a suspension for intramuscular injection. Single dose vials with gray caps and labels with gray borders are supplied in a carton containing 10 single dose vials. One vial contains 1 dose of 0.3 mL.

•
Carton of 10 single dose vials: NDC 0069-3125-10
•
Single dose vial: NDC 0069-3125-01

Multiple Dose Vials: COMIRNATY is a suspension for intramuscular injection. Multiple dose vials with gray caps and labels with gray borders are supplied in a carton containing 10 multiple dose vials or 25 multiple dose vials.

One vial contains 6 doses of 0.3 mL.

•
Carton of 10 multiple dose vials: NDC 0069-2025-10
•
Carton of 25 multiple dose vials: NDC 0069-2025-25
•
Multiple dose vial: NDC 0069-2025-01

During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.

Do not refreeze thawed vials.

Vial Storage Prior to Use

Cartons of COMIRNATY single dose vials and multiple dose vials with gray caps and labels with gray borders will arrive frozen at ultra-cold conditions in thermal containers with dry ice.

Once received, frozen vials may be immediately transferred to the refrigerator [2°C to 8°C (35°F to 46°F)], thawed and stored for up to 10 weeks. The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer. A carton of 10 single dose vials may take up to 2 hours to thaw at this temperature. A carton of 10 multiple dose vials may take up to 6 hours to thaw at this temperature.

Alternatively, frozen vials may be stored in an ultra-low temperature freezer at -90°C to -60°C (-130°F to -76°F). Do not store vials at -25°C to -15°C (-13°F to 5°F). Once vials are thawed, they should not be refrozen.

If cartons of COMIRNATY single dose vials or multiple dose vials with gray caps and labels with gray borders are received at 2°C to 8°C, they should be stored at 2°C to 8°C. Check that the carton has been updated to reflect the 10-week refrigerated expiry date.

Regardless of storage condition, the vaccine should not be used after the expiration date printed on the vial and cartons.

Vial Storage During Use

If not previously thawed at 2°C to 8°C (35°F to 46°F), allow COMIRNATY single dose vials and multiple dose vials to thaw at room temperature [up to 25°C (77°F)] for 30 minutes.

DO NOT DILUTE SINGLE DOSE VIALS OR MULTIPLE DOSE VIALS PRIOR TO USE.

COMIRNATY single dose vials and multiple dose vials with gray caps and labels with gray borders may be stored at room temperature [8°C to 25°C (46°F to 77°F)] for a total of 12 hours prior to the first puncture. After first puncture, multiple dose vials should be held between 2°C to 25°C (35°F to 77°F). Multiple dose vials should be discarded 12 hours after first puncture.

Transportation of Vials

If local redistribution is needed, single dose vials and multiple dose vials may be transported at -90°C to -60°C (-130°F to -76°F), or at 2°C to 8°C (35°F to 46°F).

17 PATIENT COUNSELING INFORMATION

Inform vaccine recipient of the potential benefits and risks of vaccination with COMIRNATY.

Inform vaccine recipient of the importance of completing the 2 dose vaccination series.

There is a pregnancy exposure registry for COMIRNATY. Encourage individuals exposed to COMIRNATY around the time of conception or during pregnancy to register by visiting https://mothertobaby.org/ongoing-study/covid19-vaccines/.

Advise vaccine recipient to report any adverse events to their healthcare provider or to the Vaccine Adverse Event Reporting System at 1-800-822-7967 and www.vaers.hhs.gov.

Prior to administering the vaccine, give the vaccine recipient the Vaccine Information Fact Sheet for Recipients and Caregivers about COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for Use in Individuals 12 Years of Age and Older. The Vaccine Information Fact Sheet for Recipients and Caregivers is available at www.cvdvaccine-us.com.

This product’s labeling may have been updated. For the most recent prescribing information, please visit https://dailymed.nlm.nih.gov/dailymed/.

Logo

Manufactured for
BioNTech Manufacturing GmbH
An der Goldgrube 12
55131 Mainz, Germany

Logo

Manufactured by
Pfizer Inc., New York, NY 10017

LAB-1490-4.0

US Govt. License No. 2229

PRINCIPAL DISPLAY PANEL — 0.3 mL Multiple Dose Vial Label

COVID-19 Vaccine, mRNA
COMIRNATY®
Age 12y & older
Rx only

DO NOT DILUTE

Vial contains 6 doses of 0.3 mL

For intramuscular use. Contains no preservative.
Discard 12 hours after first use when stored at
2 to 25°C (35 to 77°F).
First use date/time:

US License No. 2229BioNTech Manufacturing GmbH & Pfizer Inc.

NDC 0069-2025-01

PRINCIPAL DISPLAY PANEL -- 0.3 mL Multiple Dose Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 Multiple Dose Vial Carton

NDC 0069-2025-10

COVID-19 Vaccine, mRNA
COMIRNATY®

Suspension for Injection, for Intramuscular Use

DO NOT DILUTE

10 Multiple Dose Vials

Each vial contains 6 doses of 0.3 mL

For 12 years of age and older

BIONTECH
PfizerRx only

PRINCIPAL DISPLAY PANEL -- 10 Multiple Dose Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 25 Multiple Dose Vial Carton

NDC 0069-2025-25

COVID-19 Vaccine, mRNA
COMIRNATY®

Suspension for Injection, for Intramuscular Use

DO NOT DILUTE

25 Multiple Dose Vials

Each vial contains 6 doses of 0.3 mL

For 12 years of age and older

BIONTECH
PfizerRx only

PRINCIPAL DISPLAY PANEL -- 25 Multiple Dose Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.3 mL Single Dose Vial Label

COVID-19 Vaccine, mRNA
COMIRNATY®
Age 12y & older
Rx only

DO NOT DILUTE

Vial contains 1 dose of 0.3 mL

For intramuscular use.
Contains no preservative.
Discard after single use.

US License No. 2229BioNTech Manufacturing GmbH & Pfizer Inc.

NDC 0069-3125-01

PRINCIPAL DISPLAY PANEL -- 0.3 mL Single Dose Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 Single Dose Vial Carton

NDC 0069-3125-10

COVID-19 Vaccine, mRNA
COMIRNATY®

Suspension for Injection, for Intramuscular Use

DO NOT DILUTE

10 Single Dose Vials

Each vial contains 1 dose of 0.3 mL

For 12 years of age and older

BIONTECH
PfizerRx only

PRINCIPAL DISPLAY PANEL -- 10 Single Dose Vial Carton
(click image for full-size original)
COMIRNATY covid-19 vaccine, mrna injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:0069-2025
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOZINAMERAN (TOZINAMERAN) TOZINAMERAN 0.225 mg in 2.25 mL
Inactive Ingredients
Ingredient Name Strength
2-(MPEG 2000)-N,N-DITETRADECYLACETAMIDE 0.41 mg in 2.25 mL
((4-HYDROXYBUTYL)AZANEDIYL)BIS(HEXANE-6,1-DIYL)BIS(2-HEXYLDECANOATE) 3.22 mg in 2.25 mL
SUCROSE 231.8 mg in 2.25 mL
1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE 0.70 mg in 2.25 mL
CHOLESTEROL 1.40 mg in 2.25 mL
WATER
TROMETHAMINE 0.45 mg in 2.25 mL
TROMETHAMINE HYDROCHLORIDE 2.97 mg in 2.25 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0069-2025-10 10 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS (0069-2025-01)
1 NDC:0069-2025-01 2.25 mL in 1 VIAL, GLASS This package is contained within the CARTON (0069-2025-10)
2 NDC:0069-2025-25 25 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS (0069-2025-01)
2 NDC:0069-2025-01 2.25 mL in 1 VIAL, GLASS This package is contained within the CARTON (0069-2025-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125742 05/18/2022
COMIRNATY covid-19 vaccine, mrna injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:0069-3125
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOZINAMERAN (TOZINAMERAN) TOZINAMERAN 0.048 mg in 0.48 mL
Inactive Ingredients
Ingredient Name Strength
2-(MPEG 2000)-N,N-DITETRADECYLACETAMIDE 0.09 mg in 0.48 mL
((4-HYDROXYBUTYL)AZANEDIYL)BIS(HEXANE-6,1-DIYL)BIS(2-HEXYLDECANOATE) 0.69 mg in 0.48 mL
SUCROSE 49.44 mg in 0.48 mL
1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE 0.15 mg in 0.48 mL
CHOLESTEROL 0.30 mg in 0.48 mL
WATER
TROMETHAMINE 0.10 mg in 0.48 mL
TROMETHAMINE HYDROCHLORIDE 0.63 mg in 0.48 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0069-3125-10 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0069-3125-01)
1 NDC:0069-3125-01 0.48 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0069-3125-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125742 08/25/2022 08/25/2022
Labeler — Pfizer Laboratories Div Pfizer Inc (134489525)
Registrant — Pfizer Inc (113480771)
Establishment
Name Address ID/FEI Operations
Pfizer Manufacturing Belgium NV 370156507 ANALYSIS (0069-2025), ANALYSIS (0069-3125), MANUFACTURE (0069-2025), MANUFACTURE (0069-3125), PACK (0069-2025), PACK (0069-3125), LABEL (0069-2025), LABEL (0069-3125)
Establishment
Name Address ID/FEI Operations
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC 174350868 ANALYSIS (0069-2025), ANALYSIS (0069-3125), API MANUFACTURE (0069-2025), API MANUFACTURE (0069-3125)
Establishment
Name Address ID/FEI Operations
Pfizer Inc 004954111 ANALYSIS (0069-2025), ANALYSIS (0069-3125)
Establishment
Name Address ID/FEI Operations
Labor LS SE & Co. KG 314929072 ANALYSIS (0069-2025), ANALYSIS (0069-3125)
Establishment
Name Address ID/FEI Operations
Pfizer Ireland Pharmaceuticals 985586408 ANALYSIS (0069-2025), ANALYSIS (0069-3125), API MANUFACTURE (0069-2025), API MANUFACTURE (0069-3125)
Establishment
Name Address ID/FEI Operations
BioNTech Innovative Manufacturing Services GmbH 537365801 ANALYSIS (0069-2025), ANALYSIS (0069-3125)
Establishment
Name Address ID/FEI Operations
BioNTech Manufacturing GmbH 314382536 ANALYSIS (0069-2025), ANALYSIS (0069-3125)
Establishment
Name Address ID/FEI Operations
BioNTech Manufacturing Marburg GmbH 313270335 ANALYSIS (0069-2025), ANALYSIS (0069-3125), API MANUFACTURE (0069-2025), API MANUFACTURE (0069-3125)
Establishment
Name Address ID/FEI Operations
Pharmacia & Upjohn Company LLC 618054084 ANALYSIS (0069-2025), ANALYSIS (0069-3125), MANUFACTURE (0069-2025), MANUFACTURE (0069-3125), PACK (0069-2025), PACK (0069-3125), LABEL (0069-2025), LABEL (0069-3125)

Revised: 04/2023 Pfizer Laboratories Div Pfizer Inc

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