Vaccine Information: Comirnaty (Page 5 of 5)

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/.

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

Logo

Manufactured by
Pfizer Inc., New York, NY 10017

LAB-1490-2.0

US Govt. License No. 2229

PRINCIPAL DISPLAY PANEL — 0.3 mL 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. 2229 BioNTech Manufacturing GmbH & Pfizer Inc.

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

PRINCIPAL DISPLAY PANEL — 10 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
Pfizer Rx only

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

PRINCIPAL DISPLAY PANEL — 25 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
Pfizer Rx only

PRINCIPAL DISPLAY PANEL -- 25 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 0.7 mg in 2.25 mL
CHOLESTEROL 1.4 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
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), MANUFACTURE (0069-2025), PACK (0069-2025), LABEL (0069-2025)
Establishment
Name Address ID/FEI Operations
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC 174350868 ANALYSIS (0069-2025), API MANUFACTURE (0069-2025)
Establishment
Name Address ID/FEI Operations
Pfizer Inc 004954111 ANALYSIS (0069-2025)
Establishment
Name Address ID/FEI Operations
Labor LS SE & Co. KG 314929072 ANALYSIS (0069-2025)
Establishment
Name Address ID/FEI Operations
Rentschler Biopharma SE 313166479 ANALYSIS (0069-2025), API MANUFACTURE (0069-2025)
Establishment
Name Address ID/FEI Operations
Pfizer Ireland Pharmaceuticals 985586408 ANALYSIS (0069-2025)
Establishment
Name Address ID/FEI Operations
BioNTech Innovative Manufacturing Services GmbH 537365801 ANALYSIS (0069-2025)
Establishment
Name Address ID/FEI Operations
BioNTech Manufacturing GmbH 314382536 ANALYSIS (0069-2025), API MANUFACTURE (0069-2025)
Establishment
Name Address ID/FEI Operations
BioNTech Manufacturing Marburg GmbH 313270335 ANALYSIS (0069-2025), API MANUFACTURE (0069-2025)

Revised: 08/2022 Pfizer Laboratories Div Pfizer Inc

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