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Comirnaty (COVID-19 Vaccine, mRNA) Principal Display Panel (Pfizer-BioNTech COVID-19 Vaccine)

Principal Display Panel

PRINCIPAL DISPLAY PANEL - 1.8 mL Vial Label

Pfizer-BioNTech COVID-19 Vaccine
After dilution, vial contains 6 doses of 0.3 mL

For intramuscular use. Contains no preservative.

For use under Emergency Use Authorization.

DILUTE BEFORE USE. Discard 6 hours after
dilution when stored at 2 to 25°C (35 to 77°F).

Dilution date and time:

NDC 59267-1000-1

Principal Display Panel - 1.8 mL Vial Label

PRINCIPAL DISPLAY PANEL - 195 Vial Carton Label

NDC 59267-1000-2

Pfizer-BioNTech COVID-19 Vaccine
Suspension for Intramuscular Injection

195 Multiple Dose Vials
(after dilution each vial contains
6 doses of 0.3 mL)

Pfizer BIONTECH

STORAGE: Prior to dilution, store at
-80°C to -60°C (-112°F to -76°F).
Store in this carton to protect from light.

DOSAGE AND ADMINISTRATION: After
dilution, each vial contains 6 doses of 0.3 mL.
See FDA-authorized Fact Sheet or scan
QR code for information.

MUST BE DILUTED BEFORE USE with sterile
0.9% Sodium Chloride Injection, USP (not supplied).
After dilution, store the vaccine at 2°C to 25°C (35°F to 77°F).
Discard after 6 hours.
Contains no preservative.
For use under Emergency Use Authorization.
Rx only

Manufactured by
Pfizer Inc
New York, NY 10017

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

PAA166261

LOT:

EXP:

Principal Display Panel - 195 Vial Carton Label

PRINCIPAL DISPLAY PANEL - 25 Vial Carton

NDC 59267-1000-3
Rx only

Pfizer-BioNTech COVID-19 Vaccine
Suspension for Intramuscular Injection

25 Multiple Dose Vials
(after dilution each vial contains 6 doses of 0.3 mL)

MUST BE DILUTED BEFORE USE with sterile
0.9% Sodium Chloride Injection, USP (not supplied).
After dilution, store the vaccine at 2°C to 25°C (35°F to 77°F).
Discard after 6 hours.

PRINCIPAL DISPLAY PANEL - 25 Vial Carton

Indications and Usage

1 AUTHORIZED USE

Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused...

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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

For intramuscular injection only.

2.1 Preparation for Administration

...
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Dosage Forms and Strengths

3 DOSAGE FORMS AND STRENGTHS

Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection. After preparation, a single dose is 0.3 mL [see Dosage and...

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Contraindications

4 CONTRAINDICATIONS

Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech...

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Warnings and Precautions

5 WARNINGS AND PRECAUTIONS

5.1 Management of Acute Allergic Reactions

Appropriate medical treatment used to manage immediate allergic...

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Adverse Reactions

6 OVERALL SAFETY SUMMARY

It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event Reporting System (VAERS) all vaccine administration errors, all serious...

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Drug Interactions

10 DRUG INTERACTIONS

There are no data to assess the concomitant administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines.

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Use in Specific Populations

11 USE IN SPECIFIC POPULATIONS

11.1 Pregnancy

Risk...

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Description

13 DESCRIPTION

The Pfizer-BioNTech COVID-19 Vaccine is supplied as a frozen suspension in multiple dose vials; each vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP prior...

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Clinical Pharmacology

14 CLINICAL PHARMACOLOGY

14.1 Mechanism of Action

The modRNA in the Pfizer-BioNTech COVID-19 Vaccine is formulated in lipid particles,...

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Clinical Studies

18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA

18.1 Efficacy of Primary Series in Participants 16 Years of Age and Older

Study 2 is a...

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How Supplied/Storage and Handling

19 HOW SUPPLIED/STORAGE AND HANDLING

Pfizer-BioNTech COVID-19 Vaccine Suspension for Intramuscular Injection, Multiple Dose Vials are supplied in a carton containing 25 multiple...

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Patient Counseling Information

20 PATIENT COUNSELING INFORMATION

Advise the recipient or caregiver to read the Vaccine Information Fact Sheet for Recipients and Caregivers.

The vaccination provider must include...

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Emergency Use Authorization Fact Sheet for Recipients and Caregivers

VACCINE INFORMATION FACT SHEET FOR RECIPIENTS AND CAREGIVERS ABOUT COMIRNATY (COVID-19 VACCINE, mRNA) AND PFIZER-BIONTECH COVID-19...

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Fact Sheet For Healthcare Providers Administering Vaccine (Vaccination Providers)

FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION PROVIDERS)

EMERGENCY...

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Contact Information

FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION

21 CONTACT INFORMATION

For...

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