Vaccine Information: Pfizer-BioNTech Covid-19 Vaccine (Page 2 of 9)

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1

Certain kinds of immunocompromise refers to individuals who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

2

When prepared according to their respective instructions for use, the FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older can be used interchangeably without presenting any safety or effectiveness concerns.

3

Notwithstanding the age limitations for use of the different formulations and presentations described above, individuals who will turn from 11 years to 12 years of age between doses in the primary regimen may receive, for any dose in the primary regimen, either: (1) the Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 5 through 11 years of age (each 0.2 mL dose containing 10 mcg modRNA) (supplied in multidose vials with orange caps); or (2) COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 12 years of age and older (each 0.3 mL dose containing 30 mcg modRNA) (supplied in multidose vials with gray caps and multidose vials with purple caps).

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Vaccination providers administering COMIRNATY (COVID-19 Vaccine, mRNA) must adhere to the same reporting requirements.

FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION
PFIZER-BIONTECH COVID-19 VACCINE
FULL EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION: CONTENTS* 1 AUTHORIZED USE 2 DOSAGE AND ADMINISTRATION 2.1 Preparation for Administration 2.2 Administration Information 2.3 Vaccination Schedule 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Management of Acute Allergic Reactions 5.2 Myocarditis and Pericarditis 5.3 Syncope 5.4 Altered Immunocompetence 5.5 Limitation of Effectiveness 6 OVERALL SAFETY SUMMARY 6.1 Clinical Trials Experience 6.2 Post Authorization Experience 8 REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS 10 DRUG INTERACTIONS 11 USE IN SPECIFIC POPULATIONS 11.1 Pregnancy 11.2 Lactation 11.3 Pediatric Use	11.4 Geriatric Use 11.5 Use in Immunocompromised 13 DESCRIPTION 14 CLINICAL PHARMACOLOGY 14.1 Mechanism of Action 18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA 18.1 Efficacy of Primary Series in Participants 16 Years of Age and Older 18.2 Efficacy of Primary Series in Adolescents 12 Through 15 Years of Age 18.3 Immunogenicity of Primary Series in Adolescents 12 Through 15 Years of Age 18.4 Immunogenicity of a Third Primary Series Dose in Individuals with Certain Kinds of Immunocompromise 18.5 Immunogenicity of a First Booster Dose Following a Pfizer-BioNTech COVID-19 Vaccine Primary Series in Participants 18 Through 55 Years of Age 18.6 Immunogenicity of a First Booster Dose Following Primary Vaccination with Another Authorized or Approved COVID-19 Vaccine 18.7 Immunogenicity of a Second Booster Dose 19 HOW SUPPLIED/STORAGE AND HANDLING 20 PATIENT COUNSELING INFORMATION 21 CONTACT INFORMATION

FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION

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 by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 5 years of age and older.

This EUA Prescribing Information pertains only to Pfizer-BioNTech COVID-19 Vaccine supplied in a multiple dose vial with a purple cap, which is authorized for use in individuals 12 years of age and older.

2 DOSAGE AND ADMINISTRATION

For intramuscular injection only.

The storage, preparation, and administration information in this Prescribing Information apply to the Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older, which is supplied in a multiple dose vial with a purple cap and MUST BE DILUTED before use.

Pfizer-BioNTech COVID-19 Vaccine, Multiple Dose Vial with Purple Cap

Age Range	Dilution Information	Doses Per Vial After Dilution	Dose Volume
12 years and older	Dilute with 1.8 mL sterile 0.9% Sodium Chloride Injection, USP prior to use	6	0.3 mL

2.1 Preparation for Administration

Dose Preparation

Each vial MUST BE DILUTED before administering the vaccine.

Prior to Dilution

• The Pfizer-BioNTech COVID-19 Vaccine multiple dose vial with a purple cap contains a volume of 0.45 mL and is supplied as a frozen suspension that does not contain preservative.
• Each vial must be thawed before dilution.
• Vials may be thawed in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)] or at room temperature [up to 25ºC (77ºF)] [see How Supplied/Storage and Handling (19)].
• Refer to thawing instructions in the panels below.

Dilution

• Dilute the vial contents using 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP (not provided) to form the Pfizer-BioNTech COVID-19 Vaccine. Do not add more than 1.8 mL of diluent.
• ONLY use sterile 0.9% Sodium Chloride Injection, USP as the diluent. This diluent is not packaged with the vaccine and must be sourced separately. Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent.
• After dilution, 1 vial contains 6 doses of 0.3 mL.

Dilution and Preparation Instructions
Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap – VIAL VERIFICATION
✓ Purple plastic cap and purple label border.	Verify that the vial of Pfizer-BioNTech COVID-19 Vaccine has a purple plastic cap. Some vials also may have a purple label border on the label.
Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap – THAWING PRIOR TO DILUTION
(click image for full-size original)	Thaw vial(s) of Pfizer-BioNTech COVID-19 Vaccine before use either by: Allowing vial(s) to thaw in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)]. A carton of vials may take up to 3 hours to thaw, and thawed vials can be stored in the refrigerator for up to 1 month. Allowing vial(s) to sit at room temperature [up to 25ºC (77ºF)] for 30 minutes. Using either thawing method, vials must reach room temperature before dilution and must be diluted within 2 hours.
Gently × 10	Before dilution invert vaccine vial gently 10 times. Do not shake. Inspect the liquid in the vial prior to dilution. The liquid is a white to off-white suspension and may contain white to off-white opaque amorphous particles. Do not use if liquid is discolored or if other particles are observed.
Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap – DILUTION
(click image for full-size original) Add 1.8 mL of sterile 0.9% sodium chloride injection, USP.	Obtain sterile 0.9% Sodium Chloride Injection, USP. Use only this as the diluent. Using aseptic technique, withdraw 1.8 mL of diluent into a transfer syringe (21-gauge or narrower needle). Cleanse the vaccine vial stopper with a single-use antiseptic swab. Add 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP into the vaccine vial.
Pull back plunger to 1.8 mL to remove air from vial.	Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe.
Gently × 10	Gently invert the vial containing the Pfizer-BioNTech COVID-19 Vaccine 10 times to mix. Do not shake. Inspect the vaccine in the vial. The vaccine will be an off-white suspension. Do not use if vaccine is discolored or contains particulate matter.
Record the date and time of dilution.Use within 6 hours after dilution.	Record the date and time of dilution on the Pfizer-BioNTech COVID-19 Vaccine vial label. Store between 2°C to 25°C (35°F to 77°F). Discard any unused vaccine 6 hours after dilution.
Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap – WITHDRAWAL OF INDIVIDUAL 0.3 mL DOSES
Withdraw 0.3 mL dose of vaccine.	Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.3 mL of the Pfizer-BioNTech COVID-19 Vaccine preferentially using a low dead-volume syringe and/or needle. Each dose must contain 0.3 mL of vaccine. If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume. Administer immediately.