Vaccine Information: Pfizer-BioNTech Covid-19 Vaccine (Page 2 of 7)


1
When prepared according to their respective instructions for use, the FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the two EUA-authorized formulations of Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older can be used interchangeably without presenting any safety or effectiveness concerns.
2
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 their first and second dose in the primary regimen may receive, for either dose, either: (1) the Pfizer-BioNTech COVID-19 Vaccine formulation authorized for use in individuals 5 through 11 years of age (each 0.2 mL dose containing 10 mcg modRNA) (orange cap); or (2) COMIRNATY or one of the Pfizer-BioNTech COVID-19 Vaccine formulations authorized for use in individuals 12 years of age and older (each 0.3 mL dose containing 30 mcg modRNA) (gray and purple cap).
3
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 Booster Dose Following a Pfizer-BioNTech COVID-19 Vaccine Primary Series in Participants 18 Through 55 Years of Age
18.5 Immunogenicity in Solid Organ Transplant Recipients
18.6 Immunogenicity of a Booster Dose Following Primary Vaccination with Another Authorized COVID-19 Vaccine
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
Figure
(click image for full-size original)
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
Figure
(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.
Figure
(click image for full-size original)
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
Figure
(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.
Figure
(click image for full-size original)
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.
Figure
(click image for full-size original)
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.
FigureRecord 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
FigureWithdraw 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.

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