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

1
The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.
2
The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.
3
Vaccination providers administering COMIRNATY (COVID-19 Vaccine, mRNA) must adhere to the same reporting requirements.
4
The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.
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 for Individuals 12 Years of Age and Older
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 in Participants 16 Years of Age and Older
18.2 Efficacy in Adolescents 12 Through 15 Years of Age
18.3 Immunogenicity in Adolescents 12 Through 15 Years of Age
18.4 Immunogenicity in Solid Organ Transplant Recipients
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 12 years of age and older.

2 DOSAGE AND ADMINISTRATION

For intramuscular injection only.

2.1 Preparation for Administration

Prior to Dilution

  • The Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vial contains a volume of 0.45 mL, supplied as a frozen suspension that does not contain preservative. Each vial must be thawed and diluted prior to administration.
  • 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 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 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, one vial contains 6 doses of 0.3 mL. Vial labels and cartons may state that after dilution, a vial contains 5 doses of 0.3 mL. The information in this Full EUA Prescribing Information regarding the number of doses per vial after dilution supersedes the number of doses stated on vial labels and cartons.
  • Refer to dilution and dose preparation instructions in the panels below.
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)
  • 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.
DILUTION
Figure
(click image for full-size original)
  • 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 0.9% Sodium Chloride Injection, USP into the vaccine vial.
Figure
(click image for full-size original)
  • 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 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.
Figure
(click image for full-size original)
  • 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.
PREPARATION OF INDIVIDUAL 0.3 mL DOSES OF PFIZER-BIONTECH COVID-19 VACCINE
Figure
(click image for full-size original)
  • 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 low dead-volume syringes and/or needles.
  • 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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