- 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.
- 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.
- 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 multiple dose 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 multiple dose vials with gray caps and multiple dose vials with purple caps).
- 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*
* Sections or subsections omitted from the full emergency use authorization prescribing information are not listed.
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 6 months 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.
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.
|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
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.
- 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
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
Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap – DILUTION
Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe.
Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap – WITHDRAWAL OF INDIVIDUAL 0.3 mL DOSES
VxLabels.com provides trustworthy package insert and label information about marketed drugs and vaccines as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VxLabels.com. Every individual vaccine label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.