- 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 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).
- 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* || |
FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION
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 gray cap and label with a gray border, 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 gray cap and label with a gray border and MUST NOT be diluted prior to use.
|Age Range||Dilution Information||Doses Per Vial||Dose Volume|
|12 years and older||Do not dilute prior to use||6||0.3 mL|
DO NOT DILUTE
- The Pfizer-BioNTech COVID-19 Vaccine multiple dose vial with a gray cap and a label with a gray border contains a volume of 2.25 mL, and is supplied as a frozen suspension that does not contain preservative. Each vial must be thawed prior to administration. DO NOT DILUTE prior to use.
- 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.
- One vial contains 6 doses of 0.3 mL.
|Pfizer-BioNTech COVID-19 Vaccine Vial with Gray Cap and Label with Gray Border – VIAL VERIFICATION|
|Pfizer-BioNTech COVID-19 Vaccine Vial with Gray Cap and Label with Gray Border – THAWING PRIOR TO USE|
|Store in the refrigerator for up to 10 weeks prior to use.|
|Pfizer-BioNTech COVID-19 Vaccine Vial with Gray Cap and Label with Gray Border –PREPARATION OF INDIVIDUAL 0.3 mL DOSES|
|Withdraw 0.3 mL dose of vaccine.|
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