PFIZER-BIONTECH COVID-19 VACCINE- bnt162b2 injection, suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TOZINAMERAN (UNII: 5085ZFP6SJ) (TOZINAMERAN - UNII:5085ZFP6SJ)

Available from:

Pfizer Manufacturing Belgium NV

Administration route:

INTRAMUSCULAR

Therapeutic indications:

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. Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine [see Description (13)] . Risk Summary All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Available data on Pfizer-BioNTech COVID-19 Vaccine

Product summary:

The information in this section applies to the Pfizer-BioNTech COVID-19 Vaccine that is supplied in multiple dose vials with a purple cap. These multiple dose vials are supplied in a carton containing 25 multiple dose vials (NDC 59267-1000-3) or 195 multiple dose vials (NDC 59267-1000-2). After dilution, 1 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. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Do not refreeze thawed vials. Frozen Vials Prior to Use Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with purple caps arrive in thermal containers with dry ice. Once received, remove the vial cartons immediately from the thermal container and preferably store in an ultra-low temperature freezer between -90ºC to -60ºC (-130ºF to -76ºF) until the expiry date printed on the label. This information in the package insert supersedes the storage conditions printed on the vial cartons. Cartons and vials of Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with purple caps with an expiry date of December 2021 through December 2022 printed on the label may remain in use beyond the printed date until the updated expiry date shown below; as long as approved storage conditions have been maintained. Printed Expiry Date Updated Expiry Date 12/2021 ➜ 31-Dec-2022 01/2022 ➜ 31-Jan-2023 02/2022 ➜ 28-Feb-2023 03/2022 ➜ 31-Mar-2023 06/2022 ➜ 31-Mar-2023 07/2022 ➜ 30-Apr-2023 08/2022 ➜ 31-May-2023 09/2022 ➜ 30-Jun-2023 10/2022 ➜ 31-Jul-2023 11/2022 ➜ 31-Aug-2023 12/2022 ➜ 30-Sep-2023 If not stored between -90ºC to -60ºC (-130ºF to -76ºF), vials may be stored at -25°C to -15°C (-13°F to 5°F) for up to 2 weeks. Vials must be kept frozen and protected from light, in the original cartons, until ready to use. Vials stored at -25°C to -15°C (-13°F to 5°F) for up to 2 weeks may be returned one time to the recommended storage condition of -90ºC to -60ºC (-130ºF to -76ºF). Total cumulative time the vials are stored at -25°C to -15°C (-13°F to 5°F) should be tracked and should not exceed 2 weeks. If an ultra-low temperature freezer is not available, the thermal container in which the Pfizer-BioNTech COVID-19 Vaccine arrives may be used as temporary storage when consistently re-filled to the top of the container with dry ice. Refer to the re-icing guidelines packed in the original thermal container for instructions regarding the use of the thermal container for temporary storage . The thermal container maintains a temperature range of -90ºC to -60ºC (-130ºF to -76ºF). Storage of the vials between -96°C to -60°C (-141°F to -76°F) is not considered an excursion from the recommended storage condition. Transportation of Frozen Vials If local redistribution is needed and full cartons containing vials cannot be transported at -90°C to -60°C (-130°F to -76°F), vials may be transported at -25°C to -15°C (-13°F to 5°F). Any hours used for transport at -25°C to -15°C (-13°F to 5°F) count against the 2-week limit for storage at -25°C to -15°C (-13°F to 5°F). Frozen vials transported at -25°C to -15°C (-13°F to 5°F) may be returned one time to the recommended storage condition of -90ºC to -60ºC (-130ºF to -76ºF). Thawed Vials Before Dilution Thawed Under Refrigeration Thaw and then store undiluted vials in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)] for up to 1 month. A carton of 25 vials or 195 vials may take up to 2 or 3 hours, respectively, to thaw in the refrigerator, whereas a fewer number of vials will thaw in less time. Thawed at Room Temperature For immediate use, thaw undiluted vials at room temperature [up to 25ºC (77ºF)] for 30 minutes. Thawed vials can be handled in room light conditions. Vials must reach room temperature before dilution. Undiluted vials may be stored at room temperature for no more than 2 hours. Transportation of Thawed Vials Available data support transportation of one or more thawed vials at 2°C to 8°C (35°F to 46°F) for up to 48 hours. Vials After Dilution After dilution, store vials between 2°C to 25°C (35°F to 77°F) and use within 6 hours from the time of dilution. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Any vaccine remaining in vials must be discarded after 6 hours. Do not refreeze.

Authorization status:

unapproved drug other

Summary of Product characteristics

PFIZER-BIONTECH COVID-19 VACCINE- BNT162B2 INJECTION, SUSPENSION
PFIZER MANUFACTURING BELGIUM NV
----------
PFIZER-BIONTECH COVID-19 VACCINE
FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE
(VACCINATION PROVIDERS)
EMERGENCY USE AUTHORIZATION (EUA) OF THE PFIZER-BIONTECH COVID-19
VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19)
PRIMARY SERIES FOR 12 YEARS OF AGE AND OLDER
DILUTE BEFORE USE
THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) HAS ISSUED AN EMERGENCY
USE
AUTHORIZATION (EUA) TO PERMIT THE EMERGENCY USE OF THE UNAPPROVED
PRODUCT, PFIZER-BIONTECH COVID-19 VACCINE, FOR ACTIVE IMMUNIZATION TO
PREVENT COVID-19 IN INDIVIDUALS 6 MONTHS OF AGE AND OLDER.
THERE ARE 2 FORMULATIONS OF PFIZER-BIONTECH COVID-19 VACCINE
AUTHORIZED FOR
USE IN INDIVIDUALS 12 YEARS OF AGE AND OLDER:
THIS FACT SHEET 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 AND MUST BE DILUTED PRIOR TO
USE.
PFIZER-BIONTECH COVID-19 VACCINE SUPPLIED IN A MULTIPLE DOSE VIAL WITH
A
PURPLE CAP IS AUTHORIZED FOR USE TO PROVIDE:
•
•
COMIRNATY (COVID-19 VACCINE, MRNA) IS AN FDA-APPROVED COVID-19
VACCINE MADE BY PFIZER FOR BIONTECH THAT IS INDICATED FOR ACTIVE
IMMUNIZATION
TO PREVENT COVID-19 IN INDIVIDUALS 12 YEARS OF AGE AND OLDER. IT IS
APPROVED
FOR USE AS A 2-DOSE PRIMARY SERIES FOR THE PREVENTION OF COVID-19 IN
INDIVIDUALS 12 YEARS OF AGE AND OLDER. IT IS ALSO AUTHORIZED FOR
EMERGENCY USE
TO PROVIDE A THIRD PRIMARY SERIES DOSE TO INDIVIDUALS 12 YEARS OF AGE
AND
OLDER WITH CERTAIN KINDS OF IMMUNOCOMPROMISE.
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 WHEN PREPARED ACCORDING TO THEIR RESPECTIVE INSTRUCTIONS FOR
USE
CAN BE USED INTERCHANGEABLY.
THE FORMULATION SUPPLIED IN A MULTIPLE DOSE VIAL WITH A PURPLE CAP
MUST
BE DILUTED PRIOR TO USE.
THE FORMULATION SUPPLIED IN A MULTIPLE DOSE VIAL WITH A GRAY CAP AND
LABEL
WI