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 gray cap and label with a gray border, 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

Product summary:

The information in this section applies to the Pfizer-BioNTech COVID-19 Vaccine that is supplied in multiple dose vials with gray caps and labels with gray borders. These multiple dose vials are supplied in a carton containing 10 multiple dose vials (NDC 59267-1025-4) or 25 multiple dose vials (NDC 59267-1025-3). One vial contains 6 doses of 0.3 mL. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Do not refreeze thawed vials. Vial Storage Prior to Use Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with gray caps and labels with gray borders may arrive frozen at ultra-cold conditions in thermal containers with dry ice. Once received, frozen vials may be immediately transferred to the refrigerator [2ºC to 8ºC (35ºF to 46ºF)], thawed and stored for up to 10 weeks. The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer. A carton of 10 vials may take up to 6 hours to thaw at this temperature. Alternatively, frozen vials may be stored in an ultra-low temperature freezer at -90ºC to -60ºC (-130ºF to -76ºF) for up to 18 months from the date of manufacture. Do not store vials at -25°C to -15°C (-13°F to 5°F). Once vials are thawed, they should not be refrozen. If cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with gray caps and labels with gray borders are received at 2°C to 8°C (35°F to 46°F), they should be stored at 2°C to 8°C (35°F to 46°F). Check that the carton has been updated to reflect the 10-week refrigerated expiry date. Regardless of storage condition, the vaccine should not be used after 18 months from the date of manufacture printed on the vial and cartons. Expiry dates based on 18 months from the date of the manufacture are shown below. Vial Storage During Use If not previously thawed at 2ºC to 8ºC (35ºF to 46ºF), allow vials to thaw at room temperature [up to 25ºC (77ºF)] for 30 minutes. Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with gray caps and labels with gray borders may be stored at room temperature [8°C to 25°C (46°F to 77°F)] for a total of 12 hours prior to the first puncture. After first puncture, the vial should be held between 2ºC to 25°C (35°F to 77°F). Vials should be discarded 12 hours after first puncture. DO NOT DILUTE PRIOR TO USE . Vial labels and cartons may state that a vial should be discarded 6 hours after the first puncture. The information in this Full EUA Prescribing Information supersedes the number of hours printed on vial labels and cartons. Transportation of Vials If local redistribution is needed, vials may be transported at -90°C to -60°C (-130°F to -76°F) or 2°C to 8°C (35°F to 46°F).

Summary of Product characteristics

PFIZER-BIONTECH COVID-19 VACCINE- BNT162B2 INJECTION, SUSPENSION
PFIZER MANUFACTURING BELGIUM NV
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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
DO NOT DILUTE
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 GRAY CAP AND A LABEL WITH A GRAY
BORDER, WHICH IS
AUTHORIZED FOR USE IN INDIVIDUALS 12 YEARS OF AGE AND OLDER AND MUST
NOT BE
DILUTED PRIOR TO USE.
PFIZER-BIONTECH COVID-19 VACCINE SUPPLIED IN A MULTIPLE DOSE VIAL WITH
A GRAY
CAP AND A LABEL WITH A GRAY BORDER IS AUTHORIZED FOR USE TO PROVIDE:
A 2-DOSE PRIMARY SERIES TO INDIVIDUALS 12 YEARS OF AGE AND OLDER; AND
A THIRD PRIMARY SERIES DOSE TO INDIVIDUALS 12 YEARS OF AGE AND OLDER
WITH
CERTAIN KINDS OF IMMUNOCOMPROMISE.
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 RESPEC