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 an orange cap and a label with an orange border, which is authorized for use in individuals 5 through 11 years of age. The vial labels state: Age 5y to <12y. The carton labels state: For age 5 years to <12 years. 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 i

Product summary:

The information in this section applies to the Pfizer-BioNTech COVID-19 Vaccine that is supplied in multiple dose vials with orange caps and labels with orange borders. These multiple dose vials are supplied in a carton containing 10 multiple dose vials (NDC 59267-1055-4). After dilution, 1 vial contains 10 doses of 0.2 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 orange caps and labels with orange 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 4 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 orange caps and labels with orange borders are received at 2°C to 8°C (35ºF to 46ºF), they should be stored at 2°C to 8°C (35ºF to 46ºF). 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 orange caps and labels with orange 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 dilution. After dilution, the vial should be held between 2°C to 25°C (35°F to 77°F). Vials should be discarded 12 hours after dilution. 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, undiluted vials may be transported at -90°C to -60°C (-130°F to -76°F) or at 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 5 THROUGH 11 YEARS OF AGE
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.
THIS FACT SHEET PERTAINS ONLY TO PFIZER-BIONTECH COVID-19 VACCINE
SUPPLIED
IN A MULTIPLE DOSE VIAL WITH AN ORANGE CAP AND A LABEL WITH AN ORANGE
BORDER,
WHICH MUST BE DILUTED PRIOR TO USE. THE VIAL LABELS STATE: AGE 5Y TO
<12Y.
THE CARTON LABELS STATE: FOR AGE 5 YEARS TO <12 YEARS.
PFIZER-BIONTECH COVID-19 VACCINE SUPPLIED IN A MULTIPLE DOSE VIAL WITH
AN
ORANGE CAP AND A LABEL WITH AN ORANGE BORDER IS AUTHORIZED FOR USE TO
PROVIDE:
A 2-DOSE PRIMARY SERIES TO INDIVIDUALS 5 THROUGH 11 YEARS OF AGE; AND
A THIRD PRIMARY SERIES DOSE TO INDIVIDUALS 5 THROUGH 11 YEARS OF AGE
WITH
CERTAIN KINDS OF IMMUNOCOMPROMISE.
PFIZER-BIONTECH COVID-19 VACCINE WHICH IS SUPPLIED IN A MULTIPLE DOSE
VIAL
WITH AN ORANGE CAP AND A LABEL WITH AN ORANGE BORDER, SHOULD NOT BE
USED IN
INDIVIDUALS 6 MONTHS THROUGH 4 YEARS OF AGE OR INDIVIDUALS 12 YEARS OF
AGE
AND OLDER BECAUSE OF THE POTENTIAL FOR VACCINE ADMINISTRATION ERRORS,
INCLUDING DOSING ERROR.
SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS
Vaccination providers enrolled in the federal COVID-19 Vaccination
Program must report
all vaccine administration errors, all serious adverse events, cases
of myocarditis, cases
of pericarditis, cases of Multisystem Inflammatory Syndrome (MIS) in
adults and
children, and cases of COVID-19 that result in hospitalization or
death following
administration of Pfizer-BioNTech COVID-