PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT- original and omicron ba.4/ba.5 injection, suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TOZINAMERAN (UNII: 5085ZFP6SJ) (TOZINAMERAN - UNII:5085ZFP6SJ), FAMTOZINAMERAN (UNII: JSV288Q5CV) (FAMTOZINAMERAN - UNII:JSV288Q5CV)

Available from:

Pfizer Manufacturing Belgium NV

Administration route:

INTRAMUSCULAR

Therapeutic indications:

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) 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 5 years of age and older. This EUA Prescribing Information pertains only to Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), hereafter referred to as Pfizer-BioNTech COVID-19 Vaccine, Bivalent, 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, Bivalent to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent [

Product summary:

Pfizer-BioNTech COVID-19 Vaccine, Bivalent is a suspension for intramuscular injection. Multiple dose vials with orange caps and labels with orange borders are supplied in a carton containing 10 multiple dose vials. 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, Bivalent 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, Bivalent 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. Vial Storage During Use If not previously thawed at 2ºC to 8ºC (35ºF to 46ºF), allow Pfizer-BioNTech COVID-19 Vaccine, Bivalent multiple dose vials to thaw at room temperature [up to 25ºC (77ºF)] for 30 minutes. Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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. 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, BIVALENT- ORIGINAL AND OMICRON
BA.4/BA.5 INJECTION, SUSPENSION
PFIZER MANUFACTURING BELGIUM NV
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PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT
FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE
(VACCINATION PROVIDERS)
EMERGENCY USE AUTHORIZATION (EUA)
PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT
(ORIGINAL AND OMICRON BA.4/BA.5)
BOOSTER DOSE 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, BIVALENT (ORIGINAL AND
OMICRON
BA.4/BA.5) FOR ACTIVE IMMUNIZATION TO PREVENT COVID-19 IN INDIVIDUALS
5 YEARS
OF AGE AND OLDER.
PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON
BA.4/BA.5)
IS HEREAFTER REFERRED TO AS PFIZER-BIONTECH COVID-19 VACCINE,
BIVALENT. IT IS
SUPPLIED IN MULTIPLE DOSE VIALS WITH ORANGE CAPS AND LABELS WITH
ORANGE
BORDERS.
DILUTE PRIOR TO USE.
PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT IS AUTHORIZED FOR USE IN
INDIVIDUALS 5 THROUGH 11 YEARS OF AGE AND OLDER AS A SINGLE BOOSTER
DOSE
ADMINISTERED AT LEAST 2 MONTHS AFTER EITHER:
COMPLETION OF PRIMARY VACCINATION WITH ANY AUTHORIZED OR APPROVED
COVID-
19 VACCINE, OR
RECEIPT OF THE MOST RECENT BOOSTER DOSE WITH ANY AUTHORIZED OR
APPROVED
MONOVALENT COVID-19 VACCINE.
THIS FACT SHEET PERTAINS ONLY TO PFIZER-BIONTECH COVID-19 VACCINE,
BIVALENT
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, BIVALENT, 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 12 YEARS OF
AGE
AND OLDER.
SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS
Vaccination providers enrolled in the federal COVID-19 Vaccination
Program must repor