PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT- bnt162b2 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 12 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. 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 [see Description (13)] . Risk Summary No data are available regarding the use of Pfizer-BioNTech COVID-19 Vaccine, Bivalent during pregnancy. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, t

Product summary:

Single Dose Vials: Pfizer-BioNTech COVID-19 Vaccine, Bivalent is a suspension for intramuscular injection. Single dose vials with gray caps and labels with gray borders are supplied in a carton containing 10 single dose vials. One vial contains 1 dose of 0.3 mL. Multiple Dose Vials: Pfizer-BioNTech COVID-19 Vaccine, Bivalent is a suspension for intramuscular injection. Multiple dose vials with gray caps and labels with gray borders are supplied in a carton containing 10 multiple dose vials. 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, 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 [2°C to 8°C (35°F to 46°F)], 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 single dose vials may take up to 2 hours to thaw at this temperature. A carton of 10 multiple dose 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 -90°C to -60°C (-130°F to -76°F) 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 (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. Vial Storage During Use If not previously thawed at 2°C to 8°C (35°F to 46°F), allow Pfizer-BioNTech COVID-19 Vaccine, Bivalent single dose vials or multiple dose vials to thaw at room temperature [up to 25°C (77°F)] 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 the first puncture. After first puncture, the multiple dose vials should be held between 2°C to 25°C (35°F to 77°F). Multiple dose vials should be discarded 12 hours after first puncture. Transportation of Vials If local redistribution is needed, single dose vials and multiple dose 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, BIVALENT- BNT162B2 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 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, BIVALENT (ORIGINAL AND
OMICRON
BA.4/BA.5) FOR ACTIVE IMMUNIZATION TO PREVENT COVID-19 IN INDIVIDUALS
12
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 SINGLE DOSE AND MULTIPLE DOSE VIALS WITH GRAY CAPS AND
LABELS WITH
GRAY BORDERS.
DO NOT DILUTE PRIOR TO USE.
PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT IS AUTHORIZED FOR USE IN
INDIVIDUALS 12 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 SINGLE DOSE AND MULTIPLE DOSE VIAL WITH A GRAY CAP AND A
LABEL
WITH A GRAY BORDER, WHICH MUST NOT BE DILUTED PRIOR TO USE.
PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT, WHICH IS SUPPLIED IN A
SINGLE
DOSE AND MULTIPLE DOSE VIAL WITH A GRAY CAP AND A LABEL WITH A GRAY
BORDER,
SHOULD NOT BE USED IN INDIVIDUALS 6 MONTHS THROUGH 11 YEARS OF AGE.
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 myocardit