PFIZER-BIONTECH COVID-19 VACCINE

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 and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) are 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 and 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 multiple dose vials with maroon caps and labels with maroon borders, which are authorized for use in individuals 6 months through 4 years of age. Do not administer Pfizer-BioNTech COVID-19 Vaccine or 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 [see Description (13)] .       P

Product summary:

The information in this section applies to the Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent that are supplied in multiple dose vials with maroon caps and labels with maroon borders. After dilution, 1 vial contains 10 doses of 0.2 mL. Pfizer-BioNTech COVID-19 Vaccine: Multiple dose vials are supplied in a carton containing 10 multiple dose vials. Pfizer-BioNTech COVID-19 Vaccine, Bivalent: Multiple dose vials are supplied in a carton containing 10 multiple dose vials. 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 and Pfizer-BioNTech COVID-19 Vaccine, Bivalent multiple dose vials with maroon caps and labels with maroon 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 [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 vials may take up to 2 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 and Pfizer-BioNTech COVID-19 Vaccine, Bivalent multiple dose vials with maroon caps and labels with maroon 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. Examples of expiry dates based on 18 months from the date of the manufacture for the Pfizer-BioNTech COVID-19 Vaccine or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent are shown below. 01/2022 30-Jun-2023 02/2022 31-Jul-2023 03/2022 31-Aug-2023 04/2022 30-Sep-2023 05/2022 31-Oct-2023 06/2022 30-Nov-2023 Vial Storage During Use If not previously thawed at 2°C to 8°C (35°F to 46°F), allow vials to thaw at room temperature [up to 25°C (77°F)] for 30 minutes. Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with maroon caps and labels with maroon 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. Pfizer-BioNTech COVID-19 Vaccine 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-BIONTECH COVID-19 VACCINE, BIVALENT- ORIGINAL AND OMICRON
BA.4/BA.5 INJECTION, SUSPENSION
PFIZER MANUFACTURING BELGIUM NV
REFERENCE LABEL SET ID: 8003E2B9-EA36-4275-B0BA-673460FD6305
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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 AND THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT
(ORIGINAL AND OMICRON BA.4/BA.5) TO PREVENT CORONAVIRUS DISEASE
2019 (COVID-19)
FOR 6 MONTHS THROUGH 4 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
PRODUCTS, PFIZER-BIONTECH COVID-19 VACCINE AND PFIZER-BIONTECH
COVID-19
VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) , FOR ACTIVE
IMMUNIZATION
TO PREVENT COVID-19 IN INDIVIDUALS 6 MONTHS OF AGE AND OLDER.
THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON
BA.4/BA.5) IS HEREAFTER REFERRED TO AS PFIZER-BIONTECH COVID-19
VACCINE,
BIVALENT.
THE PFIZER-BIONTECH COVID-19 VACCINE AND THE PFIZER-BIONTECH COVID-19
VACCINE, BIVALENT FOR USE IN INDIVIDUALS 6 MONTHS THROUGH 4 YEARS OF
AGE ARE
SUPPLIED IN MULTIPLE DOSE VIALS WITH MAROON CAPS AND LABELS WITH
MAROON
BORDERS.
PRIMARY SERIES
PFIZER-BIONTECH COVID-19 VACCINE AND PFIZER-BIONTECH COVID-19 VACCINE,
BIVALENT ARE AUTHORIZED FOR USE IN INDIVIDUALS 6 MONTHS THROUGH 4
YEARS OF
AGE TO PROVIDE A 3-DOSE PRIMARY SERIES AS FOLLOWS:
BOOSTER DOSE
THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT IS AUTHORIZED FOR USE
IN
INDIVIDUALS 6 MONTHS THROUGH 4 YEARS OF AGE TO PROVIDE A SINGLE
BOOSTER DOSE
AT LEAST 2 MONTHS AFTER COMPLETION OF PRIMARY VACCINATION WITH 3 DOSES
OF
THE PFIZER-BIONTECH COVID-19 VACCINE .
1
2
DOSE 1: PFIZER-BIONTECH COVID-19 VACCINE
DOSE 2: PFIZER-BIONTECH COVID-19 VACCINE
DOSE 3: PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT
3
THIS FACT SHEET PERTAINS ONLY TO PFIZER-BIONTECH COVI