Vaccine Information: Pfizer-BioNTech Covid-19 Vaccine, Bivalent (Page 8 of 8)


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You may receive this Vaccine Information Fact Sheet even if your child is 11 years old. Children who will turn from 11 years to 12 years of age between doses in the primary regimen may receive, for any dose in the primary regimen, either: (1) the Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 5 through 11 years of age; or (2) COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 12 years of age and older.
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When prepared according to their respective instructions for use, 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 can be used interchangeably without presenting any safety or effectiveness concerns.
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Monovalent refers to any authorized or approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2.

PRINCIPAL DISPLAY PANEL — 0.3 mL Vial Label — 0304

Pfizer-BioNTech COVID-19 Vaccine, Bivalent
Original and Omicron BA.4/BA.5

DO NOT DILUTE
Age 12y & older

Vial contains 6 doses of 0.3 mL

For intramuscular use. Contains no preservative.
For use under Emergency Use Authorization.
After first use store at 2 to 25°C (35 to 77°F)
and discard after 12 hours. First use date and time:

NDC 59267-0304-1

PRINCIPAL DISPLAY PANEL -- 0.3 mL Vial Label -- 0304
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.3 mL Vial Carton — 0304

NDC 59267-0304-2

Pfizer-BioNTech
COVID-19 Vaccine, Bivalent

Original and Omicron BA.4/BA.5

Suspension for Intramuscular Injection

DO NOT DILUTE

10 Multiple Dose Vials

Each vial contains 6 doses of 0.3 mL

For 12 years of age and older
For use under Emergency Use Authorization.

BIONTECH Pfizer

Rx only

PRINCIPAL DISPLAY PANEL -- 0.3 mL Vial Carton -- 0304
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.3 mL Vial Label — 1404

Pfizer-BioNTech COVID-19 Vaccine, Bivalent
Original and Omicron BA.4/BA.5

DO NOT DILUTE
Age 12y & older

Vial contains 1 dose of 0.3 mL

For intramuscular use.
Contains no preservative.
For use under Emergency Use Authorization. Discard after single use.

NDC 59267-1404-1

PRINCIPAL DISPLAY PANEL -- 0.3 mL Vial Label -- 1404
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.3 mL Vial Carton — 1404

NDC 59267-1404-2

Pfizer-BioNTech
COVID-19 Vaccine, Bivalent

Original and Omicron BA.4/BA.5

Suspension for Intramuscular Injection

DO NOT DILUTE

10 Single Dose Vials

Each vial contains 1 dose of 0.3 mL

For 12 years of age and older
For use under Emergency Use Authorization.

BIONTECH Pfizer

Rx only

PRINCIPAL DISPLAY PANEL -- 0.3 mL Vial Carton -- 1404
(click image for full-size original)
PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT bnt162b2 original and omicron ba.4/ba.5 injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:59267-0304
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOZINAMERAN (TOZINAMERAN) TOZINAMERAN 0.1125 mg in 2.25 mL
BNT162B2 OMICRON (BA.4/BA.5) (BNT162B2 OMICRON (BA.4/BA.5)) BNT162B2 OMICRON (BA.4/BA.5) 0.1125 mg in 2.25 mL
Inactive Ingredients
Ingredient Name Strength
2-(MPEG 2000)-N,N-DITETRADECYLACETAMIDE 0.41 mg in 2.25 mL
((4-HYDROXYBUTYL)AZANEDIYL)BIS(HEXANE-6,1-DIYL)BIS(2-HEXYLDECANOATE) 3.22 mg in 2.25 mL
TROMETHAMINE 0.45 mg in 2.25 mL
TROMETHAMINE HYDROCHLORIDE 2.97 mg in 2.25 mL
SUCROSE 231.8 mg in 2.25 mL
1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE 0.7 mg in 2.25 mL
CHOLESTEROL 1.4 mg in 2.25 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59267-0304-2 10 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS (59267-0304-1)
1 NDC:59267-0304-1 2.25 mL in 1 VIAL, GLASS This package is contained within the CARTON (59267-0304-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
EMERGENCY USE AUTHORIZATION 09/01/2022
PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT bnt162b2 original and omicron ba.4/ba.5 injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:59267-1404
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOZINAMERAN (TOZINAMERAN) TOZINAMERAN 0.024 mg in 0.48 mL
BNT162B2 OMICRON (BA.4/BA.5) (BNT162B2 OMICRON (BA.4/BA.5)) BNT162B2 OMICRON (BA.4/BA.5) 0.024 mg in 0.48 mL
Inactive Ingredients
Ingredient Name Strength
2-(MPEG 2000)-N,N-DITETRADECYLACETAMIDE 0.09 mg in 0.48 mL
((4-HYDROXYBUTYL)AZANEDIYL)BIS(HEXANE-6,1-DIYL)BIS(2-HEXYLDECANOATE) 0.69 mg in 0.48 mL
TROMETHAMINE 0.1 mg in 0.48 mL
TROMETHAMINE HYDROCHLORIDE 0.63 mg in 0.48 mL
SUCROSE 49.44 mg in 0.48 mL
1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE 0.15 mg in 0.48 mL
CHOLESTEROL 0.3 mg in 0.48 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59267-1404-2 10 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS (59267-1404-1)
1 NDC:59267-1404-1 0.48 mL in 1 VIAL, GLASS This package is contained within the CARTON (59267-1404-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
EMERGENCY USE AUTHORIZATION 09/01/2022
Labeler — Pfizer Manufacturing Belgium NV (370156507)
Registrant — Pfizer Inc (113480771)
Establishment
Name Address ID/FEI Operations
Pfizer Manufacturing Belgium NV 370156507 ANALYSIS (59267-0304), ANALYSIS (59267-1404), MANUFACTURE (59267-0304), MANUFACTURE (59267-1404), PACK (59267-0304), PACK (59267-1404), LABEL (59267-0304), LABEL (59267-1404)
Establishment
Name Address ID/FEI Operations
Pharmacia & Upjohn Company LLC 618054084 ANALYSIS (59267-0304), ANALYSIS (59267-1404), MANUFACTURE (59267-0304), MANUFACTURE (59267-1404), PACK (59267-0304), PACK (59267-1404), LABEL (59267-0304), LABEL (59267-1404)
Establishment
Name Address ID/FEI Operations
BioNTech Innovative Manufacturing Services GmbH 537365801 ANALYSIS (59267-0304), ANALYSIS (59267-1404)
Establishment
Name Address ID/FEI Operations
BioNTech Manufacturing GmbH 314382536 ANALYSIS (59267-0304), ANALYSIS (59267-1404), API MANUFACTURE (59267-0304), API MANUFACTURE (59267-1404)
Establishment
Name Address ID/FEI Operations
BioNTech Manufacturing Marburg GmbH 313270335 ANALYSIS (59267-0304), ANALYSIS (59267-1404), API MANUFACTURE (59267-0304), API MANUFACTURE (59267-1404)
Establishment
Name Address ID/FEI Operations
Hospira, Inc. 030606222 ANALYSIS (59267-0304), ANALYSIS (59267-1404), MANUFACTURE (59267-0304), MANUFACTURE (59267-1404), PACK (59267-0304), PACK (59267-1404), LABEL (59267-0304), LABEL (59267-1404)
Establishment
Name Address ID/FEI Operations
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC 174350868 ANALYSIS (59267-0304), ANALYSIS (59267-1404), API MANUFACTURE (59267-0304), API MANUFACTURE (59267-1404)
Establishment
Name Address ID/FEI Operations
Pfizer Inc 004954111 ANALYSIS (59267-0304), ANALYSIS (59267-1404)
Establishment
Name Address ID/FEI Operations
Pfizer Ireland Pharmaceuticals 985586408 ANALYSIS (59267-0304), ANALYSIS (59267-1404)

Revised: 09/2022 Pfizer Manufacturing Belgium NV

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