Vaccine Information: Pfizer-BioNTech Covid-19 Vaccine, Bivalent (Page 14 of 14)

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The Pfizer-BioNTech COVID-19 Vaccine, Bivalent encodes the spike protein of the Original SARS CoV 2 and the Omicron BA.4/BA.5 SARS-CoV-2.
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If your child will turn 5 years old in the next 11 weeks and has not started their vaccination series, please discuss the options with your provider
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The Pfizer-BioNTech COVID-19 Vaccine, a monovalent vaccine, encodes the spike protein of only the Original SARS-CoV-2.
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Monovalent refers to a COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2.
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COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine. COMIRNATY encodes the spike protein of only the Original SARS-CoV-2.

PRINCIPAL DISPLAY PANEL — 2.6 mL Vial Label – Bivalent 0609

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

DILUTE PRIOR TO USE
Age 6m to < 5y

After dilution -10 doses of 0.2 mL

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

Dilution date and time:

NDC 59267-0609-1

PRINCIPAL DISPLAY PANEL -- 2.6 mL Vial Label – Bivalent 0609
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 Vial Carton – Bivalent 0609

Pfizer-BioNTech
COVID-19 Vaccine, Bivalent

NDC 59267-0609-2

Original and Omicron BA.4/BA.5

Suspension for Intramuscular Injection

DILUTE PRIOR TO USE

10 Multiple Dose Vials

After dilution each vial contains 10 doses of 0.2 mL

For age 6 months to < 5 years
For use under Emergency Use Authorization.

BIONTECHPfizer

Rx only

PRINCIPAL DISPLAY PANEL -- 10 Vial Carton – Bivalent 0609
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.2 mL Vial Label – Bivalent 0565

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

DILUTE PRIOR TO USE
Age 5y to < 12y

After dilution -10 doses of 0.2 mL

For intramuscular use. Contains no preservative.
For use under Emergency Use Authorization.
After dilution store at 2 to 25°C (35 to 77°F) anddiscard after 12 hours.

Dilution date and time:

NDC 59267-0565-1

PRINCIPAL DISPLAY PANEL -- 0.2 mL Vial Label – Bivalent 0565
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.2 mL Vial Carton – Bivalent 0565

Pfizer-BioNTech
COVID-19 Vaccine, Bivalent

NDC 59267-0565-2

Original and Omicron BA.4/BA.5

Suspension for Intramuscular Injection

DILUTE PRIOR TO USE

10 Multiple Dose Vials

After dilution each vial contains 10 doses of 0.2 mL

For age 5 years to < 12 years
For use under Emergency Use Authorization.

BIONTECH Pfizer

Rx only

PRINCIPAL DISPLAY PANEL -- 0.2 mL Vial Carton – Bivalent 0565
(click image for full-size original)

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

PRINCIPAL DISPLAY PANEL — 0.3 mL Vial Carton – Bivalent 0304

Pfizer-BioNTech
COVID-19 Vaccine, Bivalent

NDC 59267-0304-2

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.

BIONTECHPfizer

Rx only

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

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

PRINCIPAL DISPLAY PANEL — 0.3 mL Vial Carton – Bivalent 1404

Pfizer-BioNTech
COVID-19 Vaccine, Bivalent

NDC 59267-1404-2

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.

BIONTECHPfizer

Rx only

PRINCIPAL DISPLAY PANEL -- 0.3 mL Vial Carton – Bivalent 1404
(click image for full-size original)
PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT original and omicron ba.4/ba.5 injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:59267-0609
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOZINAMERAN (TOZINAMERAN) TOZINAMERAN 20 ug in 2.6 mL
FAMTOZINAMERAN (FAMTOZINAMERAN) FAMTOZINAMERAN 20 ug in 2.6 mL
Inactive Ingredients
Ingredient Name Strength
2-(MPEG 2000)-N,N-DITETRADECYLACETAMIDE 0.07 mg in 2.6 mL
((4-HYDROXYBUTYL)AZANEDIYL)BIS(HEXANE-6,1-DIYL)BIS(2-HEXYLDECANOATE) 0.57 mg in 2.6 mL
TROMETHAMINE 0.08 mg in 2.6 mL
TROMETHAMINE HYDROCHLORIDE 0.53 mg in 2.6 mL
SUCROSE 41.2 mg in 2.6 mL
1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE 0.12 mg in 2.6 mL
CHOLESTEROL 0.25 mg in 2.6 mL
WATER
SODIUM CHLORIDE 19.8 mg in 2.6 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59267-0609-2 10 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS (59267-0609-1)
1 NDC:59267-0609-1 2.6 mL in 1 VIAL, GLASS This package is contained within the CARTON (59267-0609-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Emergency Use Authorization 12/09/2022
PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT original and omicron ba.4/ba.5 injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:59267-0565
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOZINAMERAN (TOZINAMERAN) TOZINAMERAN 0.065 mg in 2.6 mL
FAMTOZINAMERAN (FAMTOZINAMERAN) FAMTOZINAMERAN 0.065 mg in 2.6 mL
Inactive Ingredients
Ingredient Name Strength
2-(MPEG 2000)-N,N-DITETRADECYLACETAMIDE 0.23 mg in 2.6 mL
((4-HYDROXYBUTYL)AZANEDIYL)BIS(HEXANE-6,1-DIYL)BIS(2-HEXYLDECANOATE) 1.86 mg in 2.6 mL
TROMETHAMINE 0.26 mg in 2.6 mL
TROMETHAMINE HYDROCHLORIDE 1.71 mg in 2.6 mL
SUCROSE 133.9 mg in 2.6 mL
1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE 0.4 mg in 2.6 mL
CHOLESTEROL 0.81 mg in 2.6 mL
WATER
SODIUM CHLORIDE 11.7 mg in 2.6 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59267-0565-2 10 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS (59267-0565-1)
1 NDC:59267-0565-1 2.6 mL in 1 VIAL, GLASS This package is contained within the CARTON (59267-0565-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Emergency Use Authorization 10/12/2022
PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT 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
FAMTOZINAMERAN (FAMTOZINAMERAN) FAMTOZINAMERAN 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
PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT 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
FAMTOZINAMERAN (FAMTOZINAMERAN) FAMTOZINAMERAN 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
Labeler — Pfizer Manufacturing Belgium NV (370156507)
Registrant — Pfizer Inc (113480771)
Establishment
Name Address ID/FEI Operations
Pfizer Manufacturing Belgium NV 370156507 ANALYSIS (59267-0609), ANALYSIS (59267-0565), ANALYSIS (59267-1404), ANALYSIS (59267-0304), MANUFACTURE (59267-0609), MANUFACTURE (59267-0565), MANUFACTURE (59267-1404), MANUFACTURE (59267-0304), PACK (59267-0609), PACK (59267-0565), PACK (59267-1404), PACK (59267-0304), LABEL (59267-0609), LABEL (59267-0565), LABEL (59267-1404), LABEL (59267-0304)
Establishment
Name Address ID/FEI Operations
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC 174350868 ANALYSIS (59267-0609), ANALYSIS (59267-0565), ANALYSIS (59267-1404), ANALYSIS (59267-0304), API MANUFACTURE (59267-0609), API MANUFACTURE (59267-0565), API MANUFACTURE (59267-1404), API MANUFACTURE (59267-0304)
Establishment
Name Address ID/FEI Operations
Labor LS SE & Co. KG 314929072 ANALYSIS (59267-0609), ANALYSIS (59267-0565), ANALYSIS (59267-1404), ANALYSIS (59267-0304)
Establishment
Name Address ID/FEI Operations
Pfizer Ireland Pharmaceuticals 985586408 ANALYSIS (59267-0609), ANALYSIS (59267-0565), ANALYSIS (59267-1404), ANALYSIS (59267-0304), API MANUFACTURE (59267-0609), API MANUFACTURE (59267-0565), API MANUFACTURE (59267-1404), API MANUFACTURE (59267-0304)
Establishment
Name Address ID/FEI Operations
BioNTech Innovative Manufacturing Services GmbH 537365801 ANALYSIS (59267-0609), ANALYSIS (59267-0565), ANALYSIS (59267-1404), ANALYSIS (59267-0304)
Establishment
Name Address ID/FEI Operations
BioNTech Manufacturing GmbH 314382536 ANALYSIS (59267-0609), ANALYSIS (59267-0565), ANALYSIS (59267-1404), ANALYSIS (59267-0304), API MANUFACTURE (59267-0609), API MANUFACTURE (59267-0565), API MANUFACTURE (59267-1404), API MANUFACTURE (59267-0304)
Establishment
Name Address ID/FEI Operations
BioNTech Manufacturing Marburg GmbH 313270335 ANALYSIS (59267-0609), ANALYSIS (59267-0565), ANALYSIS (59267-1404), ANALYSIS (59267-0304), API MANUFACTURE (59267-0609), API MANUFACTURE (59267-0565), API MANUFACTURE (59267-1404), API MANUFACTURE (59267-0304)
Establishment
Name Address ID/FEI Operations
Pharmacia & Upjohn Company LLC 618054084 ANALYSIS (59267-0565), ANALYSIS (59267-1404), ANALYSIS (59267-0304), MANUFACTURE (59267-0565), MANUFACTURE (59267-1404), MANUFACTURE (59267-0304), PACK (59267-0565), PACK (59267-1404), PACK (59267-0304), LABEL (59267-0565), LABEL (59267-1404), LABEL (59267-0304)
Establishment
Name Address ID/FEI Operations
Hospira, Inc. 030606222 ANALYSIS (59267-1404), ANALYSIS (59267-0304), MANUFACTURE (59267-1404), MANUFACTURE (59267-0304), PACK (59267-1404), PACK (59267-0304), LABEL (59267-1404), LABEL (59267-0304)

Revised: 05/2023 Pfizer Manufacturing Belgium NV

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