Vaccine Information: Pfizer-BioNTech Covid-19 Vaccine (Page 7 of 7)


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You may receive this Vaccine Information Fact Sheet even if your child is 12 years old. Children who will turn from 11 years to 12 years of age between their first and second dose in the primary regimen may receive, for either dose, 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.

PRINCIPAL DISPLAY PANEL — 0.2 mL Vial Label

Pfizer-BioNTech COVID-19 Vaccine
Age 5y to < 12y

DILUTE PRIOR TO USE
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 6 hours. Dilution date and time:

PAA178294

LOT/MFG

NDC 59267-1055-1

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

PRINCIPAL DISPLAY PANEL — 0.2 mL Vial Carton

Pfizer-BioNTech
COVID-19 Vaccine

NDC 59267-1055-4

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

BIONTECH
Pfizer Rx only

PRINCIPAL DISPLAY PANEL -- 0.2 mL Vial Carton
(click image for full-size original)
PFIZER-BIONTECH COVID-19 VACCINE bnt162b2 injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:59267-1055
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOZINAMERAN (TOZINAMERAN) TOZINAMERAN 130 ug in 2.6 mL
Inactive Ingredients
Ingredient Name Strength
ALC-0159 0.23 mg in 2.6 mL
ALC-0315 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:59267-1055-4 10 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS (59267-1055-1)
1 NDC:59267-1055-1 2.6 mL in 1 VIAL, GLASS This package is contained within the CARTON (59267-1055-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
EMERGENCY USE AUTHORIZATION 10/30/2021
Labeler — Pfizer Manufacturing Belgium NV (370156507)
Registrant — Pfizer Inc (113480771)
Establishment
Name Address ID/FEI Operations
Pfizer Manufacturing Belgium NV 370156507 ANALYSIS (59267-1055), MANUFACTURE (59267-1055), PACK (59267-1055), LABEL (59267-1055)
Establishment
Name Address ID/FEI Operations
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC 174350868 ANALYSIS (59267-1055), API MANUFACTURE (59267-1055)
Establishment
Name Address ID/FEI Operations
Pfizer Inc 004954111 ANALYSIS (59267-1055)
Establishment
Name Address ID/FEI Operations
Pfizer Ireland Pharmaceuticals 985586408 ANALYSIS (59267-1055)
Establishment
Name Address ID/FEI Operations
BioNTech Innovative Manufacturing Services GmbH 537365801 ANALYSIS (59267-1055)
Establishment
Name Address ID/FEI Operations
BioNTech Manufacturing GmbH 314382536 ANALYSIS (59267-1055), API MANUFACTURE (59267-1055)
Establishment
Name Address ID/FEI Operations
BioNTech Manufacturing Marburg GmbH 313270335 ANALYSIS (59267-1055), API MANUFACTURE (59267-1055)

Revised: 01/2022 Pfizer Manufacturing Belgium NV

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