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 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 — 1.8 mL Vial Label

Pfizer-BioNTech COVID-19 Vaccine
After dilution, vial contains 6 doses of 0.3 mL

For intramuscular use. Contains no preservative.

For use under Emergency Use Authorization.

DILUTE BEFORE USE. Discard 6 hours afterdilution when stored at 2 to 25°C (35 to 77°F).

Dilution date and time:

NDC 59267-1000-1

Principal Display Panel -- 1.8 mL Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 195 Vial Carton Label

NDC 59267-1000-2

Pfizer-BioNTech COVID-19 Vaccine
Suspension for Intramuscular Injection

195 Multiple Dose Vials
(after dilution each vial contains
6 doses of 0.3 mL)

Pfizer BIONTECH

STORAGE: Prior to dilution, store at
-80°C to -60°C (-112°F to -76°F).
Store in this carton to protect from light.

DOSAGE AND ADMINISTRATION: After
dilution, each vial contains 6 doses of 0.3 mL.
See FDA-authorized Fact Sheet or scan
QR code for information.

MUST BE DILUTED BEFORE USE with sterile
0.9% Sodium Chloride Injection, USP (not supplied).
After dilution, store the vaccine at 2°C to 25°C (35°F to 77°F).
Discard after 6 hours.
Contains no preservative.
For use under Emergency Use Authorization.
Rx only

Manufactured by
Pfizer Inc
New York, NY 10017

Manufactured for
BioNTech
Manufacturing GmbH
An der Goldgrube 1255131 Mainz, Germany

PAA166261

LOT:

EXP:

Principal Display Panel -- 195 Vial Carton Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 25 Vial Carton

NDC 59267-1000-3
Rx only

Pfizer-BioNTech COVID-19 Vaccine
Suspension for Intramuscular Injection

25 Multiple Dose Vials
(after dilution each vial contains 6 doses of 0.3 mL)

MUST BE DILUTED BEFORE USE with sterile
0.9% Sodium Chloride Injection, USP (not supplied).
After dilution, store the vaccine at 2°C to 25°C (35°F to 77°F).Discard after 6 hours.

PRINCIPAL DISPLAY PANEL -- 25 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:59267-1000
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOZINAMERAN (TOZINAMERAN) TOZINAMERAN 0.225 mg in 2.25 mL
Inactive Ingredients
Ingredient Name Strength
2-(MPEG 2000)-N,N-DITETRADECYLACETAMIDE
((4-HYDROXYBUTYL)AZANEDIYL)BIS(HEXANE-6,1-DIYL)BIS(2-HEXYLDECANOATE)
POTASSIUM CHLORIDE
MONOBASIC POTASSIUM PHOSPHATE
SODIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE
SUCROSE
1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE
CHOLESTEROL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59267-1000-2 195 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS (59267-1000-1)
1 NDC:59267-1000-1 2.25 mL in 1 VIAL, GLASS This package is contained within the CARTON (59267-1000-2)
2 NDC:59267-1000-3 25 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS (59267-1000-1)
2 NDC:59267-1000-1 2.25 mL in 1 VIAL, GLASS This package is contained within the CARTON (59267-1000-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
EMERGENCY USE AUTHORIZATION 12/12/2020
Labeler — Pfizer Manufacturing Belgium NV (370156507)
Registrant — Pfizer Inc (113480771)
Establishment
Name Address ID/FEI Operations
Pfizer Manufacturing Belgium NV 370156507 ANALYSIS (59267-1000), MANUFACTURE (59267-1000), PACK (59267-1000), LABEL (59267-1000)
Establishment
Name Address ID/FEI Operations
Pharmacia & Upjohn Company LLC 618054084 ANALYSIS (59267-1000), MANUFACTURE (59267-1000), PACK (59267-1000), LABEL (59267-1000)
Establishment
Name Address ID/FEI Operations
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC 174350868 ANALYSIS (59267-1000), API MANUFACTURE (59267-1000)
Establishment
Name Address ID/FEI Operations
Pfizer Inc 004954111 ANALYSIS (59267-1000)
Establishment
Name Address ID/FEI Operations
Exela Pharma Sciences, LLC 831274399 ANALYSIS (59267-1000), MANUFACTURE (59267-1000), PACK (59267-1000), LABEL (59267-1000)

Revised: 10/2022 Pfizer Manufacturing Belgium NV

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