WHO recommendation BioNtech Tozinameran/US FDA - COVID-19 mRNA vaccine (nucleoside modified)
Product Overview
Type: COVID-19 mRNA Vaccine
INN: Tozinameran
Trade name: COMIRNATY
EUL holder: BioNTech Manufacturing GmbH
Country: Germany
Responsible NRA: Food and Drug Administration
Country: United States of America
WHO EUL recommendation
Effective date: 16 July 2021
Product description
Pharmaceutical Form: Concentrate for dispersion for injection
Dosage: 30 mcg
Presentation: 2 mL Vial
Number of doses: 6 doses of 0.3 mL (after dilution)
Route of administration: Intramuscular
Age indication: 12 years and older
Shelf – life: 24 months Storage temperature: (-90°C to -60°C)
Refrigeration Storage Time (2°C to 8°C): 10 weeks
Storage Time (-20°C to 15°C): 2 weeks within the 18 months shelf life
Short Term Storage (5°C to 3°C): 31 days within the 18 months shelf life
Vaccine Vial monitor (VVM): None
Preservative: None
Adjuvant: None
Diluent: Sodium Chloride Inj. USP 0.9%
Handling of opened multi-dose vials:
WHO recommends that opened vials of this vaccine should be discarded 6 hours after opening or at the end of the immunization session, whichever comes first.
Packaging description
| Secondary Packaging: | Carton holding 195 vials (1170 doses). Dimensions: 22.9 x 22.9 x 4.0 cm |
|
Tertiary Packaging: |
Insulated box containing 5 secondary cartons with a total of 975 vials (5850 doses). Dimensions: 40 X 40 X 56 cm |
| Cold Chain Volume: | 1.8 cm3/dose (in secondary packaging) |
Product information
Pharmaceutical Form: Concentrate for dispersion for injection
Dosage: 30 mcg
Presentation: 2 mL Vial
Number of doses: 6 doses of 0.3 mL
Route of administration: Intramuscular
Age indication: 12 years and older
Shelf – life: 12 months Storage temperature: -90°C to -60°C
Refrigeration Storage Time (2°C to 8°C): 10 weeks
Freezer Storage Time (-25 °C to -15°C): DO NOT STORE
Vaccine Vial monitor (VVM): None
Preservative: None
Adjuvant: None
Diluent: N/A
Handling of opened multi-dose vials:
WHO recommends that opened vials of this vaccine should be discarded 6 hours after opening or at the end of the immunization session, whichever comes first.
Packaging description
| Secondary Packaging: | Carton holding 195 vials (1170 doses). Dimensions: 22.9 x 22.9 x 4.0 cm |
|
Tertiary Packaging: |
Insulated box containing 5 secondary cartons with a total of 975 vials (5850 doses). Dimensions: 40 X 40 X 56 cm |
| Cold Chain Volume: | 1.8 cm3/dose (in secondary packaging) |
Product information
Drug Product - Manufacturing site
- Pharmacia and Upjohn Company LLC, Kalamazoo, Michigan (Pfizer, Kalamazoo)
Pharmaceutical Form: Concentrate for dispersion for injection
Dosage: 10 mcg
Presentation: 2 mL Vial
Number of doses: 10 doses of 0.2 mL (after dilution)
Route of administration: Intramuscular
Age indication: Children from 5 to 11 years
Shelf – life: 12 months Storage temperature: -90°C to -60°C
Refrigeration Storage Time (2°C to 8°C): 10 weeks
Freezer Storage Time (-25 °C to -15°C): DO NOT STORE
Vaccine Vial monitor (VVM): None
Preservative: None
Adjuvant: None
Diluent: Sodium Chloride Inj USP 0.9%
Handling of opened multi-dose vials:
WHO recommends that opened vials of this vaccine should be discarded 6 hours after opening or at the end of the immunization session, whichever comes first.
Packaging description
| Secondary Packaging: | Carton holding 195 vials (1170 doses). Dimensions: 22.9 x 22.9 x 4.0 cm |
| Tertiary Packaging: | Insulated box containing 5 secondary cartons with a total of 975 vials (5850 doses). Dimensions: 40 X 40 X 56 cm |
| Cold Chain Volume: | 1.8 cm3/dose (in secondary packaging) |
Product information
Drug Substance - Manufacturing sites
BioNTech Manufacturing GmbH
An der Goldgrube 12, 55131 Mainz, Germany
Pfizer Andover ACMF
Wyeth BioPharma Division of Wyeth Pharmaceuticals, LLC. 1 Burtt Road Andover, MA 01810, United States
Drug Product - Manufacturing sites
Pharmacia & Upjohn Company LLC
7000 Portage Road Kalamazoo, MI 49001, United States
Hospira Inc., a Pfizer company
1776 Centennial Drive, McPherson, Kansas 67460, United States
Exelead, Inc.
6925 Guion Road, Indianapolis, IN 46268, United States
Exela Pharma Sciences, LLC, NC
320 Cooperative Way Lenoir, NC 28645 United States, and
1245 Blowing Rock Blvd Lenoir, NC 28645 United States