COMIRNATY
Product Overview
Type: COVID-19 mRNA Vaccine
INN: Tozinameran
Trade name: COMIRNATY
EUL holder: BioNTech Manufacturing GmbH
Country: Germany
Responsible NRA: European Medicines Agency
Country: The Netherlands
WHO EUL recommendation
Effective date: 31 December 2020
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): 1 month (31 days) up to 48 hours may be use for transportation
Freezer Storage Time (-25°C to -15°C): 2 weeks 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). External dimensions: 40 X 40 X 56 cm |
| Cold Chain Volume: | 1.8 cm3/dose (in secondary packaging) |
Product information
WHO Summary of Product Characteristics
Drug product - Manufacturing sites
Baxter Oncology GmbH
Kantstraße 2, 33790 Halle/Westfalen, Germany
BioNTech Manufacturing GmbH
Kupferbergterrasse 17 - 19, 55116 Mainz, Germany
Pfizer Manufacturing Belgium NV
Rijksweg 12, 2870 Puurs, Belgium
Mibe GmbH Arzneimittel
Münchener Straβe 15, 06796 Brehna, Germany
Sanofi-Aventis Deutschland GmbH
Bereich Handelsprodukte, Industriepark Hoechst,
Brueningstrasse 50, H500, H590, H600, H750, H785, H790, 65926 Frankfurt am Main, Germany
Patheon Italia S.p.A.,
Viale G.B. Stucchi, 110, 20900 – Monza (MB), Italy
Pharmaceutical Form: Concentrate for dispersion for injection
Dosage: 30 mcg
Presentation: 2 mL Vial
Number of doses: 1 dose of 0.3 mL
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
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: N/A
Packaging description
| Secondary Packaging: | Carton holding 10 vials (10 doses). Dimensions: 3.7 x 8.9 x 4.7 cm |
|
Tertiary Packaging: |
Box containing 48 secondary cartons with a total of 480 vials (480 doses). Dimensions: 27.7 X 20.1 X 19.7 cm |
| Cold Chain Volume: | 15.47 cm3/dose (in secondary packaging) |
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: 24 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
WHO Summary of Product Characteristics
Drug Product - Manufacturing sites
Pfizer Manufacturing Belgium NV
Rijksweg 12, 2870 Puurs, Belgium
Sanofi-Aventis Deutschland GmbH
Bereich Handelsprodukte, Industriepark Hoechst, Brueningstrasse 50, H500, H590, H600, H750, H785, H790, 65926 Frankfurt am Main, Germany
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: 24 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
WHO Summary of Product Characteristics
Drug Product - Manufacturing sites
-
Pfizer Manufacturing Belgium NV
Rijksweg 12, 2870 Puurs, Belgium
Pharmaceutical Form: Concentrate for dispersion for injection
Dosage: 3 mcg
Presentation: 2 mL Vial
Number of doses: 10 doses of 0.2 mL (after dilution)
Route of administration: Intramuscular
Age indication: Children between 6 months to 4 years
Shelf – life: 24 months Storage temperature: -90°C to -60°C
Refrigeration Storage Time (2°C to 8°C): 10 weeks within the 18 months shelf-life
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: 3.7 x 22.2 x 22 cm |
| Tertiary Packaging: | Insulated box containing 5 secondary cartons with a total of 975 vials (5850 doses). Dimensions: 54 X 39 X 39 cm |
| Cold Chain Volume: | 1.5 cm3/dose (in secondary packaging) |
Drug Product - Manufacturing sites
Pfizer Manufacturing Belgium NV
Rijksweg 12, 2870 Puurs, Belgium
Drug substance - Manufacturing sites
BioNTech Manufacturing GmbH
An der Goldgrube 12, 55131 Mainz, Germany
BioNTech Manufacturing Marburg GmbH
Emil-von-Behring-Strasse 76, 35401 Marburg, Germany
Pfizer Ireland Pharmaceuticals
Grange Castle Business Park, Clondalkin, Dublin 22, Ireland
Diluent supplier
| Manufacturer | Ampoule volume | No. of ampoules |
Secondary packaging (HxLxW) cm |
No. of secondary cartons in tertiary packaging | No. of ampoules in tertiary packaging |
Tertiary packaging (HxLxW) cm |
| Pfizer Perth, Australia | 10 mL | 50 | 8.8 x 18.7 x 10.5 | 12 | 600 | 19.5 x 43.5 x 27 |
| Fresenius Kabi, USA | 20 mL | 25 | 8.7 x 8.6 x 4.2 | 40 | 1000 | 45.7 x 17.8 x 17.8 |
| Pfizer Manufacturing, Belgium | 2 mL | 950 |
65.0 x 373.0 x 275.0 |
3 | 2850 | 226 x 398 x 298 |
| Kwang Myung Pharm Co, Ltd | 5 mL and 10 mL | 25 | 13.0 x 12.0 x 12.0 | 24 | 600 | 30.5 x 38 x 51 |