COMIRNATY Original/Omicron
Product Overview
Type: COVID-19 mRNA Vaccine
INN: Tozinameran/Riltozinameran
Trade name: COMIRNATY
EUL holder: BioNTech Manufacturing GmbH
Country: Germany
Responsible NRA: European Medicines Agency (EMA)
Country: The Netherlands
Product description
INN: Tozinameran/Riltozinameran
Pharmaceutical Form: Sterile dispersion for injection
Dosage: 15/15 mcg
Presentation: 2.25 mL Vial
Number of doses: 6 doses of 0.3 mL
Route of administration: Intramuscular
Age indication: 5 years and older
Shelf – life: 24 months Storage temperature: -90°C to -60°C
Refrigeration Storage Time (2°C to 8°C): 10 weeks within the 12 months shelf life
Vaccine Vial monitor (VVM): None
Preservative: None
Adjuvant: None
Diluent: None
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.
WHO EUL recommendation
Effective date: 19 October 2022
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) |
Drug product - Manufacturing sites
Pfizer Manufacturing Belgium NV
Rijksweg 12, 2870 Puurs, Belgium.
Sanofi-Aventis Deutschland GmbH
Brueningstrasse 50 (H500, H590, H600, H750, H785, H790), 65926 Frankfurt am Main, Germany.
mibe GmbH Arzneimittel
Munchener Strasse 15. 06796 Brehna, Germany
Product description
INN: Tozinameran/Famtozinameran
Pharmaceutical Form: Sterile dispersion for injection
Dosage: 15/15 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 within the 18 months shelf life
Vaccine Vial monitor (VVM): None
Preservative: None
Adjuvant: None
Diluent: None
Handling of opened multi-dose vials: N/A
WHO EUL recommendation
Effective date: 11 July 2023
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: |
15.5 cm3/dose (in secondary packaging) |
Product description
INN: Tozinameran/Famtozinameran
Pharmaceutical Form: Sterile dispersion for injection
Dosage: 15/15 mcg
Presentation: 2.25 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 within the 18 months shelf life
Vaccine Vial monitor (VVM): None
Preservative: None
Adjuvant: None
Diluent: None
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.
WHO EUL recommendation
Effective date: 11 November 2022
Packaging Description
| Secondary packaging: |
a. Carton holding 10 vials (60 doses). Dimensions: 4.7 x 8.9 x 3.7 cm b. Carton holding 25 vials (150 doses). Dimensions: 3.9 x 8.3 x 8.3 cm c. Carton holding 195 vials (1170 doses). Dimensions: 3.7 x 22.2 x 22 cm |
| Tertiary Packaging: |
a. Insulated box containing 48 secondary cartons with a total of 480 vials (2880 doses). Dimensions: 20.1 x 19.7 x 23.7 cm b. Insulated box containing 20 secondary cartons with a total of 500 vials (3000 doses). Dimensions: 54 x 39 x 39 cm. c. Insulated box containing 5 secondary cartons with a total of 975 vials (5850 doses). Dimensions: 59 X 39 X 39 cm |
| Cold Chain Volume: |
a. 2.57 cm3/dose b. 1.79 cm3/dose (in secondary packaging) c. 1.54 cm3/dose |
Drug product - Manufacturing sites
Pfizer Manufacturing Belgium NV
Rijksweg 12, 2870 Puurs, Belgium.
Sanofi-Aventis Deutschland GmbH,
Brueningstrasse 50 (H500, H590, H600, H750, H785, H790), 65926 Frankfurt am Main, Germany.
mibe GmbH Arzneimittel
Munchener Strasse 15. 06796 Brehna, Germany
Baxter Oncology GmbH,
Kantstrasse 2, 33790 Halle/Westfalen, Germany
Product description
INN: Tozinameran/Famtozinameran
Pharmaceutical Form: Concetrate for dispersion for injection
Dosage: 5/5 mcg
Presentation: 1.3 mL Vial
Number of doses: 10 doses of 0.2 mL
Route of administration: Intramuscular
Age indication: 5 to 12 years of age
Shelf – life: 24 months Storage temperature: -90°C to -60°C
Short Term Storage (5°C to 3°C): 10 weeks within the 12 months shelf life
Vaccine Vial monitor (VVM): None
Preservative: None
Adjuvant: None
Diluent: Sodium Chloride 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.
WHO EUL recommendation
Effective date: 17 April 2023
Packaging Description
| Secondary packaging: |
a. Carton holding 10 vials (60 doses). Dimensions: 4.7 x 8.9 x 3.7 cm b. Carton holding 25 vials (150 doses). Dimensions: 3.9 x 8.3 x 8.3 cm c. Carton holding 195 vials (1170 doses). Dimensions: 3.7 x 22.2 x 22 cm |
| Tertiary Packaging: |
a. Insulated box containing 48 secondary cartons with a total of 480 vials (2880 doses). Dimensions: 20.1 x 19.7 x 23.7 cm b. Insulated box containing 20 secondary cartons with a total of 500 vials (3000 doses). Dimensions: 54 x 39 x 39 cm. c. Insulated box containing 5 secondary cartons with a total of 975 vials (5850 doses). Dimensions: 59 X 39 X 39 cm |
| Cold Chain Volume: |
a. 2.57 cm3/dose b. 1.79 cm3/dose (in secondary packaging) c. 1.54 cm3/dose |
Drug product - Manufacturing sites
Patheon Italia S.p.A.,
Viale G.B. Stucchi, 110, 20900, Monza, Italy
mibe GmbH Arzneimittel,
Münchener Straβe 15, 06796 Brehna, Germany
Product description
INN: Tozinameran/Famtozinameran
Pharmaceutical Form: Sterile dispersion for injection ready to use
Dosage: 5/5 mcg
Presentation: 2 mL Vial
Number of doses: 1 dose or 6 doses of 0.3 mL
Route of administration: Intramuscular
Age indication: 5 to 11 years of age
Shelf – life: 12 months Storage temperature: -90°C to -60°C
Short Term Storage (5°C to 3°C): 10 weeks within the 12 months shelf life
Vaccine Vial monitor (VVM): None
Preservative: None
Adjuvant: None
Diluent: Not required
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.
WHO EUL recommendation
Effective date: 17 April 2023
Packaging Description
| Secondary packaging: |
a. Carton holding 10 SDV (10 doses). Dimensions: 3.7 x 8.9 x 4.7 cm b. Carton holding 10 MDV (60 doses). Dimensions: 4.7 x 8.9 x 3.7 cm c. Carton holding 25 MDV (150 doses). Dimensions: 3.9 x 8.3 x 8.3 cm d. Carton holding 195 MDV (1170 doses). Dimensions: 3.7 x 22.2 x 22 cm |
| Tertiary Packaging: |
a. Box containing 48 secondary cartons with a total of 480 vials (480 doses). Dimensions: 27.7 X 20.1 X 19.7 cm b. Insulated box containing 48 secondary cartons with a total of 480 vials (2880 doses). Dimensions: 20.1 x 19.7 x 23.7 cm c. Insulated box containing 20 secondary cartons with a total of 500 vials (3000 doses). Dimensions: 54 x 39 x 39 cm. d. Insulated box containing 5 secondary cartons with a total of 975 vials (5850 doses). Dimensions: 59 X 39 X 39 cm |
| Cold Chain Volume: |
a. 15.5 cm3/dose b. 2.57 cm3/dose b. 1.79 cm3/dose (in secondary packaging) c. 1.54 cm3/dose |
Product description
INN: Tozinameran/Famtozinameran
Pharmaceutical Form: Sterile dispersion for injection
Dosage: 1.5/1.5 mcg
Presentation: 1.3 mL Vial
Number of doses: 10 doses of 0.2 mL
Route of administration: Intramuscular
Age indication: 6 months to 4 years of age
Shelf – life: 24 months
Storage temperature: -90°C to -60°C
Short Term Storage (5°C to 3°C): 10 weeks within the 12 months shelf life
Vaccine Vial monitor (VVM): None
Preservative: None
Adjuvant: None
Diluent: Sodium Chloride 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.
WHO EUL recommendation
Effective date: 19 October 2023
Packaging Description
| Secondary packaging: |
Carton holding 10 vials (100 doses). Dimensions: 9.3 x 4.5 x 3.8 cm |
| Cold Chain Volume: |
1.59 cm3/dose (in secondary packaging) |
Product Leaflet
COMIRNATY®ORIGINAL/OMICRON BA.4-5 (1.5/1.5 mcg)