COMIRNATY Omicron XBB
Product Overview
Type: COVID-19 mRNA Vaccine
INN: Raxtozinameran
Trade name: COMIRNATY
EUL holder: BioNTech Manufacturing GmbH
Country: Germany
Responsible NRA: European Medicines Agency (EMA)
Country: The Netherlands
Product description
Pharmaceutical Form: Sterile dispersion for injection
Dosage: 30 mcg
Presentation: Vial
Number of doses: 1 dose and 6 doses of 0.3 mL
Route of administration: Intramuscular
Age indication: 12 years and older
Shelf – life: 18 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: 30 October 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 195 MDV (1170 doses). Dimensions: 22.9 x 22.9 x 4.0 cm |
| Tertiary Packaging: |
a. Insulated 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 5 secondary cartons with a total of 975 vials (5850 doses). Dimensions: 40 x 40 x 56 cm |
| Cold Chain Volume: |
a. 15.5 cm3/dose (in secondary packaging) b, 1.8 cm3/dose (in secondary packaging) |
Product description
Pharmaceutical Form: Sterile dispersion for injection
Dosage: 10 mcg
Presentation: Vial
Number of doses: 10 doses of 0.2 mL
Route of administration: Intramuscular
Age indication: Children aged 5 to 11 years
Shelf – life: 18 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: 30 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: |
1.6 cm3/dose (in secondary packaging) |
Product description
Pharmaceutical Form: Sterile dispersion for injection
Dosage: 10 mcg
Presentation: Vial
Number of doses: 1 dose and 6 doses of 0.3 mL
Route of administration: Intramuscular
Age indication: Children aged 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 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: 30 October 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 195 MDV (1170 doses). Dimensions: 22.9 x 22.9 x 4.0 cm |
| Tertiary Packaging: |
a. Insulated 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 5 secondary cartons with a total of 975 vials (5850 doses). Dimensions: 40 x 40 x 56 cm |
| Cold Chain Volume: |
a. 15.5 cm3/dose (in secondary packaging) b. 1.8 cm3/dose (in secondary packaging) |
Product description
Pharmaceutical Form: Sterile dispersion for injection
Dosage: 3 mcg
Presentation: Vial
Number of doses: 10 doses of 0.2 mL
Route of administration: Intramuscular
Age indication: Infants and children agred 6 months to 4 years
Shelf – life: 18 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: 30 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: |
1.6 cm3/dose (in secondary packaging) |