COMIRNATY Original/Omicron BA.4-5 (5/5 mcg)
Product Overview
Type: COVID-19 mRNA Vaccine
INN: Tozinameran/Famtozinameran
Trade name: COMIRNATY
EUL holder: BioNTech Manufacturing GmbH
Country: Germany
Responsible NRA: European Medicines Agency (EMA)
Country: The Netherlands
WHO EUL recommendation
Effective date: 17 April 2023
Product description
Pharmaceutical Form: Sterile 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: 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: 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.
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