Corbevax
Product Overview
Type: COVID-19 Vaccine (Recombinant protein subunit)
INN: N/A
Trade name: Corbevax®
EUL holder: Biological E. Ltd.
Country: India
Responsible NRA: Drug Controller General, India (DCGI)
Country: India
WHO EUL recommendation
Effective date: 15 January 2024
Product description
Pharmaceutical Form: Suspension for injection
Presentation: Vial
Number of doses: 1, 10 and 20 doses (0.5 mL per dose)
Route of administration: Intramuscular
Age indication:
The vaccine is indicated for individuals aged 12 years and above with at least four weeks interval between the doses. The vaccine can also be useas a booster dose ≥6 months after completion of primary immunization wiht two doses od Covishield in individials 18 years above.
Shelf – life: 24 months Storage temperature: 2°C - 8°C
Vaccine Vial monitor (VVM): Type 14
Preservative: None
Adjuvant: Aluminium hydroxide and CpG1018 (as co-adjuvant) in Tris buffer.
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.
Packaging description
Secondary Packaging: |
a. Single dose presentation: Carton of 48 single dose vials (SDV). Dimension: 14.5 x 18.8 x 4.5 cm. b. 10 dose presentation: Carton of 24 multidose vials (240 doses). Dimensions: 14.5 x 18.8 x 4.5 cm. c. 20 dose presentation: Carton of 30 multidose vials (600 doses). Dimensions: 14.8 x 12.4 x 6.5 cm. |
Tertiary Packaging: |
a. Carton box containing 32 secondary cartons (1536 vaccines/ 1536 doses). b. Carton box containing 32 secondary cartons (768 vaccines/ 7680 doses). c. Carton box containing 18 secondary cartons (540 vaccines/ 10800 doses). |
Cold Chain Volume |
a. 14.7 cm3/dose b. 2.9 cm3/dose c. 2.0 cm3/dose |