Skip to main content

Corbevax

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).
Dimensions: 66 x 53 x 43 cm.

b. Carton box containing 32 secondary cartons (768 vaccines/ 7680 doses).
Dimensions: 66 x 53 x 43 cm.

c. Carton box containing 18 secondary cartons (540 vaccines/ 10800 doses).
Dimensions: 66 x 53 x 43 cm.

Cold Chain Volume
(in secondary packaging):

a. 14.7  cm3/dose

b. 2.9    cm3/dose

c. 2.0    cm3/dose