COVOVAX



Product Overview


Type:                           COVID-19 vaccine (SARS-CoV-2 rS Protein Nanoparticle [Recombinant])


INN:                             N/A


Trade name:               COVOVAX™


EUL holder:                Serum Institute of India Pvt. Ltd. (SIIPL)


Country:                      India


Responsible NRA:     Central Drugs Standard Control Organization (CDSCO)


Country:                      India


 

WHO EUL recommendation


Effective date:             17 December 2021


 

Product description


Pharmaceutical Form:                   suspension for injection                                   


Presentation:                                   2 mL and 5 mL vial


Number of doses:                           1 dose and 10 doses (0.5 mL per dose)


Route of administration:                Intramuscular


Age indication:                                12 years and older


Shelf – life:                                       9 months     Storage temperature:   2°C to 8°C      


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.


 

Packaging description

Secondary packaging:

a) 1 dose presentation:
Carton with 50 vials (50 doses).
Dimensions: 18.5 x 9.5 x 4.5 cm

b) 10 dose presentation:
Carton with 50 vials (500 doses)
Dimensions: 18.5 x 9.5 x 6.0 cm

Tertiary packaging:

a) 1 dose presentation:
Carton with 1200 vials (1200 doses)
Dimensions: 71.5 x 60.5 x 63.5 cm

b) 10 dose presentation:
Carton with 1200 vials (12000)
Dimensions: 71.5 x 60.5 x 63.5 cm

Cold Chain Volume (in secondary packaging):

a) 15.8 cm3/dose

b) 2.1 cm3/dose

 

Drug substance - Manufacturing sites


Serum Institute of India Pvt. Ltd.
212/2, Hadapsar, Pune - 411028, INDIA

Serum Institute of India Pvt. Ltd.
S. No. 105-110, Manjari BK, Tal -Haveli, Pune-412307, INDIA


 

Drug product - Manufacturing sites


Serum Institute of India Pvt. Ltd.
212/2, Hadapsar, Pune - 411028, INDIA

Serum Institute of India Pvt. Ltd.
S. No. 105-110, Manjari BK, Tal-Haveli, Pune - 412307, Maharashtra, INDIA