Product Overview

Type:                         COVID-19 Vaccine (ChAdOx1-S ([recombinant])

INN:                           N/A

Trade name:             COVISHIELD

EUL holder:               Serum Institute of India Pvt. Ltd

Country:                    India

Responsible NRA:    Central Drugs Standard Control Organization​ (CDSCO)

Country:                     India


WHO EUL recommendation

Effective date:            15 February 2021

WHO Recommendation for EUL of COVISHIELD™ submitted by Serum Institute of India Pvt Ltd (Published: 26 February 2021)



Product description

Pharmaceutical Form:                   Suspension for injection                                    

Presentation:                                   2 mL vial and 5 mL vial

Number of doses:                            2 doses (0.5 mL per dose) and 10 doses (0.5 mL per dose)

Route of administration:                Intramuscular

Age indication:                                18 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. Carton of 50 vials (2 doses/vial) (100 doses/carton). Dimensions: 18.5 x 9.5 x 4.0 cm

 b. Carton of 50 vials (10 doses/vial) (500 doses/carton). Dimensions: 18.5 x 9.5 x 6.0 cm

Tertiary Packaging: 

 a. 6 secondary packaged cartons (300 vials/600 doses). Dimensions: 31.0 x 19.0 x 9.3 cm 

 b. 6 secondary packaged cartons (300 vials/3000 doses). Dimensions: 31.0 x 19.0 x 9.3 cm 

Cold Chain Volume in

secondary packaging:

 a. 7.03 cm3/dose      

 b. 2.109 cm3/dose         


Product characteristics and Package leaflet

WHO Package Leaflet for Health Workers