WHO recommendation Serum Institute of India Pvt Ltd - COVID-19 Vaccine (ChAdOx1-S [recombinant]) - COVISHIELD™



 

Product Overview

   
Vaccine type: COVID-19 Vaccine (ChAdOx1-S ([recombinant])    
Commercial name: COVISHIELD™    
EUL holder: Serum Institute of India Pvt. Ltd    
Country: India    
URL: https://www.seruminstitute.com/    
Manufacturing sites: See box below "Manufacturing sites"    
Responsible NRA: Central Drugs Standard Control Organization    
Country: India    
URL: https://cdsco.gov.in/opencms/opencms/en/Home/    
 

WHO Recommendation

   
Effective date: 15 February 2021    
 

Product Description

   
Pharmaceutical form: Solution for injection    
Presentation: Vial    
Number of doses: 2 and 10 doses    
Diluent: Not applicable    
Route of administration: Intramuscular    
Age indication: Individuals aged 18 years and older    
Shelf-life: 9 months at storage temperature: 2°C to 8°C           
Vaccine vial monitor: None    
Secondary packaging: COVIDSHIELD-2dose: Carton holds 50 vaccine vials (100 doses)
Dimensions: 18.5 x 9.5 x 4.0 cm

COVIDSHIELD-10 dose: Carton holds 50 vaccine vials (500 doses)
Dimensions: 18.5 x 9.5 x 6.0 cm

   
Tertiary packaging: COVIDSHIELD-2dose: 6 secondary packaged cartons containing 50 vials per carton
(300 vials /600 doses): Dimensions: 31.0 x 19.0 x 9.3 cm

COVIDSHIELD-10 dose: 6 secondary packaged cartons containing 50 vials per carton
(300 vials /3000 doses): Dimensions: 31.0 x 19.0 x 9.3 cm              
   
Cold chain volume: 7.03 (2 dose vial)
2.109 (10 dose vial)
cm3 (in secondary packaging)  
Preservative: Not applicable with concentration: Not applicable
Handling of opened multidose-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.