Tuberculosis (BCG)

BCG Vaccine, Serum Institute of India, Ltd.
WHO Pre-Qualified
Diseases Targeted: 
Tuberculosis (TB)
Vaccine Trade Name: 
BCG Vaccine, Serum Institute of India, Ltd.
Vaccine Type: 

BCG Vaccine, Live, Freeze-Dried, Attenuated

Manufacturer: 
Serum Institute of India, Ltd.
Country of Manufacture: 
India
Date of prequalification or approval: 
Thursday, May 29, 2003
NRA of Record: 
CDSCO (India)
Presentation(s): 

10/ 20 dose vial + ampoule of diluent

Pharmaceutical Formulation: 
Lyophilized + Sodium Chloride 1 ml diluent
Route of administration: 
intradermal (0.05 mL dose for children under one year) (0.1 mL dose for recipients over one year)
Shelf life: 
24 months at 2 - 8 °C
Preservative: 
None
Vaccine Vial Monitor: 
Type 30
Cold Chain volume per dose (cm3): 

 2.611 (0.1 mL dose) 1.305 (0.05 mL dose)

Secondary Packaging: 

Carton of 50 vials (active) + carton of 50 ampoules of diluent

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.