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Click on icon to see table/diagram/imageBEVAC is a sterile suspension containing highly purified, non-infectious major surface antigen of the Hepatitis-B virus produced by recombinant DNA technology. The antigen is adsorbed onto high affinity aluminium hydroxide gel particles and hence the suspension appears almost white and translucent. BEVAC is available in paediatric dose vials (containing 10 μg HBsAg/dose) as well as adult dose vials (containing 20 μg HBsAg/dose). The vaccine meets the requirements of WHO and BP.
Recombinant technology: The hepatitis-B surface antigen (HBsAg) has been developed in genetically engineered yeast cells of Pichia pastoris which carry the gene that codes for the major surface antigen protein of the hepatitis-B virus (HBV). HBsAg expressed in yeast cells is purified by complex physical, chemical and biochemical processes. The resultant highly purified surface antigen assembles spontaneously into spherical particles of an average diameter of 20-24 nm containing non-glycosylated polypeptides in a lipid matrix. An extensive and rigorous in-house R&D processes characterized and confirmed that these 20-24 nm spherical particles resemble that natural HBsAg protein in their antigenic properties. The efficacy and safety of the formulated BEVAC is ensured through stringent adherence to the highest standards of bio-process control and consistent quality assurance measures. No substance of human origin is used in the manufacture of HBsAg protein.
Immunological Properties: In clinical trials, BEVAC induced specific antibodies in the vaccinees against hepatitis B virus. Three doses of BEVAC immunization elicited high protective humoral antibody levels in of the recipients.
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