The Human Biologicals Institute (HBI), a division of Indian Immunologicals Limited (IIL) has launched Elovac-B recombinant DNA (r DNA) Hepatitis-B vaccine across the country. The vaccine is manufactured in its plant at Gachibowli, Hyderabad. The vaccine is available in 0.5 ml and 5 ml vials.

Hepatitis B vaccine (recombinant) is a non-infectious recombinant viral vaccine derived from hepatitis B surface antigen (HBsAg) produced in yeast cells. The vaccine is indicated for immunisation against infection caused by all known subtypes of Hepatitis B virus. Elovac-B should not be administered to any person who has experienced a hypersensitivity reaction to any component of any Hepatitis B recombinant DNA vaccine.

The company will initially target domestic market and plans to start exporting the vaccine in next two to three years. The launch of the vaccine has come in the time when the Government is considering the inclusion of Hepatitis-B vaccine in Extended Programme of Immunisation (EPI), which is expected by November 2006.

HBI will make the vaccine available through its 2000 Abhayrab clinics spread across the country. The Hyderabad facility that manufactures Hepatitis-B vaccine also produces other vaccines. The facility has a 100 million-dose capacity. The company has invested close to Rs 50 crore in setting up the facility.

The Hepatitis B Virus (HBV) is a double-stranded, enveloped virus of the Hepadnviridae family. With a genome of only 3200 base pairs, the virus is one of the smallest DNA viruses known. Worldwide, two billion people are estimated to be infected by HBV. Of these, 360 million are chronically infected and at risk of serious illness and death from cirrhosis and hepatocellular cancer (HCC), diseases that are estimated to cause about 700,000 deaths each year worldwide.

According to WHO, there are about 350 million carriers of hepatitis B virus worldwide. The hepatitis virus is spread through unsafe injection practices and needle stick injuries. Most infants born to mothers who are carriers are at risk of being infected. There are recombinant DNA and plasma-derived vaccines available worldwide, and three doses are considered to be ideal.

The company plans to develop monoclonal antibodies and other biologicals in future. It plans to introduce Measles vaccine by December 2006 while a series of combination vaccines are expected to be launched in 2007. A combo vaccine of Hib + Hep A is likely to be introduced by mid 2008.