Bharat Biotech's REVAC-B+TM - Hepatitis B Vaccine Crosses 150 million Mark

New Revac-Bmcf The First Vaccine in the World to be manufactured free of Thiomersol (Mercury) and Cesium Chloride

Hyderabad|India|: Bharat Biotech International Limited (BBIL/Bharat Biotech) the multi-dimensional biotechnology company specializing in product-oriented research, development and manufacturing of vaccines and bio-therapeutics announced that it has crossed production and delivery of more than 150 million doses of REVAC-B+TM, recombinant hepatitis B vaccine since its launch in October 1998.

REVAC-B+TM has been marketed and sold in more than 30 countries worldwide with manufacturing and quality standards on par with USFDA, EMEA and WHO guidelines. The Vaccine has established an excellent safety and efficacy profile since its launch 10 years ago.

In his comments, Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech said, “The success of REVAC-B+TM bears testimony to our solid emphasis on R&D to develop vaccines that carry excellent safety and efficacy profiles. The Next Generation REVAC-Bmcf (Thiomersol and Cesium Chloride Free*) Recombinant Hepatitis-B Vaccine manufactured by us are cost-effective and address the safety concerns expressed by parents and members of the medical profession.” He added.

Bharat Biotech is a major supplier of the Cesium Chloride Free Hepatitis-B Vaccines, It has taken steps to ensure a smooth transition for customers from the traditional Hepatitis-B vaccine to the new preservative-free REVAC-Bmcf (Thiomersol and Cesium Chloride Free*) vaccine apart from effectively upgrading and optimizing production technologies to ensure the phasing out of thiomersol as preservative in some of BBIL products.

REVAC-Bmcf (Thiomersol and Cesium Chloride Free*) vaccine contains the same components utilized in BBIL’s previous Hepatitis-B vaccine, but now it is supplied preservative-free in a single-dose vial. Bharat Biotech had successfully manufactured a preservative-free pediatric vaccine of a highly reputed MNC on a contract basis and the product was exported to a regulated market in Far East.

The preservative thiomersal which contains mercury is used in the production process for many vaccines. There are trace amounts of thiomersol left over from the production process that cannot be removed, but these amounts are so small that Regulatory agencies consider the vaccine to be preservative-free. The Global Advisory Committee on Vaccine Safety of WHO in its July 2006 Statement on thiomersol stated that it does not support concerns over safety of thiomersol. The Immunization Safety Review Committee of the National Academy of Sciences Institute of Medicine, USA, however, recommends for a phase-out of thiomersol as a preservative in vaccines.