The vaccine was approved in India last year based on the results of phase II trial on 70,000 human subjects (aged one year and over) conducted in Kolkata by the National Institute of Cholera and Enteric Diseases (NICED). The Kolkata trials found the oral cholera vaccine to provide over 67 percent protection and no decline in protection over two years. Shantha Biotech has spent $1.5 million to set up facilities for Shanchol production.

A collaborative effort

The bivalent inactivated-whole-cell oral cholera vaccine has been developed in collaboration with the International Vaccine Institute (IVI), Seoul, South Korea. IVI scientists developed this vaccine, with funding from the Bill & Melinda Gates Foundation, by significantly modifying a vaccine used and produced only in Vietnam by VA Biotech, so that it meets international GMP standards and WHO production guidelines.

Following field trials in India and Vietnam showing the new vaccine to be safe and immunogenic in both adults and children, IVI scientists transferred the technology for the vaccine to Shantha Biotechics. "Shanchol is the first new vaccine to be developed and licensed with funding from the Gates Foundation, also the first licensed vaccine developed by the IVI" says Mr Varaprasad Reddy, Managing Director, Shantha Biotechnics, Hyderabad, India.

The IVI aims to make this vaccine available for use in public health programs in India and other cholera-affected countries in Asia and Africa to control endemic cholera, also to help control large scale outbreaks.

Going forward

Shantha has applied to WHO for pre-qualification of Shanchol, to allow its purchase by United Nations agencies, including UNICEF, and to facilitate its use in other countries. The company is currently producing 1.5 million doses of the vaccine but Mr Reddy has plans to scale it up to 10 million doses in the next few years.