It is being billed as India's first social innovation and novel vaccine development project. On May 14, the Department of Biotechnology will announce the results of phase three efficacy studies in India for a low-cost, locally made rotavirus vaccine that is likely to be launched in the first quarter of 2014.
Rotavirus is by far the most common cause of severe diarrhea in infants and young children worldwide and of diarrhea-related deaths in developing countries. The World Health Organization estimates that between 90,000 and 153,000 children die from rotavirus infection in India each year. According to the WHO, more than 2.3 million children below five years of age die in India annually. Of these, about 334,000 die from diarrhea-related diseases.
The department has partnered with Hyderabad-based company Bharat Biotech and four US organisations for the vaccine. These are the National Institutes of Health, the Centers for Disease Control and Prevention, Stanford University School of Medicine, and the non-governmental organisation PATH.
Currently, two vaccines are available to guard against rotavirus - GlaxoSmithKline's Rotarix and Merck's Rota Teq. Rotarix is priced at Rs 2,398 for the complete course that comprises two doses. Bharat Biotech Chairman and Managing Director Krishna M. Ella had told Business Today three years ago that the goal of the project on rotavirus was to launch the vaccine at one-tenth the existing market price.
According to the website of PATH, the vaccine's trial was launched in March 2011 and 6,800 infants are enrolled as part of the trial at three sites in India. These sites are the Centre for Health Research and Development in New Delhi, Shirdi Sai Baba Rural Hospital at the King Edward Memorial Hospital Research Centre in Pune, and the Christian Medical College in Vellore. Other organisations involved in the study include the Department of Biotechnology's Translational Health Science and Technology Institute.
The May 14 announcement may throw some light on the trial details and perhaps indicate the expected launch date and price of the vaccine. Also, it is not known yet if the vaccine will be included in the government's national immunization programme. Currently, seven vaccines are part of the government's regular vaccine protocol to prevent diseases such as tuberculosis, diphtheria, whooping cough, tetanus, polio, measles and hepatitis B.
Hyderabad-based Shantha Biotechnics, part of multinational drug maker Sanofi, and Serum Institute in Pune are among the other Indian companies that are developing affordable rotavirus vaccines.