Rotavirus is the leading cause of half a million children deaths a year in the world, one-fifth of which happen in India, through dehydration from virus-induced diarrhea. A partnership between Government of India's Department of Biotechnology (DBT) and the Bharat Biotech company has presented promising Phase III clinical trial data at the International Symposium on Rotavirus Vaccines for India.

The late stage double-blind, placebo-controlled clinical trial, enrolling 6,799 infants, showed that the Indian-developed vaccine, ROTAVAC, is effective and safe in preventing rotavirus in poor areas of the country. Severe dehydrating diarrhea was cut by more than half (56 percent) during the first year of life after vaccination. Trial data also showed that the protection from infection lasted well into the second year of life for infants.

"This is an important scientific breakthrough against rotavirus infections, the most severe and lethal cause of childhood diarrhoea, responsible for approximately 100,000 deaths of small children in India each year," said DBT Secretary Dr. K. Vijay Raghavan. "The clinical results indicate that the vaccine, if licensed, could save the lives of thousands of children each year in India."

Although other vaccines such as Rotarix, sold by GlaxoSmith Kline, and RotaTeq, sold by Merck, have been valuable on the market for the last few years, the cost is considerable for the developing world, at $5 a dose. The vaccine developed by the Indian government and private corporate partnership places the cost of the vaccine at $1, well in the reach for individual families, governments, and non-governmental organizations (NGO).

"Vaccines work to save and protect children from diseases like rotavirus for a lifetime. This public-private partnership is an exemplary model of how to develop affordable technologies that save lives." said Bill Gates, co-chair of the Bill & Melinda Gates Foundation, which funded part of the research.

The new vaccine only requires three administrations, unlike the other vaccines on the market that require two doses. Even though the dosing is more, the total cost would be $3 a child rather than $10 with the other vaccines. In children who were given the oral polio vaccine at the same time, there were no adverse reactions and children became immune to both infections.

Information about the clinical trials for the vaccine can be found on

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