The Government of India's Department of Biotechnology (DBT) and Bharat Biotech have announced the development of a rotavirus vaccine that will be sold at $1 per dose, once approved. Results from a Phase III clinical trial showed that the ROTAVACÂ® vaccine decreased the incidence of severe rotavirus diarrhoea by 56% during the first year of life, and the protection conferred by the vaccine also continued into the second year of life. The clinical trial enrolled 6,799 infants across three sites in India.
“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. VijayRaghavan. “The clinical results indicate that the vaccine, if licensed, could save the lives of thousands of children each year in India.”
ROTAVACÂ® is an oral vaccine and is administered to infants in a three-dose course at the ages of 6, 10, and 14 weeks. At a price of US$1 (54 rupees; Â£0.65) per dose, ROTAVACÂ® will be more affordable than other rotavirus vaccines already on the market, if it is licensed by the Drugs Controller General of India (DCGI). Last year, the GAVI Alliance negotiated a bulk supply of rotavirus vaccines from GlaxoSmithKline and Merck at $2.50 per dose (and GSK's Rotarix and Merck's RotaTeq turned out to be more cost-effective than previously thought).
“With its low price and strong efficacy, ROTAVACÂ® has the potential to significantly reduce the incidence of severe diarrhoea due to rotavirus among children in India,” said Dr M.K. Bhan, Advisor to the Indian Academy of Pediatrics and former DBT Secretary.
The vaccine's development resulted from a unique partnership between Indian and international researchers, with partners including DBT, Bharat Biotech, the US National Institutes of Health (NIH), the US Centers for Disease Control and Prevention (CDC), Stanford University School of Medicine, and PATH.
“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. (See video of Kim Bush, Director of Life Sciences Partnerships, Global Health Program at the Bill and Melinda Gates Foundation, discuss â€˜Investing in Global Health').
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