India Develops First Indigenous Rotavirus Vaccine

The Government of India and Bharat Biotech have announced positive Phase III results from India’s first indigenous, low-priced rotavirus vaccine.

AsianScientist (May 20, 2013) – The Government of India’s Department of Biotechnology (DBT) and Bharat Biotech announced on Tuesday positive Phase III clinical trial results from its first indigenous, low-priced rotavirus vaccine, which may soon be available for just US$1 per dose.

The randomized, double-blind, placebo-controlled Phase III clinical trial enrolled 6,799 infants at three sites in India. ROTAVAC® was administered as an oral vaccine to infants in a three-dose course at the ages of 6, 10, and 14 weeks, alongside routine immunizations in the UIP vaccines recommended at these ages.

Data from the trial, presented on Wednesday at the International Symposium on Rotavirus Vaccines for India – The Evidence and the Promise, showed ROTAVAC® to have an excellent safety and efficacy profile. According to results from the clinical study, the vaccine significantly reduced severe rotavirus diarrhea by 56 percent during the first year of life, with protection continuing into the second year of life. Moreover, the vaccine also showed impact against severe diarrhea of any cause.

“This is an important scientific breakthrough against rotavirus infections, the most severe and lethal cause of childhood diarrhea, 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.”

Bharat Biotech previously announced a price of US$1 per dose of the vaccine. The company will soon file for registration of the vaccine with the Drugs Controller General of India (DCGI).

Partners on the vaccine project included 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 the nongovernmental organization, PATH. The vaccine development partnership was supported by DBT, the Bill & Melinda Gates Foundation, the Research Council of Norway, and the UK Department for International Development.

“Vaccines work to save and protect children from diseases like rotavirus for a lifetime,” said Bill Gates, Co-Chair of the Bill & Melinda Gates Foundation. “This public-private partnership is an exemplary model of how to develop affordable technologies that save lives.”


Source: PATH; Photo:
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