Rotavirus Vaccine Developed in India Demonstrates Strong Efficacy

The Government of India's Department of Biotechnology (DBT) and Bharat Biotech announced positive results from a Phase III clinical trial of a rotavirus vaccine developed and manufactured in India. Data from the trial, presented on May 14, 2013 at the International Symposium on Rotavirus Vaccines for India—The Evidence and the Promise, showed ROTAVAC® to have an excellent safety and efficacy profile. The clinical study demonstrates for the first time that the India-developed rotavirus vaccine ROTAVAC® is efficacious in preventing severe rotavirus diarrhea in low-resource settings in India. ROTAVAC® significantly reduced severe rotavirus diarrhea by more than half—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. Vijay Raghavan. "The clinical results indicate that the vaccine, if licensed, could save the lives of thousands of children each year in India." The vaccine was developed through a unique social innovation partnership that brought together the experience and expertise of Indian and international researchers as well as the public and private sectors. The vaccine originated from an attenuated strain of rotavirus that was isolated from an Indian child at the All India Institute of Medical Sciences in New Delhi in 1985-86. Since then, partners have 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.
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