PATH congratulates the government of India’s Department of Biotechnology and Bharat Biotech on their release of positive phase 3 clinical trial results for ROTAVAC®, the first efficacious rotavirus vaccine to be developed exclusively in India. Results demonstrate the vaccine successfully protects against rotavirus infections, one of the most lethal forms of diarrhea in young children.
“The clinical study results showing ROTAVAC® to be safe and efficacious are tremendously exciting,” said Steve Davis, PATH president and CEO. “This unique social innovation partnership, which brought together a consortium of scientists and experts from a range of agencies and sectors in India and the United States, provides a great collaborative model for meeting a public health need—a more affordable rotavirus vaccine.”
ROTAVAC®’s manufacturer, Bharat Biotech, previously announced a price for the vaccine of US$1 a dose, making it a more affordable, appropriate alternative to existing rotavirus vaccines, especially in low-resource settings.
“Rotavirus is the most severe and lethal cause of diarrhea, taking the lives of approximately 100,000 young children each year in India alone,” Davis said. “PATH is pleased and honored to have played a role in reaching this incredible milestone, and we congratulate all of the partners involved on these positive clinical trial results.”
PATH has provided technical assistance to Bharat Biotech and the consortium on issues such as vaccine stability, the development of special harvesting techniques, using cleaner preparation methods, and designing and implementing clinical trials that meet international standards.
International collaborators on ROTAVAC® included the government of India’s Department of Biotechnology, Bharat Biotech, the US National Institutes of Health, the US Centers for Disease Control and Prevention, Stanford University School of Medicine, the Bill & Melinda Gates Foundation, the Research Council of Norway, the United Kingdom Department for International Development, and PATH.
The phase 3 trial began in March 2011 and enrolled more than 6,000 participants across three sites in India. Bharat Biotech will soon file for registration of the vaccine in India. If licensed by the Drugs Controller General of India, the vaccine will be a more affordable alternative to the rotavirus vaccines already on the market.