Hyderabad, Feb. 13: Bharat Biotech International Ltd, a biotechnology firm, said on Monday that Rotavirus Vaccine Development Project would be conducting clinical trials with vaccine lots produced by the company for developing a rotavirus vaccine. RVDP will be using the same strains, 116E and I321, of vaccines that showed promising results in Phase I trial using pilot lots of the candidate rotavirus vaccines manufactured at the National Institutes of Health in the United States, a BBIL press release said.
Rotavirus is the leading cause of severe diarrhoea in children worldwide and accounts for approximately 400,000 hospitalisations and 160,000 deaths in India alone.
The Phase I trials on 116E and I321 were conducted in New Delhi. The RVDP consisting of the Department of Biotechnology, Bharat Biotech, Society for Advanced Studies, New Delhi, the Centres for Disease Control and National Institutes of Health in the US, the IISc-Bangalore, and Standford University, have worked together for the past several years. The two candidate vaccines represent the products of two independent research teams from RVDP who have worked in parallel for more than a decade under the auspices of the Indo-US Vaccine Action Programme and have combined their efforts through the RVDP.
The RVDP receives financial support primarily from the Gates Foundation, through the Programme for Appropriate Technology in Health Seattle, with additional support from the Indo-US VAP, the Department of Biotechnology, and government of India. |