Department of Biotechnology (DBT) and Bharat Biotech, along with a few other supporting organizations, today announced successful completion of phase III clinical trial of a rotavirus vaccine, for the first time developed fully from the molecule stage in India.
The vaccine Rotavac showed excellent safety and efficacy profile after the completion of the phase III trials that enrolled nearly 7000 infants in India at three sites, announced Dr M K Bhan, who was instrumental in identifying the strains in 1980 and thereafter led the stupendous project.
“We will be filing the dossier sometime in July for licence from the Drug Controller General of India and we hope to launch it in the markets in eight to nine months,” said Dr Krishna M Ella, chairman and managing director of Bharat Biotech, at a press conference here.
The vaccine, which claimed to be matching with the exiting two other vaccines in efficacy and safety, will be affordable and have the possibility to be included in the national immunization programme. “We have an agreement with Bharat Biotech to make it available at a price of one US dollar (Rs.54) and to the other developing countries,” Dr Bhan said.
Clinical study demonstrated that vaccine is efficacious in preventing severe rotavirus diarrhoea in low-resource settings in India. It significantly reduced severe rotavirus diarrhoea by more than half –56 per cent during the first year of life, with protection continuing into the second year of life.
“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,” DBT Secretary Dr K Vijaya Raghavan said.
The vaccine was developed through a unique social innovation partnership that brought together the experience and expertise of Indian and international researchers. The vaccine originated from an attenuated (weakened) 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 Institute of Health (NIH), the US Centres for Disease Control and Prevention (CDC), Standford University School of Medicine, and the non-government organisation PATH.
The vaccine development was also supported by Bill & Melinda Gates Foundation, the Research Council of Norway and the UK Department for International Development.