The vaccine has been developed by Hyderabad-based Bharat Biotech and department of biotechnology to combat diarrhea
New Delhi: The oral rotavirus vaccine Rotavac, which has been developed by Hyderabad-based Bharat Biotech and the department of biotechnology to combat diarrhoea, will be available for sale from next week in India.
Prime Minister Narendra Modi launched the vaccine in New Delhi on Monday.
Half of the world’s rotavirus diarrhoeal deaths are reported from India; the three-dose indigenously developed vaccine is expected to bring down the number (around 80,000 infant deaths are caused by rotavirus diarrhoea).
The results of the phase-III clinical trials for the efficacy of the vaccine, which were published in Lancet journal last year, showed it to be effective in the prevention of diarrhoea and reducing hospitalisations. These trials were conducted at three sites in Delhi, Pune and Vellore.
“Ten thousand babies were part of the trial and we provided them with a health package for three years taking care of all the child’s health needs, vaccine related or non-vaccine related," said Krishna Ella, chairman and managing director of Bharat Biotech International Ltd.
“The vaccine showed 56% efficacy in the first and second year and is cross-protective against a variety of strains."
Ella has promised that governments of lower-income countries will be provided the vaccine at $1 per dose. The vaccine was derived from a new strain of rotavirus 116E, isolated from a child at the All India Institute of Medical Sciences in New Delhi in 1986.
The vaccine development partnership was supported by Bill and Melinda Gates Foundation, the Research council of Norway, and the UK Department of International Development.
Ella hopes that the price of the vaccine will drop, as demand is high in India. Bharat Biotech’s factory in Hyderabad is capable of producing 500 million doses of the drug, Ella said.
“The huge burden of Rotavirus disease worldwide underscores the need for a safe, effective and affordable rotavirus vaccine for all countries," said Roger Glass, director, Fogarty International Centre National Institute of Health, US.
Glass added that the impact of the vaccine will be enormous in India where rotavirus is responsible for one third of hospitalisations for diarrhoea in children.
Ella told reporters in New Delhi that his company now has eight new molecules that will be used to make vaccines against diseases that have a significant impact on India.