In an important breakthrough, Indian scientists have successfully developed a low-cost vaccine that has proved to be effective in preventing the deadly diarrhoea-causing rotavirus which is responsible for the deaths of over 1.6 lakh children under the age of five in the country annually.
Vaccine producer Bharat Biotech is likely to launch the vaccine ‘Rotavac’ in the first quarter of 2014 in the market for around Rs50-55 per dose — much cheaper than other rotavirus vaccines. Currently, foreign pharma majors GlaxoSmithKline’s Rotarix and Merck’s Rota Teq are available for around Rs2,000 per dose.
Once launched commercially, many developing countries would be able to include this affordable vaccine in their vaccination programs.
“Phase III trials of Rotavac has shown a 56 per cent decline in severe diarrhoea caused by the rotavirus during the first year of life, with protection continuing into the second year of life,” former Secretary of the Department of Biotechnology MK Bhan, who isolated the rotavirus strain in 1985 while pursuing research at AIIMS, told the reporters on Tuesday.
He was speaking at the function wherein the Department of Biotechnology and Bharat Biotech jointly announced positive results from a phase II clinical trial the vaccine developed and manufactured in India.
Krishna M Ella, Chairman of Bharat Biotech said,
“We are planning to file a dossier with the Drug Controller General of India (DCGI) in July. We will come to the market after getting the requisite regulatory clearances.”
Rotavac is a oral vaccine administered to infants in a three-dose course at the ages of six, 10 and 14 weeks alongside routine immunisations recommended at these ages.
The DBT has partnered with Hyderabad-based company Bharat Biotech and four US organisations for the vaccine. These are the National Institutes of Health, the Centers for Disease Control and Prevention, Stanford University School of Medicine, and the non-Governmental organisation PATH.
The vaccine’s trial was launched in March 2011 and 6,800 infants are enrolled as part of the trial at three sites in India. These sites are the Centre for Health Research and Development in New Delhi, Shirdi Sai Baba Rural Hospital at the King Edward Memorial Hospital Research Centre in Pune, and the Christian Medical College in Vellore. Other organisations involved in the study include the Department of Biotechnology’s Translational Health Science and Technology Institute.