India on Tuesday unveiled its first breakthrough vaccine for severe rotavirus diarrhoea, which kills more than 1 lakh children under five in the country every year. Billed as India?s first social innovation and novel vaccine development project, the locally made affordable vaccine?Rotavac?is likely to be launched in the first quarter of 2014.
?We are planning to file a dossier with the drug regulator DCGI in July. We will come to the market after getting the requisite regulatory clearances,? said Krishna M Ella, CMD of Hyderabad-based Bharat Biotech, which has partnered with the department of biotechnology and four US organisations for development of this vaccine.
The National Institutes of Health, the Centres for Disease Control and Prevention, Stanford University School of Medicine, and the non-governmental organisation PATH are part of the team which developed the vaccine.
The drug regulator is expected to take at least 8-9 months to give its verdict post which if Bharat Biotech gets a licence, commercial production of the vaccine would commence.
Bharat Biotech has announced a price of $1 per dose ? much cheaper than other rotavirus vaccines available in the market. Currently, two vaccines are available to guard against rotavirus – GlaxoSmithKline?s Rotarix and Merck?s Rota Teq which are available at a cost of $7-8 per dose.
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.
?Rotavac significantly reduced severe rotavirus diarrhoea by more than half,? said MK Bhan, former secretary, department of biotechnology, who isolated the rotavirus strain in 1985 while pursuing research at AIIMS. He added that India will become key supplier of rotavirus vaccine for developing countries in the coming years.
The results of the phase III clinical trials of the Rotavac vaccine, a culmination of efforts spanning 28 years, released at an international conference pegged its efficacy at 56% in the first year of life.
?The results indicate that the vaccine, if licensed, could save the lives of thousands of children each year in India,? said K Vijay Raghavan, secretary, department of biotechnology.
The vaccine may also be included in the government?s national immunisation programme. Currently, seven vaccines are part of the government?s regular vaccine protocol to prevent diseases such as tuberculosis, diphtheria, whopping cough, tetanus, polio, measles and hepatitis B.
Hyderabad-based Shantha Biotechnics, part of multinational drug maker Sanofi, and Serum Institute in Pune are among the other Indian companies that are developing affordable rotavirus vaccines.