Scientists today unveiled the first completely indigenous and affordable vaccine to prevent severe rotavirus diarrhoea, which kills more than one lakh children under the age of five in India very year.
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 per cent in the first year of life.
"Rotavac significantly reduced severe rotavirus diarrhoea by more than half," M K Bhan, former Secretary, Department of Biotechnology, who isolated the rotavirus strain in 1985 while pursuing research at AIIMS, told reporters here.
However, commercial prodcution of the vaccine would take some time as it is yet to get clearance from the Drug Controller General of India (DCGI).
"We are planning to file a dossier with the DCGI in July. We will come to the market after getting the requisite regulatory clearances," Krishna M Ella, Chairman and Managing Director, Bharat Biotech, said.
Bharat Biotech, which has been associated in the development of vaccine candidates and clinical trials, has announced a price of USD 1 per dose--much cheaper than other rotavirus vaccines available in the market.
Officials said there were two licensed rotavirus vaccines introduced in more than 40 countries but they remain out of reach for many in the developing world.
"The results indicate that the vaccine, if licensed, could save the lives of thousands of children each year in India," K VijayRaghavan, Secretary, Department of Biotechnology, said.
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.
