The Rotavac vaccine, which is a culmination of efforts spanning 28 years, has an efficacy of 56 per cent if administered in the first year of life, according to scientists who released the results of the Phase III clinical trials of the vaccine.
"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.
"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 one (about Rs 54.7 )per dose--much cheaper than other rotavirus vaccines available in the market. The price of the vaccine now used is in the range of Rs 800 to 900.
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"The results indicate that the vaccine, if licensed, could save the lives of thousands of children each year in India," K Vijay Raghavan, Secretary, Department of Biotechnology, said.
Rotavac is an 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.
According to a study in Lancet, Rotavirus is most common causative agent of moderate-to-severe diarrhoea (MSD) among infants below 11 months age group in India.