An order of 3.8 million rotavirus doses (Rotasiil) was placed by the Union Health Ministry. Rotasiil was developed by the Serum Institute of India for the Universal Immunization Programme (UIP) that served around 26 million children.
The vaccine is manufactured by the Pune-based Serum Institute Manufacturer and is awaiting instructions from the Ministry of Health and Family Welfare for the distribution purpose. The vaccine will be available for sale in the domestic market later this year.
The phase 3 efficacy study performed in India for Rotasiil vaccine is published in the Vaccine journal. According to the published results, the vaccine is proven to be safe and have shown significant efficacy against severe rotavirus gastroenteritis. In the year 2013, 47,100 rotavirus fatalities were reported in India and are around 22 percent of the global occurrence.
The Pune based Serum institute partnered with PATH, the international non-profit organization to evaluate the vaccine in phase 3 clinical efficacy study. Around 6 sites around India enrolled 7500 infants in the trial. Rotasiil is an oral vaccine that is used for infants in a three-day course in the initial stages of life such as 6,10 and 14 weeks of age.
Rotasiil can be administered at the same time as the routine vaccinations under the UIP. This vaccine is reported to have reduced severe rotavirus diarrhoea by more than a third that comes around 39.5 percent over two years. The efficacy percentage was around 55 against the life-threatening cases of rotavirus diarrhoea, that represents the highest risk of dehydration and fatality.
Dr. Rajeev Dhere, executive director, Serum Institute said, “The results indicate that Rotasiil could save the lives of tens of thousands of children annually in India and globally.”