New vaccine Rotasil by Serum Institute of India, safe against severe rotavirus gastroenteritis
Pune/Maharashtra, September 26: The Serum Institute of India Pvt. Ltd’s rotavirus vaccine BRV-PV called as ROTASIIL vaccine would be safe will provide significant efficacy against severe rotavirus gastroenteritis. ROTASIIL reduced severe rotavirus diarrhea by more than a third that is 39.5 percent over two years.
According to reliable sources, Dr. Rajjev Dhere who is the Executive Director of the Serum Institute said that “We are delighted with these results, which indicate that ROTASIIL could save the lives of tens of thousands of children each year in India and around the world. The international nonprofit PATH partnered with Serum Institute on evaluating this vaccine in the Phase 3 efficacy study.
Six study sites across India enrolled 7,500 infants in the trial. ROTASIIL is an oral vaccine administered to infants in a three-dose course at 6, 10, and 14 weeks of age, at the same time as routine vaccinations under India’s Universal Immunization Programme. Read here Experts believe that Rota vaccines may save infants from occult practices in Odisha villages. The Government of India has placed an order for 3.8 million doses of ROTASIIL to use in the Universal Immunization Programme, which serves 26 million children.
Serum Institute has manufactured the vaccine doses and is awaiting instructions from the Ministry of Health and Family Welfare for their distribution. ROTASIIL will also be available for sale in India’s private market later this year. Serum Institute is pursuing World Health Organization (WHO) prequalification to make this vaccine available for global procurement. PATH and Serum Institute partnered to conduct a separate Phase 3 study in India to gather additional data required for WHO prequalification; results from that study will be submitted for publication this year.
“This is great news for India. The results and successful licensure of this rotavirus vaccine is an exciting and encouraging milestone toward the public health goal of improving the supply of affordable rotavirus vaccines, both in India and worldwide,” said Dr. David Kaslow, PATH’s Vice President for Essential Medicines and Global Head of the Center for Vaccine Innovation and Access.
Medecins Sans Frontieres and Epicentre are also evaluating the efficacy and safety of ROTASIIL in a separate Phase 3 study in Niger. That study is still ongoing, but results from the primary analysis (one year of data) also showed the vaccine to be highly efficacious for the prevention of severe rotavirus diarrhea and to have an excellent safety profile.
(Inputs from PTI)