Pune: The Government of India has placed an order for 3.8 million doses of Serum Institute of India’s 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.
Earlier the results from a Phase 3 efficacy study in India of the Serum’s rotavirus vaccine ROTASIIL (also known as BRV‐PV) were published in the journal Vaccine. The study showed the vaccine to be safe, well tolerated, and to provide significant efficacy against severe rotavirus gastroenteritis.
ROTASIIL reduced severe rotavirus diarrhea by more than a third – 39.5 percent over two years. Significantly, the vaccine efficacy was nearly 55 percent against the most severe and potentially life‐ threatening cases of rotavirus diarrhea, which represent the highest risk of dehydration, hospitalizations, and deaths. The results demonstrated by ROTASIIL in India appear generally comparable to the performance of RotaTeq® and Rotarix® in Bangladesh and in some African countries.
In 2013, an estimated 47,100 rotavirus deaths occurred in India, 22 percent of all rotavirus deaths that occurred globally
Dr Rajeev Dhere, executive director of the Serum Institute, under whose leadership this vaccine has been developed, commented, “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, potentially, 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.
The office of the Drugs Controller General of India, through its subject expert committee, reviewed the Phase 3 safety and efficacy results and subsequently inspected Serum Institute’s manufacturing facilities leading to licensure of ROTASIIL in January 2017.
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.