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Serum Institute’s Rotavirus Vaccine,Shows Efficacy Against Diarrhea

Pune-based vaccine and immuno-biologicals firm, Serum Institute of India, has now announced the successful Phase 3 results for its rotavirus vaccine BRV‐PV known as ROTASIIL®. The study has proved to be safe, well tolerated, and to provide significant efficacy against severe rotavirus gastroenteritis.

The vaccine reduced severe rotavirus diarrhea by more than a third – 39.5 percent over two years. Significantly, the vaccine efficacy was found to be 55 percent against the most severe and potentially lifethreatening case of rotavirus diarrhoea. Furthermore, results demonstrated by ROTASIIL in India appear generally comparable to the performance of RotaTeq® and Rotarix® in Bangladesh and in some African countries.

“Rotavirus is the most common cause of diarrhea and one of the leading causes of under‐five child mortality. Rotavirus accounts for approximately 40 percent of all diarrhea cases requiring treatmen. Rehydration therapy is an important part of treating dehydration due to diarrheal diseases, including rotavirus.” Says Dr. Naveen Thacker, President of Asia Pacific

Pediatric Association (APPA) and Strategic Advisor on Immunization for International Pediatric Association (IPA),”However, parents often bring children with severe diarrhea to the hospital at the last minute. With the rotavirus vaccines now available in the

Universal Immunization Programme, the high disease burden will certainly see a decline.”
More than half a million children under the age of five die each year due to diarrhea worldwide of which a major chunk is attributable to rotavirus- in 2013, an estimated 215,000 of deaths were due to rotavirus, with more than 90 percent occurring in developing countries.

“In 2013, an estimated 47,100 rotavirus deaths occurred in India, 22 percent of all rotavirus deaths that occurred globally. A new indigenous vaccine is a welcome step for children in India, and it will help save children from death and disability”, said Dr. Pramod Jog, President, Indian Academy of Pediatrics, 2016 and Standing Committee Member, International Pediatric Association (IPA).

Rotavirus vaccination, owing to the strong public health value, has been recommended by the WHO in all countries- especially those with high diarrhea‐related mortality in children including India. There are currently two globally available rotavirus vaccines that have been introduced in more than 90 countries worldwide. Both vaccines are effective, and the accumulated evidence shows major reductions in rotavirus‐related hospitalizations and deaths in the countries where they have been introduced.

The BRV‐PV (ROTASIIL) is a bovine‐human reassortant rotavirus vaccine developed by the US National Institutes of Health and licensed to several manufacturers for further development. It contains rotaviruses against the most common rotavirus serotypes (G1, G2, G3, G4, and G9).

The Phase 3 efficacy trial was undertaken in partnership with the international nonprofit PATH. The trial enrolled 7,500 infants across six sites, and was 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.

“This is great news for India,” noted Dr. David Kaslow, PATH’s vice president for Essential Medicines and global head of the Center for Vaccine Innovation and Access. “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.”

The Government of India has presently 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 accordingly manufactured the vaccine doses and is awaiting further 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.

“India now has another rotavirus vaccine that is manufactured indigenously. This is a win for the children of the country as it will support the Government of India’s efforts to roll out the rotavirus vaccine across the country through the Universal Immunization Programme”, said Dr. M.K. Bhan, Former Secretary, Department of Biotechnology, Government of lndia.

Dr. Gagandeep Kang, Executive Director of Translational Health Science & Technology Institute, Faridabad, India, and member of the ROTA Council said,“I am delighted that India has another rotavirus vaccine. Scientific studies have shown that rotavirusvaccines are making a major public health impact. Swift and significant declines in hospitalizations and deaths due to rotavirus and all‐cause diarrhea have been observed in many of the countries that have introduced rotavirus vaccines into their national immunization programs.”

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