However, small differences in effectiveness against individual strains may lead to the emergence of escape strains over time making continued monitoring of circulating strains important following vaccine introduction. Risk-benefit analyses in several countries that have introduced rotavirus

vaccine into their national immunization programs have found that the benefits of rotavirus vaccination greatly outweigh the risk. While the analyses are country-specific and vaccine-specific, countries like India with high rotavirus mortality burden will likely benefit from the introduction of rotavirus vaccine IWR-1 concentration even if there is a low level risk of intussusception. However, each country must weigh its own benefit-risk scenario prior to vaccine introduction. India

has its own rotavirus vaccines in the pipeline with phase 3 trials of the 116E vaccine completed and those of other candidates expected to start soon. Once this vaccine is available for use in India and as other vaccines become available, many issues including performance and impact under conditions of routine SB203580 in vivo use, effectiveness against currently circulating strains, safety, and cost-effectiveness will need to be examined. However, the experience of the international community with the two currently available oral rotavirus vaccines does provide insight into the likely performance and impact of the Indian 116E vaccine. Due to the high rotavirus mortality burden, the introduction either of a vaccine will likely have a notable impact on disease burden, protect against a wide variety of circulating strains, and result in a decrease in the economic burden of rotavirus in India. Studies to examine rotavirus vaccine impact and safety using many of the study designs employed by international researchers can help answer many of these questions and provide

support for sustained use of rotavirus vaccine in India. None of the authors have a conflict of interest The Working Group meeting on March 20, 2012 was convened and supported by the Department of Biotechnology. The Working Group consisted of Rashmi Arora, Deputy Director, Epidemiology and Communicable Diseases, Indian Council for Medical Research, Ministry of Health and Family Welfare. Ajay Khera, Deputy Commissioner (Immunization), Ministry of Health and Family Welfare, Government of India. T. S. Rao, Advisor, Department of Biotechnology, Ministry of Science and Technology, Government of India. M.K. Bhan, Secretary, Department of Biotechnology, Ministry of Science and Technology, Government of India. Ashish Bavdekar, Associate Professor of Paediatrics, KEM Hospital, Pune. Temsunaro R. Chandola, Centre for Health Research and Development, Society for Applied Studies, Delhi. Nita Bhandari, Director, Centre for Health Research and Development, Society for Applied Studies, Delhi.