The

MDS estimates the proportionate mortality due to diarrhea in <5 year children to be 13.2%. Thus the under-5 diarrheal mortality rate in India is 8.04 per 1000 live births or an annual mortality of 160.80 per 100,000 children. see more In the IRSSN, 1405 (39%) of 3580 children hospitalized with diarrhea during this period tested positive for rotavirus. Using WHO CHERG approach [20] of applying rotavirus proportion in hospitalized diarrhea to mortality data, the <5 rotavirus diarrhea mortality rate is 2.89/1000 live births or an annual rate of 58 per 100,000 children. Applying these rates of mortality to the 2011 birth cohort of India, estimated at 27,098,000 children, we estimate 78,583 deaths occur each year due to rotavirus with 59,336 of these deaths occurring in the first two years of life. Based on the 2241 child years of follow up in five birth cohorts, with 108 diarrheal hospitalizations including 32 rotavirus diarrheal hospitalizations, the rotavirus hospitalization

rate was 1427 per 100,000 children <2 years. The IRSSN data identified 88.2% of all <5 rotavirus diarrheal hospitalization occurs in children <2 years of age [12] providing a corrected estimate of 643 hospitalizations per 100,000 children <5 years age or 872,000 hospitalizations annually in India (Table 2). Unpublished data from a large phase III clinical trial, where 1500 children in Vellore were followed up for the first two years life and healthcare provided for without cost to participants, provide a ratio of 3.75 rotavirus outpatient

visits for every rotavirus hospitalization. The number of rotavirus diarrheal episodes GSK126 clinical trial and requiring outpatient visit is thus estimated annually in India at 3,270,000. The < 5 year rotavirus gastroenteritis rate in the four cohorts where rotavirus testing was performed was 8394 episodes per 100,000 children. Extrapolating this rate to India’s < 5 population 11.37 million episodes of rotavirus diarrhea occur each year. The vaccine efficacy (VE) of Rotavac® against severe hospitalized rotavirus gastroenteritis was 53.6% and that against rotavirus gastroenteritis of any severity was 34%. The 4 month to 5 year risk of rotavirus related death, hospitalization and outpatient visit were 251, 2714, and 9891 per 100,000 children. Introduction of Rotavac® in the National Immunization Program at current immunization coverage would result in 26,985 fewer deaths, 291,756 fewer hospitalizations and 686,277 fewer outpatient visits each year in India assuming no indirect effects for the vaccine (Table 3). The NNV to prevent one rotavirus related death was 743 children, while vaccinating 69 children would prevent a rotavirus hospitalization. Similarly, for every 29 children vaccinated one rotavirus outpatient visit can be averted. The median total direct cost (medical and non-medical) associated with rotavirus hospitalization was calculated at Rs. 8417 at a tertiary care hospital, Rs. 6969 at a secondary level hospital and Rs.