OBJECTIVE. In February 2006, a safe, efficacious, orally administered pentavalent human-bovine reassortant rotavirus vaccine was licensed and recommended for routine immunization of all children in the United States. We assessed the health and economic impacts of a national rotavirus immunization program in the United States.

METHODS. Monte Carlo cost-effectiveness analyses, from health care and societal perspectives, of vaccination of a hypothetical US birth cohort of 4010000 children monitored from birth to 59 months of age were performed. We compared the disease and economic burden of rotavirus infection in an unvaccinated cohort of children with one vaccinated at 2, 4, and 6 months with pentavalent human-bovine reassortant rotavirus vaccine.

RESULTS. A routine rotavirus immunization program would prevent 13 deaths, 44000 hospitalizations, 137000 emergency department visits, 256000 office visits, and 1100000 episodes requiring only home care for children <5 years of age in the United States. Assuming costs of administration of $10, the break-even price per dose of vaccine was $42 from the societal perspective and $12 from the health care perspective. From the societal perspective, at the manufacturer's price of $62.50 per dose, vaccination would cost $138 per case averted, $3024 per serious case averted, and $197190 per life-year saved, at a total cost of $515 million to the health care system and $216 million to society. Key variables influencing the results were parental workdays lost, costs of hospitalization, emergency department visits, and child care.

CONCLUSIONS. Despite a higher burden of serious rotavirus disease than estimated previously, routine rotavirus vaccination would unlikely be cost-saving in the United States at present. Nonetheless, rotavirus vaccination may still be considered a cost-effective intervention.

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