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In 1999, the first rotavirus vaccine licensed in the USA was withdrawn 9 months after introduction due to an association with intussusception that was detected in post-licensure surveillance. This association prompted large clinical trials designed to ensure the safety of two current live oral rotavirus vaccines, RotaTeq and Rotarix, which have since been recommended for use worldwide. Following their introduction, post-licensure studies have focused not only on the effectiveness and impact of these vaccines, but also on continued surveillance for intussusception. Most recent evidence from several countries shows a small increased risk of intussusception following vaccination with Rotarix and RotaTeq within the context of their demonstrated benefits. This review summarizes the available data on the safety of rotavirus vaccines with regards to intussusception.

Prior to the introduction of rotavirus vaccines in 2006, rotavirus was the leading cause of severe gastroenteritis among US children

Rotavirus vaccines have had a dramatic impact on morbidity and mortality from diarrhea among children in high- and middle-income countries that have introduced the vaccine into their national immunization programs. Widespread introduction of rotavirus vaccine in developing countries is imminent and their full potential in reducing the global burden from severe childhood diarrhea may soon be realized. The objectives of this paper are to describe the remaining issues and challenges in ensuring the success of the global rotavirus vaccination program and to discuss further research needed to help address them.

The WHO has recently recommended the inclusion of rotavirus vaccine in the national immunization programs of all countries. In countries in the Americas, Europe and Australia that have adopted routine childhood immunization against rotavirus, significant reductions in the burden of severe childhood diarrhea have been observed. Besides protecting vaccinated children, disease rates also appear to be reduced in unvaccinated children, suggesting indirect benefits from vaccination (i.e., herd protection). Early clinical trial data from Africa and Asia are promising, and further efforts are needed to optimize the benefits of vaccination in developing countries where vaccines are likely to have their greatest impact.