Rotavirus gastroenteritis continues to cause substantial morbidity and mortality worldwide, despite widespread breastfeeding and use of oral rehydration therapy. This burden of disease indicates that an effective, safe rotavirus vaccine is needed, and in 1998 the first rhesus-human reassortant rotavirus tetravalent vaccine, Rotashield, was licensed in the United States. However, the recommendations for its use were withdrawn in 1999 because of the recognition of an uncommon but serious adverse event, intussusception. A workshop in September 2001 was held to review the subsequent developments and research regarding this association, the proceedings of which are summarized here. Although the pathogenesis of this association remains unknown, epidemiologic evidence supports a causal relationship, with a population attributable risk of ∼1 per 10 000 (range of 1 in 5000 to 1 in 12 000) vaccine recipients. Whether this association will exist with other candidate rotavirus vaccine strains and whether the attributable risk for intussusception would be similar in other populations administered this vaccine are unclear. Because perceptions of vaccine safety derive from the relative disease burdens of the illness prevented and adverse events induced, the acceptance of rare adverse events may vary substantially in different settings. Nevertheless, a continuing consensus on the need for a safe and effective vaccine to prevent rotavirus gastroenteritis, especially for use in developing countries, exists.

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