This article summarizes the proceedings of a workshop sponsored by the National Institutes of Health and the National
Vaccine Program Office, and held in Bethesda, Maryland, on January 21, 2000. The objective of the meeting was to focus research toward an understanding of the basis for the possible association between
intussusception and the reassortant rhesus-human
rotavirus vaccine tetravalent (
RRV-TV). After numerous reports of
intussusception after administration of
RRV-TV, the manufacturers of this
vaccine voluntarily withdrew it from the United States market. The American Academy of Pediatrics, the Advisory Committee on Immunization Practices, and the American Academy of Family Physicians also withdrew their original recommendations for administration of
RRV-TV to children at 2, 4, and 6 months of age. These actions will have global implications for the prevention of morbidity and mortality attributable to
rotavirus infection. Benefit-cost ratios for the use of
RRV-TV will be substantially different in developing countries compared with developed countries. Therefore, extensive research is needed in both of these settings, to further our understanding of the epidemiology, pathogenesis, and pathology of both rotavirus disease and
intussusception to enable optimal prevention. The workshop reviewed the current understanding of the possible association between
RRV-TV and
intussusception, as well as the possible association between a variety of
viral infections and
intussusception. The workshop also identified critical areas of research regarding this possible association. This research will be essential not only for the development of safe and effective
rotavirus vaccines, but for the development of other oral
vaccines as well.