This article summarizes the proceedings of a workshop sponsored by the Nati
onal Institutes of Health and the National Vaccine Program Office, and held
in Bethesda, Maryland, on January 21, 2000. The objective of the meeting w
as to focus research toward an understanding of the basis for the possible
association between intussusception and the reassortant rhesus-human rotavi
rus vaccine tetravalent (RRV-TV). After numerous reports of intussusception
after administration of RRV-TV, the manufacturers of this vaccine voluntar
ily withdrew it from the United States market. The American Academy of Pedi
atrics, the Advisory Committee on Immunization Practices, and the American
Academy of Family Physicians also withdrew their original recommendations f
or 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 compa
red with developed countries. Therefore, extensive research is needed in bo
th of these settings, to further our understanding of the epidemiology, pat
hogenesis, and pathology of both rotavirus disease and intussusception to e
nable optimal prevention. The workshop reviewed the current understanding o
f the possible association between RRV-TV and intussusception, as well as t
he possible association between a variety of viral infections and intussusc
eption. The workshop also identified critical areas of research regarding t
his possible association. This research will be essential not only for the
development of safe and effective rotavirus vaccines, but for the developme
nt of other oral vaccines as well.