Intussusception, Rotavirus, and Oral Vaccines: Summary of a Workshop
Georges Peter, MD* and Martin G. Myers,
MD
* Department of Pediatrics, Brown Medical School, and Division of
Pediatric Infectious Diseases, Rhode Island Hospital, Providence, Rhode Island National Vaccine
Program Office, Washington, DC
Rotavirus gastroenteritis continues to cause substantial morbidityand 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 in1998 the
first rhesus-human reassortant rotavirus tetravalentvaccine,
Rotashield, was licensed in the United States. However,the
recommendations for its use were withdrawn in 1999 becauseof the
recognition of an uncommon but serious adverse event,intussusception.
A workshop in September 2001 was held to reviewthe subsequent
developments and research regarding this association,the proceedings
of which are summarized here. Although the pathogenesisof this
association remains unknown, epidemiologic evidencesupports a causal
relationship, with a population attributablerisk of
1 per 10 000 (range of 1 in 5000 to 1 in
12 000) vaccinerecipients. Whether this association will exist with
other candidaterotavirus vaccine strains and whether the
attributable riskfor intussusception would be similar in other
populations administeredthis vaccine are unclear. Because
perceptions of vaccine safetyderive from the relative disease
burdens of the illness preventedand adverse events induced, the
acceptance of rare adverse eventsmay vary substantially in different
settings. Nevertheless,a continuing consensus on the need for a safe
and effectivevaccine to prevent rotavirus gastroenteritis,
especially foruse in developing countries, exists.
Abbreviations: CDC, Centers for Disease Control and
Prevention ACIP, Advisory Committee on Immunization Practices RRV-TV,
rhesus-human reassortant rotavirus tetravalent vaccine NIH, National
Institutes of Health NVPO, National Vaccine Program Office NVAC, National
Vaccine Advisory Committee WHO, World Health Organization GAVI, Global
Alliance on Vaccines and Immunization NIAID, National Institute of Allergy and
Infectious Diseases VAERS, Vaccine Adverse Events Reporting System
Received for publication Jun 14, 2002; accepted Aug 20, 2002.
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