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PEDIATRICS Vol. 107 No. 6 June 2001, p. e97

ELECTRONIC ARTICLE:
Intussusception Among Recipients of Rotavirus Vaccine: Reports to the Vaccine Adverse Event Reporting System

Received Nov 27, 2000; accepted Jan 29, 2001.

Lynn R. Zanardi*, Penina HaberDagger , Gina T. MootreyDagger , Manette T. Niu§, Melinda WhartonDagger , and the VAERS Working Group

From the * Epidemic Intelligence Service Program, Epidemiology Program Office, Centers for Disease Control and Prevention, Atlanta, Georgia; Dagger  Epidemiology and Surveillance Division, National Immunization Program, Centers for Disease Control and Prevention, Atlanta, Georgia; and the § Vaccine Safety Branch, Division of Epidemiology, Office of Biostatistics and Epidemiology, Food and Drug Administration, Rockville, Maryland.

Background.  Rotavirus vaccine was licensed on August 31, 1998, and subsequently recommended for routine use among infants. To assess rare adverse events, postlicensure surveillance was conducted.

Objective.  To describe the cases of intussusception among rotavirus vaccine recipients reported to the Vaccine Adverse Event Reporting System from October 1998 through December 1999.

Setting and Participants.  Infants vaccinated with rotavirus vaccine in the United States.

Outcome Measures.  Intussusception confirmed by radiology, surgery, or autopsy report with medical record documentation or confirmed by a primary health care provider.

Results.  There were 98 confirmed cases of intussusception after vaccination with rotavirus vaccine reported to the Vaccine Adverse Event Reporting System; 60 of these developed intussusception within 1 week after vaccination. Based on calculations using vaccine distribution data and intussusception incidence rates from 2 separate databases, an estimated 7 to 16 cases would have been expected to occur in the week after vaccination by chance alone.

Conclusion.  Using a passive surveillance system for vaccine adverse events, we observed at least a fourfold increase over the expected number of intussusception cases occurring within 1 week of receipt of rotavirus vaccine. Other studies were initiated to further define the relationship between rotavirus vaccine and intussusception. In light of these and other data, the rotavirus vaccine manufacturer voluntarily removed its product from the market, and the recommendation for routine use of rotavirus vaccine among US infants has been withdrawn.  Key words:  intussusception, rotavirus vaccine, Vaccine Adverse Event Reporting System, vaccine safety.


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