Intussusception among Infants Given an Oral Rotavirus Vaccine
Trudy V. Murphy, M.D., Paul M. Gargiullo, Ph.D., Mehran S. Massoudi, Ph.D., M.P.H., David B. Nelson, B.S., Aisha O. Jumaan, Ph.D., M.P.H., Catherine A. Okoro, M.S., Lynn R. Zanardi, M.D., M.P.H., Sabeena Setia, M.P.H., Elizabeth Fair, M.P.H., Charles W. LeBaron, M.D., Melinda Wharton, M.D., M.P.H., John R. Livingood, M.D., for The Rotavirus Intussusception Investigation Team
Background Intussusception is a form of intestinal obstructionin which a segment of the bowel prolapses into a more distalsegment. Our investigation began on May 27, 1999, after ninecases of infants who had intussusception after receiving thetetravalent rhesushuman reassortant rotavirus vaccine(RRV-TV) were reported to the Vaccine Adverse Event ReportingSystem.
Methods In 19 states, we assessed the potential associationbetween RRV-TV and intussusception among infants at least 1but less than 12 months old. Infants hospitalized between November1, 1998, and June 30, 1999, were identified by systematic reviewsof medical and radiologic records. Each infant with intussusceptionwas matched according to age with four healthy control infantswho had been born at the same hospital as the infant with intussusception.Information on vaccinations was verified by the provider.
Results Data were analyzed for 429 infants with intussusceptionand 1763 matched controls in a casecontrol analysis aswell as for 432 infants with intussusception in a case-seriesanalysis. Seventy-four of the 429 infants with intussusception(17.2 percent) and 226 of the 1763 controls (12.8 percent) hadreceived RRV-TV (P=0.02). An increased risk of intussusception3 to 14 days after the first dose of RRV-TV was found in thecasecontrol analysis (adjusted odds ratio, 21.7; 95 percentconfidence interval, 9.6 to 48.9). In the case-series analysis,the incidence-rate ratio was 29.4 (95 percent confidence interval,16.1 to 53.6) for days 3 through 14 after a first dose. Therewas also an increase in the risk of intussusception after thesecond dose of the vaccine, but it was smaller than the increasein risk after the first dose. Assuming full implementation ofa national program of vaccination with RRV-TV, we estimatedthat 1 case of intussusception attributable to the vaccine wouldoccur for every 4670 to 9474 infants vaccinated.
Conclusions The strong association between vaccination withRRV-TV and intussusception among otherwise healthy infants supportsthe existence of a causal relation. Rotavirus vaccines withan improved safety profile are urgently needed.
Source Information
From the Epidemiology and Surveillance Division (T.V.M., P.M.G., D.B.N., A.O.J., L.R.Z., E.F., C.W.L., M.W., J.R.L.), the Immunization Services Division (M.S.M., S.S.), and the Data Management Division (C.A.O., P.M.G.), National Immunization Program, Centers for Disease Control and Prevention, Atlanta. Benjamin Schwartz, M.D., Epidemiology and Surveillance Division, National Immunization Program, Centers for Disease Control and Prevention, was also an author.
Address reprint requests to Dr. Murphy at the Epidemiology and Surveillance Division, National Immunization Program, 1600 Clifton Rd. NE, Mail Stop E-61, Atlanta, GA 30333, or at tvmurphy{at}cdc.gov.
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