Relationship between Pentavalent Rotavirus Vaccine and Intussusception: A Retrospective Study at a Single Center in Korea

PURPOSE Despite withdrawal of RotaShield® and the development of second generation live attenuated rotavirus vaccines, concerns remain regarding the relationship between rotavirus vaccine and intussusception. Nevertheless, since there is no study in Korea, we reviewed data from cases at Severance Children's Hospital to determine the association between rotavirus vaccine and intussusception. MATERIALS AND METHODS Patients coded as intussusception and following a prescription of RotaTeq® from 2007 to 2013 were reviewed. We calculated comparative incidence figures (CIFs) and 95% confidence intervals (CIs) to compare the risk of intussusception in Korea with the risk in the United States. Expected cases within the four-week post-vaccination window were calculated by applying rates of intussusception from data compiled by the Health Insurance Review and Assessment Service (for a five-year period) to numbers of vaccinations. RESULTS In total, 10530 doses of pentavalent rotavirus vaccine were administered. A total of 65 intussusception cases were diagnosed, although only two cases occurred within four weeks after vaccination. This was compared to six cases within 999123 doses in United States from April 2008 to March 2013 (CIF, 31.63; CI, 31.33-31.93). When we adjusted incidence rate differences for both countries, the CIF decreased to 7.05 (CI, 6.72-7.40). When we compared our identified cases with the expected cases from our hospital, there was no increased intussusception occurring within four weeks of vaccination. CONCLUSION We found no association between pentavalent rotavirus vaccine and intussusception. Therefore, rotavirus vaccination should be considered due to its benefits of preventing rotavirus-associated diseases.