More on RotaShield and Intussusception: The Role of Age at the Time of Vaccination

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Abstract
Background RotaShield, a vaccine intended to prevent severe rotavirus diarrhea, was withdrawn in July 1999, 9 months after it became available in the United States, because of a temporal association with intussusception events that occurred in vaccinated infants. We explore here the effect of age on the risk of intussusception. Methods We reanalyzed a case-control database of the Centers for Disease Control and Prevention by use of a 21-day window, to define vaccine-associated events. We obtained data on vaccine use from the National Immunization Survey and estimated the age-stratified background incidence of intussusception by use of Healthcare Cost and Utilization Project data. We combined these data to estimate how absolute risk varies with age and to model the projected population-attributable risk associated with 3 different vaccination schedules. Results We found that the incidence of intussusception associated with the first dose of vaccine increased with age. Infants ⩾90 days old accounted for 80% of cases of intussusception associated with a first dose but had received only 38% of first doses. Modeling of the recommended schedule of vaccination at ages 2, 4, and 6 months projected 1 intussusception event/11,000–16,000 vaccine recipients; modeling of a 2-dose schedule beginning in the neonatal period projected 1 intussusception event/38,000–59,000 vaccine recipients. Conclusions The practice of initiating immunization after age 90 days, which we call “catch-up” vaccination, contributed disproportionately to the occurrence of intussusception associated with the use of RotaShield. A fully implemented 2-dose vaccination schedule begun during the neonatal period would lead to, at most, a 7% increase in the incidence of intussusception above the annual background incidence.