Was the risk of intussusception evaluated for RotaTeq?
Yes, a large study of over 70,000 children designed specifically to assess a risk of intussusception similar to what was found for the previous rotavirus vaccine was conducted before licensure of RotaTeq. The results of this study did not show an increased risk of intussusception for RotaTeq when compared to those infants who received placebo. In order to further observe RotaTeq for the potential that it could be associated with increased rates of intussusception or other serious adverse events, the manufacturer, Merck and Co., Inc., has committed to conducting another study after licensure of approximately 44,000 children, and CDC will also conduct a large study in its Vaccine Safety Datalink Program (VSD), which evaluates vaccine safety among approximately 80,000 US infants every year. In addition, for the first three years of licensure the manufacturer will report cases of intussusception to FDA within 15 days of receiving them, and all other serious side effects on a monthly basis.
