Intussusception and rotavirus vaccines

The association between the first oral rotavirus vaccine to be licensed in the U.S. (Rotashield®) and intussusception has presented a major challenge to the effort to reduce the global burden related to rotavirus infection. Although the risk of developing intussusception following immunization with Rotashield® is low, debate continues about the estimation of intussusception risk and the events surrounding the withdrawal of the vaccine. The experience with Rotashield® has highlighted the wisdom of parallel clinical trials in developing and developed countries and the value of post-licensure surveillance for the detection of uncommon adverse events. This review retraces the steps leading up to the withdrawal of the Rotashield® vaccine and reflects on how this experience has influenced the development of other rotavirus vaccines.