In the late 1990s a different rotavirus vaccine was associated with intussusception and removed from the market. The new vaccine has been tested in over 70,000 children and no link with intussusception was found. As part of ongoing vaccine safety monitoring a large study of Rotarix® in Mexico suggested there may be a small increase in the risk of developing intussusception following the first vaccine dose.
The U.S. Centers for Disease Control and Prevention (CDC) reviewed all the information available. They recommended that as the increased risk of intussusception is extremely small and the benefits of rotavirus vaccination are great, Rotarix® continue to be used to prevent rotavirus disease.