In 1999, the first rotavirus vaccine licensed in the USA was withdrawn 9 months after introduction due to an association with intussusception that was detected in post-licensure surveillance. This association prompted large clinical trials designed to ensure the safety of two current live oral rotavirus vaccines, RotaTeq and Rotarix, which have since been recommended for use worldwide. Following their introduction, post-licensure studies have focused not only on the effectiveness and impact of these vaccines, but also on continued surveillance for intussusception. Most recent evidence from several countries shows a small increased risk of intussusception following vaccination with Rotarix and RotaTeq within the context of their demonstrated benefits. This review summarizes the available data on the safety of rotavirus vaccines with regards to intussusception.

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