Intussusception and rotavirus vaccination: a review of the available evidence

Abstract

Two live oral rotavirus vaccines (RotaTeq) and Rotarix) have recently been recommended by the WHO for inclusion into the national immunization programs of countries worldwide. Owing to the association of the withdrawn Rotashield vaccine with intussusception, these two new rotavirus vaccines underwent large clinical trials of over 60,000 infants each to assess safety with regard to this medical condition. For these two new vaccines, clinical trials and available postmarketing safety monitoring data do not indicate a risk of intussusception after vaccination, although a low-level risk cannot be excluded at present. We review these safety data for the new vaccines and for Rotashield to provide background information relevant for considering age recommendations for rotavirus vaccination.