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Prior to the introduction of paediatric rotavirus vaccination, rotavirus was the most common cause of infectious gastroenteritis to result in the hospitalisation of children and accounted for about 450 000 deaths in children per year worldwide.1 Use of the first rotavirus vaccine, RotaShield (Wyeth Lederle), was discontinued within 1 year of US licensure after intussusception was identified in about 1 of every 10 000 children within 2 weeks of vaccination.2
Two new rotavirus vaccines, RotaTeq (RV5, Merck) and Rotarix (RV1, GlaxoSmithKline), when assessed in prelicensure studies of >60 000 infants were not associated with an increased risk of intussusception. Since US licensure of RV5 in 2006 and RV1 in 2008, these vaccines have been carefully monitored for safety. Postlicensure studies in Mexico, Brazil and Australia have identified a relationship between …
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