RotaTeq™: a three-dose oral pentavalent reassortant rotavirus vaccine

Rotavirus (RV) is a leading cause of diarrhea worldwide, and will infect every child by their 5th birthday. The 3-dose oral pentavalent RV vaccine (RotaTeq), consisting of serotypes G1, G2, G3, G4 and P1A[8], was licensed in the USA in 2006. The first dose should be administered between the ages of 6 and 12 weeks and the third dose should be given before the age of 32 weeks (USA) or 26 weeks (Europe). In a large clinical trial, the vaccine prevented 74% of cases of RV gastroenteritis, and 98% of cases of severe RV gastroenteritis (based on a symptomatology scoring scale) in the first rotavirus season. Vaccine efficacy in the second season was 62.6% against any RV gastroenteritis and 88% against severe disease. Vaccine efficacy in reducing hospitalizations and emergency department visits was 94.5% up to 2 years after vaccination. Results from a large clinical trial, as well as ongoing postmarketing surveillance, indicate that the vaccine is safe and well tolerated, without evidence of increased risk of intussusception. Further research is needed to establish vaccine efficacy in developing countries, particularly in Africa and Asia. Dissemination efforts should focus on ensuring the vaccine reaches the poorest children in whom disease morbidity and mortality is the highest.