Pentavalent rotavirus vaccine (RotaTeq): a review of its use in the prevention of rotavirus gastroenteritis in Europe.

In Europe, rotavirus gastroenteritis is associated with a significant health, economic and social burden, as it is responsible for large numbers of hospitalizations and other healthcare encounters among infants and children, as well as numerous days of work lost by parents and caregivers. RotaTeq is a three-dose, orally administered, live, pentavalent human-bovine reassortant rotavirus vaccine used for the active immunization of infants for prevention of rotavirus gastroenteritis. The protective efficacy of RotaTeq has been evaluated in terms of its effects on the incidence of rotavirus gastroenteritis and on healthcare resource use. Clinical trial data from REST (a randomized, double-blind, placebo-controlled, multinational study in approximately 70,000 healthy infants aged 6-12 weeks) and various subgroup analyses, including a large European cohort, have shown that RotaTeq may be administered at the same time as various other routine vaccines, has high and sustained efficacy covering the main period of risk for rotavirus gastroenteritis, has early protective efficacy after the first and second doses, reduces rotavirus gastroenteritis-associated hospitalization and emergency department and physician visits, and is generally well tolerated. Moreover, RotaTeq has demonstrated efficacy against the five most prevalent serotypes of rotavirus in Europe (G1-G4, G9), in terms of reductions in associated healthcare resource use. There is also evidence that the widespread use of RotaTeq may provide herd immunity, as it appears to have indirect benefits in older, unvaccinated children. Reports on the 'real world' effectiveness of RotaTeq in Europe are just emerging, but data from the US have shown a rapid and marked reduction in rotavirus burden nationwide during the approximately 2-year period following the introduction of RotaTeq and the subsequent availability of official recommendations advocating universal use of the vaccine as part of routine childhood immunization. Similar benefits have also been demonstrated in Australia after the introduction of a publicly funded rotavirus vaccination programme. Postmarketing surveillance data from the US have not identified any concerns, such as an association with intussusception or Kawasaki disease, related to the safety of RotaTeq. In conclusion, RotaTeq is a generally well tolerated vaccine that has efficacy against the five most prevalent serotypes of rotavirus in Europe and provides sustained efficacy over the main risk period for rotavirus gastroenteritis in infants and children, reducing hospitalizations and emergency department visits by decreasing the incidence and severity of illness.