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 ≈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 ≈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. 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.