Spotlight on Pentavalent Rotavirus Vaccine (RotaTeq®) 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 ≈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 † Adapted and reproduced from Drugs 2010; 70 (9): 1165-1188. The full text article^[1] was reviewed by: H. Antunes, Gastroenterology, Hepatology and Nutrition Unit, Pediatrics Department, Braga Hospital, Braga, Portugal; G. Gabutti, Department of Clinical and Experimental Medicine, Hygiene and Occupational Health Unit, University of Ferrara, Ferrara, Italy; D. Gendrel, Service de Pédiatrie, Hôpital Saint-Vincent-de-Paul, Paris, France; F. Omeñaca, Neonatal Unit, Department of Neonatology, La Paz Hospital, Madrid, Spain. The manufacturer of the agent under review was offered an opportunity to comment on the original article during the peer review process. Changes based on any comments received were made on the basis of scientific and editorial merit. The preparation of the original article and this spotlight was not supported by any external funding. 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.