US CDC and the WHO reaffirm their support for continued use of Merck & Co's RotaTeq

The US Centers for Disease Control and Prevention (CDC) and the World Health Organization have declared their support for the continued use of RotaTeq (live oral pentavalent rotavirus). In separate press releases, the agencies stressed the precautionary nature of the US Food and Drug Administration's warning of a possible risk of intestinal twisting in children given Merck & Co's rotavirus vaccine (Marketletter February 19).

In its statement, the CDC says that it "continues to support the Advisory Committee on Immunization Practices recommendation for routine immunization of all US infants with three doses of RotaTeq administered orally at ages two, four and six months." Intussusception, a form of bowel obstruction highlighted by the FDA in relation to RotaTeq, occurs spontaneously in the absence of vaccination, the CDC noted, adding that there are a number of cases that occur every year in children in the age group recommended for RotaTeq (six-32 weeks of age) and are not related to the vaccine. The number of cases reported to date is consistent with that expected on the basis of background rates in unvaccinated children.

The Global Advisory Committee on Vaccine Safety, an expert scientific advisory body established by the WHO to provide independent scientific assessment of vaccine safety, echeod the CDC, stating that the 28 cases of intussusception cases reported to date does not exceed the number expected based on background rates for the US infant population, and therefore does not suggest an increased risk of intussusception with RotaTeq.