FDA approves Merck's Rotateq to prevent rotavirus gastroenteritis

By Lisa Kerner

Erie, Pa., Feb. 3 - Merck & Co., Inc. said the Food and Drug Administration approved Rotateq (rotavirus vaccine, live, oral, pentavalent), the only vaccine available in the United States to prevent rotavirus gastroenteritis, a leading cause of severe diarrhea in infants and young children.

Rotateq is an oral, three-dose vaccine given to infants between the ages of six to 32 weeks, according to a company news release.

The company said an estimated 2.7million episodes of rotavirus gastroenteritis occur each year in children under five in the United States, resulting in about 250,000 emergency room visits and up to 70,000 hospitalizations.

The FDA approval of Rotateq is based on data from Merck's phase 3 clinical trials of more than 70,000 infants, including the Rotavirus Efficacy and Safety Trial (REST).

Rotateq prevented 98% of severe cases of rotavirus gastroenteritis and prevented 74% of rotavirus gastroenteritis cases of any severity caused by serotypes targeted by the vaccine (G1, G2, G3, G4) compared to a placebo.

The incidence of serious adverse events within six weeks of a dose of Rotateq was comparable among vaccine and placebo recipients. The most frequently reported serious adverse events were bronchiolitis, gastroenteritis, pneumonia, pyrexia, and urinary tract infection, the company said.

"Because of the high rotavirus mortality rates seen in the developing world, we plan to initiate clinical trials of Rotateq in economically disadvantaged countries in Africa and Asia," Mark Feinberg, vice president of policy, public health and medical affairs, Merck Vaccines, said in the release.

Merck has two other vaccines currently under review by the FDA and other regulatory agencies around the world - Zostavax ,an investigational vaccine to prevent shingles, and Gardasil, a cervical cancer vaccine.

Merck is a global research-driven pharmaceutical company based in Whitehouse Station, N.J.

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