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RotateQ Garners FDA Committee's Vote on Efficacy and Safety
"Rotavirus is a common childhood disease that sends hundreds of thousands of children to the doctor's office every year in the United States alone," said Peter S. Kim, Ph.D., president, Merck Research Laboratories. "We are pleased that the Advisory Committee agreed that the data presented showed that ROTATEQ reduced the effects of this potentially serious disease. We look forward to working with the FDA on the next steps of the application review process."
The Advisory Committee also recommended that Merck continue to develop and conduct post-licensure studies to assess the safety and efficacy of ROTATEQ if it is approved for use. The Advisory Committee's recommendation was based on data presented from Phase III clinical trials including the Rotavirus Efficacy and Safety Trial (REST), one of the largest vaccine clinical trials ever conducted.
The committee's recommendation will be considered by the FDA in its review of the Biologics License Application (BLA) that Merck submitted for ROTATEQ on April 5, 2005. The FDA is not bound by the committee's recommendation but takes its advice into consideration when reviewing investigational vaccines seeking approval. Merck has also filed for licensure of ROTATEQ in more than 50 other countries worldwide.
ROTATEQ is an investigational oral vaccine that targets the five strains of rotavirus - G1, G2, G3, G4 and P1 - that cause most rotavirus disease worldwide. ROTATEQ was studied in infants as a three-dose vaccine, given at four- to ten-week intervals with the first dose administered at age six to 12 weeks and compared to placebo.
About Rotavirus Gastroenteritis
Rotavirus causes approximately one-third of diarrhea-associated hospitalizations in developing countries and more than 500,000 deaths worldwide every year in children under five. In the United States, rotavirus accounts for an estimated 70,000 hospitalizations and 500,000 visits to primary care offices. Although symptoms vary, those typically associated with rotavirus gastroenteritis include vomiting, fever, abdominal pain and watery diarrhea which can persist for three to nine days. The severity of rotavirus gastroenteritis ranges from asymptomatic to dehydrating gastroenteritis that can be fatal. The incidence of rotavirus is similar in developed and developing countries, which suggests that differences in environment (e.g., clean water, hygiene or sanitation) do not prevent this disease.
During the first few years of life, a child typically has several rotavirus infections. The highest rates of gastroenteritis are generally in children under two years of age, who are also at the greatest risk for severe disease. Nearly all children will be infected with rotavirus by age five. There are several different serotypes of rotavirus and the prevalence of these serotypes varies by geographic region and can change from season to season. Children gradually develop immunity against different strains of the virus after several infections.
ROTATEQ is one of three Merck vaccines currently being evaluated by the FDA. The FDA and other regulatory agencies around the world are reviewing applications for ZOSTAVAX, Merck's investigational vaccine to prevent shingles and shingles-associated pain in adults, and GARDASIL, the Company's investigational HPV and cervical cancer vaccine.