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Merck's Rotateq rotavirus vaccine deemed safe, effective by FDA advisory committee
By Angela McDaniels
Seattle, Dec. 14 - Merck & Co. Inc. said phase 3 clinical data submitted to the Vaccines and Related Biological Products Advisory Committee of the U.S. Food and Drug Administration convinced the committee that its rotavirus gastroenteritis vaccine Rotateq is safe and effective.
"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," president of research laboratories Peter S. Kim said in a company news release.
The 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 recommendation was based on data presented from placebo-controlled phase 3 clinical trials that included 70,000 infants, the company said.
The committee's recommendation will be considered during the FDA's review of the Biologics License Application 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 said it has filed for licensure of Rotateq in more than 50 countries.
Rotateq is a three-dose vaccine. During trials, its was given at four- to 10-week intervals with the first dose administered between the ages of six and 12 weeks.
Rotavirus gastroenteritis is the most common cause of severe dehydrating diarrhea in infants and young children, causing an estimated 250,000 emergency department visits and 500,000 visits to physicians offices each year in the United States, the company said.
Merck is a pharmaceutical company based in Whitehouse Station, N.J., that develops vaccines and medicines in more than 20 therapeutic categories.
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