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FDA Advisory Committee Recommends US Approval of Rotavirus Vaccine
Date:2/20/2008

Vaccine has the Potential to Save Thousands of Lives in Poor Countries

GAITHERSBURG, Md., Feb. 20 /PRNewswire-USNewswire/ -- The US Advisory Committee on Vaccines and Related Biological Products issued a positive recommendation today on the use of rotavirus vaccines, potentially bringing greater protection to children in the US from this common and sometimes fatal cause of severe diarrhea. After reviewing data from clinical trials on the safety and efficacy of Rotarix(R), manufactured by GlaxoSmithKline Biologicals (GSK), the committee recommended that the US Food and Drug Administration (FDA) approve the company's application for licensure. The FDA should make its ultimate decision on Rotarix(R) licensure in the US within the coming weeks. Another rotavirus vaccine, RotaTeq(R) manufactured by Merck & Co., Inc., received FDA approval in 2006.

Globally, rotavirus accounts for more than 500,000 deaths and two million hospitalizations annually. Ready access to good medical care means that children in industrialized countries rarely die from rotavirus infection. Children in the poorest countries, however, suffer the greatest burden: more than 90 percent of deaths due to rotavirus occur in the developing world, where access to simple, lifesaving treatment is severely limited.

"Vaccines against rotavirus remain the most effective way to prevent this deadly disease," notes Dr. John Wecker, director of PATH's Rotavirus Vaccine Program. "Making rotavirus vaccines available to the children in poor countries who face the greatest risk of dying must be a high priority."

Every child in the world will contract rotavirus at least once before the age of three, regardless of income level or geographic location. Because vaccination is the only way to prevent hospitalizations from severe rotavirus infection in industrialized countries and the mortality it causes in low-resource settings, the World Health Organization (WHO) strongly recommends the incl
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SOURCE PATH
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