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Merck vaccine safe, effective: FDA panel
FDA committee recommends Merck's Rotateq
December 14, 2005: 4:14 PM EST
By Aaron Smith, CNNMoney.com staff writer

NEW YORK (CNNMoney.com) - An advisory committee for the Food and Drug Administration recommended the approval of a Merck vaccine that would protect children against a rotavirus that causes severe diarrhea, the agency said.

The committee voted unanimously on Wednesday in favor of Rotateq as a safe and effective vaccine in preventing the rotavirus in children and babies, said an FDA spokesman. The vaccine still has to be approved by the FDA before it can enter the market, but the agency follows the advice of its committees most of the time.

Merck (up $0.32 to $29.22, Research) submitted Rotateq, an experimental vaccine that is administered orally, to the FDA on April 5.

Rotavirus is the most common cause of severe diarrhea among children, causing more than 600,000 deaths annually worldwide and results in 55,000 hospitalizations in the U.S. every year, according to the Centers for Disease Control and Prevention.

On Thursday, an FDA advisory panel will vote on Zostavax, another Merck experimental vaccine. The vaccine would be used to prevent herpes zoster, a skin rash also known as shingles.

To read about Merck's Vioxx mistrial, click here.  Top of page

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