Wyeth's RotaShield Nears US Approval
Wyeth-Ayerst's vaccine against rotavirus, RotaShield, has beenrecommended for approval by the US Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee. RotaShield looks set to be the first rotavirus vaccine to reach the market. It has also been filed in Europe, where it will be sold as Rotamune.
The panel voted unanimously that RotaShield is safe and effective against rotavirus gastroenteritis, which affects nearly every child by the age of four and leads to dehydration and death in a million children every year. RotaShield appears to have the greatest efficacy against severe disease, the panel agreed.
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