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GSK's Rotarix wins FDA committee backing

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An FDA advisory panel agreed Wednesday that GlaxoSmithKline's Rotarix vaccine was safe and effective, recommending the anti-rotavirus shot for agency approval. Rotarix is designed to help protect infants from gastrointestinal illness caused by that virus. The FDA is set to say yea or nay by April 3.

If approved for sale, Rotarix will compete with Merck's RotaTeq, which has been on the market since 2006. Because the U.S. is the only major market where rotavirus vaccine has been recommended for all kids, this is a key battleground for GSK. RotaTeq has the first-to-market advantage, analysts say, but Rotarix has a chance to grab market share because it requires only two doses versus RotaTeq's three.

FDA officials have been monitoring Merck's version for links to a bowel problem called intussusception. Last year, the agency told the public about 28 reports of intussusception among infants given RotaTeq. The CDC later said the proportion of cases among vaccinated children was smaller than in the general population.

Rotarix likely would be monitored as well, even though GSK's clinical trials, which included more than 75,000 children, didn't uncover an increased risk of intussusception among vaccinated kids. Six cases were reported among kids who got the vaccine and seven who got placebo.

- see the FDA's briefing documents on Rotarix
- read the story at CNN Money
- check out the article in the Wall Street Journal

Related Articles:
FDA to review GSK's rotavirus vaccine. Report
GSK outlines planned vaccine product launches. Report
FDA approves Merck's rotavirus vaccine. Report


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