Rotarix vaccine approved for rotavirus prevention

The FDA has approved Rotarix (live oral rotavirus vaccine, from GlaxoSmithKline) for the prevention of rotavirus gastroenteritis in infants. Rotarix offers protection against the most commonly circulating rotavirus types in the U.S. and allows infants to complete the two-dose vaccination series by four months of age. Clinical data published on Rotarix show that protection was sustained through the first two years of life and was highly efficacious against rotavirus hospitalizations (96%) and severe rotavirus gastroenteritis (90%). In addition, Rotarix was shown to be effective against rotavirus gastroenteritis of any severity (79%).

Rotarix is expected to be available in the second half of 2008.

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