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Vaccine News and Commentary from the University of Pennsylvania Center for Bioethics

Wednesday, March 01, 2006

GSK rotavirus vaccine approved by EU

Rotarix, the GSK rotavirus vaccine, received EU approval Monday. Forbes, among other places, had the details.

While GSK's vaccine is out in front on the international stage, it's yet to be licensed in the United States. RotaTeq, the rotavirus vaccine from Merck, was licensed by the FDA in December. As was widely reported last week, CDC's Advisory Committee on Immunization recommended routine vaccination with RotaTeq for all newborns at 2, 4, and 6 months. Here's the Washington Post story.

For those confused by news accounts of vaccines in development, similar products from competing manufacturers, and the maze of regulatory steps required in the U.S., the American Academy of Pediatrics has a very useful table on its website that provides the trade name, target, manufacturer, age range, licensure status, and AAP/ACIP recommendations (if any) for vaccines recently approved or currently in the approval process. The page is updated regularly and is a great resource. A link has been added on the right of the page.

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