Today (May 18), the FDA's Vaccines And Related Biological Products Advisory Committee met to discuss the approval of Merck's HPV vaccine candidate, GARDASIL. The panel voted unanimously for approval (13-0). Background briefing documents, including the FDA's analyses of the data from Merck's two large efficacy trials in women (Future I & II), are now available on the FDA dockets website. Transcripts from the hearing will also be posted there when they're available. The vaccine is expected to receive full FDA approval for marketing by June 8th. A number of media outlets have already picked up the story, including CNN Money, Associated Press, and Reuters.
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