VRBPACVaccines and Related Biological Products Advisory Committee
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As a result, the overwhelming majority of the "CIN 2/3 or worse"cases used for evaluation of efficacy and listed in the VRBPAC Background Document on Gardasil[TM] HPV Quadrivalent Vaccine presented at the May 18, 2006 VRBPAC Meeting must have been CIN 2 lesions.
In view of the pending review of Merck's new application for expanded use of Gardasil[TM] as a vaccine to prevent "anal dysplasia and cancer" in both men and women, Erickson also sent a letter to all members of the VRBPAC, requesting the Committee to use appropriate primary endpoint and reliable HPV genotyping methods to evaluate the efficacy of the vaccine, based on the same scientific arguments put forth in the letter addressed to the FDA Commissioner.
Connor, MedImmune's senior vice president, clinical development, said, "We are very pleased with the outcome of today's VRBPAC meeting and believe that the results move us closer to our goal of bringing FluMist to market by the 2003-2004 flu season.