L Shi1, HL Sings1, JT Bryan1, B Wang1, Y Wang1, H Mach1, M Kosinski1, MW Washabaugh1, R Sitrin1
and E Barr1
February 2007
GARDASILs (Merck, Whitehouse Station, NJ) is a non-infectious recombinant, quadrivalent vaccine prepared from the highly purified virus-like particles (VLPs) of the major capsid proteins of human papillomavirus (HPV) types 6, 11, 16, and 18. GARDASILs is the first vaccine approved for use in women aged 9–26 years for the prevention of cervical cancer and genital warts, as well as vulvar and vaginal precancerous lesions. This report describes some of the key preclinical efforts, achievements in pharmaceutical development, in vivo animal evaluation, and clinical trial data.
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