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FDA Agrees to Review 9-Valent HPV Vaccine
The biologics license application (BLA) for V503, an investigational 9-valent human papillomavirus (HPV) vaccine, has been accepted for standard review by the FDA.
In November 2013, the vaccine’s developer (Merck) announced that vaccination with V503 had prevented approximately 97% of cervical, vaginal, and vulvar precancers caused by HPV types 31, 33, 45, 52, and 58 in a pivotal phase III efficacy study. V503 also generated immune responses to HPV types 6, 11, 16, and 18 that were non-inferior to those generated by Merck’s Gardasil (human papillomavirus quadrivalent [types 6, 11, 16, and 18] vaccine, recombinant).
V503 includes five more HPV types (31, 33, 45, 52, and 58) in addition to the four HPV types (6, 11, 16, and 18) in Gardasil.