Subject: Gardasil Pediatric Utilization and Safety Review for Pediatric Advisory Committee Meeting
On June 8, 2006, the US Food and Drug Administration approved the first vaccine against the human papillomavirus (HPV). Gardasil was initially licensed for females aged 9–26 years for the prevention of cervical cancer and precancerous lesions, as well as genital warts caused by the vaccine serotypes (6, 11, 16 and 18). Although Gardasil was also initially indicated for the prevention of vulvar and vaginal precancerous lesions (VIN and VaIN), the indication for the prevention of vulvar and vaginal cancer was not approved until September 12, 2008. This minor label change is the trigger for this pediatric utilization and safety review, and is the subject of this memorandum. The addition of these two final cancer endpoints did not alter the vaccine’s target population and did not result in material changes to the recommendations for clinical use promulgated by the Advisory Committee on Immunizations and Practices (ACIP).
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