On November 17, 2010, the Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee endorsed the expanded use of Gardasil® (Merck, Whitehouse Station NJ), the three-dose human papillomavirus (HPV) vaccine , to prevent anal intraepithelial neoplasia and anal cancer caused by HPV strains 6, 11, 16, and 18. HPV is thought to be the cause of 90% of anal cancers. This decision was based on a subset of results of a phase III double-blind, placebo-controlled study in which 4,065 males were randomized 1:1 to receive a three-dose regimen of Gardasil or aluminum adjuvant-containing saline.
In the trial, 602 participants (15%) were men who had sex with men (MSM) which presents a higher risk for developing anal cancer. By the study end 3% of participants in the MSM Gardasil group developed anal intraepithelial neoplasia or anal cancer, compared with 12% in the MSM placebo group. The vaccine was 78% effective at preventing anal intraepithelial neoplasia associated with HPV strains 6, 11, 16, and 18, and 75% effective at preventing advanced dysplasia.
Gardasil received initial approval in 2006 for girls and women aged 9 through 26 for the prevention of diseases including cervical, vulvar and vaginal cancer caused by HPV types 16 and 18 and genital warts caused by HPV types 6 and 11. Additionally, it is approved for prevention of the precancerous or dysplastic lesions including:
- Cervical intraepithelial neoplasia grades 1 -3 and cervical adenocarcinoma in situ
- Vulvar intraepithelial neoplasia grade 1
- Vaginal intraepithelial neoplasia grades 2 and 3
It 2009, Gardasil received approval for boys and men 9 through 26 years of age for prevention of genital warts caused by HPV types 6 and 11. Gardasil is administered through three intramuscular injections given at 0, 2 months and 6 months.
The briefing document presented to the Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee can be downloaded at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM231483.pdf
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