Gardasil is a prophylactic HPV vaccine, meaning that it is designed to prevent the initial establishment of HPV infections. For maximum efficacy, it is recommended that girls receive the vaccine prior to becoming sexually active. However, women who were already infected with one or more of the four HPV types targeted by the vaccine (6, 11, 16, or 18) were protected from clinical disease caused by the remaining HPV types in the vaccine.
Since Gardasil will not block infection with all of the HPV types that can cause cervical cancer, the vaccine should not be considered a substitute for routine pap smears.
Fewer HPV infections mean fewer complications from the virus and less time and money spent on the detection, work-up, and treatment of cervical cancer and its immediate precursor, cervical dysplasia. It prevents infertility caused by cervical biopsies and reduces the severe respiratory problems of children who are infected by HPV from their mothers. In addition, protection against HPV 6 and HPV 11 is expected to eliminate 90% of the cases of genital warts. Gardasil also protects against vulvar and vaginal cancers caused by HPV types 16 and 18.
Merck is seeking FDA approval to market Gardasil to older women aged 27 to 45. As of the early part of 2009, the FDA has requested final trial data before it approves the drug for this age group.
HPV infections, including HPV 16, contribute to some head and neck cancer. In principle HPV vaccines may help reduce incidence of such cancers caused by HPV, but this has not been demonstrated.
Use in males
Gardasil is also effective in males, providing protection against genital warts and some potentially precancerous lesions caused by some HPV types. An ongoing study of 4,065 males demonstrated the efficacy of Gardasil in males who did not have HPV infection prior to vaccination. and a FDA advisory committee recommended approval on September 9, 2009. The FDA approved this recommendation on October 16, 2009. In the UK HPV vaccines are already licensed for males aged 9 to 15 and for females aged 9 to 26.
Gardasil is in particular demand among gay men, who are at significantly increased risk for genital warts and anal cancer caused by HPV.
HPV vaccines may be useful in preventing anal cancer caused by HPV types 16 and 18. A 2005 study in San Francisco, California found that 95 percent of HIV-infected gay men also had anal HPV infection, of which 50 percent had precancerous HPV-caused lesions. Type 16 is also associated with oropharyngeal squamous-cell carcinoma, a form of throat cancer.
Further Reading
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