On September 9, 2009, a U.S. FDA advisory panel voted for approval of the use of Gardasil® for the prevention of genital warts in males ages nine through 16. The age range was based on safety data for this age group. However, another U.S. FDA advisory panel, on 10/21/2009, voted against the routine use of Gardasil for vaccination of all young boys.[1]
Human papillomaviruses (HPV) are probably the sole cause of cancers of the cervix and have been associated with cancers of the vulva, vagina, penis, and rectum. Epidemiologic and molecular biology studies have also suggested that HPV infection may be associated with cancers of the head and neck.
Gardasil® (Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) is already approved by the U.S. Food and Drug Administration for the prevention of cervical, vulvar, and vaginal cancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18 in girls and young women nine through 26 years of age. Cervarix®, a HPV-16/18 AS04-adjuvanted vaccine made by GlaxoSmithKline, has also been recently approved for the same indications as Gardasil.
Male HPV can lead to genital warts, penile cancer, perianal cancer, anal cancer, and head and neck cancer. In addition, it contributes to HPV infection in women and subsequent cervical disease, including cervical cancer. Although males can spread the virus, and many other countries have approved the HPV vaccine for use in males, it has not been approved for males in the United States. However, researchers from the H. Lee Moffitt Cancer Center have reported that Gardasil has now been shown to prevent genital lesions in men ages 16 to 26. Researchers from M. D. Anderson have recommended vaccination of boys and girls against HPV for prevention of squamous cell cancers of the head and neck as well as for prevention of cervical cancer.
However, researchers from Harvard have reported that including boys in a HPV vaccination program may not be cost effective for preventing cervical and other cancers. This analysis may have affected the decision of the U.S. advisory panel to reject routine vaccination of boys.
Comments: The most important part of these decisions is the approval for administering Gardasil to boys for the prevention of genital warts. Families should be informed that vaccination of boys is likely to have more benefits than just the prevention of genital warts but may also decrease the risk of developing several HPV-related cancers as well as decreasing the risk of transmitting HPV to unvaccinated females.
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