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Home HPV and Men HPV and Men HPV Vaccine for Males: How well does it work and who should get it?

HPV Vaccine for Males: How well does it work and who should get it?

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Heidi Bauer, MD, MS, MPH
Co-Director, HPV Vaccine Workgroup, California Department of Public Health

In October 2009, the Food and Drug Administration licensed quadrivalent human papillomavirus vaccine (Gardasil®, Merck & Co. Inc.) for use in males aged 9 through 26 years for the prevention of genital warts. This vaccine protects against infection with four HPV types: 6, 11, 16 and 18. HPV types 6 anBauerd 11 cause genital warts and HPV types 16 and 18 cause cancers in the genital area. Gardasil had been licensed since 2006 for use in females aged 9 through 26 years for prevention of HPV 6, 11, 16, and 18-related vaginal, vulvar, and cervical precancers and cancers as well as genital warts.1

Are Males at Risk for HPV?
Yes. Most males will be exposed to HPV through sexual contact at some point in their lifetimes. HPV types 6 and 11 cause approximately 90% of genital warts. Half a million cases of genital warts are estimated to occur each year in the United States among sexually active men and women. Cancers caused by HPV are relatively uncommon in males. These cancers include anal, penile, and oral cancers caused primarily by HPV type 16.

Does the HPV Vaccine Work in Males?
Yes. Gardasil® is highly effective for prevention of genital warts in males.2 The clinical trials that studied effectiveness enrolled over 4,000 males aged 16 through 26 years. The effectiveness for the prevention of genital warts related to the vaccine types among males who received all three vaccine doses and were not previously infected with HPV was almost 90%. Males who were already infected with the HPV types included in the vaccine did not benefit from getting vaccinated. Gardasil is most effective when given before exposure to HPV through sexual contact.

Is the Vaccine Safe?
Yes. The most common side effects were injection-site reactions like pain, redness, and swelling. Most of these reactions were mild or moderate. Headache and fever were the most commonly reported systemic adverse reactions.

Should Males Get the Vaccine?
Although the Advisory Committee on Immunization Practices (ACIP) does not recommend Gardasil® for routine use among males, the three-dose series of Gardasil® may be given to males aged 9 through 26 years to reduce their likelihood of acquiring genital warts. There were two main reasons that ACIP did not recommend routine vaccination for males. First, male vaccination would not be cost-effective if we have high levels of HPV vaccine coverage in females. Second, data on effectiveness for protection against genital cancers in males was not available at the time that ACIP made its recommendation. There is a possibility that ACIP will recommend routine vaccination in males in the future if vaccination rates continue to be low or the vaccine is proven to prevent cancers caused by HPV in males.

Although private insurance policies may vary in their payment for the vaccine, the federally funded Vaccines for Children program provides the vaccine for eligible males through age 18. The cost of the vaccine is $120 for each dose. This cost does not include fees for the office visit or administration of the vaccine. Males interested in getting the vaccine should talk to their health care provider.

Centers for Disease Control and Prevention. FDA Licensure of Quadrivalent Human Papillomavirus Vaccine (HPV4, Gardasil) for Use in Males and Guidance from the Advisory Committee on Immunization Practices (ACIP). MMWR May 28, 2010 / 59(20);630-632. Accessed June 9, 2010 (click here to download).
Food and Drug Administration. Product approval-prescribing information [package insert]. Gardasil [human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant], Merck & Co, Inc: Food and Drug Administration 2009. Accessed June 9, 2010 (click here to download).