Should Young Men Be Vaccinated With Gardasil®?

Laurie L. Briceland, PharmD


August 24, 2009


Would the vaccination of young men with human papillomavirus quadrivalent (types 6, 11, 16 and 18) vaccine (Gardasil®) help prevent infection and spread of human papillomavirus (HPV)?

Response from Laurie L. Briceland, PharmD
Professor and Director, Experiential Education, Department of Pharmacy Practice, Albany College of Pharmacy, Albany, New York

Reduction of vaccine-preventable diseases occurs through conference of direct protection in the target population vaccinated as well as indirect conference to the community through herd immunity.[1] Currently, the primary target population for HPV vaccination is adolescent girls between the ages of 9 or 10 years to 13 years, prior to sexual debut, as they are likely to be naive to vaccine-related HPV types.[2] Vaccination of males with the HPV vaccine is not indicated given that vaccine efficacy trials in the adolescent male population are not yet concluded.[3]

Gardasil® safety and immunogenicity trials included 9- to 15-year-old boys and demonstrated a robust immunologic response in this population. If efficacy in males is demonstrated in clinical trials, it is likely that vaccination may be recommended for prevention of anogenital warts (and, indirectly, infection and anogenital neoplasia and warts in partners); a subset of anal, penile, oral, and head and neck cancers; and juvenile respiratory papillomatosis in their children.[3]

Vaccination strategies introduced to prevent cervical cancer should be implemented primarily to achieve high coverage (> 70%) in a primary target population of young adolescent girls. The World Health Organization currently does not recommend HPV vaccination of males because high coverage in the primary target of adolescent girls is expected to be more cost-effective in reducing cervical cancer than including vaccination of males.[2]

Some suggest that male vaccination will be cost-effectively justified when female coverage rates are low; some estimate that without school-entry HPV vaccination requirements in place, < 30% coverage rates will be achieved, and male vaccination may be welcome to provide herd immunity.[1] Until efficacy trial data are released (expected in 2009),[1] no definitive recommendations on male vaccination can be promulgated. Therefore, vaccination of males with Gardasil® is currently not indicated.