CDC Confirms Effectiveness of HPV Vaccine in Men

CDC's Advisory Committee on Immunization Practices (ACIP) has confirmed its earlier provisional advice on vaccinating boys against human papillomavirus.

In October, ACIP acknowledged the Food and Drug Administration's (FDA) approval of Merck & Co.'s quadrivalent HPV vaccine Gardasil for males ages 9-26 to reduce their likelihood of acquiring genital warts. However, ACIP stopped short of advising the three-shot series for routine use among males. ACIP recommends routine HPV vaccination only among girls ages 11-12, with catch-up vaccinations for females ages 13 to 26.

In an update published Friday, ACIP notes Gardasil's safety and its "high efficacy" for preventing genital warts. That said, mathematical modeling suggests that adding males to a routine vaccination program "is not the most cost-effective" when female uptake of Gardasil is above 80 percent. At lower uptake rates, male vaccination "might be cost-effective," though results "vary substantially across models," ACIP said.

The burden of HPV is heaviest on females, ACIP noted. Improving coverage in females ages 11-12 "could potentially be a more effective and cost-effective strategy than adding male vaccination," ACIP suggested.

Men who have sex with men (MSM) are at risk for conditions associated with HPV types targeted by Gardasil, ACIP said. MSM have a higher incidence of certain diseases and cancers including intraepithelial neoplasias, anal cancers, and genital warts. Gardasil reportedly is highly effective in preventing anal intraepithelial neoplasias in MSM, according to the update. However, clinical trial data for Gardasil among MSM were not available to ACIP before October, nor have they been fully reviewed by FDA, ACIP said.

The complete report, "FDA Licensure of Quadrivalent Human Papillomavirus Vaccine (HPV4, Gardasil) for Use in Males and Guidance from the Advisory Committee on Immunization Practices (ACIP)," was published in Morbidity and Mortality Weekly Report (2010;59(20):630-632).

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