Gardasil 9 Age Range for Males
Gardasil 9 is FDA-approved for males aged 9 through 26 years. 1
Routine Vaccination Recommendations
ACIP recommends routine HPV vaccination for all boys at ages 11-12 years, though vaccination can begin as early as age 9 years. 2, 3, 4
Dosing Schedule by Age at Initiation
Males aged 9-14 years: 2-dose schedule with the second dose given 6-12 months after the first dose (if the second dose is given earlier than 5 months after the first, a third dose is required at least 4 months after the second dose) 5, 3, 1
Males aged 15-26 years: 3-dose schedule at 0,2, and 6 months (minimum intervals: 4 weeks between doses 1 and 2, and 12 weeks between doses 2 and 3) 5, 3, 1
Catch-Up Vaccination
ACIP recommends catch-up HPV vaccination for all males through age 26 years who have not been vaccinated previously or have not completed the vaccine series. 2, 3
Males aged 13-21 years: Catch-up vaccination is strongly recommended if not previously vaccinated 2, 5
Males aged 22-26 years: Vaccination may be given, though providers should inform patients that vaccination at older ages is less effective in lowering cancer risk due to likely prior HPV exposure 2, 5, 4
Special High-Risk Populations Through Age 26
Men who have sex with men (MSM) should be vaccinated through age 26 years regardless of prior vaccination status. 2, 5, 3, 4
Immunocompromised males, including those with HIV infection, should receive a 3-dose schedule through age 26 years, regardless of age at initiation. 5, 3, 4
Adults Aged 27-45 Years
The FDA expanded approval for Gardasil 9 to include males aged 27-45 years in October 2018, but ACIP does not recommend routine catch-up vaccination for this age group. 2
- Shared clinical decision-making is recommended for some males aged 27-45 years who are not adequately vaccinated and may be at risk for new HPV infection, recognizing that most sexually active adults have already been exposed to HPV and vaccine effectiveness is substantially lower due to prior infections 2, 3
Clinical Rationale for Male Vaccination
Vaccination provides approximately 90% efficacy against anal intraepithelial neoplasia grades 2/3 and anal cancer in males. 4
The vaccine achieves approximately 90% efficacy against genital warts in HPV-naïve males and approximately 67% efficacy in intention-to-treat populations. 4
Male vaccination reduces HPV transmission to female partners, thereby lowering their risk of cervical, vulvar, and vaginal cancers. 4
Important Clinical Considerations
No pre-vaccination testing (HPV DNA test or antibody assay) is required before administering the vaccine 3, 4
Vaccination is most effective when given before exposure to HPV through sexual activity, as approximately 24% of teenagers report sexual activity by 9th grade and the cumulative incidence of HPV infection approaches 40% within the first two years after first sexual intercourse 4
All recipients should be observed for 15 minutes after administration due to risk of syncope 1