What is the maximum age for Gardasil 9 (Human Papillomavirus 9-valent vaccine) vaccination in males?

Maximum Age for Gardasil 9 Vaccination in Males

The maximum age for Gardasil 9 vaccination in males is 26 years. 1

FDA-Approved Age Range

The FDA prescribing information for Gardasil 9 explicitly states that the vaccine is indicated in boys and men 9 through 26 years of age for prevention of anal cancer, genital warts, and anal intraepithelial neoplasia caused by HPV types covered by the vaccine. 1 The FDA label further specifies that "safety and effectiveness of GARDASIL 9 have not been assessed in individuals older than 26 years of age." 1

Guideline Recommendations by Age Group

Routine Vaccination (Ages 11-21)

• Males aged 13-21 years who have not been vaccinated previously or who have not completed the series should receive catch-up vaccination. 2
• Routine vaccination should be initiated at age 11 or 12 years, with the series starting as early as age 9 years. 2

Permissive Vaccination (Ages 22-26)

• Males aged 22-26 years may be vaccinated based on individual clinical decision-making. 2
• This represents a permissive rather than routine recommendation, meaning vaccination is not universally recommended but can be offered after shared decision-making. 2

Special Populations Through Age 26

• Men who have sex with men (MSM) should receive vaccination through age 26 years if not previously vaccinated. 2, 3
• Immunocompromised males, including those with HIV infection, should receive vaccination through age 26 years if not previously vaccinated. 2

Critical Counseling Point for Ages 22-26

Providers must inform males aged 22-26 years who have not been previously vaccinated that vaccination at older ages is less effective in lowering cancer risk. 2, 4 This reduced effectiveness occurs because:

• Vaccine effectiveness decreases with increasing age, increasing number of sexual partners, and greater likelihood of prior HPV exposure. 2
• The vaccine is most effective when administered before exposure to HPV through sexual contact. 2, 4, 5

Dosing Schedule by Age

Ages 9-14 Years at First Dose

• 2-dose schedule: 0 and 6-12 months 1
• If the second dose is given earlier than 5 months after the first dose, a third dose must be administered at least 4 months after the second dose. 1

Ages 15-26 Years at First Dose

• 3-dose schedule: 0,2, and 6 months 1
• This applies regardless of when subsequent doses are actually administered—the determining factor is age at first dose. 5

Common Pitfalls to Avoid

• Do not vaccinate males over age 26 years: There are no safety or efficacy data beyond this age, and the FDA has not approved use in this population. 1
• Do not delay vaccination in the 22-26 age group waiting for "ideal" circumstances—approximately 24% of adolescents report sexual intercourse by 9th grade, and HPV infection incidence is nearly 60% within 2 years after sexual initiation in males. 5
• Do not assume vaccination eliminates the need for anal cancer screening in high-risk populations who have been advised to undergo such screening. 1