Gardasil for Men – Does It Work?

David Fuller

Last Updated On: July 29, 2025

Genital warts might not be life-threatening, but they can be uncomfortable, distressing, and surprisingly common, especially among men. Studies estimate that up to 137 cases per 10,000 person-years occur in unvaccinated populations, with HPV types 6 and 11 being the usual culprits.

While the HPV vaccine Gardasil is often promoted for women to help prevent cervical cancer, it’s just as relevant for men. In fact, clinical trials have shown that Gardasil can cut the risk of genital warts in men by up to 90%, particularly in those aged 16 to 26.

So, does Gardasil really work for men? In this article, we’ll break down what the research says, who should consider getting vaccinated, and why it’s not just a “women’s vaccine” anymore.

Key Takeaways

• HPV affects men too, not just women. It can cause genital warts and serious cancers like anal, penile, and oropharyngeal cancers.
• Gardasil 9 offers strong protection against both low-risk (types 6 and 11) and high-risk (types 16, 18, 31, 33, 45, 52, and 58) HPV strains in males.
• Early vaccination works best. Administering the vaccine before sexual activity (ideally between ages 9 and 12) ensures the most effective immune response.
• Clinical trials confirm Gardasil’s efficacy in men, with similar protection levels as seen in women. Phase 3 trials also show excellent safety results.
• MSM and immunocompromised men benefit significantly from vaccination, with strong recommendations to vaccinate up to age 45 under clinical guidance.
• HPV vaccination rates among boys are rising, with 75.1% of U.S. boys aged 13–17 receiving at least one dose by 2020.
• Addressing concerns about the side effects of Gardasil through education and reassurance is key to improving vaccine confidence and coverage.
• Gardasil is a safe, reliable, and globally approved vaccine that offers long-term health protection for men across diverse populations.

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HPV‑Related Conditions in Men Preventable by Gardasil

Although HPV is often framed as a women’s health issue due to its link to cervical cancer, it also causes a range of serious health problems in men. Gardasil, especially the 9-valent version (Gardasil 9), plays a key role in protecting men from these overlooked conditions. By covering both high-risk and low-risk HPV types, Gardasil provides broad, targeted protection for males across various age and risk groups.

• Genital Warts: HPV types 6 and 11 cause most genital warts in men. These visible, uncomfortable growths affect both health and quality of life. Gardasil 9 offers up to 99% protection against these strains, drastically reducing not only the incidence but also the recurrence of warts. Protection is strongest when the vaccine is given before HPV exposure, typically in early adolescence.
  
• Anal and Penile Cancer: High-risk strains (HPV 16, 18, 31, 33, 45, 52, and 58) are associated with cancers of the anus and penis. Gardasil 9 is the only FDA-approved vaccine that prevents the majority of these cancers in men. Men who have sex with men (MSM) and immunocompromised individuals are at particularly elevated risk and stand to benefit most from complete vaccination.
  
• Oropharyngeal Cancers: HPV-16 is strongly linked to cancers of the throat, especially the oropharynx, and disproportionately affects men. Gardasil helps reduce the oral HPV infections that are considered surrogate markers for these cancers. While definitive cancer prevention data is still pending, current evidence supports significant risk reduction. This makes Gardasil an important tool for preventing one of the fastest-growing HPV-associated cancers in men.

Clinical Trial Data on Gardasil Efficacy in Male Populations

Multiple clinical trials have demonstrated Gardasil’s effectiveness in preventing both visible symptoms (like warts) and persistent HPV infections in males aged 16 to 26. Participants showed robust immune responses—especially those vaccinated before becoming sexually active—supporting early vaccination as a powerful public health strategy for men.

Immunobridging studies comparing antibody responses in males and females revealed comparable levels of protection, confirming that men benefit just as much from the vaccine. These findings reinforce calls for gender-neutral HPV vaccination programs and provide strong rationale for public funding and universal coverage.

In a Phase 3 trial conducted in Japan, Gardasil 9 demonstrated effectiveness against all nine targeted strains in male participants. The study found no new safety concerns, adding to the consistent track record seen in global post-marketing data. The results confirm that Gardasil 9 remains a trusted and safe option for HPV prevention in men worldwide.

Gardasil Recommendations for MSM and Immunocompromised Men

Gardasil is crucial for high-risk male populations, such as MSM and immunocompromised men, who are more vulnerable to persistent infections and HPV-related cancers. Because these individuals benefit less from herd immunity, direct protection through vaccination becomes even more vital.

• MSM: This group faces a higher burden of anal cancer and genital warts due to increased HPV exposure and lower indirect protection. Health authorities strongly recommend vaccination up to age 45, especially before potential exposure. Even if exposure has already occurred, the vaccine can still offer meaningful protection.
  
• Immunocompromised Men: For men with HIV or those on immunosuppressive treatments, Gardasil provides a valuable line of defense. Although it may not fully restore immune control, it helps reduce viral persistence and lowers the risk of complications. Clinical guidelines support shared decision-making for men up to age 45, ensuring protection is tailored to individual needs.

Proactive vaccination in these groups is not just a personal health investment, but a step toward reducing the overall burden of HPV-related diseases and improving public health equity.

Encouraging HPV Vaccination Uptake Among Males

While male HPV vaccination rates used to lag behind those of females, uptake has significantly improved in recent years. According to the CDC, as of 2020, 75.1% of boys aged 13–17 had received at least one dose of the HPV vaccine, and 58.6% had completed the full series. Among young adult males aged 18–26, initiation rose from 22.1% in 2013 to 39.9% by 2018.

To keep this momentum, it’s essential to normalize HPV vaccination for boys through school-based programs, parental education, and strong clinician recommendations. Early vaccination between ages 9 and 12 leads to stronger immune responses and more effective long-term protection.

Public concerns about the side effects of the Gardasil vaccine can also influence vaccine hesitancy. However, clear communication from healthcare providers can ease anxiety. Common side effects are typically mild and temporary. Emphasizing the vaccine’s strong safety profile is key to increasing trust and uptake among male patients and their families.

Conclusion 

Gardasil offers powerful protection against HPV-related diseases in men, including genital warts, anal and penile cancers, and throat cancers. Supported by extensive clinical research, immunobridging data, and global safety surveillance, Gardasil continues to be a trusted option for routine and catch-up vaccination.

With rising coverage rates and growing awareness of HPV’s impact on men, the role of Gardasil in male health is clearer than ever. Whether administered in adolescence or later under shared clinical decision-making, it represents one of the most effective tools in preventive medicine today.

FAQs

1. Is Gardasil effective in males?

Yes. Clinical trials show that Gardasil significantly reduces the risk of external genital lesions and persistent HPV infection in men aged 16–26, with immunogenicity comparable to females. 

2. Does Gardasil prevent anal cancer in MSM?

It does. Gardasil protects MSM—especially those with HIV—against anal precancers and cancer caused by high-risk HPV types like 16/18.

3. Are there side effects men should expect?

Common side effects include injection-site tenderness, mild fever, headache, or fatigue. These are generally mild and short-lived. Severe reactions are rare, and sinus care guidelines mitigate the risk of fainting.

4. What is the recommended serology for men?

Males aged 9–14 receive two doses (6–12 months apart). Those 15–45 receive three doses at 0, 1–2 months, and 6 months. Shared decision-making is advised for adults aged 27–45 regarding the benefit.

References

Goldstone SE, Giuliano AR, Palefsky JM, et al. Efficacy, immunogenicity, and safety of a quadrivalent HPV vaccine in men: results of an open-label, long-term extension of a randomised, placebo-controlled, phase 3 trial. Lancet Infect Dis. 2022;22(3):413-425. doi:10.1016/S1473-3099(21)00327-3

Patel H, Wagner M, Singhal P, Kothari S. Systematic review of the incidence and prevalence of genital warts. BMC Infect Dis. 2013;13(1):39. 

HPV vaccine: Get the facts. Mayo Clinic. https://www.mayoclinic.org/diseases-conditions/hpv-infection/in-depth/hpv-vaccine/art-20047292