HPV Vaccine: Types, Safety & Who It Is For

HPV (Human Papillomavirus) is a common sexually transmitted infection that can lead to several types of cancer, including anal, cervical, vulvar, vaginal, penile, and oropharyngeal (throat) cancers. Fortunately, there is a highly effective HPV vaccine that is widely given to young people to reduce their risk of infection and prevent long-term complications. In this article we cover everything you need to know about the HPV vaccine - the different types available in the US and UK, who it's for, how it's administered, its safety profile, and the Anal Cancer Foundation's advocacy work to expand access.

HPV causes 5% of the world's cancer. In the 1990s, work began to create a vaccine that would prevent the infection that causes hundreds of thousands of cancers a year, including anal cancer. The vaccine became available in 2006.

Please note that the information on this page should not be used as a substitution for medical advice. Any questions regarding your medical health should be directed to your primary care physician.

What is the HPV Vaccine?

The HPV vaccine protects against the human papillomavirus, the virus responsible for nearly all cervical cancers and more than 90% of anal cancers. The vaccine does not contain any live viral particles or viral DNA. Instead, it is made up of tiny proteins that look like the outside of a real human papillomavirus - called virus-like particles, or VLPs. These VLPs cannot cause HPV infection or any HPV-related disease.

Six vaccines are available worldwide to prevent HPV. Each protects against a different number of HPV strains, but all of them target HPV16 and HPV18 - the two strains most commonly linked to cancer. Together, HPV16 and HPV18 cause 70% of cervical carcinomas, 91% of anal cancers, 80% of vulvar and vaginal cancers, 63% of penile cancers, and 89% of oropharyngeal cancers. Gardasil and Gardasil 9 protect against additional HPV types, and therefore additional cancers and warts caused by those types.

In the US, two vaccines are approved by the Food and Drug Administration (FDA): Gardasil 9 and Gardasil. The UK has approved one vaccine for use in its national immunization program: Gardasil 9. Recommendations differ between countries because each regulatory body has its own rules, regulations, and timelines for approval.

Gardasil

Gardasil was first approved by the FDA in 2006 and became the first vaccine on the market to protect against HPV. It was approved by the UK Department of Health in 2012 and replaced Cervarix in the national immunization program. Over time, Gardasil is being phased out in favor of Gardasil 9 in the US.

Gardasil is indicated for the prevention of:

• Infection by cancer-causing HPV types 16 and 18, and wart-causing HPV types 6 and 11
• Anal cancer and precancer in males and females caused by HPV types 16 and 18
• Cervical, vulvar, and vaginal cancers and precancers in females caused by HPV types 16 and 18
• Genital warts caused by HPV types 6 and 11

Gardasil 9

In December 2014, Gardasil 9 was approved for use in the US by the FDA. In March 2015, it was included in the CDC vaccination guidelines. Gardasil 9 is an update from Gardasil, adding protection against five additional HPV strains - 31, 33, 45, 52, and 58. It was subsequently approved by the European Commission for use in the EU, which meant it was automatically licensed in the UK, and it is now the vaccine used in the UK's national immunization program.

Gardasil 9 is indicated by the FDA for:

• Females and males aged 9–45
• Prevention of cancer-causing HPV types 16, 18, 31, 33, 45, 52, and 58, and wart-causing HPV types 6 and 11
• Prevention of anal cancer and precancer in males and females caused by the seven high-risk HPV types listed above
• Prevention of cervical, vulvar, and vaginal cancers and precancers in females caused by the seven high-risk HPV types listed above
• Prevention of anogenital warts in males and females caused by HPV types 6 and 11

Who is the HPV Vaccine For?

The HPV vaccine is recommended for both males and females, starting as early as age 9. Both the FDA (US) and NHS (UK) recommend that even people already infected with one HPV strain should be vaccinated if they fall within the recommended age bracket - the body can be exposed to more than one strain at any time, and the vaccine will help prevent cancer caused by the other covered types.

Children Aged 11 or 12

In the US, the CDC recommends routine HPV vaccination for all male and female children aged 11–12, though vaccination can begin as early as age 9. Early vaccination is encouraged because pre-teens mount a stronger immune response, and because protection is greatest when the vaccine is given before any exposure to HPV.

In the UK, girls and boys aged 12 to 13 are routinely offered the first HPV vaccination in school Year 8.

HPV Vaccination for Men Who Have Sex with Men (MSM)

In the UK, HPV vaccination is also offered through sexual health (GUM) and HIV clinics to gay, bisexual, and other men who have sex with men (GBMSM):

• One-dose routine for eligible GBMSM under 25
• Two-dose routine for eligible GBMSM aged 25 to 45
• Three-dose routine for those who are immunosuppressed or known to be HIV-positive

This program exists because GBMSM are at significantly higher risk of HPV-related anal cancer, and historically were not captured by the school-based (originally girls-only) immunization program.

Age Limit

• US: Catch-up vaccination is recommended up to age 26. The vaccine is FDA-approved for ages 9–45. For adults aged 27–45, the CDC recommends shared decision-making with a healthcare provider, as the average benefit is lower at older ages.
• UK: Individuals who missed their HPV vaccination in school Year 8 can continue to have the vaccine up to their 25th birthday through the NHS catch-up program.

Who Should Not Get Vaccinated?

According to CDC recommendations, individuals with severe allergies to any component of the vaccine should not be vaccinated. Discuss any known allergies with your medical provider before vaccination.

If you are mildly sick or unwell, you can still get vaccinated. If you are experiencing moderate to severe illness, it's best to wait until you have recovered.

Women are not recommended to receive any HPV vaccine while pregnant, in either the US or the UK. Breastfeeding women may still receive the vaccine. If you are in the UK, be sure to discuss any concerns with your provider prior to vaccination.

How is the HPV Vaccine Given?

The HPV vaccine is given as an injection into the upper arm muscle. The number of doses depends on the country, age at first dose, and immune status.

United States:

• Ages 9–14: Two doses, 6–12 months apart
• Ages 15–26: Three doses over six months - the second dose one to two months after the first, and the third dose six months after the first
• Immunocompromised individuals: Three doses regardless of age

In October 2016, the CDC changed its recommendation to two doses for adolescents under 15.

United Kingdom:

• Routine adolescent program: One-dose schedule for all children in school Year 8 (ages 12–13)
• Eligible GBMSM under 25: One-dose routine
• Eligible GBMSM aged 25–45: Two-dose routine
• Immunosuppressed or HIV-positive individuals: Three-dose routine
• Catch-up: One dose up to the 25th birthday

Individuals who started their HPV vaccination schedule and had already received one dose by September 2023 are considered fully vaccinated.

In the US, the CDC's Advisory Committee on Immunization Practices (ACIP) has noted that the vaccines are interchangeable - if providers cannot complete all doses with the same vaccine series, they can use any of the available vaccines to finish the series. The UK recommends completing the series with the same vaccine used for the first dose.

How Effective is the HPV Vaccine?

The HPV vaccine is among the most effective vaccines ever developed. Gardasil was approved after four multinational studies in which 21,000 women aged 16–26 showed that Gardasil had an almost 100% effectiveness rate in preventing precancerous cervical, vaginal, and vulvar lesions, and genital warts.

Gardasil 9 was approved after a global randomized controlled trial that showed it to be 97% effective against cancers caused by the five additional HPV types (31, 33, 45, 52, and 58), and equally effective against the four HPV types shared with Gardasil (6, 11, 16, and 18).

Real-world data from vaccinated populations show dramatic declines in HPV infection rates and in precancerous cervical lesions, particularly in countries with high vaccination uptake. Early data also suggest reductions in cervical cancer incidence among women who were vaccinated as adolescents.

Why is HPV Vaccination Important?

HPV is responsible for about 5% of all cancers worldwide. In the US alone, HPV causes tens of thousands of cancers every year across six cancer types - anal, cervical, oropharyngeal, penile, vaginal, and vulvar. The vaccine can prevent the vast majority of these cancers when administered before exposure to HPV.

Unlike screening, which can detect cancer early but cannot prevent infection, vaccination stops HPV-related disease at its source. It is particularly important for protecting against cancers for which no routine screening program exists - including anal, oropharyngeal, and penile cancers.

HPV Vaccine Safety

Each HPV vaccine has been proven through research monitored by US and UK regulatory authorities to be both effective and safe. A wealth of resources about HPV vaccine safety and common side effects is available on the CDC's website. In the US, the CDC and FDA closely monitor the HPV vaccine and all other licensed vaccines. In the UK, the regulatory body responsible for ensuring vaccine safety is the Medicines and Healthcare Products Regulatory Agency (MHRA).

Since the HPV vaccine was introduced in 2006, hundreds of millions of doses have been distributed worldwide, and ongoing surveillance continues to confirm its strong safety profile.

How Does the HPV Vaccine Work?

Once the vaccine is injected, the virus-like particles (VLPs) trick the body into thinking the actual virus is present. This “imitation infection” stimulates the immune system to start making antibodies to protect against the virus and clear it from the body.

Once the imitation infection has been cleared, the body is left with a supply of “memory” cells that remember how to fight the infection in the future. If the body later encounters the real virus, it can produce antibodies much faster thanks to that memory.

To see the other ingredients in the vaccine that keep it stable and help stimulate the immune system, check the CDC's vaccine ingredient website, or read more information on vaccine composition generally.

Side Effects

The HPV vaccine has a well-established safety profile. Most side effects are mild and short-lived. The most commonly reported include:

• Pain, redness, or swelling at the injection site
• Fever
• Headache or tiredness
• Nausea
• Muscle or joint pain

Fainting has been reported in adolescents after vaccination. For this reason, the CDC recommends patients sit or lie down for 15 minutes after the injection. Serious allergic reactions are rare. Side effects from the HPV vaccine are no more common than those reported for other routine adolescent vaccinations.

Where to Get the HPV Vaccine

In the US, the HPV vaccine is typically given at:

• Pediatricians' offices and family doctors
• OB/GYN offices
• Local and state health departments
• Many pharmacies (age requirements vary by state)
• School-based health centers

In the UK, the HPV vaccine is given:

• In schools (the routine program for Year 8)
• At GP surgeries (for catch-up and immunosuppressed patients)
• At sexual health (GUM) and HIV clinics (for eligible GBMSM and certain other groups)

Cost

In the US, the HPV vaccine is covered by most private health insurance plans, Medicaid, and Medicare as a preventive service with no out-of-pocket cost. For children under 19 who are uninsured, underinsured, Medicaid-eligible, or American Indian/Alaska Native, the federal Vaccines for Children (VFC) program provides the vaccine at no cost. Without insurance coverage, the vaccine costs approximately $200–$300 per dose.

In the UK, the HPV vaccine is free through the NHS for everyone eligible under the national immunization program, including school-based vaccination, catch-up vaccination up to age 25, and the GBMSM program.

How Long Does the HPV Vaccine Last?

Current data show that protection from the HPV vaccine lasts at least 12+ years after vaccination, with no evidence of waning immunity. Long-term studies are ongoing, but based on the data available so far, no booster dose is currently recommended. Recommendations may be updated as more data accumulate.

History

The HPV vaccine was born out of decades of research into the link between human papillomavirus and cancer. Its approval marked a major turning point in cancer prevention - the first vaccine shown to prevent a cancer caused by an infection.

When Did the HPV Vaccine Come Out?

The first HPV vaccine - Gardasil - was approved by the FDA in 2006. It became the first vaccine on the market to protect against HPV, after four multinational studies (one of them in the United States) demonstrated near-100% effectiveness in preventing precancerous cervical, vaginal, and vulvar lesions and genital warts in 21,000 women aged 16–26.

A study showing Gardasil's effectiveness in preventing HPV-associated anal disease in men was presented before the FDA's Vaccines and Related Biological Products Advisory Committee on November 17, 2010. The Anal Cancer Foundation presented testimony at this hearing. The FDA approved Gardasil for the prevention of anal precancer and cancer in both men and women on December 22, 2010. The Foundation also led a coalition of organizations to present three more testimonies in 2011, encouraging the CDC to make HPV vaccination for males as much a part of their routine vaccination schedule as it was for females. For more details, please read our testimonies.

The Centers for Disease Control and Prevention has suggested, although it is not yet proven in studies, that these vaccines will also prevent certain types of HPV-associated head and neck cancers.

A second-generation vaccine, Gardasil 9, was approved in December 2014 after a global randomized controlled trial showed it to be 97% effective against cancers caused by five additional HPV types (31, 33, 45, 52, and 58) - and equally effective as Gardasil against the four shared types (6, 11, 16, and 18).

The UK's HPV vaccination program began in England in 2008 following a recommendation by the Joint Committee on Vaccination and Immunisation (JCVI). The JCVI issued its recommendation after a thorough examination of published and unpublished evidence of vaccine efficacy and safety, as well as studies demonstrating the burden of HPV disease and the cost-effectiveness of an immunization program. The original recommendation called for routine vaccination of 12- and 13-year-old girls with a catch-up schedule for girls aged 14–18. Cervarix was used in the UK program from 2008 until September 2012, when the program switched to Gardasil, which protects against two additional strains (HPV 6 and 11) that cause genital warts. In March 2014, the JCVI advised that a two-dose schedule was likely to be as effective as the three-dose schedule being used at the time, and the two-dose schedule was implemented in the UK in September 2014.

A major turning point came in 2018, when the JCVI recommended the inclusion of boys in the HPV vaccination programme in the UK - after years of advocacy from the Anal Cancer Foundation and partner organizations.

FAQs

Does the HPV Vaccine Help if Already Infected?

Yes - but with an important caveat. The HPV vaccine does not treat an existing HPV infection or cure any HPV-related disease already present. However, because HPV has multiple strains and the vaccine protects against several of them, someone infected with one HPV type can still benefit from protection against the other types covered by the vaccine. Both the FDA and the NHS recommend that people who have been exposed to HPV still receive the vaccine if they are within the recommended age range.

Should I Continue to Be Screened After HPV Vaccination?

Yes. Even after vaccination, women and men should continue to be monitored by their clinician for precancerous lesions. The vaccines do not protect against HPV infections that existed before vaccination, nor do they protect against the less common high-risk HPV strains not included in the vaccine.

Why is the HPV Vaccine Given at a Young Age?

The HPV vaccine is most effective when given before exposure to HPV - that is, before the start of sexual activity. Pre-teens also mount a stronger immune response to the vaccine than older adolescents and young adults, which is why younger age groups typically require only two doses instead of three.

HPV Vaccine Ingredients

The active ingredient in HPV vaccines is virus-like particles (VLPs) - tiny, non-infectious proteins that mimic the outer shell of the human papillomavirus. Vaccines also contain an aluminum-based adjuvant to boost the immune response, along with small amounts of yeast protein, salts, and water. The vaccine does not contain any live virus or viral DNA and cannot cause HPV infection. A complete list of ingredients is available on the CDC's vaccine ingredient website.

Should I Get the HPV Vaccine?

If you are between the ages of 9 and 26 and have not yet been vaccinated, you are strongly encouraged to get the HPV vaccine. If you are between 27 and 45, the CDC recommends a conversation with your healthcare provider about whether vaccination is right for your personal situation. Ultimately, the decision should be made in consultation with a qualified medical provider who can review your health history and exposure risks.

UK Advocacy

To combat the harm that non-gender-neutral vaccination continues to do in the UK, an organization called HPV Action (HPVA) was founded to reduce the health burden of HPV. HPVA is a collaborative partnership of 51 patient and professional organisations - including the Anal Cancer Foundation - that runs an advocacy campaign aiming to achieve gender-neutral HPV vaccination. The campaign's goal is that all boys and girls be protected against HPV and the cancers it causes, through equal access to the vaccine and routinely offering the HPV vaccine to both boys and girls.

Video credit: survivornet

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