What is the HPV Vaccine?

On this page we provide general information about the HPV vaccines available in the US and UK. We list each vaccine - Gardasil 9 and Gardasil – and detail what each is indicated for in both the US and UK and for whom. We also provide a little more background into the history of HPV vaccination in each country, frequently asked questions about HPV vaccination and the Anal Cancer Foundation’s pivotal role in cancer prevention through our vaccine advocacy.

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. The vaccine became available in 2006. In the US, it is recommended that both male and female children aged 11-12 be vaccinated against HPV. Catch-up vaccination is recommended up to the age of 26. In the UK, girls and boys aged 12 to 13 years will be routinely offered the first HPV vaccination when they're in school Year 8. Those who missed their HPV vaccination in school Year 8 can continue to have the vaccine up to their 25th birthday.

Both the FDA (US) and NHS (UK) recommend that even people infected with one strain of the virus should be vaccinated if they are in the recommended age bracket. The body can be exposed to more than one strain at any given time and the vaccination will work to prevent cancer caused by the other types.

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

Meet the Vaccines

There are two vaccines available worldwide to prevent HPV. Each vaccine protects against a different number of HPV strains. However, each available vaccine protects against HPV16 and HPV18, the two HPV types most commonly found in cancers. Of all HPV-associated cancers, these two HPV strains cause 70% of cervical carcinomas, 91% of anal cancer, 80% of vulvar and vaginal cancers, 63% of penile cancer and 89% of oropharyngeal cancers. Gardasil and Gardasil 9 protect against additional HPV types, and therefore additional cancers and warts caused by these types.

In the US, two vaccines are approved by the Food and Drug Administration (FDA) for the prevention of HPV: Gardasil 9 and Gardasil.

The UK has approved one vaccination for use in their immunization program: Gardasil. Gardasil has been used in the UK’s national vaccination program since 2012. Most recently, the European Commission gave marketing approval for Gardasil 9 in the EU after the European Medicines Agency recommended its approval for use. This means that Gardasil 9 is automatically licensed for use in the UK, although it does not mean automatic inclusion in the national immunization program.

The recommendations are at times different in the UK and US because each vaccine regulatory body has different rules, regulations and timetables for the approval of vaccines.

In the US, the Center for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) recently released recommendations regarding the interchangeability of the vaccines. That is, if providers are unable to administer all three doses of the same vaccine series, they can complete the three-dose series using any of the available vaccines, providing they are the appropriate vaccine for the target user. The UK recommends that individuals complete their vaccination series with the same type of vaccine as that with which they started.

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 indicated by the FDA for the following:

Females and males aged 9-45.
Prevention of cancer-causing HPV types 16, 18, 31, 33, 45, 52 and 58 and wart-causing types HPV types 6 and 11.
Prevention of anal cancer and precancer in males and females caused by HPV types 16, 18, 31, 33, 45, 52, and 58.
Prevention of cervical, vulvar and vaginal cancer and precancer in females caused by HPV types 16, 18, 31, 33, 45, 52, and 58.
Prevention of anogenital warts in males and females caused by HPV types 6 and 11.
The vaccine is administered as three doses over six months in the following schedule: first dose, the second dose one to two months later, and the third dose six months after the first dose.
This vaccine is an update from Gardasil by adding protection against five additional HPV strains—31, 33, 45, 52 and 58.

Most recently, the European Commission gave marketing approval for Gardasil 9 in the EU, which comes after the European Medicines Agency recommended its approval for use. This means that Gardasil 9 is automatically licensed for use in the UK, although it does not mean automatic inclusion in the national immunization program. The JCVI is currently embarking on pricing and procurement exercises, with the results predicted to be available at the end of 2015.

Gardasil

In 2006, Gardasil was first approved for use in the US by the FDA. It was approved by the UK Department of Health in 2012 and replaced Cervarix in the national immunization program. It is expected that over time Gardasil will be replaced by Gardasil 9 in the US.

In both the US and UK, Gardasil is indicated for the following:

Prevention of infection by cancer-causing HPV types 16 and 18 and wart-causing HPV types 6 and 11.
Prevention of anal cancer and precancer in males and females caused by HPV types 16 and 18.
Prevention of cervical, vulvar and vaginal cancers and precancers in females caused by HPV types 16 and 18.
Prevention of genital warts caused by HPV types 6 and 11.

In the US, Gardasil is recommended for the following:

All male and female children aged 11-12.
Catch up vaccination is recommended for males and females up to 26 years old.
The vaccination is approved for individuals from the ages of 9 to 45.
It is administered as three doses over six months in the following schedule: first dose, the second dose one to two months later, and the third dose four months after the second dose.
In October 2016, the CDC changed its recommendation to two doses across six months for adolescents under 15 years old. It will be working with relevant stakeholders (parents, insurance companies, providers) to implement the change.

In the UK, Gardasil is recommended for the following:

Boys and girls from the age of 12 to 13.
It is administered as two doses. The first dose is offered in school year 8 in England and Wales, S1/S2 in Scotland and school year 9 in Northern Ireland with the second dose from six months to 24 months.

In 2019 the UK’s Joint Committee on Vaccination and Immunisation (JCVI) recommended that the HPV vaccine also be offered to men who have sex with men (MSM) aged 14-60 who identify themselves at sexual health clinics.

In March 2014, the JCVI changed the policy for Gardasil from a three-dose vaccination schedule to a two-dose schedule for females under the age of 15 following European Medicine Agency (EMA) guidelines. This is because immune response to the vaccine is higher at a younger age.

Frequently asked questions

Please remember that this information is not to be used as a substitute for medical advice or information. Please use this as supplemental material to review for your own personal knowledge and always consult a medical provider before making any medical decisions.

should i continue to be screened after vaccination?

Yes. Even after vaccination, it is recommended that women and men 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 other, less common high-risk HPV strains.

How does the HPV Vaccine work?

The vaccine does not contain any live viral particles or viral DNA. Instead, the HPV vaccine is made up of tiny proteins that look like the outside of a real human papillomavirus. These are called virus-like particles or VLPs. The vaccine does not cause infection with HPV, nor any diseases related to HPV. To see the other ingredients in the vaccine that keep it stable and also help stimulate the immune system to respond, check the CDC’s vaccine ingredient website. Or read more information on vaccine composition generally.

Once the vaccine has been injected, the virus-like particles trick the body into thinking that the actual virus is present. This 'imitation infection' stimulates the immune system to start making antibodies to protect you 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, which will remember how to fight the infection in the future. If the body later encounters the real virus, it is able to make these antibodies even faster as it has the memory of the 'infection'.

what should i know about vaccine safety?

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

who should not get vaccinated?

According to CDC recommendations, individuals with severe allergies to any of the components in the vaccines should avoid vaccination. Discuss any allergies your child might have with your medical provider.

If you are mildly sick or unwell, you can still get vaccinated. If you are experiencing moderate to severe illness, you should avoid vaccination until you have recovered.

The above recommendations come from US sources, so if you are in the UK please be sure to discuss concerns you might have with your provider prior to vaccination.

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.

Vaccine Background - US

Doctor injecting patient with HPV vaccine

Gardasil is indicated to prevent cervical, anal, vaginal and vulvar precancer and cancer and genital warts in women. It is also approved for the prevention of anal precancer and cancer and genital warts in men.

Gardasil was first approved by the FDA in 2006 and became the first vaccine on the market to protect against HPV. It was approved after four multinational studies (one that took place in the United States) 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.

A study showing Gardasil is effective in preventing HPV-associated anal disease in men was presented before the FDA's Vaccine and Biological Advisory Committee on November 17, 2010. The data submitted to the FDA illustrated that preventing infection by HPV16 and HPV18 would lead to significantly reduced rates of anal precancer and cancer. The Anal Cancer Foundation presented testimony at this November FDA hearing. The FDA approved Gardasil for both men and women for the prevention of anal precancer and cancer on December 22, 2010.

The Foundation also led a coalition of organizations to present three more testimonies in 2011 to encourage the CDC to protect males against HPV by making the 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.

It has been suggested by the Centers for Disease Control and Prevention, although not proven in studies, that these vaccines will also prevent certain types of HPV-associated head and neck cancers.

Most recently, in December 2014, the FDA approved Gardasil 9 after a global randomized control trial determined it to be 97% effective in protecting against the cancers caused by five additional HPV types - 31, 33, 45, 52 and 58. It was also determined to be as effective as Gardasil in protecting against the 4 HPV types that the vaccines share – 6, 11, 16 and 18.

Vaccine Background - UK

The HPV vaccination program began in England in 2008 following recommendation by the Joint Committee on Vaccination and Immunisation (JCVI). The JCVI issued a recommendation after a thorough examination of both published and unpublished evidence of vaccine efficacy and safety, as well as after reviewing studies that demonstrated the burden of HPV disease and the cost effectiveness of an immunization program. The recommendation included routine vaccination of 12 and 13-year-old girls with a catch-up schedule for girls aged 14-18.

Cervarix was used in the program from 2008 until September 2012, when the program switched to Gardasil. Gardasil provides protection against two more HPV strains than Cervarix. These are HPV types 6 and 11, which are known to cause genital warts.

In March 2014, the JCVI advised that a two-dose schedule was likely to be just as effective as the three-dose schedule that was being implemented at that time. This advice is based on a Canadian study demonstrating that a two-dose vaccination schedule at 0 and 6-months in 9-13 year-old girls elicited an immune response comparable to that of three doses in older (16-26 year-old) women. The effective immune response from this study was sustained at 36 months of follow-up. In September of that year, this two-dose schedule was implemented in the UK, with the first dose offered to 12-13 year-old girls and the second offered 12 months later.

The most recent developments include the JCVI recommendation that the HPV vaccine also be offered to men who have sex with men (MSM) aged 14-60 who identify themselves at sexual health clinics ('GUM' clinics). This is still at the recommendation stage and it does not seem as though the vaccination is being offered to men at these clinics at this point in time. The Anal Cancer Foundation submitted testimony in response to this recommendation commending the JCVI in their initial efforts but explaining that they do not go far enough in protecting men against infection with deadly HPV. All boys must be protected against HPV before they come into contact with the virus and when their immune response is highest, which is in their preteen years.

In 2018, the JCVI recommended the inclusion of boys in the HPV vaccination programme in the UK.

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, of which the Anal Cancer Foundation is one, that runs an advocacy campaign aiming to achieve gender-neutral HPV vaccination. The campaign goal is that all boys and girls be protected against HPV and the cancers it causes. This will be achieved through equal access to the vaccine by providing equal access to, and routinely offering, the HPV vaccine to both boys and girls.

Video credit: survivornet

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