Document history

Background to the HPV vaccination programme

On the advice of the Joint Committee on Vaccination and Immunisation (JCVI), an HPV national vaccination programme was introduced in 2008 to protect secondary school Year 8 girls (aged 12 to 13 years old) against cervical cancer. At that time, a catch-up programme also took place to vaccinate girls aged 13 to 18 years old.

The recommendation for a 3 dose schedule of HPV vaccine in the vaccination programme for adolescent girls was reviewed by JCVI in May 2014. Following this, a 2 dose schedule was recommended for girls under fifteen years of age as antibody response to 2 doses was found to be as good as a 3 dose course.

Emerging evidence from evaluation of the programme has shown that the number of young women with pre-cancerous cervical disease is falling (Scotland data), and that the number of infections of HPV types 16 and 18, the main cancer-causing types, has reduced by 86% in 16 to 21 year old women in England. In 2018, 10 years after vaccination was introduced, no HPV16 and/or 18 infections were detected in 16 to 18 year olds, indicating the programme has succeeded in delivering both direct and indirect protection. In 2019, the rate of genital wart diagnoses among 15 to 17 year old girls was 91% lower compared to 2015 and a decline of 81% was seen in the same aged heterosexual boys over the same period, suggesting substantial herd protection. Current indications are that this protection will last for many years.

In June 2012, the JCVI asked the Health Protection Agency (now UK Health Security Agency (UKHSA), previously Public Health England (PHE)), to undertake modelling studies to assess the impact and cost effectiveness of HPV vaccination of men who have sex with men (MSM), as this group were expected to receive very little indirect protection or benefit from the HPV vaccination programme offered to adolescent females.

In 2015, JCVI advised that all MSM up to and including 45 years who attend sexual health and/or HIV treatment services should be offered the vaccine.

In 2016, a successful PHE-led pilot was set up which offered vaccine to MSM through existing appointments at selected local sexual health services in England. In April 2018, the vaccination programme was extended to include MSM up to and including 45 years attending all specialist sexual health and HIV services.

In 2017, JCVI considered evidence for extending the HPV vaccination programme to boys. At that time, extending the programme to boys was not considered cost effective and JCVI was unable to recommend extension.

Following stakeholder responses to this interim advice, additional analyses were conducted which adjusted for the long natural history of HPV associated disease. This analysis found extension of HPV vaccination to boys to be cost effective and it is anticipated that ongoing reduction in the incidence of cervical cancer, other cancers in both men and women and genital warts will substantially reduce the burden of HPV-related diseases.

In September 2019, the existing HPV vaccination programme was extended to boys from 12 years of age and this is expected to provide clear health benefits including:

• direct protection for vaccinated boys against HPV infection and associated disease such as anogenital warts, anal, penile and oropharyngeal cancers
• protection against HPV for MSM by offering them vaccination before their sexual debut
• indirect protection for non-vaccinated males and females

At its meeting in June 2016 the Chair of the Joint Committee on Vaccination and Immunisation (JCVI) noted that the 9-valent vaccine was the preferred vaccine for the girls’ programme because of the additional health benefits that it provided in protecting against the 5 additional cancer causing HPV types.

In early 2022 the Gardasil 9 vaccine will be introduced into the programme and supplied for those eligible for the HPV vaccine (adolescents aged 12 to 13 years and those who remain eligible until they turn 25 years of age, and MSM up to and including 45 years of age). As the programme transitions to Gardasil 9, some individuals will receive a mixed schedule during the switch. Both Gardasil and Gardasil 9 vaccines should be considered interchangeable and vaccination should not be delayed due to preference for either vaccine.

This guidance provides information for healthcare practitioners about HPV programme eligibility, scheduling and vaccine administration.

The Green Book Human papillomavirus (HPV) Chapter 18a

The Green Book HPV Chapter 18a includes detailed information about HPV, the history and epidemiology of the disease and the vaccination programme.

Healthcare practitioners should familiarise themselves with this Green Book chapter before offering or advising on HPV vaccination and refer to relevant parts of the chapter for information on the following:

• history and epidemiology of the disease
• the HPV vaccination
• storage
• presentation
• HPV immunisation programme
• dosage and schedule for HPV vaccines licensed in the UK
• previous incomplete HPV vaccination
• administration
• disposal
• recommendations for the use of the vaccine
• National adolescent HPV vaccination programme
• HPV vaccination programme for men who have sex with men (MSM)
• contraindications
• adverse reactions
• supplies

The HPV vaccination programme

The HPV vaccine is recommended for:

• all adolescents (boys and girls) in school Year 8 (usually aged 12 and 13)
• MSM up to and including 45 years of age attending Specialist Sexual Health Services and/or HIV clinics regardless of risk, sexual behaviour or disease status

Girls remain eligible to receive the vaccine up to their 25th birthday, and boys in the eligible cohort (born after 1 September 2006) remain eligible to receive the vaccine until their 25th birthday. Older boys (born before 1 September 2006) have not been offered the vaccine as they are already benefitting greatly from the indirect protection provided by the HPV vaccination programme to date.

MSM older than 45 years are not eligible for HPV vaccination under the national NHS England procured service.

Although the universal adolescent HPV programme will be delivered as a school-based programme, eligible individuals who are home-schooled, or schooled outside of mainstream schooling should also be offered the vaccine.

Individuals with a similar risk profile to MSM

JCVI considers that there may be considerable benefit in offering the HPV vaccine to other individuals who have a similar risk profile to that seen in the sexual health and HIV clinic attending MSM population, including some MSM over 45 years of age, ex-workers, HIV positive women, and HIV positive men. Clinicians are able to offer vaccinations outside of the national programme using individual clinical judgement, and HPV vaccination could therefore be considered for such individuals on a case-by-case basis.

In these instances, vaccine should be purchased directly from the manufacturer and costs reclaimed. Vaccine stock centrally procured for the schools-based or the MSM programme should not be used for this purpose.

Transgender individuals

The eligibility of transgender women (women who were assigned male at birth) should be a case-by-case clinical decision based on a risk assessment that includes the woman’s sexual behaviour and the sexual behaviour of their partners. Transgender women are eligible if their risk of acquiring HPV is equivalent to the risk of MSM eligible for the HPV vaccine.

Transgender men (men who were assigned female at birth) are eligible for vaccination if they have sex with other men, attend specialist sexual health or HIV services and are aged 45 and under. If they have previously completed a course of HPV vaccination as part of the girls’ school Year 8 HPV vaccine programme, no further doses need be given.

Vaccination of individuals not eligible to receive HPV vaccine as part of an NHS-approved vaccination programme

For these individuals, if following a clinical assessment HPV vaccine is clinically indicated, the vaccine can be prescribed but must be sought separately from the national immunisation stock.

Vaccine supplied to practices free of charge via ImmForm cannot be used for this purpose. GP surgeries should order HPV vaccine directly from the manufacturer and then reclaim the cost of the vaccine.

Some parents may opt to make alternative arrangements to have their child immunised with the HPV vaccine if their child does not meet the eligibility criteria for the routine programme. Parents should be informed that if the vaccine is not clinically indicated and a private arrangement is made for vaccination, the provider may charge for the service as this arrangement is outside of the national programme.

Individuals moving from abroad

Males and females moving to the UK from overseas who have not been offered protection against HPV in their country of origin and who meet the eligibility criteria for HPV vaccine should be offered vaccine if they are under 25 years of age. This would include females born after 1 September 1991, males born after 1 September 2006 and MSM attending specialist sexual health service clinics up to 45 years of age.

Recommended vaccine

During 2022, the vaccine supplied for the adolescent HPV and HPV–MSM programmes will change from Gardasil to Gardasil 9. It is expected that UKHSA will begin to supply Gardasil 9 in early 2022, although this timing is dependent on depletion of UKHSA’s stocks of Gardasil.

Once UKHSA start to supply Gardasil 9, for a period of time, both vaccines may be locally available in different areas as teams exhaust their local Gardasil stocks at a different pace. Both vaccines can be used interchangeably and there should be no delay due to preference for either vaccine.

Gardasil

Gardasil is licensed for use from 9 years of age and it is the vaccine that has been used in the NHS since 2012. Gardasil provides protection against 4 HPV types: 16 and 18, 2 high risk HPV types that can lead to cancer; and 6 and 11, the 2 HPV types that cause approximately 90% of all anogenital warts in males and females.

Gardasil 9

Gardasil 9 is licensed for use from 9 years of age and provides protection against 9 HPV types: 6, 11, 16, 18, 31, 33, 45, 52, 58. This vaccine will become available for use from early 2022.

The vaccine is made from the proteins that make up the outer coat of the virus types. These proteins assemble into small spheres that are called virus-like particles (VLPs). VLPs are not infectious and cannot cause HPV-associated cancers or genital warts as they do not contain the virus’s DNA. However, VLPs are very immunogenic, which means that they induce high levels of antibody production by the body. Following vaccination with HPV vaccine, the immune system should mount a response against the VLPs. Upon subsequent exposure to the live virus, the immune system reacts quickly to prevent infection.

The WHO vaccine-preventable diseases monitoring system 2020 global summary lists over 120 countries using HPV vaccine around the world. Over 10.5 million doses were given in the first 10 years of the HPV vaccine programme in the UK and more than 100 million people have been vaccinated worldwide.

Gardasil 9 offers protection against 5 additional types of HPV (31, 33, 45, 52, 58) which, although less common than types 16 and 18, are also considered high-risk. Gardasil 9 is expected to prevent the majority of cervical, vaginal and vulvar cancers and premalignant lesions, as well as genital warts associated with HPV.

HPV vaccine excipients

Vaccine excipients can be found in the vaccine’s summary of product characteristics (SPC):

Neither Gardasil nor Gardasil 9 contain thiomersal or porcine gelatine.

Vaccine efficacy

Gardasil has been shown to be highly effective in preventing HPV infection for the serotypes contained in the vaccine.

In clinical trials in young women with no previous history of HPV infection, the vaccine was shown to be 99% effective at preventing pre-cancerous lesions associated with HPV types 16 and 18. Gardasil is also 99% effective at preventing genital warts associated with vaccine types in young women.

Although Miltz and others concluded that there was no evidence that HPV vaccines are effective in preventing vaccine-type HPV-associated pre-cancer in women with evidence of prior HPV exposure, it has been suggested that they may be an effective post-treatment adjuvant form of therapy by boosting immunity, reducing recurrences or preventing re-infection in people with a history of previously treated high-grade anal intraepithelial neoplasia (HGAIN).

Prior infection with an HPV type does not diminish the efficacy of the vaccine against other HPV types included in the vaccine. To get the best protection, it is important that the full course of vaccination is received.

A clinical trial of Gardasil in men indicated that it can prevent anal cell changes caused by persistent HPV infection, and genital warts. HPV vaccines have not been shown to have an impact on an existing infection or any of the outcomes of an existing HPV infection, such as anogenital warts, but may boost immunity and prevent re-infection or reduce recurrences in people with established disease.

Vaccine dosage and schedule

Gardasil and Gardasil 9 should be administered as a 0.5ml dose. The schedule for number of doses depends on age:

Individuals less than 15 years of age

HPV vaccine should be administered as a 2 dose schedule at 0 and 6 to 24 months.

Any interval between doses of between 6 and 24 months is clinically acceptable. As long as the first dose was received before the age of 15 years the 2 dose schedule can be followed. For example, if the first dose was given aged 14 years but the patient does not re-present in clinic until 17 years of age, only 1 further dose needs to be given.

Individuals 15 years of age and above (where the course is initiated after the 15th birthday)

HPV vaccine should be administered as a 3 dose schedule at 0, 2 and 6 months.

In a 3 dose schedule, the second dose should be administered at least 1 month after the first dose and the third dose should be administered at least 3 months after the second dose. All 3 doses should ideally be given within 1 year, however a 24 month period is clinically acceptable.

Any eligible individual that started but did not complete the schedule before reaching the age of 25 years, should complete the vaccination course.

MSM attending specialist sexual health services

Any eligible patient that started, but did not complete the schedule before reaching the age of 46 years, should complete the vaccination course.

Immunosuppressed individuals

Immunosuppressed individuals or those known to be HIV positive should be offered a 3-dose schedule at 0, 2 and 6 months. See Green Book Human Papillomavirus (HPV) Chapter 18a for details.

Duration of protection

Current studies suggest that protection is maintained for at least 10 years although it is expected to last longer and may be lifelong. Long term follow up studies are underway to evaluate this and will determine the need for any boosters.

There is currently no recommendation for any booster dose of HPV vaccine following a primary course.

Vaccine safety

The safety of HPV vaccine has been established through rigorous testing in clinical trials followed by extensive global use with millions of doses administered to date. As with any medicinal product, some people may experience a side effect (see adverse reactions section below), but these are generally mild, of short duration and outweighed by the benefits of the vaccine.

The US Centers for Disease Control and Prevention (CDC) have posted clear advice on their website supporting the safety of HPV vaccine.

Postural orthostatic tachycardia syndrome (POTS)

POTS is 4 times more common in females and has peak onset in adolescence. Given the number of girls vaccinated, a large number of diagnoses of POTS around the age HPV vaccine is given would be expected, regardless of any association with the vaccine.

In previous years, concerns regarding the safety of the HPV vaccine have been raised in the UK and other European countries, with some parents and pressure groups linking the vaccine to POTS. In June 2015, the JCVI carried out a routine review of HPV vaccine safety and concluded that it had no concerns about the safety of the HPV vaccine. The European Medicines Agency (EMA) has also conducted an independent review and, in line with findings from the UK’s MHRA, concluded that available evidence does not support that HPV vaccines cause complex regional pain syndrome (CPRS) or POTS.

HPV vaccine was temporarily suspended by the Japanese government in 2013 but as no causal link was found between the vaccine and the illnesses reported in Japan the suspension was lifted in 2020. No other health authorities have taken similar action, and the World Health Organization continues to endorse the HPV vaccine.

Various worldwide independent health bodies and authorities have also reviewed the safety of the HPV vaccine and all have concluded that the evidence does not support a link between HPV vaccine and the development of a range of chronic illnesses.

HPV vaccine ordering

There are separate order lines for the adolescent and MSM HPV programmes on ImmForm. The correct one must be used to order vaccine volumes for each programme, even where an ImmForm account holder is ordering for both.

HPV vaccine storage

HPV vaccine should be stored in a vaccine refrigerator between +2°C and +8°C. The vaccines should be stored in the original packaging to protect them from light and should not be frozen. Further information on vaccine storage is available in the vaccine SPC, the patient group direction (PGD) and from the manufacturer.

Effectiveness cannot be guaranteed for vaccines unless they have been stored at the correct temperature. Those responsible for the ordering, storage and use of vaccines should be familiar with the recommendations in the Green Book Chapter 3. Vaccines should not be over-ordered or stockpiled.

Consent

Obtaining consent

Where doses of HPV vaccine are being given in school, it may be more practical to obtain written consent for both doses of HPV vaccine from parents once rather than separately for each dose. As the 2 HPV doses may be given across 2 different academic years (Year 8 and Year 9) in areas delivering a school-based programme, if written consent is sought from parents, this need only be done once for the full course.

Written consent

In the routine school-based immunisation programmes, an information leaflet and consent form is usually sent to the parent to complete and return as they are not present at the time of vaccination. Email or electronic forms of consent are increasingly being used. Consent forms should not act as a barrier to immunisation and they should be as simple to complete as possible. Any information being collected about the young person, such as their health and immunisation status, or medications being taken, should be relevant to the immunisation being offered.

Verbal consent

On the day of the immunisation session, some school nurses and school immunisation teams attempt to make contact with the parent or guardian of young people who are keen to be immunised but who have not returned a written consent form. This enables them to obtain consent over the phone which maximises uptake and reduces the need for additional catch-up sessions. This strategy also has the added benefit of including people who are unable to complete written consent forms due to language or literacy issues.

Self-consent

As is clearly outlined in the Green Book Consent chapter, some young people can self-consent. If a parent cannot be reached on the phone at the time of the immunisation session, self-consent should be used, where appropriate, to ensure the child is protected:

• young people aged 16 and 17 are presumed, in law, to be able to consent to their own medical treatment
• younger children who understand fully what is involved in the proposed procedure (referred to as ‘Gillick competent’) can also give consent, although ideally their parents will be involved. Although there is no lower age for Gillick competency, as this will vary from child to child, some immunisation teams choose to reserve this option for senior school children
• if a person aged 16 or 17 or a Gillick-competent child consents to treatment, a parent cannot override that consent
• if the health professional taking consent felt a child was not Gillick-competent then the consent of someone with parental responsibility would be sought
• if a person aged 16 or 17 or a Gillick-competent child refuses treatment that refusal should be accepted. It is unlikely that a person with parental responsibility could overrule such a refusal.

A number of local areas are already successfully using self-consent for young people aged 16 or 17 and Gillick-competent children in their schools-based programmes. Some teams advise parents in the information provided, that the young person will be offered the opportunity to self-consent if the completed consent form is not returned. Self-consent can also increase inclusion where parents have language or literacy issues and could also reduce the need for additional immunisation sessions at the school.

Vaccine administration

Administering HPV vaccine

HPV vaccine should be administered according to the manufacturer’s instructions and healthcare professionals are encouraged to read the individual vaccine summary of product characteristics (SPC) to ensure accurate delivery of the product. Prior to use, the pre-filled syringe should be shaken well to obtain a white, cloudy suspension.

The vaccine should be administered by a single intramuscular injection (I/M) into the deltoid area of the upper arm. Healthcare professionals should choose an appropriate needle length to ensure an intramuscular (IM) administration depending on the size and weight of the patient.

A small air bubble may be visible in the prefilled syringe. This is not harmful and should not be removed prior to administration. This small bolus of air injected following administration of medication clears the needle and prevents a localised reaction from the vaccination. To try to expel it risks accidently expelling some of the vaccine and therefore not giving the patient the full dose.

Accurate records should be kept to ensure there is clear evidence of which HPV vaccine has been administered and Gardasil or Gardasil 9 should be specified.

Vaccination for individuals with bleeding disorders

Individuals with bleeding disorders may be vaccinated intramuscularly if, in the opinion of a doctor familiar with the individual’s bleeding risk, vaccines or similar small volume intramuscular injections can be administered with reasonable safety by this route. If the individual receives medication or treatment to reduce bleeding, for example treatment for haemophilia, intramuscular vaccination can be scheduled shortly after such medication or treatment is administered. Individuals on stable anticoagulation therapy, including individuals on warfarin who are up to date with their scheduled INR testing and whose latest INR was below the upper threshold of their therapeutic range, can receive intramuscular vaccination. A fine needle (equal to 23 gauge or finer calibre such as 25 gauge) should be used for the vaccination, followed by firm pressure applied to the site (without rubbing) for at least 2 minutes.

If in any doubt, consult with the clinician responsible for prescribing or monitoring the individual’s anticoagulant therapy.

The individual or carer should be informed about the risk of haematoma from the injection.

Administering the HPV vaccine at the same time as other vaccines

Gardasil and Gardasil 9 are inactivated vaccines and will not be affected by, nor interfere with other inactivated or live vaccines given at the same time, or at any interval from each other.

If more than 1 vaccine is given at the same time, the vaccines should be given at separate sites, preferably in a different limb. If given in the same limb, they should be given at least 2.5cm apart. The site at which each vaccine was given should be noted in the individual’s records.

MSM Hepatitis B vaccination status

Clinics or clinicians should take the opportunity to check (and correctly code) patients’ hepatitis B virus (HBV) vaccination status. Hepatitis B vaccination uptake amongst MSM attending specialist sexual health services is below national targets, both for first dose uptake and for completion of 3 doses of vaccine. Recording of both HBV immunity and hepatitis B vaccine delivery by clinician coding is also suboptimal. The UK’s risk-based vaccination policy for hepatitis B includes MSM and maintaining high vaccine coverage in MSM is important to avoid outbreaks of HBV infection.

Further information is available in the Green Book Hepatitis B Chapter 18and in the British Association for Sexual Health and HIV (BASHH)’s National Guidelines for the Management for Viral Hepatitides 2017 interim update.

Cautions and contraindications for receiving Gardasil or Gardasil 9

There are very few individuals who cannot receive HPV vaccines. Where there is doubt, instead of withholding immunisation, appropriate advice should be sought from a consultant with immunisation expertise, a member of the screening and immunisation team or from the local health protection team.

Minor illnesses without fever or systemic upset are not valid reasons to postpone immunisation. If an individual is acutely unwell, immunisation may be postponed until they have fully recovered. This is to avoid confusing the differential diagnosis of any acute illness by wrongly attributing any signs or symptoms to any possible adverse effects of the vaccine.

Gardasil and Gardasil 9 should not be administered to those who have had:

• confirmed anaphylaxis to a previous dose of the vaccine OR
• confirmed anaphylaxis to any constituent or excipient of the vaccine

For the composition and full list of vaccine excipients refer to the specific Summary of Product Characteristics (SPC):

Yeast allergy

Although Gardasil and Gardasil 9 vaccines are grown in yeast cells, the final product does not contain any yeast. Individuals with a yeast allergy can receive Gardasil or Gardasil 9 vaccine as this is not a contraindication.

Individuals with underlying medical conditions

Immunosuppression

There is no data for 2 dose schedules for immunocompromised individuals. For this reason, a 3 dose schedule should be offered to individuals who are known to be immunocompromised at the time of immunisation. Re-immunisation should be considered after treatment is finished and/or recovery has occurred.

Specialist advice may be required, see Green Book Chapter 7 and Chapter 18a.

HIV positive individuals

Eligible individuals with human immunodeficiency virus (HIV) infection should be given HPV vaccine regardless of CD4 count, antiretroviral therapy use or viral load. Evidence suggests individuals with HIV infection are at increased risk of acquiring HPV and persistent infection, as well as frequent carriage of multiple HPV types and increased risk of HPV-related rapidly progressive malignancies.

There are limited data on 3 dose schedules in HIV-infected individuals; however HPV vaccines are known to be safe and immunogenic when given to individuals infected with HIV with no adverse impact on CD4 cell counts or viral load observed.

There are no data to support giving fewer than 3 doses among HIV-infected individuals, therefore only a 3 dose schedule should be offered to individuals in the eligible cohort who are known to be HIV-infected. The immune response to this vaccination and its effectiveness may be less than that observed among those who are non-HIV infected.

Adverse reactions following Gardasil vaccination

In clinical vaccine trials the most common adverse reactions observed were injection-site reactions (77.1% of vaccinees within 5 days following any HPV vaccination visit). These include mild to moderate short-lasting pain, redness and swelling at the injection site. Other reactions commonly reported are headache, fever, nausea and dizziness. These adverse reactions are usually mild or moderate in intensity.

Adverse reactions following Gardasil 9 vaccination

In clinical vaccine trials the most common adverse reactions observed were injection-site reactions (84.8% of vaccinees within 5 days following any vaccination visit). These include mild to moderate short-lasting pain, redness and swelling at the injection site. Other reactions commonly reported are headache, fever, nausea and dizziness. These adverse reactions were usually mild or moderate in intensity.

For a detailed list of adverse reactions associated with Gardasil or Gardasil 9 refer to the manufacturer’s summary of product characteristics (SPC) or the patient information leaflet (PIL):

Reporting adverse reactions to HPV vaccine

Any suspected adverse reactions following administration should be reported to the Medicines and Healthcare Products Regulatory Agency (MHRA) using the yellow card reporting scheme.

PGDs and patient information

Patient group directions (PGDs) and off-label use

Gardasil and Gardasil 9 are prescription only medicines and should only be administered using 1 of the following:

• prescription written manually or electronically by a registered medical practitioner or other authorised prescriber
• Patient Specific Direction (PSD)
• Patient Group Direction (PGD)

UKHSA have developed a national PGD template which should be reviewed and authorised locally before use. Off-label use of licensed products can be permitted under a PGD if that use is included within the PGD.

Incomplete or interrupted schedules

Individuals who have not had their first HPV vaccine dose by 15 years of age

Eligible individuals who have not had their first dose of HPV vaccine by the time they are 15 years of age should be offered the 3 dose schedule at 0, 2 and 6 months.

Eligible individuals with a history of receiving an incomplete course of HPV vaccine

Where an individual in the eligible cohort (females born after 1 September 1991 and males born after 1 September 2006) presents with an incomplete vaccination history, every effort should be made to clarify what doses they have had and when they were administered.

The course should be completed according to a vaccination schedule of 0, 2 and 6 months or 0 and 6 to 24 months, depending on the age of the individual when the first dose was administered and whether 1 or 2 doses have already been given. If the course is interrupted, it should be resumed but not repeated.

Eligible individuals who commenced a 3 dose schedule before the age of 15 years and who received the first 2 doses of vaccine at least 6 months apart do not require a third dose and should be considered to have completed the full course.

Individuals who have received 2 doses less than 6 months apart should receive a third dose (given according to the guidance in the schedule section above) as 2 doses less than 6 months apart is not considered adequate to provide long term protection.

Vaccines administered at less than the recommended interval

Where vaccines have been given at less than the recommended interval, the dose should be repeated once the recommended time period has elapsed and at least 4 weeks from the last dose given. Individuals should be advised this may lead to an increased risk of local reaction.

If an individual following the 2 dose schedule has received their vaccine doses at less than a 6 month interval, a third dose should be given. Although the number of days within a 6 month period can vary depending on what time of the year it covers, 2 doses of Gardasil given less than 6 months apart should not be considered adequate to provide long-term protection. As the Green book HPV Chapter 18a and HPV PGD recommend a minimum interval of 6 months between doses, vaccination sessions that are less than 6 months apart should not routinely be scheduled.

Administration of an incomplete dose

In the event that Gardasil or Gardasil 9 vaccine is administered at less than the recommended 0.5 ml dose, the vaccination will need to be repeated because the dose that the individual received may not be sufficient to evoke a full immune response. Where possible, the dose should be repeated on the same day or as soon as possible thereafter.

Gardasil/Gardasil 9 scheduling

Individual or parent requests the same vaccine for the second dose

Gardasil and Gardasil 9 should be considered as interchangeable and there should be no delay due to preference for either vaccine. Individuals may receive 2 doses of Gardasil, 2 doses of Gardasil 9 or a mixed schedule.

Individual or parent is concerned about the reason Gardasil is being replaced with Gardasil 9

Gardasil has an excellent safety record established after use of more than 7 million doses in the routine immunisation programme in the UK since 2012, with millions more doses used in other countries. No serious new safety issues have been found with Gardasil since it was introduced in the UK and it has been shown to provide good protection against cervical and other HPV-related cancers.

Individual or parent requests Gardasil 9 even though they have completed a course of Gardasil vaccine

The primary purpose of the national immunisation programme is to protect against HPV-related cancers. Gardasil has been shown to give good protection against HPV related cancers caused by HPV types 16 and 18. It would not be appropriate therefore as part of the NHS programme to offer Gardasil 9 to those who have had a full course of Gardasil.

Training and resources

Full details on the HPV vaccine programmes are available from GOV.UK (including training materials, slide set for healthcare practitioners, posters and leaflets):

You can order paper copies of the leaflets and download social media cards to promote HPV vaccination at the Health Publications website.

COVER data

Vaccine coverage data for the adolescent HPV programme

The routine HPV vaccine coverage collection for the adolescent programme will not be impacted by the switch to Gardasil 9.

Dose 1 and dose 2 coverage of HPV vaccine will continue to be evaluated for both males and females in school Year 8 (ages 12 to 13 years old) and Year 9 (ages 13 to 14 years old) as part of the routine universal programme.

HPV coverage is based on aggregated school level data. The data is entered manually on a secure web platform called ImmForm. For more information, please see: Annex B: HPV vaccine coverage data and annual HPV coverage reports.

Vaccine coverage data collection for the MSM HPV vaccination programme

Accurate recording of all vaccine doses given and reasons for not offering or giving the vaccine to eligible MSM (via the codes available in surveillance and reporting systems) is essential.

Further information on MSM HPV vaccine coverage collection available in Annex B and Annex C of the HPV immunisation programme Gardasil 9 letter.

Further resources

UKHSA Immunisation against infectious diseases (The Green Book) Chapter 18a Human papillomavirus (HPV).

HPV immunisation programme: introduction of Gardasil 9 letter.

Collection of HPV vaccination programme documents and resources.

Collection of HPV vaccination programme for men who have sex with men (MSM) documents and resources.

Summary of Product Characteristics for Gardasil available on the electronic Medicines Compendium:

UKHSA Immunisation Patient Group Direction (PGD) templates.

Centers for Disease Control and Prevention (CDC) HPV Vaccine Efficacy.

CDC HPV Vaccine Safety.

European Medicines Agency Gardasil 9.

HPV vaccination for MSM: posters and leaflets.