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The purpose of this guidance is to provide information for healthcare practitioners aboutÌýHPVÌýprogramme eligibility, scheduling and vaccine administration.

Background to the HPV vaccination programme

Schedule changes

On the advice of the Joint Committee on Vaccination and Immunisation (JCVI), anÌýHPVÌýnational vaccination programme was introduced in September 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 all girls aged 13 to 18 years old.

The recommendation for a 3 dose schedule ofÌýHPVÌývaccine in the vaccination programme for adolescent girls was reviewed byÌýJCVIÌýin 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 to a 3 dose course.

In 2015,Ìý³Ù³ó±ð JCVI advised that allÌýgay, bisexual and other men who have sex with men (GBMSM)Ìýup to and including 45 years of age who attend sexual health and/orÌýHIVÌýclinics should be offered the HPV vaccine. The JCVI advice was made on the basis that this group were at higher risk of HPV infection and related disease and were expected to receive lower indirect protection or benefit from theÌýadolescent female HPVÌývaccination programme.

After a successful pilot programme in 2016, in April 2018, the HPV vaccination programme was extended to includeÌýGBMSMÌýup to and including 45 years attending all specialist sexual health services (SHSs) andÌýHIVÌý³¦±ô¾±²Ô¾±³¦²õ.

In 2017,Ìý³Ù³ó±ð JCVI considered evidence for extending theÌýHPVÌývaccination programme to boys. At that time, extending the programme to boys was not considered cost effective andÌýJCVIÌýwas unable to recommend extension.

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

In September 2019, the HPVÌývaccination programme was extended to boys from 12 years of age with the expectation that it would provide clear additional health benefits including:

• direct protection for vaccinated boys againstÌýHPVÌýinfection and associated disease such as genital warts, anal, penile and oropharyngeal cancers
• protection againstÌýHPVÌý´Ú´Ç°ùÌýGBMSMÌýby offering them vaccination before their sexual debut
• indirect protection for non-vaccinated males and females

JCVI noted that extending the offer of the HPV vaccine to boys would also improve the resilience of the UK programme, accelerate the control of cervical cancer in women and has the potential to eliminate HPV vaccine types in the UK.

On 1 April 2022, the HPV schedule changed from a 3 dose schedule to a 2 dose schedule for those starting the programme when they were aged 15 years and above and for those eligible through the GBMSM targeted programme. People known to be living with HIV, including those on antiretroviral therapy, or known to be immunocompromised at the time of immunisation continued to be offered a 3 dose schedule.

From 1 September 2023, based on advice from the JCVI, the HPV vaccination schedule will change to:

• a 1 dose schedule for the routine adolescent programme and GBMSM programme for eligible individuals less than 25 years of age
• a 2 dose schedule for the GBMSM programme for eligible individuals from the age of 25 years (0, 6 to 24 months)
• a 3 dose schedule for eligible individuals who are immunosuppressed and those known to be living with HIV, including those on antiretroviral therapy (0, 1, 4 to 6 month schedule)

Summary of changes to the HPV vaccination programme since 2008

Year	Change to HPV programme
September 2008	HPV national vaccination programme introduced for Year 8 girls (aged 12 to 13 years old).
Ìý	A catch-up programme also took place to vaccinate all girls aged 13 to 18 years old.
September 2012	Gardasil vaccine (4 HPV types) replaced the previously used Cervarix vaccine (2 HPV types)
September 2014	3 dose schedule reduced to a 2 dose schedule for girls under 15 years of age.
April 2018	The HPV vaccination programme was extended to include GBMSM up to and including 45 years attending all specialist SHSs and HIV clinics.
September 2019	The HPV vaccination programme was extended to boys from 12 years of age.
April 2022	The HPV schedule changed from a 3 dose schedule to a 2 dose schedule for those starting the programme when they were aged 15 years and above and for those eligible through the GBMSM programme. People known to be living with HIV, including those on antiretroviral therapy, or known to be immunocompromised at the time of immunisation continued to be offered a 3 dose schedule.
July 2022	Change from Gardasil (4 HPV types) to Gardasil 9 vaccine which provides protection against the 9 HPV types: 6,11,16,18, 31, 33, 45, 52, 58.
September 2023	The HPV vaccination schedule to change to:
Ìý	a 1 dose schedule for the routine adolescent programme and GBMSM programme for eligible individuals less than 25 years of age
Ìý	a 2 dose schedule from the age of 25 years for the GBMSM programme (0, 6 to 24 month schedule)
Ìý	a 3 dose schedule for eligible individuals who are immunosuppressed and those known to be living with HIV, including those on antiretroviral therapy (0, 1, to 6 month schedule)

HPV vaccine changes

Cervarix HPV vaccine (which protected against the 2 main cancer causing HPV types 16 and 18) was offered from the start of the programme in September 2008 until September 2012 when Gardasil (which protected against the 2 main cancer causing HPV types 16 and 18 and additionally the 2 types, 6 and 11, responsible for causing genital warts) was used instead.

In summer 2022, the Gardasil 9 vaccine was introduced into the programme to replace the previously used Gardasil vaccine. The 9-valent vaccine protects against 5 additional cancer causingÌýHPVÌýtypes (31, 33, 45, 52, 58). Gardasil 9 is the vaccine currently being supplied for those eligible for theÌýHPVÌývaccine (adolescents aged 12 to 13 years and those who are eligible until they turn 25 years of age, andÌýGBMSMÌýup to and including 45 years of age).

The Green Book human papillomavirus (HPV) chapter 18a

The Green BookÌýHPVÌýchapter 18a includes detailed information aboutÌýHPV, the history and epidemiology of the disease, the vaccination programme and the HPV vaccine.

Healthcare practitioners should familiarise themselves with this Green Book chapter before offering or advising onÌýHPVÌývaccination.

The HPV vaccination programme

The change from a 2 dose to 1 dose schedule in September 2023

This schedule change follows a very detailed review of the available evidence by the JCVI. TheyÌýhave been reviewing the mounting evidence about protection from a single dose ofÌýHPVÌývaccine since 2018 and have been considering a potential change in the vaccine schedule to one dose of theÌýHPVÌývaccine during this time.

The first major review of a one dose schedule took place in June 2020. The evidence for a one dose schedule primarily came from post hoc analysis of trials for the bivalent and quadrivalent vaccines which showed equivalent efficacy between one and 2 doses for these vaccines. JCVI was ready to recommend a move to one dose in 2020 but needed to wait to see more data on the 9-valent vaccine from ongoing trials specifically designed to evaluate one dose efficacy. After a further review of the latest evidence on one dose schedules in December 2021, which included one dose trial data for the 9-valent vaccine, the committee issued an interim statement for consultation on 10 February 2022. By June 2022 JCVI was able to conclude its advice and issued a statement in August 2022, on a move from a 2 dose to a one dose schedule for the routine adolescent programme and GBMSM programme for eligible individuals aged under 25 years.

The JCVI consider that the cumulative evidence now clearly shows that 1 dose (of Cervarix, Gardasil or Gardasil 9) provides similar protection to that induced by 2 doses. Both trial and non-trial evidence shows that initial vaccine efficacy from 1 dose is very high and likely comparable to that from 2 doses. In addition, the long duration (more than 10 years) of protection already seen is associated with a steady antibody level which has ongoing persistence and is expected to continue along the same trajectory. The antibody level achieved from one-dose is associated with high efficacy against persistent infection of HPV vaccine types.

The World Health Organization (WHO) have also looked at and subsequently updated their . Their paper states that a single-dose schedule can provide comparable efficacy and durability of protection to a 2 dose regimen. The recommendation for an alternative single-dose off-label scheduling option for routine and multi-age-cohort catch-up vaccination was made in 2022. Single dose schedules are now being considered in several countries and have already been recommended in Australia, Mexico, Nigeria and Bangladesh and introduced in Cape Verde, Tonga and the Solomon Islands.

HPV vaccine eligibility

There is no change to the eligibility criteria when the schedule changes in September 2023.

TheÌýHPVÌývaccine is recommended for:

• all adolescents (boys and girls) in school Year 8 (usually aged 12 and 13)
• GBMSMÌýup to and including 45 years of age attending specialist SHSs and/orÌýHIVÌýclinics 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 on/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 from the indirect protection provided by theÌýHPVÌývaccination programme to date.

GP practices are required to provide HPV vaccinations to eligible adolescent girls and boys who have reached the age of 14 years and are under 25 years, who missed vaccination under the schools’ programme.

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

GBMSMÌýolder than 45 years are not eligible forÌýHPVÌývaccination under the national NHS England procured service

Individuals who were eligible for and started a 2 dose schedule

For anyone under 25 years of age who is eligible for HPV vaccine and commenced but did not complete a 2 dose schedule (this may include for example, those who started their HPV vaccination programme in the 2022 to 2023 academic year), the following applies:

• those who started their HPV vaccination schedule and have already received one dose of the vaccine will be considered fully vaccinated
• those who have not yet received any HPV vaccinations will be eligible to receive one dose of the HPV vaccine

This applies both to those eligible for the universal adolescent programme and those eligible for the GBMSM programme who are under 25 years of age.

GBMSM aged 25 years and older (up to and including 45 years) should continue on the 2 dose HPV vaccination schedule. The recommendation to continue with 2 doses is because there is currently insufficient evidence of the efficacy of a single dose in this age group. However, if they received 1 dose prior to their 25th birthday, they do not require a second dose.

Eligible individuals who are known to be immunosuppressed at the time of vaccination and those who are living with HIV, including those on antiretroviral therapy should continue to be offered a 3 dose schedule as per the Green Book HPV chapter.

Summary table of universal adolescent programme

Date of birth	Eligible from academic year	Schedule from 1 September 2023
1 September 2010 to 31 August 2011	2023 to 2024	1 dose HPV schedule
1 September 2009 to 31 August 2010	2022 to 2023	consider fully vaccinated if received one dose of the HPV vaccine
Born before 1 September 2009	various	1 dose HPV schedule

Summary table of GBMSM programme

Cohort	Schedule from 1 September 2023
GBMSM under 25 years	1 dose schedule for those not yet vaccinated.
Ìý	Consider fully vaccinated if have received 1 dose
GBMSM aged 25 years to 45 years (inclusive)	2 dose schedule

Individuals moving from abroad

Males and females moving to the UK from overseas who have not been offered protection againstÌýHPVÌýin their country of origin and who meet the eligibility criteria forÌýHPVÌývaccine should be offered vaccine. This would include both females born on/after 1 September 1991 and males born on/after 1 September 2006 if they are under 25 years of age, andÌýGBMSMÌýattending specialist SHSs up to 45 years of age. Refer to the Vaccination of individuals with uncertain or incomplete immunisation status algorithm if required.

Individuals with a similar risk profile toÌýGBMSM

JCVIÌýconsiders that there may be considerable benefit in offering theÌýHPVÌývaccine to individuals attending SHSs or HIV clinics who were not eligible for the routine adolescent HPV programme and are deemed to have a similar risk profile to that seen in the GBMSM population. This includes some transgender individuals, sex workers, and men and women living with HIV infection. Those whose risk of acquiring HPV is considered equivalent to the risk of GBMSM eligible for the HPV vaccine, should be offered vaccination.

Vaccination of individuals not eligible to receiveÌýHPVÌývaccine as part of an NHS-approved vaccination programme

For these individuals, if following a clinical assessment,Ìýthe clinician believes that HPVÌývaccine 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 orderÌýHPVÌývaccine 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 theÌýHPVÌývaccine 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.

Individual or parent with queries about the one dose HPV vaccine schedule from September 2023

Individuals or parents who have queries about the single dose HPV vaccine schedule for individuals under 25 years of age should be given the opportunity to discuss these with their local School Aged Immunisation Service (SAIS) and be provided with the evidence which supports the move to a single dose schedule. Further information about this is provided above and also in the Green Book HPV chapter and the JCVI statement on a one-dose schedule for the routine HPV immunisation programme.

Recommended vaccine

Gardasil 9

Gardasil 9 is licensed for use from 9 years of age and provides protection against 9ÌýHPVÌýtypes: 6, 11, 16, 18, 31, 33, 45, 52, 58.

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).ÌýVLPsÌýare not infectious and cannot causeÌýHPV-associated cancers or genital warts as they do not contain the virus’s DNA. However,ÌýVLPsÌýare very immunogenic, which means that they induce high levels of antibody production by the body. Following vaccination withÌýHPVÌývaccine, the immune system should mount a response against theÌýVLPs. Upon subsequent exposure to the live virus, the immune system reacts quickly to prevent infection. An adjuvant (aluminium hydroxyphosphate sulfate) is added to increase the immune response made.

At least 113 countries globally have introduced HPV vaccine. By 2022, more than 500 million doses of HPV vaccine had been distributed worldwide and more than 15 million doses had been given in the UK.

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

HPV vaccine excipients

Vaccine excipients can be found in the Summary of Product Characteristics (SPC) for .

Gardasil 9 does not contain thiomersal or porcine gelatine.

Vaccine effectiveness and impact of the programme to date

Gardasil has been shown to be highly effective in preventingÌýHPVÌýinfection for the serotypes contained in the vaccine.

In clinical trials in young women with no previous history ofÌýHPVÌýinfection, the vaccine was shown to beÌý99% effectiveÌýat preventing pre-cancerous lesions associated withÌýHPVÌýtypes 16 and 18. Gardasil is also 99% effective at preventing genital warts associated with vaccine types in young women. A of Gardasil in men indicated that it can prevent anal cell changes caused by persistentÌýHPVÌýinfection, and genital warts.

In 2021, evidence from , published in the Lancet, showed that theÌýHPVÌývaccine has dramatically reduced cervical cancer rates by almost 90% in women in their 20s who were offered the vaccine aged 12 to 13 years in England, when compared to an unvaccinated population. It also showed that the HPV immunisation programme has successfully almost eliminated cervical cancer in women born since September 1, 1995 and that the HPV vaccination programme has prevented around 450 cervical cancers and 17,200 cases of precancerous conditions over an 11 year period.

Earlier evidence had shown that the number of young women with pre-cancerous cervical disease has decreased significantly (Scotland data), and that the number of infections with HPVÌýtypes 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 2021, the rate of genital warts diagnoses among 15 to 17 year old girls was 85% lower compared to 2017 and a decline of 80% was seen in the same aged heterosexual boys over the same period, suggesting substantial herd protection.

Prior infection with anÌýHPVÌýtype does not diminish the efficacy of the vaccine against otherÌýHPVÌýtypes included in the vaccine.

HPVÌývaccines have not been shown to have an impact on an existing infection or any of the outcomes of an existingÌýHPVÌýinfection, such as genital warts, but may boost immunity and prevent re-infection or reduce recurrences in people with established disease.

Vaccine dosage and schedule

Gardasil 9 should be administered as a 0.5ml dose and from 1 September 2023 should be offered with the following schedules:

• routine adolescent programme and GBMSM programme for eligible individuals less than 25 years of age: a single dose of HPVÌývaccine should be administered
• from the age of 25 years for the GBMSM programme: 2 doses of HPVÌývaccine should be administered at 0 and 6 to 24 months
• individuals who are immunosuppressed and those known to be living with HIV: 3 doses of HPVÌývaccine should be administered at 0, 1 and 4 to 6 months

Individuals who are immunocompromised

Currently, there is no data on fewer than 3 doses for those living with HIV or those who are immunosuppressed. For this reason, a 3 dose schedule should still be offered to individuals who are known to be living with HIV, including those on antiretroviral therapy, or who are known to be immunosuppressed at the time of immunisation.

Suboptimal immunogenicity of HPV vaccine in transplant patients has been observed. Additional doses of vaccine may be considered after treatment is finished and/or recovery has occurred depending on treatment received. Specialist advice may be required.

Individuals who are living with HIV

Eligible individuals who are HIV positive should be offered regardless of CD4 count, antiretroviral therapy use or viral load. Evidence suggests individuals living withÌýHIVÌýare at increased risk of acquiringÌýHPVÌýand persistent infection. They are also more likely to have frequent carriage of multipleÌýHPVÌýtypes and have an increased risk ofÌýHPV-related rapidly progressive malignancies.

HPVÌývaccines are known to be safe and highly immunogenic when given to individuals who areÌýHIVÌýpositive with no adverse impact on CD4 cell counts or viral load observed.

There are no data to support giving fewer than 3 doses to individuals who are HIV positive. For this reason, a 3-dose schedule at 0,1 and 4 to 6 months should continue to be offered to individuals in the eligible cohort who are known to be HIV positive. Antibody levels may be lower in individuals who are HIV positive compared to individuals who are HIV negative. However, despite this, HPV vaccines appear to show good efficacy in this population.

Individuals who have received Cervarix or Gardasil

Individuals who have received Cervarix or Gardasil Individuals under 25 years who have received a single dose of Cervarix or Gardasil (the 4 HPV type-containing vaccine) should be considered protected by this dose. The evidence for a one dose schedule primarily came from post hoc analysis of trials for the bivalent and quadrivalent HPV vaccines and these showed equivalent efficacy between one and 2 doses for these vaccines.

Further studies once Gardasil 9 became available confirmed that one dose of this vaccine also showed equivalent efficacy between one and 2 doses of this vaccine.

Eligible individuals with a history of receiving an incomplete course ofÌýHPVÌývaccine

Where an individual in one of the cohorts eligible for more than 1 dose of HPV vaccine (GBMSM aged 25 years and over and individuals who are immunosuppressed or known to be living with HIV, including those on antiretroviral therapy) presents with an incomplete HPV vaccination history, every effort should be made to clarify what doses they have had and when they were administered.

It is not necessary to restart the course for either group, even if there has been a longer than recommended interval between doses. If the course is interrupted, it should be resumed but not repeated.

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 ofÌýHPVÌývaccine following a primary course.

Vaccine safety

The safety ofÌýHPVÌývaccine 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.

Both the and the have posted clear advice on their website supporting theÌýsafety ofÌýHPVÌývaccine. The safety of the HPV vaccine has been regularly reviewed by the Global Advisory Committee for Vaccine Safety (GACVS) and they have not found any safety concerns.

HPVÌývaccine ordering

HPV vaccine for use in the delivery of the NHS HPV programme can be ordered from the UK Health Security Agency (UKHSA) via ImmForm in the usual way. When placing orders for HPV vaccine, providers are asked to consider the schedule change and make sure that locally held stocks of vaccine are rotated in fridges so that wastage is minimised.

There are separate order lines for the adolescent and GBMSM HPVÌýprogrammes 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

HPVÌývaccine 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 vaccineÌýSPC, 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

Guidance on informed consent can be found in chapter 2 of the Green Book and a for provider use is also available.

The currently approved schedule for HPV vaccine is a 2 dose course. Use of a single dose is therefore off-label but it is in accordance with JCVI advice, as outlined in the Green Book.

In line with advice from the Medicines and Healthcare products Regulatory Agency (MHRA), where authoritative advice and current practice supports the use of a medicine outside the terms of its licence, it is not always necessary to draw attention to this when seeking consent. Further useful guidance about this is available in the following:

Off-label or unlicensed use of medicines: prescribers’ responsibilities.

Off-label vaccines: introductory guide for healthcare professionals.

Off-label vaccines: a guide for parents.

Written consent

To support informed consent, School-Aged Immunisation Service Providers should ensure that parents have been provided with an information leaflet alongside the consent form.

Email or electronic forms of consent are increasingly being used. Consideration should be given for appropriate routes to reach parents/families who may not easily access information digitally. Providers should make sure parents have sight of the HPV information leaflet published by UKHSA. This leaflet is available in 33 different languages and other formats such as British Sign Language and Easy Read.

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 only be relevant to the immunisation being offered.

UKHSA has developed a template consent form for the adolescent HPV programme.

Verbal consent

On the day of the immunisation session, school nurses and school immunisation teams should 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 consent to be obtained 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 therefore addressing inequalities.

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

HPVÌývaccine should be administered according to the manufacturer’s instructions and healthcare professionals are encouraged to read the individual 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 (IM) into the deltoid area of the upper arm (or the anterolateral area of the thigh if this is not possible). Healthcare professionals should choose an appropriate needle length to ensure an intramuscular (IM) administration. Longer length needles are recommended for morbidly obese individuals to ensure the vaccine is injected into muscle.

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.

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 9 is an inactivated vaccine 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 one vaccine is given at the same time, the vaccines should be given at separate sites, preferably in a different limb. If it is necessary to give them 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.

GBMSMÌýHepatitis 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 amongstÌýGBMSMÌýattending specialist SHSs is below national targets, both for first dose uptake and for completion of 3 doses of vaccine. Recording of bothÌýHBVÌýimmunity and hepatitis B vaccine delivery by clinician coding is also suboptimal. The UK’s risk-based vaccination policy for hepatitis B includesÌýGBMSMÌýand maintaining high vaccine coverage inÌýGBMSMÌýis important to avoid outbreaks ofÌýHBVÌýinfection.

Further information is available in the Green Book Hepatitis B chapter 18 and in the British Association for Sexual Health andÌýHIVÌý(BASHH)’s .

Cautions and contraindications for receiving Gardasil 9

There are very few individuals who cannot receiveÌýHPVÌývaccines. 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 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 (SPC).

Yeast allergy

Although Gardasil 9 is grown in yeast cells, the final vaccine product does not contain yeast as an excipient or ingredient, and at most would only contain very small trace amounts of yeast protein (<0.007 micrograms).

Yeast allergy is not a contraindication to the HPV vaccine.

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 of vaccination). These include mild to moderate short-lasting pain, redness and swelling at the injection site. Other reactions commonly reported are headache, fever, fatigue, nausea and dizziness. These adverse reactions were usually mild or moderate in intensity.

For a detailed list of adverse reactions associated with Gardasil 9 refer to the manufacturer’s or the .

Reporting adverse reactions toÌýHPVÌývaccine

Any suspected adverse reactions following administration should be reported to the MHRA through the online , by downloading the Yellow Card app or by calling the Yellow Card scheme on 0800 731 6789 9am – 5pm Monday to Friday.

PGDs and patient information

PGDs and off-label use

Gardasil 9 is a prescription only medicine and should only be administered using one 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)

UKHSAÌýhave developed 2 nationalÌýHPV PGDÌýtemplates (one for the adolescent programme and one for the GBMSM programme) which should be reviewed and authorised locally before use.

Administration errors

Doses administered at less than the recommended interval in error

Whenever possible, individuals eligible for more than 1 dose of HPV vaccine should follow the schedules recommended (2 doses on 0, 6 to 24 months schedule from the age of 25 years for the GBMSM programme and 3 doses on 0, 1, 4 to 6 month schedule for eligible individuals who are immunosuppressed and those known to be living with HIV, including those on antiretroviral therapy).

Where vaccines have inadvertently been given at less than the recommended interval, the dose given early should be discounted and should be repeated once the recommended time period has elapsed and at least 4 weeks from the dose given early in error.

However, there is some clinical data that suggests that the interval between doses on the 2 dose schedule can be reduced to a minimum interval of 5 months for Gardasil 9. Therefore, if the second dose is inadvertently given after 5 months to an individual aged 25 years or over who is eligible for the GBMSM programme, this would count as a valid dose. Two doses given to these individuals less than 5 months apart for Gardasil 9 should not be considered adequate to provide long term protection and the dose given early should be discounted. It should be repeated once the recommended time period has elapsed and at least 4 weeks from the dose given early in error.

Administration of an incomplete dose

In the event that 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.

COVER data

Vaccine coverage data collection for the universal adolescentÌýHPVÌýprogramme

HPV coverage is based on aggregated school level data. The data is entered manually on the secure web platform, ImmForm.

The routineÌýHPVÌývaccine coverage collection for the adolescent programme will not be impacted by the change in the vaccine schedule and coverage of the 1 dose programme 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.

data via ImmForm is available on 51²è¹Ý.

on 51²è¹Ý.

Vaccine coverage data collection for theÌýGBMSMÌýHPVÌývaccination programme

HPV vaccination uptake collections for the NHS GBMSM HPV vaccination programme will not be significantly impacted by the change to the vaccine schedule in September 2023. Vaccine coverage (uptake and completion) will continue to be evaluated for GBMSM aged up to and including 45 years attending specialist sexual health services (SHSs) and HIV clinics.

HPV vaccination data for GBMSM is entered for all attendances via the GUMCAD and HARS mandatory reporting systems for SHSs and HIV clinics, respectively. GUMCAD and HARS clinical guidance will be updated to clearly indicate the change to a one dose schedule for GBMSM less than 25 years old (with the exception of immunocompromised and GBMSM living with HIV, who will continue to receive a 3 dose schedule). This will include guidance stating Sexual Health and HIV Activity Property Type (SHHAPT), now SNOMED CT, coding for vaccination course completion should be recorded after dose one is administered for those receiving a first dose from 1 September 2023.

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

are available on 51²è¹Ý.

Cervical screening

Cervical screening is offered to all women and people with a cervix aged 25 to 64 years in the UK. This is to detect infection with ‘high risk’ types of HPV. If these types of HPV are found, the sample is then checked for precancerous changes in the cervix so that early treatment reduces the chances of cancer developing.

HPV vaccine does not protect against all HPV types so cervical screening remains important and should be carried out according to the national screening programme policy. It is important that healthcare practitioners communicate the ongoing need for young women to attend cervical screening appointments regardless of vaccination status.

Resources

UKHSA and NHS England. HPV Vaccination Programme: Change in schedule for the routine adolescent HPV programme and eligible MSM under age 25 years., 20 June 2023.

Centers for Disease Control and Prevention (CDC) and .

Adolescent vaccine coverage: user guidance for submitting vaccine coverage data via ImmForm.

, 5 August 2022.

and for Gardasil 9.

UKHSAÌýImmunisation against infectious diseases (The Green Book) .

UKHSAÌýImmunisation against infectious diseases (The Green Book) chapter 2 Consent.

UKHSAÌýImmunisation .

UKHSA collection of and documents and resources. Includes health professional guidance and patient resources in a variety of different languages and accessible formats.

WHO. , July 2017.

WHO. .

Document history

Version number	Change details	Date
1	HPVÌývaccination: Information for healthcare practitioners (previous version).	Last update June 2019
2	HPVÌývaccination programme for gay, bisexual and other men who have sex with men (GBMSM).	First published 28 March 2018. Last update 5 April 2018
3	HPVÌýadolescent vaccination programme guidance andÌýGBMSMÌývaccination programme guidance combined into one document. Information about Gardasil 9 vaccine added.	September 2021
4	Added link to a 2021 study under vaccine efficacy section.	November 2021
5	From 1 April 2022 move from 3 doses to 2 doses of HPV vaccine for eligible individuals starting the course over 15 years of age and those receiving HPV vaccine through the GBMSM vaccination programme.	March 2022
6	Section on yeast, and section on vaccines given at less than the recommended interval, updated to bring in line with latest Green Book chapter.	April 2022
7	From 1 September 2023, move from 2 doses to 1 dose for eligible individuals receiving HPV vaccine aged under 25 years of age.	June 2023