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Overview

This Guidelines for Nurses  summary provides information for healthcare practitioners about human papillomavirusHPV programme eligibility, scheduling, and vaccine administration.

Recommendations included: the HPV vaccination programme; recommended vaccine; vaccine dosage and schedule; duration of protection; vaccine safety; vaccine administration; cautions and contraindications; individuals with underlying medical conditions; adverse reactions; and Gardasil®/Gardasil® 9 HPV vaccine scheduling.

Recommendations not included: HPV vaccine ordering and storage; consent; patient group directions and patient information; incomplete or interrupted schedules; training and resources; cover of vaccination evaluated rapidly data; and further resources.

For a complete list of recommendations, refer to the full guideline.

This guideline combines the men who have sex with men (MSM) vaccination programme guidance with HPV adolescent vaccination programme guidance.

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

  • The Joint Committee on Vaccination and Immunisation 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 her 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 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.
  • During 2022, the vaccine supplied for the adolescent HPV and HPV-MSM programmes will change from Gardasil to Gardasil 9. It is expected that the UK Health Security Agency (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 starts 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, the two high-risk HPV types that can lead to cancer; and 6 and 11, the two 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 nine HPV types: 6, 11, 16, 18, 31, 33, 45, 52, and 58. This vaccine will become available for use from early 2022.

Vaccine dosage and schedule

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

Individuals under 15 years of age

  • HPV vaccine should be administered as a two-dose schedule at 0 and 6–24 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 two-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 one 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 three-dose schedule at 0, 2, and 6 months
  • In a three-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 three 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.

Immunosuppressed individuals

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

  • As with any medicinal product, some people may experience a side effect (see the section, Adverse reactions), but these are generally mild, of short duration, and outweighed by the benefits of the vaccine.

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 two doses of Gardasil, two doses of Gardasil 9, or a mixed schedule.

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

  • 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 as part of the NHS programme to offer Gardasil 9 to those who have had a full course of Gardasil.

For recommendations on postural orthostatic tachycardia syndrome, HPV vaccine ordering and storage, and consent, refer to the full guideline.

Vaccine administration

  • 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 prefilled syringe should be shaken well to obtain a white, cloudy suspension
  • The vaccine should be administered by a single intramuscular (IM) injection into the deltoid area of the upper arm. Healthcare professionals should choose an appropriate needle length to ensure an 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 IM 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, IM 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 international normalised ratio (INR) testing and whose latest INR was below the upper threshold of their therapeutic range, can receive IM 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 one 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 2.5 cm 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. HBV uptake amongst MSM attending specialist sexual health services is below national targets, both for first dose uptake and for completion of three doses of vaccine. Recording of both HBV immunity and HBV vaccine delivery by clinician coding is also suboptimal. The UK’s risk-based vaccination policy for HBV includes MSM, and maintaining high vaccine coverage in MSM is important to avoid outbreaks of HBV infection.

Cautions and contraindications

  • There are very few individuals who cannot receive the HPV vaccine. 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
  • Gardasil and Gadasil 9 should not be administered to those who have had:
    • a confirmed anaphylactic reaction to a previous dose of the vaccine OR
    • a confirmed anaphylactic reaction to any constituent or excipient of the vaccine
  • For the composition and full list of excipients of the vaccine, refer to the specific SPC
  • Individuals with a yeast allergy can receive Gardasil or Gardasil 9 vaccine as this is not a contraindication.

Individuals with underlying medical conditions

Immunosuppression

  • A three-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.

HIV-positive individuals

  • Eligible individuals with HIV infection should be given HPV vaccine regardless of cluster of differentiation 4 count, antiretroviral therapy use, or viral load
  • A three-dose schedule should be offered to individuals in the eligible cohort who are known to be HIV-infected.

Adverse reactions

  • In clinical vaccine trials the most common adverse reactions observed were injection-site reactions. 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
  • Any suspected adverse reactions following administration should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card reporting scheme.

For recommendations on patient group directions and patient information, incomplete or interrupted schedules, and training and resources, refer to the full guideline.

 

Full guideline:

UK Health Security Agency. HPV vaccination guidance for healthcare practitioners. UKHSA, 2021. Available at: gov.uk/government/publications/hpv-universal-vaccination-guidance-for-health-professionals

Published date: 13 April 2018.

Last updated: 30 September 2021.

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