HPV Vaccination Guidance for Healthcare Practitioners

Overview

This concise Guidelines summary includes information on the human papillomavirus (HPV) vaccine programme, which is set to change in September 2023. This summary includes recommendations on vaccine eligibility, dosage and schedule, administration, and cautions and contraindications, from the UK Health Security Agency (UKHSA)'s HPV vaccination guidance for healthcare practitioners.

This summary also includes information from the UKHSA's HPV universal vaccination information for health professionals from September 2023 print document, addressing myths around HPV vaccination.

Reflecting on your Learnings

Reflection is important for continuous learning and development, and a critical part of the revalidation process for UK healthcare professionals. Click here to access the Guidelines Reflection Record.

The HPV Vaccination Programme

The Change from a Two-dose to One-dose Schedule in September 2023

• The Joint Committee on Vaccination and Immunisation (JCVI) considers that the cumulative evidence now clearly shows that one dose (of Cervarix, Gardasil, or Gardasil 9) provides similar protection to that induced by two doses.

HPV Vaccine Eligibility

• There is no change to the eligibility criteria when the schedule changes in September 2023
• The HPV vaccine is recommended for:
  • all adolescents (boys and girls) in school year 8 (usually aged 12 and 13)
  • Gay, bisexual, and men who have sex with men (GBMSM) up to and including 45 years of age attending specialist sexual health services (SHSs) 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 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 the HPV vaccination 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 of age, who missed vaccination under the schools’ programme
• Although the universal adolescent HPV programme 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
• GBMSM older than 45 years of age are not eligible for HPV vaccination under the national NHS England procured service.

Individuals who were Eligible for and Started a Two-dose Schedule

• For anyone under 25 years of age who is eligible for HPV vaccine, and commenced but did not complete a two-dose schedule (this may include, for example, those who started their HPV vaccination programme in the 2022–2023 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 of age) should continue on the two-dose HPV vaccination schedule. The recommendation to continue with two doses is because there is currently insufficient evidence of the efficacy of a single dose in this age group. However, if they received one 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 three-dose schedule as per the Green Book HPV chapter.

Table 1: Summary Table of the Universal Adolescent Programme

Table 2: Summary Table of the GBMSM 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
• This would include both females born on or after 1 September 1991 and males born on or after 1 September 2006 if they are under 25 years of age, and GBMSM attending specialist SHSs up to 45 years of age.

Individuals with a Similar Risk Profile to GBMSM

• The JCVI considers that there may be considerable benefit in offering the HPV vaccine 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

For recommendations on vaccination of individuals not eligible to receive HPV vaccine as part of an NHS-approved vaccination programme, and on individual or parent with queries about the one dose HPV vaccine schedule from September 2023, refer to the full guideline.

Recommended Vaccine

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, and 58
• In comparison with Gardasil, Gardasil 9 offers protection against five 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
• Gardasil 9 does not contain thiomersal or porcine gelatine.

For information on vaccine effectiveness and impact of the programme to date, refer to the full guideline.

Vaccine Dosage and Schedule

• Gardasil 9 should be administered as a 0.5 ml dose, and from 1 September 2023 should be offered with the following schedules:
  • routine adolescent programme and GBMSM programme for eligible individuals <25 years of age: a single dose of HPV vaccine should be administered
  • from the age of 25 years for the GBMSM programme: two doses of HPV vaccine should be administered at 0 months and 6–24 months
  • individuals who are immunosuppressed and those known to be living with HIV: three doses of HPV vaccine should be administered at 0, 1, and 4–6 months.

Individuals who are Immunocompromised

• Currently, there are no data on fewer than three doses for those living with HIV or those who are immunosuppressed. For this reason, a three-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.

Individuals who are Living with HIV

• Eligible individuals who are HIV-positive should be offered HPV vaccine regardless of CD4 count, antiretroviral therapy use, or viral load.

Individuals who have Received Cervarix or Gardasil

• Individuals under 25 years of age who have received a single dose of Cervarix or Gardasil (the 4 HPV type-containing vaccine) should be considered protected by this dose.

Eligible Individuals with a History of Receiving an Incomplete Course of HPV Vaccine

• Where an individual in one of the cohorts eligible for more than one 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 of HPV vaccine following a primary course.

For information on vaccine safety, HPV vaccine ordering and storage, and consent, refer to the full guideline.

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 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 (or the anterolateral area of the thigh if this is not possible). Healthcare professionals should choose an appropriate needle length to ensure an 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 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 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 2.5 cm apart. The site at which each vaccine was given should be noted in the individual’s records.

GBMSM Hepatitis B Vaccination Status

• Clinics or clinicians should take the opportunity to check (and correctly code) patients’ hepatitis B virus vaccination status
• Further information is available in the Green Book Hepatitis B chapter 18 and in the British Association for Sexual Health and HIV’s National Guidelines for the Management for Viral Hepatitides 2017 interim update.

Cautions and Contraindications for Receiving 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 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
• 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. 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.

Reporting Adverse Reactions to HPV Vaccine

• Any suspected adverse reactions following administration should be reported to the Medicines and Healthcare Products Regulatory Agency (MHRA) through the online Yellow Card scheme, by downloading the Yellow Card app, or by calling the Yellow Card scheme on 0800 731 6789, 09.00–17.00, Monday to Friday.

For recommendations on administration errors, information on COVER data, and patient information, refer to the full guideline.

Cervical Screening

• Cervical screening is offered to all women and people with a cervix aged 25–64 years in the UK
• 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.

Addressing Myths about HPV Vaccination