Gardasil® 9 therapeutic indications

GARDASIL® 9 is indicated for active immunisation of individuals from the age of 9 years against the following HPV diseases:

  • Premalignant lesions and cancers affecting the cervix, vulva, vagina and anus caused by vaccines HPV types.
  • Genital warts (Condyloma acuminata) caused by specific HPV types.
The use of GARDASIL® 9 should be in accordance with official recommendations.

HCPs must consult the SmPC for further information before making any prescribing decisions.

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to MSD (Tel: 0208 154 8000).

By clicking the above link, you will leave the MSD website and be taken to the MHRA website.

Background

  • 2007

    HPV immunisation programme for girls recommended

    In 2007 the Joint Committee for Vaccination and Immunisation (JCVI) met and recommended a Human Papillomavirus (HPV) immunisation programme for girls aged 12–13 years old with a catch-up programme instigated to immunise girls aged 13–18 years old1. In 2008, when this programme came into place the aim at that time was to reduce the risk of cervical cancer caused by the HPV types 16 and 18, which were included in the vaccines2.

  • 2014

    Dose reduction for under 15s

    Since its introduction the HPV immunisation programme has remained under review by JCVI, and the programme has changed over the intervening years. The initial 3 dose schedule was reduced to a 2 dose schedule for recipients under 15 years of age in May 20143.

  • 2015

    MSM up to and including age 45 became eligible for HPV vaccination

    In 2015 the JCVI advised that all men who had sex with men (MSM) up to and including 45 years of age should be offered HPV vaccination4, this programme is delivered via specialist sexual health and HIV services. Since the introduction of the programme for eligible girls in 2008 the JCVI continued to review evidence and data in consideration of extending the programme to other groups, including boys.

  • 2018

    Universal HPV programme announced for girls & boys

    In 2018 the JCVI released a statement indicating that a combined girls’ and boys’ programme was likely to be cost-effective compared to no vaccination5. In 2018 a universal HPV programme was announced for eligible boys and girls which commenced in September 20196.

  • 2021

    Change from Gardasil® to Gardasil® 9 vaccine used in the NIP

    In July 2021 it was announced that the vaccine used in the programme would change from Gardasil® (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed) to Gardasil® 9 (containing HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58). Once the remaining central supplies of Gardasil® had been issued Gardasil® 9 would be issued in late 2021 or early 20227.

There may be slight differences between implementation of the HPV immunisation programme in Scotland, Northern Ireland and Wales. Immunisers working in countries other than England should ensure that they are following relevant guidance specific to the area in which they practice (The Scottish Government (2022)8, 32; Public Health Agency Northern Ireland (2022)9, 33 and Welsh Government (2022)10, 34).

Current programme in 2022

The HPV immunisation programme is delivered in all UK nations, with the same eligible groups being offered the vaccination 11, 12, 32, 33, 34. The HPV vaccination is recommended for all eligible girls and boys aged 12 and 13. The HPV programme for these adolescents is primarily delivered by School Age Immunisation Services (SAIS), however provision can vary from area to area (immunisers in general practice should establish the arrangements in their area).

Key points about the change to the programme

For information on the NHS National Immunisation Programme please refer to the relevant UK Health Security Agency website.

Vaccine supply for both the adolescent (and catch-up groups) and MSM eligible groups is ordered by providers from the national supply via the ImmForm Platform. Orders can be placed weekly and delivered within a few days35.

Rationale for the programme

Impact of the HPV NIP in the UK

HPV vaccines have been shown to be highly effective at preventing HPV infection for the serotypes contained in the vaccines.

Since the commencement of the programme, English sexually transmitted infection surveillance has shown a reduction in CIN (cervical intraepithelial neoplasia) and genital warts in both sexes28. Two systematic reviews and meta-analysis of global studies25, 26 found reduction in HPV infections caused by type 16 and 18 (high risk types), significant reductions in genital warts and pre-cancerous lesions among vaccinated cohorts. Additionally, there were significant reductions in genital warts in males and females who were not vaccinated indicating herd effects. In Scotland, a 7-year cross-sectional study evaluating the changes in the prevalence of HPV following a national bivalent HPV vaccination programme, showed substantial reductions in HPV16 and 18 from 28.9% (95% CI 26.7–31.1) in 2009 to 4.8% (3.8–5.9) in 2015 (unadjusted OR 0.12, 95% CI 0.10–0.16; linear p value <0.0001)27.

In 2020, the rate of first episode genital warts diagnoses among girls aged 15 to 17 years attending Sexual Health Services, was 95% lower compared to 2016 (6.6 vs 129.7 per 100,000 population). Most of these girls would have been offered the quadrivalent HPV vaccine (Gardasil®) when aged 12 to 13 years old28. An 89% decline (3.5 vs 32.5 per 100,000 population) in the incidence of genital warts was seen in heterosexual boys of the same age over the same period, suggesting substantial herd protection. A more modest, but still substantial decline of 58% was seen in MSM of the same age, though numbers of diagnoses among young MSM remain small28.

In a 2021 study, it’s estimated that cervical cancer rates have been reduced by almost 90% in women in their 20s who were offered the vaccine at age 12 & 13 years in England, when compared to an unvaccinated population29.

This observational study uses modelling data from a total of 13.7 million years of follow up of women aged 20 to younger than 30-years-old, across 4 different cohorts29.

The decision to vaccinate an individual should take into account the risk for previous HPV exposure and potential benefit from vaccination. For more information on the safety profile and vaccine effectiveness of Gardasil® 9 please click here to be taken to the SmPC.*

*this link will direct you to a third party website.

The full impact of the national HPV immunisation programme on cervical cancer is yet to be fully realised. As more women who have been vaccinated since 2008 enter the cervical screening programme, at age 25 years, more evidence of prevention of HPV infection is likely to become evident.

Improving uptake

In the early years of the programme (2008–2013/14), national uptake in England for 3 doses of HPV for girls aged 12–13 years was consistently over 86%, with over 40% of Primary Care Trusts in England achieving at least 90%13. Assessing uptake and coverage of HPV vaccination, and comparing one year with another, has been complicated by changes in the programme and different delivery models across the country. Uptake varies by area with some areas in England showing increasing uptake between 2015 and 2019 and other areas seeing declining uptake14. Uptake in Scotland8 has historically been slightly higher than England, Northern Ireland and Wales over the years9,10, however all four UK nations have reported a drop in uptake since the start of the SARS-CoV-2 pandemic8,9,10,16.

The SARS-CoV-2 pandemic in early 2020 has had a major impact on coverage of the HPV immunisation programme delivery in 2019-20 and 2020-218,9,10,15,16. National reports reveal declines in uptake in 2019–20 and 2020–21 of the order of 20-30% when compared with the pre-pandemic years, with large variations by region within each country8,9,10,15,16. Closure of schools and a requirement for students to stay home if they tested positive has meant that some young people were unable to receive their immunisation at school, as planned. School Age Immunisation Teams continue to work hard to offer catch-up immunisations to eligible students who missed it16,17,18.

In England, the GP contract letter of 10th March 202119 detailed GP contract changes pertaining to vaccination and immunisation. This letter states that…

GP practices are required to provide (HPV) vaccinations to adolescent girls and boys who have attained the age of 14 years but who have not attained the age of 25 years who have missed vaccination under the schools programme.

Vaccines given to these eligible young people in General Practice will attract an item of service fee of £10.06 per dose administered19. The changes to the GP contract and payment arrangements support the importance of General Practice participation in the catch-up efforts within the HPV immunisation programme.

General Practice in England are only required to offer HPV vaccination to young people aged over 14 and less than 25 years of age opportunistically or when it is requested19. GP practices are not expected to proactively offer the immunisation to patients since the service is commissioned to be delivered through SAISs20. Immunisers in Scotland, Northern Ireland and Wales should familiarise themselves with the relevant contracts and financial arrangements in their nations.

This document provides a summary of strategies that General Practices can employ in order to increase HPV immunisation uptake opportunistically or when requested. Strategies for improving immunisation uptake are drawn from studies of other immunisation programmes, especially influenza immunisation delivery21, 22, 23.

Many of the strategies to increase vaccine uptake are transferrable across all the immunisation programmes, including HPV.

HPV immunisation delivery arrangements

Each practice should decide how best to ensure all eligible young people who request missed HPV immunisation, or who are missing HPV vaccine doses and are attending the practice for other reasons, are offered the HPV vaccine.

Strategies could include:

1

Ensuring a registered healthcare professional, trained and competent in immunisation, is available all or most of the time the General Practice is open.

2

Check in advance the HPV immunisation history of young people attending the practice for other vaccines (e.g., national programme vaccines like COVID-19 or flu, or travel vaccines).

3

Check in advance the HPV immunisation history of young people attending the practice for other healthcare provision (e.g., medication reviews, contraception advice, cervical screening, non-acute illness, counselling, or Mental Health support appointments).

Staff Responsibilities

Identify a named lead member of staff with responsibility for the immunisation service (in England a GP contract requirement19).

Ensure all staff in the practice know who the immunisation lead person is.

Ensure every member of the practice knows their role and responsibilities with regard to HPV immunisation programme delivery.

Keep requested and opportunistic HPV immunisation catch-up on the practice staff meeting agenda.

Ensure all immunisers understand the rationale for the HPV programme and have access to HPV resources11, 12, 32, 33 and are skilled at addressing myths pertaining to HPV24.

Get all staff involved in encouraging young eligible patients to discuss and consider HPV immunisation.

Ensure 12-13 year old teenagers, and others who are not eligible for HPV immunisation at the practice, are signposted to relevant providers. Those aged 12 up to their 14th birthday should be referred to the School Age Immunisation Services. Groups eligible for vaccination via sexual health services should be informed of that arrangement.

Ensure the practice’s ability to offer missing HPV vaccine to eligible young people aged between 14 and less than 25 years of age is known to other healthcare professionals who may engage with such young people: local pharmacists, physiotherapists, phlebotomists, opticians, dentists, contraception services or sexual health services. This will enable them to advocate HPV immunisation and signpost eligible patients to ask about HPV immunisation.

Practice goals

1
Set a goal of ensuring all eligible young people registered in the practice have received their HPV immunisation (either via another provider or if eligible via the practice).
2
Create computer searches to check immunisation status, measure uptake and progress towards the goal.
3
Maximise practice remuneration by ensuring systems are in place to claim payment for HPV immunisation activity20.
4
Advertise the practice arrangements for young people to access missing HPV vaccines.

Identify eligible patients

1
Create a system for identifying eligible patients who may attend the practice for other reasons; to see the GP, the phlebotomist, the physiotherapist etc. Use IT alerts, flags or sticky notes to alert staff to the opportunity to discuss immunisation with the patient.
2
If HPV immunisation is not recorded on an eligible patient’s GP record check the HPV immunisation status with the local Child Health Information System (CHIS) or Child Health department.
3
Check that the correct codes to capture HPV immunisation data are in your system and that staff know which codes to use.

Clinics and appointments

Ensure that there are some doses of HPV vaccine in the fridge for any opportunistic or requested immunisation activity. However, staff should take care not to over order to reduce the risk of vaccine expiry and subsequent wastage.

Provide opportunistic HPV vaccine to eligible young people at other vaccine clinics (e.g., Flu, COVID-19, MMR vaccines or travel vaccines)

Have mechanisms and reminders for offering HPV vaccine catch-up to young women who book for cervical screen appointments and are still under the age of 25 years (in England they will be sent their first invitation at age 24.5 years)31. Staff in Scotland, Northern Ireland and Wales need to check invitation arrangements in their country.

Consider checking young parents HPV eligibility and status when they attend for immunisations for their children and offer HPV vaccine opportunistically.

For young people requesting HPV catch-up of missed vaccines allow variable methods for booking an appointment – online, by phone or via the NHS App.

Make arrangements to immunise eligible young people who are unable to easily attend the practice such as those in care or with special needs.

Consider appointment times convenient to young people in education or full-time work.

Ensure all vaccinated patients have access to the patient information leaflet provided with the vaccine.

Highlight the vaccination offer to all practice users

Display HPV vaccine information leaflets and posters in the reception and waiting rooms.

Place prominent information about the HPV immunisation programme on the practice website, Facebook page and other social media.

Consider advertising the practice offer and arrangements in local venues frequented by teenagers and young adults such as hairdressers, barbers, beauty salons, pubs and cafés.

Service provision at regular intervals in the year
(i.e. quarterly)

Review HPV immunisation uptake against your goals; how many eligible teenagers and young adults in your practice seem to be unprotected against HPV?

Review the provision of opportunistic immunisation; do your arrangements work for eligible groups? What lessons have been learnt? Does provision need to be adapted?

Keep staff involved in service provision planning, informed of any changes to the arrangements or eligibility of teenagers and young adults.

Download HPV Vaccination Best Practice Guide

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References and useful resources

1. JCVI (2007). Minutes of Meeting held on Wednesday 17th October 2007. https://webarchive.nationalarchives.gov.uk/ukgwa/20120907151250/http:/ www.dh.gov.uk/ab/JCVI/DH_095044 Accessed February 2023

2. Department of Health (2008). Introduction of Human Papillomavirus vaccine into the National Immunisation Programme. [ARCHIVED CONTENT] PL CMO (2008)4, PL CNO (2008)3, PL CPHO (2008)2: Introduction of Human Papillomavirus Vaccine into the national immunisation programme : Department of Health - Publications (nationalarchives.gov.uk) Accessed February 2023

3. Department of Health, Public Health England (PHE) and NHS England (2014). Joint letter – Change in schedule from three to two doses in the HPV Vaccination Programme. https://www.gov.uk/government/publications/schedule-change-from-3-to-2-doses-in-the-hpv-vaccination-programme Accessed February 2023

4. JCVI (2015). JCVI statement on HPV vaccination of men who have sex with men. November 2015. https://www.gov.uk/government/publications/jcvi-statement-on-hpv-vaccination-of-men-who-have-sex-with-men Accessed February 2023

5. JCVI (2018). Statement on HPV vaccination July 2018. https://www.gov.uk/government/publications/jcvi-statement-extending-the-hpv-vaccination-programme-conclusions Accessed February 2023

6. Public Health England (2019). Introduction of a universal HPV immunisation programme. https://www.gov.uk/government/publications/hpv-universal-immunisation-programme0implementation-letter Accessed February 2023

7. Public Health England (2021). Changes to the vaccine of the HPV immunisation programme. https://www.gov.uk/government/publications/hpv-immunisation-programme-introduction-of-gardasil-9-letter Accessed February 2023

8. Public Health Scotland (2022). Immunisation – Child Health. https://beta.isdscotland.org/topics/child-health/immunisation/ Accessed February 2023

9. Public Health Agency Northern Ireland (2022). Vaccination Coverage – School based vaccination. https://www.publichealth.hscni.net/directorate-public-health/ health-protection/vaccination-coverage Accessed February 2023.

10. Public Health Wales (2022). Immunisation and Vaccines. https://phw.nhs.wales/topics/immunisation-and-vaccines/ Accessed February 2023

11. UK Health Security Agency (UKHSA) (2019). Immunisation against infectious diseases (The Green Book) Chapter 18a Human papillomavirus (HPV). https://www.gov.uk/government/publications/human-papillomavirus-hpv-the-green-book-chapter-18a Accessed February 2023

12. UK Health Security Agency (UKHSA) (2021). HPV vaccination guidance for healthcare practitioners. https://www.gov.uk/government/publications/hpv-universal-vaccination-guidance-for-health-professionals Accessed February 2023

13. Public Health England (2015). Human Papillomavirus (HPV) Vaccine Coverage in England, 2008/09 to 2013/14: A review of the full six years of the three-dose schedule. Human papillomavirus (HPV) immunisation programme review: 2008 to 2014 - GOV.UK (www.gov.uk)

14. Public Health England (2019). Annual HPV vaccine coverage in England: 2018 to 2019. https://www.gov.uk/government/statistics/hpv-vaccination-coverage-in-adolescent-females-in-england-2018-to-2019 Accessed February 2023

15. Public Health England (2021). Annual HPV vaccine coverage in England: 2019 to 2020. https://www.gov.uk/government/publications/hpv-vaccination-coverage-in-adolescent-females-and-males-in-england-2019-to-2020 Accessed February 2023

16. UK Health Security Agency (2021). Human papillomavirus (HPV) coverage estimates in England: 2020 to 2021. https://www.gov.uk/government/statistics/human-papillomavirus-hpv-vaccine-coverage-estimates Accessed February 2023

17. Public Health Scotland (2021). HPV immunisation statistics Scotland school year 2020/21 – Full Report. https://www.publichealthscotland.scot/publications/hpv-immunisation-statistics-scotland/hpv-immunisation-statistics-scotland-hpv-immunisation-statistics-scotland-school-year-202021/

18. Public Health Wales (2021). Vaccine Uptake in Children in Wales July to September 2021. Cover 140: Wales November 2021 https://phw.nhs.wales/topics/immunisation-and-vaccines/cover-national-childhood-immunisation-uptake-data/cover-archive-folder/quarterly-reports/cover-140-wales-november-2021-july-to-september-2021/ Accessed February 2023

19. NHS England and NHS Improvement (2021). Update on Vaccination and immunisation changes for 2021/22 dated 10 March 21. https://www.england.nhs.uk/wp-content/uploads/2021/03/B0434_Update-on-vaccination-and-immunisation-changes-for-202122-v4.pdf Accessed February 2023

20. NHS Digital (2022). HPV vaccination programme. https://digital.nhs.uk/services/general-practice-gp-collections/service-information/hpv-vaccination-programme Accessed February 2023

21. Dexter LJ, Teare MD, Dexter M, et al. Strategies to increase influenza vaccination rates: outcomes of a nationwide cross-sectional survey of UK general practice. BMJ Open 2012;2:e000851. doi: 10.1136/bmjopen-2011-000851 Strategies to increase influenza vaccination rates: outcomes of a nationwide cross- sectional survey of UK general practice. - Abstract - Europe PMC

22. Katie V Newby, Joanne Parsons, Jessica Brooks, Rachael Leslie, Nadia Inglis, Identifying strategies to increase influenza vaccination in GP practices: a positive deviance approach, Family Practice, Volume 33, Issue 3, June 2016, Pages 318–323, https://doi.org/10.1093/fampra/cmw016

23. Public Health England (2019). Increasing influenza immunisation uptake among children: best practice guidance for general practice. https://www.gov.uk/government/publications/flu-vaccine-best-practice-guide-for-gps Accessed February 2023

24. Public Health England (2021). HPV universal vaccination: factsheets for health professionals. https://www.gov.uk/government/publications/hpv-vaccination-and-cervical-cancer-addressing-the-myths Accessed February 2023

25. Drolet M, Bénard E, Boily MC, et al (2015). Population-level impact and herd effects following human papillomavirus vaccination programmes: a systematic review and meta-analysis. Lancet ID, 2015. https://www.sciencedirect.com/science/article/pii/S1473309914710734?via%3Dihub Accessed February 2023

26. Drolet M, Bénard E, Perez N, et al (2019). Population-level impact and herd effects following the introduction of human papillomavirus vaccination programmes: updated systematic review and meta-analysis - The Lancet

27. Kavanagh K, Pollock KG, Cuschieri K, Palmer T, Cameron RL, Watt C, Bhatia R, Moore C, Cubie H, Cruickshank M, Robertson C. Changes in the prevalence of human papillomavirus following a national bivalent human papillomavirus vaccination programme in Scotland: a 7-year cross-sectional study. Lancet Infect Dis. 2017 Dec;17(12):1293-1302. doi: 10.1016/ S1473-3099(17)30468-1. Epub 2017 Sep 28. PMID: 28965955. https://pubmed.ncbi.nlm.nih.gov/28965955/ Accessed February 2023

28. Public Health England (2020). Sexually Transmitted Infections and Chlamydia Screening in England, 2020. (Data on File available on request) Accessed February 2023

29. Falcaro M, Castanon A, Ndlela B et al (2021). The effects of the national HPV vaccination programme in England, UK, on cervical cancer and grade 3 cervical intraepithelial neoplasia incidence: a register-based observational study. The Lancet, vol. 398, no. 10316, pp. 2084-2092. The effects of the national HPV vaccination programme in England, UK, on cervical cancer and grade 3 cervical intraepithelial neoplasia incidence: a register-based observational study - The Lancet

30. Public Health England (2019). HPV vaccine could prevent over 100,000 cancers. https://www.gov.uk/government/news/hpv-vaccine-could-prevent-over-100-000-cancers Accessed February 2023

31. Public Health England (2021). Cervical screening: programme overview. https://www.gov.uk/guidance/cervical-screening-programme-overview Accessed February 2023

32. Health Protection Scotland (2022). Human papilloma (HPV). https://www.hps.scot.nhs.uk/a-to-z-of-topics/human-papillomavirus/ Accessed February 2023

33. Public Health Agency Northern Ireland (2019). Human Papillomavirus (HPV) Vaccination Programme: Factsheet for healthcare professionals. https://www.publichealth.hscni.net/sites/default/files/2019-08/HPV%20factsheet%20for%20professionals.pdf Accessed February 2023

34. NHS 111 Wales (2022). HPV Vaccine. https://111.wales.nhs.uk/livewell/vaccinations/HPVvaccine Accessed February 2023

35. UKHSA (2022). ImmForm. https://portal.immform.phe.gov.uk Accessed February 2023

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