Correspondence

Annex A: HPV vaccine information and guidance for healthcare professionals

Published 27 July 2021

Why has the vaccine been changed?

The 9-valent vaccine Gardasil® 9 (manufactured by Merck Sharp & Dohme Limited (MSD)) received licensing approval from the European Medicines Agency (EMA) for a 2 dose schedule in adolescent girls in April 2016 and is licensed for individuals aged 9 up to and including 14 years of age (Summary of Product Characteristics (SPC), Gardasil9).

For the 9-valent vaccine, the indication is based on:

• non-inferiority with the 4 vaccine types in the 4-valent vaccine for girls, women and men,
• demonstration of efficacy against human papillomavirus (HPV) types 31, 33, 45, 52 and 58 in girls and women, and
• demonstration of non-inferior immunogenicity against the Gardasil 9 HPV types in boys and girls aged 9 to 15 years and men aged 16 to 26 years, compared to girls and women aged 16 to 26 years

Gardasil® 9 can be used for all those eligible: adolescents aged 12 to 13 years and those who remain eligible until they turn 25 years of age, and men who have sex with men (MSM) up to 45 years.

At its meeting in June 2016, the Chair of the Joint Committee on Vaccination and Immunisation (JCVI) summarised that the 9-valent vaccine was the preferred vaccine for the girls’ programme because of the additional health benefits that it provided in protecting against the 5 additional cancer causing HPV types. The JCVI has not made any statements or given any advice about the vaccine of choice for a gender-neutral programme.

Vaccine supply

Public Health England (PHE) will continue to supply vaccine for the HPV programme in the usual way and will issue the remaining central supplies of Gardasil® before the switch to Gardasil® 9, which will occur at some point between late 2021 and early 2022. ImmForm customers should refer to the ImmForm website for updates on timing of the switch.

Gardasil® 9 will be supplied for both arms of the HPV programme (adolescents aged 12 to 13 years and those who remain eligible until they turn 25 years of age, and MSM up to 45 years). As the programme transitions to Gardasil® 9, some individuals will receive a mixed schedule during the switch. The 2 vaccines should be considered interchangeable and vaccination should not be delayed due to preference for either vaccine.

Local supplies of Gardasil® should not be ringfenced for those who have already received a first dose of Gardasil®. Local supplies of Gardasil® should be used up prior to switching to Gardasil® 9.

Patient Group Directions (PGDs)

New PGD templates to support the provision of Gardasil® 9 will be published from July 2021.

Funding and service arrangements

From 1 April 2021 all provision of vaccination and immunisation services in general practice are essential services (with the exception of childhood and adult seasonal flu). A single item of service fee has been implemented for all doses delivered in vaccination programmes funded through the General Medical Services (GMS) contract, including where additional doses are required to meet clinical need and where children are vaccinated outside the routine schedule.

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, and who have missed vaccination under the schools’ programme. Those eligible who missed vaccination in schools will be able to receive the vaccination opportunistically, or if requested, until the age of 25. Eligibility for boys includes males born on or after 1 September 2006. An item of service fee will only be applicable for those vaccinations administered by the GP practice.

Payment for HPV will not be supported with an automated data extraction and monthly payment via CQRS for 2021 to 2022 and will remain a manual service for this year.

School aged providers are commissioned on the basis of 100% offer to all those eligible, including those who are home-schooled. Routine offer of vaccination is made for those eligible aged 12 or 13 years in school year 8. Funding arrangements with commissioned providers remain unchanged.

Information for healthcare professionals and patients

Detailed clinical guidance on HPV immunisation is contained in chapter 18a of Immunisation Against Infectious Disease (the green book). Please note a revised HPV chapter is due to be published shortly.

Healthcare professional information and guidance to support the HPV programme will be updated to reflect the above changes, including a training slide set, and become available on the HPV immunisation programme webpage from July 2021.

Updated public information materials will be available on the HPV immunisation programme webpage and to order from the Health Publications website before September 2021.

Consent

There will need to be a clear communication with parents and eligible adolescents and robust arrangements will be needed to obtain consent for immunisation. Guidance on consent can be found in the guidance for health professionals and chapter 2 in the green book.

The consent form template will be updated.