Correspondence

Annex E: HPV programme question and answers

Published 27 July 2021

Is Gardasil® inferior to Gardasil® 9?

Gardasil® has been shown to be highly effective in preventing the types of human papillomavirus (HPV) infection for which it is indicated. Evidence from clinical trials has shown that protection is maintained for at least 10 years but is expected to last much longer and may be lifelong. Gardasil® has been shown to give good protection against HPV types 16 and 18 which account for around 70% of all cervical cancers and HPV6 and HPV11, the 2 HPV types that cause approximately 90% of all anogenital warts in males and females. In clinical trials in young women with no previous history of HPV infection, the vaccine was 99% effective at preventing pre-cancerous lesions associated with HPV types 16 and 18. Gardasil® is also 99% effective at preventing genital warts associated with vaccine types in young women.

What should we say to those who request 2 doses of the same vaccine?

While the vaccine supplied for HPV vaccinations is changing from Gardasil® to Gardasil® 9, there will only be one type of vaccine available for the adolescent and men who have sex with men (MSM) programmes at any given time. Therefore, depending on when the transition occurs for the respective programme, individuals may receive 2 doses of Gardasil®, 2 doses of Gardasil® 9, or a mixed schedule. The 2 vaccines should be considered interchangeable and vaccination should not be delayed due to preference for either vaccine.

What do we say to those who have already been vaccinated?

They did exactly the right thing in being vaccinated. As a result of their vaccination, they are significantly less likely to be infected by HPV types 16 and 18 that cause over 70% of cervical cancers in the UK – which is an excellent outcome.

Should those who received Gardasil® now be boosted or revaccinated?

Gardasil® provides good protection against HPV-related cancers and boosters or revaccination after the initial course are not required.

Is there something wrong with Gardasil®?

No. Gardasil® has an excellent safety record established after use of more than 7 million doses in the routine immunisation programme in the UK since it was first used in 2012, with more doses used in other countries. 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.

Is Gardasil® 9 a new vaccine? Do we know how safe it is?

Gardasil® 9 has been used extensively in other countries since it was first licensed in 2015 and its safety is well established. The Medicines and Healthcare Products Regulatory Agency (MHRA) and the Joint Committee on Vaccination and Immunisation (JCVI) keep the safety of vaccines under review.

How will you monitor if there are any adverse reactions when Gardasil® 9 starts to be used?

As with any vaccine or medicine newly introduced in the UK, the MHRA will closely monitor the safety of Gardasil® 9. Health professionals and those vaccinated will be asked to help confirm the safety profile by reporting any suspected side effects through the Yellow Card Scheme, and the MHRA will regularly review any such reports using statistical and epidemiological techniques.

My child has completed the course of Gardasil® but I want them to be vaccinated with Gardasil® 9 so they are protected against these further strains.

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. It would not be appropriate therefore as part of the NHS programme to offer Gardasil® 9 to those who have had a full course of Gardasil®.