The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, I begin by congratulating the noble Lord, Lord Patel of Bradford, on securing this debate and on bringing this important subject to your Lordships’ House. I understand the noble Lord’s concerns on this issue. Vaccines provide vital protection from a large number of diseases, including the human papilloma virus. We need to ensure that they are used as effectively as possible and that those who would most benefit from them are included in any vaccination programmes that we implement.
As has been mentioned, the Government are advised on all immunisation matters by the statutory body, the Joint Committee on Vaccination and Immunisation. The JCVI keeps all immunisation matters under review, providing advice and recommendations to Ministers on all current and potential vaccination programmes. It is, therefore, to the JCVI that we look for expert advice when considering issues such as those raised today.
The UK’s current HPV vaccination programme, based on advice from the JCVI, began in 2008, and its aim is to prevent cancers relating to HPV infection, specifically cervical cancer. HPV is a sexually transmitted disease. Our main objective, therefore, is to provide HPV vaccine to young women before they reach an age when exposure to HPV infection increases and vaccination would become less effective because many would have already been infected. For that reason, the vaccine is offered to all girls in school year 8—that is, at ages 12 to 13 years. As HPV is responsible for virtually all cases of cervical cancer, prevention of this disease remains the primary aim of the current programme.
The UK’s HPV vaccination programme has been a considerable success. Almost 8 million doses have been administered across the UK since 2008 and this country has among the highest rates of HPV vaccine coverage achieved in the world. In England, 86.7% of girls eligible for routine vaccination in the 2013-14 academic year completed the three-dose course and 89.8% have received at least two doses of vaccine.
The noble Baroness, Lady Hollins, asked about herd immunity. When recommending introduction of the programme in 2008, the JCVI considered that once 80% coverage among girls was achieved, which we have now attained, the vaccination of boys was likely to provide little additional benefit in preventing cervical cancer in girls. As the noble Lord, Lord Patel, made clear, with high uptake of HPV vaccine among girls, many boys will also be protected against other HPV-related cancers such as anal cancer and head and neck cancers, because transmission of HPV between girls and boys should be substantially lowered.
However, as I mentioned, the JCVI keeps all vaccination programmes under review and has recognised that under the current programme the protection that accrues from reduced HPV transmission from vaccinated girls may not be provided to men who have sex with men, or MSM, because they are less likely to have sexual contact with vaccinated women. Given increasing evidence of the association between HPV infection and oral, throat, anal and penile cancers, and the impact of HPV vaccination on such infections, the JCVI set up an HPV sub-committee in October 2013 to consider a number of key issues around HPV vaccination, including the question of potentially extending the programme to MSM and adolescent boys—that is, to protect those who may go on to become MSM—or to both. The committee has also noted the public, parliamentary and third-sector concern about this issue and agreed that evaluation of potential extensions to the programme to include MSM, adolescent boys, or both, should be a priority.
Your Lordships may be aware that last November, following very careful consideration of the evidence, the JCVI published for consultation provisional advice that a targeted HPV vaccination programme should be introduced for MSM aged between 16 and 40 years attending genitourinary medicine and HIV clinics. The JCVI consultation ended on 7 January 2015 and we await the committee’s final advice on this matter.
The JCVI’s HPV sub-committee is also giving consideration to work modelling the impact and cost-effectiveness of extending HPV vaccination to adolescent boys. I am advised that it is currently anticipated that a model being developed at Warwick University could be presented to the sub-committee in the second half of this year. A separate model being developed by Public Health England may not now be completed until early 2017. I also understand that the JCVI and its HPV sub-committee may need to consider both studies before taking a final view on the impact and cost-effectiveness of extending HPV vaccination to adolescent boys and may therefore not be in a position to do so before early 2017. The JCVI has noted that the cost-effectiveness of an HPV programme for adolescent boys is not certain, because the high coverage rates achieved for adolescent girls are highly likely to interrupt HPV transmission and provide indirect protection for boys to such an extent that there may be little additional benefit to be accrued from extending the programme. However, the committee agreed that a detailed cost-effectiveness analysis was required to fully understand the potential benefits of any proposals.
The noble Baronesses, Lady Gould and Lady Wheeler, asked why there has to be this two-year delay. Work to model the impact and cost-effectiveness of vaccinating adolescent boys with HPV vaccine is dependent on the completion of work by PHE on an individual-based model for HPV screening, as the intention was to use the completed screening model as a basis on which to model adolescent male vaccination. An individual-based model is critical to proper assessment of an adolescent boys’ vaccination programme. Individual-based models are very complex and mathematical; they simulate the impact of an intervention on individuals within a population through time and take a considerable amount of time and resource to develop. The screening model is now not due to be completed until early this year. Although disappointed that modelling work on the cost-effectiveness of HPV vaccination of adolescent boys by PHE will not begin until early 2015, the JCVI agreed that in order to expedite the work it would not be advisable to take any shortcuts, which could undermine the validity of the outputs. As I said, the PHE model may not now be completed until early 2017. The HPV sub-committee will meet during 2015 to review the progress of these studies and will report its findings to the JCVI following consideration of work modelling the impact and cost-effectiveness of extending HPV vaccination to adolescent boys.
Your Lordships will be aware that the NHS budget is a finite resource. New vaccination programmes and extensions to existing programmes will usually represent a significant cost to the health service, in terms of both vaccine purchase and its administration to individuals. It is therefore essential that any advice or recommendations from the JCVI on changes to the national vaccination programme be supported by evidence to show that they would be a cost-effective use of resources.
The noble Lord, Lord Patel, asked about an equalities assessment. An equality impact assessment was completed in 2008 for the introduction of the national HPV vaccination programme for girls. At that time, vaccination for boys for HPV was considered to be not cost-effective for the prevention of cervical cancer.
The noble Countess, Lady Mar, raised the issue of the Japanese experience. HPV vaccines, in fact, remain licensed for use in Japan and continue to be available for girls and women who wish to receive them. The decision of the Japanese authorities temporarily to stop their active recommendation for immunisation due to reports of chronic pain was a precautionary move while they gathered more data. However, EU regulators have reviewed the issue and concluded that there is currently insufficient evidence to indicate that HPV vaccines may be a cause of chronic pain or chronic pain syndrome, which has also been associated with needle injection itself—that is to say, not specific to the vaccine. It remains the case that a causal relationship with HPV vaccines has not been established.
The Countess of Mar
My Lords, I am sorry to interrupt, but even the manufacturers recognise autoimmune dysfunction as a result of their vaccines.
Earl Howe
My Lords, I will take that point away and respond to the noble Countess in writing, as I do not have briefing on it. Suffice it to say, lest there be any doubt, we consider vaccine safety to be of paramount importance. The Medicines and Healthcare products Regulatory Agency has closely evaluated the safety of the HPV vaccine since it was first introduced in this country. The agency takes every report of suspected adverse reactions very seriously and keeps safety under continual review. Again, the view remains that there is currently insufficient evidence to indicate that illnesses are a side-effect of the vaccine.
The MHRA recently completed an epidemiological study of myalgic encephalomyelitis and chronic fatigue syndrome following HPV vaccination. This found no evidence to suggest that the vaccine may be a cause of the condition. The results of the study were published in a peer-reviewed scientific journal in 2013, as I am sure the noble Countess is aware. It is estimated that more than 30 million females worldwide have been vaccinated with HPV vaccine. The United States health authorities have also extensively reviewed HPV vaccine safety and the World Health Organization is assured by its safety.
Time is against me, so I will write to noble Lords on those points that I have not been able to cover. Let me just say that this is very much work in progress. Clarity on timelines cannot be achieved until the JCVI HPV sub-committee has met and reviewed the available evidence. We anticipate that sufficient evidence for the JCVI to be able to offer final advice on the vaccination of men who have sex with men will become available during 2015 but that sufficient evidence for the JCVI to be able to offer advice on the vaccination of adolescent boys may not now become available until 2017 at the earliest. I am afraid that I cannot give any comfort on an earlier date. I recognise that 2017 seems a long way off. However, I hope that the noble Lord will agree that it is essential that the JCVI does its work thoroughly and comprehensively before finalising its advice to the Government. He asked whether Ministers will meet the JCVI to discuss this. I will pass that recommendation to my honourable friend Jane Ellison MP, the Minister for Public Health.
The noble Baroness, Lady Hollins, requested that the issue of men with learning difficulties should specifically be brought to the attention of the JCVI. All girls are covered, regardless of disability, so this is an issue that could be brought to the attention of the JCVI and officials will do that.
Finally, I thank the noble Lord once again for initiating today’s debate. I very much hope that the discussion has been helpful in providing reassurance of our commitment.