Health: Human Papilloma Virus
(9 years, 10 months ago)
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Lord Patel of Bradford
To ask Her Majesty’s Government what action they are taking to include all adolescent boys in the national vaccination programme for human papilloma virus.
Lord Patel of Bradford (Lab)
My Lords, I am most grateful for the opportunity to discuss the very important issue of whether adolescent boys as well as girls should be included in the national vaccination programme for HPV—human papilloma virus. I thank all noble Lords who will be speaking in this short but important debate, and express my gratitude to Peter Baker, former chief executive of the Men’s Health Forum and the current campaign director of HPV Action, for all his expert advice and guidance.
This debate is particularly timely because the Joint Committee on Vaccination and Immunisation—JCVI—is currently looking at whether the national HPV vaccination programme should include boys. I have a particular interest in the outcome through my role as chair of the All-Party Parliamentary Group on Men’s Health. Some two years ago, the all-party group held a meeting jointly with the All-Party Group on Sexual and Reproductive Health in the UK. The chair of that group, my noble friend Lady Gould of Potternewton, and I heard evidence from two distinguished speakers—Professor Margaret Stanley from Cambridge University and Mr Peter Greenhouse, a consultant in sexual health from Bristol—which absolutely opened my eyes to the avoidable risks to the health of men caused by HPV infection.
I realised that HPV is not just a problem for women. It does not cause just cervical cancer but other cancers in women and a wide range of cancers in men as well. We know that HPV can cause, in men and women, cancers in the head and neck, as well as anal cancer. In women it can cause vaginal and vulval cancer, and in men penile cancer. In fact, worldwide HPV is understood to cause 5% of all cancers and is thought to be behind the steep rise in oral cancers in the past 20 years.
Unfortunately, HPV is a very common and easily acquired sexually transmitted infection. The majority of people—probably over 80%—will be infected with HPV at some stage in their lives. The good news is that most people’s bodies clear the virus naturally and it causes no lasting damage. But in others it can persist, especially if they have weakened immune systems, and can lead to potentially life-threatening problems. HPV is not just a cause of cancer; it is also responsible for genital warts and a very unpleasant but fortunately much rarer condition called RRP—recurrent respiratory papillomatosis. This can cause serious breathing problems and is very difficult to treat.
Thirty-six organisations have come together as HPV Action to make the case for gender-neutral vaccination; in other words, protecting both males and females from the consequences of HPV infection. These 36 organisations are major names in the fields of cancer, sexual health, men’s health, oral health and public health; in fact, one of them is the Royal Society for Public Health, of which I happen to be a vice-president. HPV Action has informed me that some 2,000 cases of cancer in men are caused each year in the UK by HPV. Around 48,000 men also develop genital warts as a result of HPV infection, and about 600 men and boys live with RRP. This is a huge burden for the individuals affected and their families, and a significant issue for the NHS, which has to find the resources to treat and care for them.
It seems patently unfair that we exclude boys from a vaccination programme that can easily prevent a wide range of diseases, including several types of cancer. This makes no sense on the grounds of equity or public health. I also wonder if it might even be unlawful to exclude boys from this programme under our current equality legislation. I would be very interested to hear from the Minister whether this is the case and whether an equality impact assessment has been undertaken on this issue.
With regard to the JCVI’s timescale for a decision on adolescent boys, in 2014 it stated that it would be in a position to make a recommendation later this year. Unfortunately, in the past few weeks we have heard that the JCVI will not be taking a view until early 2017. Given the facts and figures that I have just presented, this delay is totally unacceptable. I ask the Minister to meet the JCVI urgently to discuss how the decision-making process can be accelerated. Any continued delay is causing many, many more people to suffer avoidable ill health. In fact, I believe that the case for vaccinating boys is already proven and that Ministers should make a decision now to vaccinate boys as soon as possible.
Of course, as always, there are arguments put forward that seek to justify excluding boys. I will briefly address a couple of these. First, it has been argued that the current vaccination programme for girls is so good that it protects males as well. It is true that the programme reaches over 80% of girls; 80% is the level at which the population as a whole is believed to be well protected. The UK HPV vaccination programme is without doubt one of the best programmes in the world for girls. But it is not perfect. There are some areas, notably in London, where vaccination rates in girls are well below 80%. The latest data for Enfield, for example, show that just 67% of girls received all the doses they needed. A recent study by University College London also found that girls from black or other ethnic minority backgrounds were less likely to have been vaccinated than girls from white or Asian ethnic backgrounds. These shortfalls leave large numbers of unvaccinated girls and women at risk of contracting HPV and limit the efficacy of the wider vaccination programme.
Evidence from Denmark clearly shows that while HPV vaccination for girls is reducing the incidence of genital warts in girls, it is not reducing the incidence of warts in boys. This suggests very strongly that boys are continuing to be infected with HPV, either by unvaccinated Danish girls or by girls from countries without a vaccination programme. Men in the UK, as in Denmark, do not conveniently have sexual contact just with women brought up in their own country. It is also the case that not all men have sexual contact with women of their own age group. For those men who have partners who are older than the first female cohort to receive the vaccination, the risk of HPV infection and disease will remain.
Secondly, there are some who believe that the problem with not vaccinating males is largely confined to those who have sex not only with women but also—or instead—with men. It is true that men who have sex with men are, in general, more seriously affected by HPV. Rates of anal cancer in this group have risen sharply in recent years, and anal cancer rates are even higher in men who have sex with men who are HIV positive. It has been suggested that the solution to this problem could be to offer HPV vaccinations to men who have sex with men, on attendance at a GUM clinic. Indeed, this step was recently recommended by the JCVI. In my view, and in the view of HPV Action and other experts, this is a useful but certainly nowhere near a sufficient response. It might be of some help to individuals who receive the vaccine, but it is not an effective solution for all men, or indeed for all men who have sex with men.
That is because we know that people generally become infected with HPV very soon after their first sexual experiences. That is why it is best to vaccinate before a person begins sexual activity. It is also best because the body’s immune response is greater if the vaccine is administered before the age of 16. But if we wait until men who have sex with men turn up at GUM clinics, they are likely already to have had sex with one or more sexual partners. There is lots of evidence to prove that the median age of men approaching GUM clinics is their late 20s and early 30s.
As we cannot practically or ethically identify and vaccinate the 12 and 13 year-old boys who will in their adult lives go on to have sexual activity with other men, the only effective way to protect men who have sex with men is to vaccinate all boys. This would, of course, also protect all other men and increase the level of protection for unvaccinated girls, especially in those areas where, as I have just mentioned, vaccination rates are below 80%.
The proposal to vaccinate all boys has far-reaching support. In fact, it is now hard to find anyone in the field of public health in the UK who does not support gender-neutral vaccination. Significantly, other countries are already vaccinating their boys. Australia, several Canadian provinces and Austria have already introduced gender-neutral vaccination programmes, and the United States is recommending vaccination for both sexes.
I want briefly to mention the issue of cost. HPV Action estimates that the additional cost of extending the HPV vaccination programme to boys in the UK would be in the region of £20 million to £22 million. This relatively small cost has to be set against the economic impact of HPV-related disease. In England, the cost of treating genital warts alone is estimated to be more than £52 million a year. The cost of treating RRP has been estimated at £4 million a year and there are the costs of treating a rising number of HPV-related cancers.
I serve as chairman of Bradford Teaching Hospitals NHS Foundation Trust, so noble Lords will appreciate that I am very interested in health interventions that are cost-effective, as this one clearly would be. But, ultimately, any decision about whether to vaccinate boys should not be made solely on a financial basis, although that is very clear cut. I believe that public health, equity and, above all, the human costs of HPV-related disease for both sexes must be the primary considerations. I would be grateful if the Minister could assure the House that the Government will act quickly to vaccinate both boys and girls in the UK.
Baroness Hollins (CB)
My Lords, I thank the noble Lord, Lord Patel of Bradford, for initiating this important debate. It comes at a time of growing consensus within the medical community that now is the right point to extend HPV vaccination to all boys. It is the only effective and equitable solution to protect against HPV infection. I want to focus my remarks during this debate on the role of HPV in a range of cancers affecting men and the growing evidence that the best way to target HPV in boys is to vaccinate them in school. I shall also raise concerns about a group which is often overlooked in discussion: men with learning disabilities. I ask the Minister to remember this group of men in his response.
There is no doubt that incidences of cancers associated with HPV are going up. The UK has seen a recent rise in the incidence of HPV-related oropharyngeal carcinoma among men, and I understand from the research of Professor Margaret Stanley, who has already been mentioned in this debate, that this has the fastest rising incidence of any cancer—15% a year. Over the past four decades, rates of anal cancer in both men and women in the UK have risen steadily. It is estimated that 90% of anal cancer in men is related to HPV infection, and roughly six people die every week in the UK from this cancer. Infection with HPV is also responsible for nearly all cases of genital warts.
Men who have sex with men are especially at risk of exposure to HPV infection because they are completely outside the vaccinated herd. Reflecting on the comments of the noble Lord, Lord Patel, I presume that if only 80% of girls are vaccinated, since girls are only half the population, that must reduce the effectiveness of the herd to 40%. Does it? The incidence of anal cancer in this group is estimated to be similar to that of cervical cancer in an unscreened population of women.
A not insignificant number of boys will be sexually abused before reaching adulthood, including boys with learning disabilities, who are at much higher risk of abuse and are less likely to have received sex education or to know how to report abuse. Although some improvements have been made, the sexual health needs of those with learning disabilities have, for the most part, been overlooked. This is particularly worrying as evidence suggests that men with learning disabilities who have sex with men are less likely to identify themselves as gay and therefore are less likely to have access to formal or informal sexual education, which places them at even greater risk of getting STIs or even HIV.
It is against this backdrop that HPV Action has been formed. It is a coalition of organisations that support gender-neutral vaccination. It includes the British Dental Association, the Royal College of Obstetricians and Gynaecologists, the Royal Society for Public Health and the Faculty of Public Health, among others. All agree that the case for vaccinating both sexes against HPV is growing stronger. The House will wish to be reminded that my interests include being chair of the board of science of the British Medical Association. The British Medical Association, which represents doctors, has also said that it now believes that there is an overwhelming case for expanding the school-based HPV vaccination programme to include boys. This was debated at the 2014 annual representatives’ meeting, and members voted to accept this evidence and advocate for equity in the vaccination programme.
It is clear that scientific and medical opinion now largely believes that HPV vaccination will prevent many cases of head, neck and penile cancer, and an increasing number of clinicians and public health organisations in the UK recommend HPV vaccination for boys. There is also a growing consensus that the most effective approach to providing this protection to boys would be to provide vaccination in school. To ensure that vaccine recipients are protected, they must receive the immunisation prior to the initiation of sexual activity. As such, there are concerns that providing immunisation only at GUM clinics would not do this effectively. It is not practical to offer HPV vaccination only to men who have sex with men because, to be most effective, boys should receive the vaccine prior to the age of sexual activity. The optimum age for this would be 12 or 13. It is clear that 12 or 13 year-old boys would not attend GUM clinics. We have already heard that the median age for first attendance is around 28 or 29. Boys of 12 or 13 may be unaware of their sexual orientation.
In the existing school-based vaccination programme, we already have an appropriate mechanism for vaccine delivery. From September last year, the HPV vaccination schedule was reduced to two doses. This reduction now provides capacity—this is an important point—to extend the school-based HPV vaccination programme to include boys. I believe that this presents us with a real opportunity, and providing HPV vaccination to all boys in schools will guarantee that high vaccine coverage rates are achieved. If we were to take this step, we would not be the first. Australia, Canada and the USA already offer HPV vaccination to boys.
The introduction of HPV vaccination to protect women against cervical cancer has made a significant contribution to reducing incidences of HPV infection among young women in the UK. This undoubtedly represents a significant health gain. However, there is now overwhelming evidence—and consensus—that there is a case for expanding the school-based HPV vaccination programme to include boys.
Baroness Gould of Potternewton (Lab)
My Lords, I, too, congratulate my noble friend Lord Patel of Bradford on securing this important and rather urgent debate. It is urgent because there are more than 100 different types of HPV being passed from one person to another, not only by sexual contact but by skin-to-skin transmission and through non-sexual routes of HIV transmission, which include vertical transmission from mother to newborn baby. As my noble friend said, HPV is very easily acquired. It is reckoned that most women and men will acquire it at some time during their lives.
This discussion on vaccination for boys takes me back to the early 2000s, when we made similar requests for HPV vaccination for girls, when I was chair of the Independent Advisory Group on Sexual Health and HIV. We need only look at the success of that campaign. It is now the norm for secondary schoolgirls aged 11 to 13 to be routinely offered the vaccination as prevention against cervical cancer. Boys were not included at the time, although our campaign argued strongly that Gardasil should be the chosen vaccine so that they could be vaccinated against genital warts. Not to include boys was a mistake, which we are now trying to rectify.
Since then, the non-vaccination of boys has been a growing issue and concern, as it has become evident that in fact it has serious public health consequences. As a result, as has been said, the BMA reports that there is a growing consensus in the UK that extending vaccination to all boys represents the only effective answer to the question of how to ensure that all are protected against HPV infection. To add to the list of organisations that we have already heard, that is also supported by Cancer Research UK and Jo’s Cervical Cancer Trust and a large number of organisations that work in the field of men’s health.
As has been said, there is increasing evidence of the association between HPV and the many types of cancer and precancerous lesions caused by HPV. A reduction of precancerous lesions would help to reduce the rate of penile and anal cancer in men, as confirmed by Cancer Research UK. As it says, 90% of anal cancer in men is related to HPV infection. A recent statement by the Royal College of Surgeons makes it clear that scientific evidence suggests that the vaccination of boys could help to prevent anal cancer and cancer of the oropharynx and tonsils. The college goes on to say that those types of cancer are increasing. Data from 2012 showed that while there were 2,483 cases of cervical cancer and decreasing, there were also many cases of oropharyngeal cancer and tonsil cancer, which is fast growing.
On getting throat cancer, the actor Michael Douglas got a great deal of publicity—as though it was something unique—when he spoke out about the link between the virus and throat cancer. That view is supported by the Throat Cancer Foundation, which also firmly believes that schoolboys should receive the HPV vaccine to protect against throat cancer. James Rae, head of the foundation, has called the disease a “ticking timebomb”, because boys are routinely exposed to a virus that can cause loss of life. Nor should we ignore in that list of cancers, as has been said, the possibility of head and neck cancers occurring because of HPV.
The importance of the vaccine Gardasil is that it is a protection against genital warts. HPV is responsible for nearly all cases of genital warts. Genital warts are not only a source of infection but can be a source of sexual shame and embarrassment. The medical treatment can be long, often requiring multiple visits for treatments from which there is, unfortunately, no absolute cure. Clinical trials in Australia have shown that the vaccine is 89% effective in preventing genital warts but less effective in those who have already been exposed to HPV. That outcome surely illustrates and identifies not only the need but also the sense of early intervention well before boys become sexually active and are potentially exposed to the virus. To roll out the vaccine to boys would also help to reduce incidence of cervical cancer in women. Equally, at the appropriate age we should also give children information about the risks and about the protection that condoms and dental dams provide. However, they will not absolutely remove transmission; the greater guarantee has to be a vaccine.
At the start of the review in 2013 the JCVI set up a sub-committee to assess whether the programme should be extended to adolescent boys, men who have sex with men or both. As has been said, the review was due to report in 2015. The JCVI concluded that men who have sex with men should be offered the HPV vaccine, and of course that is welcome. However, that will not protect the majority of men who have sex with men because, as has been said, they attend GUM clinics at a rather later age, by which time they may have had multiple sexual partners and so be at risk before they attend a sexual health clinic.
The question that has to be asked, as other noble Lords have asked, is: why the two-year delay to 2017? That delay seems to focus on the model being developed by Public Health England. Maybe the Minister can tell the House if representation has been made to Public Health England, which I spoke to this evening, so that the Government can honour their original and welcome commitment.
I will make two final points. The cost of a jab of vaccine is £45. If that is multiplied by the nearly 400,000 boys who should be vaccinated, the total cost would be around £23 million per annum. We might say that that is a lot of money, but if that figure is set alongside the cost of the treatments for the consequences of HPV, there would be savings, be it in the treatment of the various cancers or of genital warts. To take just two instances, it is estimated that the treatment for throat cancer costs the NHS £45,000 per patient. The cases are not all caused by HPV, but the number that is caused by it is growing, so there could still be substantial savings. Add to that the cost of treating genital warts of the figure we just heard—£52 million each year—and add the cost of treatment for anal and penile cancers and head and neck cancers. Put it all together and it is clear that over a period there would be savings to the NHS. Can the Minister say whether that exercise has been undertaken, so that we can show that in fact there is a financial case for implementing the vaccination of boys against the HPV virus? In addition, the fact that the HPV vaccination schedule has been reduced to two doses should mean that there is the capacity within the existing school-based programme to extend that vaccination programme to include boys.
My second and last point relates to the question of equity. Withholding a health intervention from any group at risk of easily preventable diseases is inequitable and discriminatory. Not vaccinating boys may be, as has been said, in breach of the Equality Act—I think it is—because it discriminates against boys who are at risk because of the withholding of a particular health intervention. Vaccinating girls is not sufficient; men will continue to have sexual contact with unvaccinated women, whether in this country, where according to Public Health England the critical 80% threshold for girls is not being met in many parts of the UK, or they may have sexual partners outside the UK. It might also be said that providing vaccination to gay men only discriminates against heterosexual men. Therefore, this question of discrimination should be looked at.
The human cost of HPV-related diseases has to be the primary consideration, and this is a genuine opportunity to make progress in the fight against cancer by a simple jab at a cost of £45. Lives can be saved each year if boys are given the same vaccination that protects girls from developing cancer. Other countries have been named, such as Canada, Australia and the United States, but one country has not been mentioned: South Korea, which has vaccinated boys and shown the efficiency of the vaccine. I therefore ask the Minister why we have to wait another two years for a decision, or even longer before the programme starts. The answer has to be prevention—a programme of prevention that provides for a gender-neutral vaccination strategy in schools for all 11, 12 and 13 year-old boys and girls.
The Countess of Mar (CB)
My Lords, I am grateful to the noble Lord, Lord Patel of Bradford, for bringing this question to our attention this evening. I am afraid that I do not share his enthusiasm or that of my noble friend Lady Gould for HPV vaccines.
I know that the Minister is aware of my concerns about the safety of human papilloma virus vaccination when it is used in girls. The problems that I have taken to him over the past two years do not apply only to girls and young women in the UK. Wherever HPV vaccine programmes exist there also exist high numbers of adverse reaction reports. After only six weeks, the Japanese Government withdrew their recommendation for the administration of HPV vaccine as a result of adverse event reports for Gardasil that were 26 times higher, and those for Cervarix 52 times higher, than those for the annual flu vaccination. One-quarter of these adverse events were considered serious. Denmark has recorded a quarter of adverse events as serious, while Italy reports adverse events at a rate of 219 per 100,000, 10 times higher than most of the other vaccines administered in Italy. According to the High Court in India, where 24,000 girls were vaccinated during demonstration projects, an estimated 1,200 were left with chronic health problems and/or autoimmune disorders. In the USA, HPV vaccines account for nearly 25% of the entire Vaccine Adverse Event Reporting System, or VAERS, a system that was established in 1990—and HPV vaccines were not introduced before mid-2006. In France, Spain and Colombia, there are ongoing court cases relating to girls who are suffering chronic ill health following HPV vaccination. In the USA, the National Vaccine Injury Compensation Programme has awarded $5,877,710 dollars to 49 HPV vaccine-damaged victims, and to date there have been 200 claims filed. This demonstrates that my concerns are not confined just to the UK.
Merck, the manufacturers of the vaccine Gardasil, admits in its own research documents, where Gardasil is compared with a new vaccine, Gardasil 9, that of 7,378 girls who were vaccinated, 2.5%—that is, 185—suffered serious adverse events. It also admits that 3.3%—that is, 240—suffered autoimmune disorders. A serious adverse event must fit one of the following criteria: death; life-threatening; disability or permanent damage; hospitalisation; congenital abnormality or birth defect; or the requirement to intervene to prevent permanent impairment. It is likely that such events in the general population would be higher because certain at-risk groups are excluded from clinical trials but not from vaccination programmes.
Cancer rates are always quoted as so many per 100,000; in the case of the Gardasil clinical trial, there would be 2,500 serious adverse events per 100,000 vaccinated. UK cancer cases are identified as 8.8 per 100,000 and with deaths as three per 100,000. UK HPV vaccine yellow card adverse reaction reports have been identified at 341 per 100,000, with serious reports numbering 108 per 100,000. We must not lose sight of the fact that the MHRA admits that possibly only 10% of adverse events are reported. A report represents a person and, within that report, the symptoms experienced by the individual are listed. The MHRA identifies the number of reports received, and the number of symptoms from individual reports are put under the appropriate headings in the MHRA statistics.
Interestingly, at the meeting of the JCVI HPV sub-committee, the MHRA reported:
“No significant new safety concerns have been identified during 2012/13 since Gardasil was introduced”.
In the light of what I have already said, I ask the Minister just how significant a serious reaction must be before it becomes a safety concern. How many have to report serious reactions before preventive action is taken? Are more than 108 per 100,000 young people to have their lives destroyed in order to save a possible 8.8 per 100,000 lives from cancers which, if detected early by the PAP screening programme for cervical cancer, which is not known to cause deaths or serious side-effects, can be treated?
Had the Minister been at the meeting of the All-Party Parliamentary Group for Vaccine Damaged People last week, he would have heard of the tragic lives many of the young women are leading. He would have seen videos of two young women who are bedridden—young women who, had they not been vaccinated with Cervarix or Gardasil, would have been leading active lives and, instead of being totally dependent on their parents, would have been about to fly the nest, go to university and be productive members of society. They represent many more in the UK and worldwide whose lives have been totally destroyed.
Gardasil has been on the market in the USA since June 2006 and has two of the high-risk HPV strains, 16 and 18, which are believed may lead to cervical cancer. The VAERS is now receiving reports from Gardasil-vaccinated women who have developed HPV infection, cervical dysplasia or cervical cancer. There are some 15 high-risk strains of HPV which are thought to be cancer-causing. These reports could well represent only the tip of the iceberg. Even the Minister’s honourable friend Anne Milton acknowledged on 7 July 2011 that:
“There is a possibility that other HPV strains could replace HPV 16 and 18 following the introduction of the HPV vaccination programme. However, there is no data with which to determine whether and how quickly this would take place”.
I have read the JCVI interim position statement on HPV vaccination of men who have sex with men, dated November 2014. It seems that the jury is still out as to the science behind offering HPV vaccination to this group, though they would appear to be the most vulnerable to HPV infection. I believe that the JCVI is rightly cautious. I understand that the human papilloma virus has never been proven to cause cancer by itself and that HPV vaccines have never been proven to prevent a single case of cancer. Other risk factors must be present for cancer to develop. According to the World Health Organization, only 0.15% of all people exposed to any high-risk strain of HPV will ever develop cervical cancer. There is no guarantee that eliminating one risk factor for the development of cancer will have any impact on the disease incidence or mortality rate, and there is no guarantee that any suppressed oncogenic HPV type will not mutate over the next 20 years to become more dangerous.
I have seen what has happened to our girls and young women when vaccination goes wrong. Do we really want all young boys to be just as vulnerable?
Baroness Wheeler (Lab)
My Lords, I, too, am very grateful to my noble friend Lord Patel for securing this debate and providing the opportunity to address this important issue. I also pay tribute to his contribution and work as chair of the All-Party Parliamentary Group on Men’s Health and to his dogged and persistent campaigning on the need to give teenage boys the HPV vaccine to prevent men getting cancers. Indeed, we have been very fortunate today to have the expert contributions from other strong campaigners on this and other key sexual health issues.
As we have heard, there is certainly a compelling case for challenging the Joint Committee’s 2008 conclusion that evidence did not support applying the universal programme of HPV vaccination for girls to boys. We have heard today how the contention that for boys such a programme would provide little additional benefit or be cost effective—because vaccine efficacy was high, and high coverage in girls would provide herd protection for boys—is increasingly difficult to sustain.
HPV Action, which leads the campaign for a gender-neutral HPV vaccination programme, is an authoritative voice on this issue and an umbrella body whose members include a wide range of leading public health, cancer, oral health, sexual health and men’s health organisations. The BMA, the Royal College of Physicians, the Royal Society for Public Health, and the charities Cancer Research and others, such as Jo’s Cervical Cancer Trust, all strongly support the campaign for the vaccine and the vaccination itself. The latter stresses that vaccinating both girls and boys at a young age may be the best way to achieve the greatest protection for females against the risk of cervical cancer, and that extending the vaccine to boys would provide universal protection to both sexes from many other HPV-related cancers. The BMA points to “overwhelming evidence” supporting extending the HPV vaccine to all boys as well as girls before they start having sex. Indeed, there is growing consensus in the UK and internationally that extending the HPV vaccination to boys represents the only effective, equitable solution to ensure that all are protected.
We can also acknowledge that the JCVI’s recent recommendation for men who have sex with men—MSM—to be offered HPV vaccinations when they attend sexual health clinics is an important step forward. However, we have heard today the strong concerns that this is not enough to protect MSM, and that the reality is that most MSM will remain unvaccinated. The most effective protection for MSM and heterosexual men is to vaccinate all adolescent boys before they become sexually active. The JCVI consultation on MSM ended this month. Does the Minister have any update on the level of response and do the Government have an estimated date for receiving the JCVI’s final advice?
There is also strong evidence that vaccinating boys will also help to protect women. The Royal Society for Public Health says:
“While the vaccination for girls does offer herd immunity for boys, this doesn’t take account of transient populations and presumes that males remain within the herd. Men may still contract HPV elsewhere (e.g. travelling abroad) or from females in the UK who have had the vaccination”.
On HPV vaccine for adolescent boys, the JCVI, in its November 2014 MSM interim statement, expresses disappointment that the modelling work on the impact and cost-effectiveness of the programme by Public Health England is not able to begin until this year, when, as we have heard, it had originally been expected to have taken place so that recommendations could come through this year. The JCVI is right to stress that it would be inadvisable to take shortcuts in the process of modelling which might undermine the validity of the results, but I hope that the Minister acknowledges the widespread concern that the delay and the revised estimated date for the recommendations of early 2017 is causing. I hope that he can shed some further insight on the reasons for the PHE delay and on what action the Government will be able to take to help the JCVI bring this date forward. The HPV action estimate is that every year that passes leaves 400,000 boys unvaccinated and unprotected. That is a worrying figure indeed. The noble Baroness, Lady Hollins, expressed particular concern about the position of boys with learning difficulties. I look forward to hearing the Minister’s response to that because it is obviously a very important issue.
Obviously, the JCVI work on the impact and cost-effectiveness of vaccinating adolescent boys is crucial, balancing the cost of the vaccination programme with the cost of treating HPV-related diseases, which is considerably more. My noble friend Lady Gould spelt out the costs involved in that. The RSPH’s call to action on extending the vaccine programme to all 12 to 13 year-old boys calls for the negotiation of a cost-effective HPV vaccine based on the Australian Government’s experience, which managed to secure a reduced cost per dosage of the vaccine for boys. My noble friend Lady Gould also referred to the changes last year in the vaccination programme for girls from three doses to two. The savings involved in that could have the potential to be invested in extending the programme to boys.
Finally, I underline the RSPH’s call for the need for a major campaign to increase public awareness of the risk of transmitting or contracting the HPV virus, and the potential impact that HPV can have on everyone. This is especially important in schools as a key part of the PSHE schools programme. Labour is strongly committed to, and in favour of, sex and relationship education being compulsory in all publicly funded schools in an age-appropriate way. The Minister will know that we tabled key amendments on this during the course of the then Children and Families Bill, but there was strong resistance from the then Education Secretary, Michael Gove. We also underlined the need to update the statutory sex and relationship guidance issued by the education department to schools, which has not been updated since 2000. In the spirit of joined-up government, I conclude by asking the Minister if the Department of Health will lead the way on this. Is it undertaking any work on this, and will he ensure that HPV awareness forms part of this work?
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.