Oireachtas Joint and Select Committees
Thursday, 20 December 2012
Joint Oireachtas Committee on Health and Children
Gardasil Vaccine (HPV) and Meningococcal Group B Vaccine: Discussion
We are dealing this morning with issues related to the Gardasil vaccine for HPV and the meningococcal group B vaccine. I welcome the witnesses to the committee and apologise for the delay. We had a lengthy meeting in private session.
I wish to advise the witnesses that by virtue of section 17(2)(l) of the Defamation Act 2009, witnesses are protected by absolute privilege in respect of the evidence they are to give to this committee. If they are directed by it to cease giving evidence on a particular matter and continue to so do, they are entitled thereafter to only qualified privilege in respect of their evidence. They are directed that only evidence connected with the subject matter of these proceedings is to be given and asked to respect the parliamentary practice to the effect that, where possible, they should not criticise or make charges against a person or persons or an entity by name or in such a way as to make him, her or it identifiable. Members are reminded of the long-standing ruling of the Chair to the effect that they should not comment on, criticise or make charges against a person outside the Houses or an official by name or in such a way as to make him or her identifiable.
Ms Paula Byrne:
I thank the committee for allowing me to speak today. All the information I present is based on published articles by established scientists writing in recognised peer-reviewed medical journals, and it is referenced in the material that I have previously submitted to the committee.
Despite the current economic climate, we are spending €10 million per year on a vaccine against cervical cancer which has not been proven in any part of the world to work. In the words of Dr. Charlotte Haug of the Norwegian Medical Association, writing in the New England Journal of Medicine about HPV vaccines, we cannot base costly decisions on unproven assumptions. Dr. Haug is one of the many clinicians and scientists around the world who have raised serious concerns about HPV vaccines. With more than 20 years of experience in health care fields, and currently studying for a master's degree in health economics, I became concerned about Gardasil while researching an article that was published in The Irish Times. In France, Gardasil is prohibited from being promoted as protective against cervical cancer because it is clear the impact of the vaccine is unknown.
There are three important questions to ask here. Is it necessary? No, it is not. Is it effective? We do not know. Is it safe? Again, we do not know. Against this backdrop, we are vaccinating 12 year old girls, 99.9% of whom are unlikely to ever develop cervical cancer. For the 0.1% who do develop it, on average it will be in 30 years' time. Dr. Diane Harper, one of the lead scientists working on the development of the vaccine, has stated that if Gardasil is given to 11-year-old girls, and the vaccine does not last at least 15 years, then there is no benefit, only risk, for these young girls. Does this make sense? Does it not make more sense to put our limited resources into strengthening screening programmes that cannot cause harm and whose effectiveness we know? In Ireland, the HSE leaflet promoting the vaccine states on its front cover that the HPV vaccine protects us from cervical cancer. This is plainly untrue. When the State makes a strong recommendation to its citizens about a health intervention, the information should be based on fact, not conjecture. It is up to the parent of each child receiving this vaccine to make this informed decision and they can only do so if they have the correct information. By exaggerating the benefits of the vaccine, parents are unable to make accurate and informed decisions. The marketing of this vaccine has been criticised, and an article in the American Journal of Bioethics noted on Gardasil that pharmaceutical lobbying is a poor substitute for well-reasoned public health debate. Consent for a medical procedure in Ireland must legally be full, free and informed. I doubt if anyone here is comfortable with actively misinforming the public. I ask the committee to ensure this leaflet and promotional material are changed to represent the evidence.
For politicians, getting the best value for money is crucial. All of the members here today are at the coalface of budgetary restrictions and every day they deal with the fallout for constituents whose front-line services are being cut. It is vital that our scarce resources are spent only on evidence-based medical interventions. During previous Dáil debates on this issue it has been stated that failure to introduce this vaccine could result in the unnecessary deaths of women. This sort of emotive statement makes it very difficult for politicians to tease out the scientific facts, but this is what I am asking the committee to do.
This vaccine is unproven and represents a massive waste of valuable resources. My recommendations to the committee are that the programme should be discontinued based on the current facts and, at the very least, parents must not be misled and this promotional material should be changed so it is truthful. I put these issues before the committee because I believe, and I am sure members do too, that politicians have a duty of care to the people to defend their right to make informed choices for their children.
Ms Jacqueline Hogan:
Professor Harald zur Hausen, the person who isolated the HPV vaccine, stated that although the vast majority of women clear the infection through their own immunological systems, persistent infection remains in around 1% of women, and these are the women at risk from cervical cancer. In Ireland at present, all 12- and 13-year-old girls in first year of secondary school are being subjected to a vaccine for a disease they may never come into contact with. That is not even to state that the HPV infection goes on to create cancer. Many people have had HPV infection without developing cancer. That is an important statement: all our girls are being subjected to this vaccine in first year but only 1% are likely to have the infection.
The adverse reactions reported as a result of the vaccine have been noted by Judicial Watch, the public interest group based in Washington that investigates and prosecutes Government corruption. It announced that it has received new documents from the US Food and Drug Administration, dated 19 October 2011, under the US freedom of information legislation, detailing reports of adverse reactions to the vaccine. The report details 26 new deaths between 1 September 2010 and 15 September 2011, as well as incidents of seizures, paralysis, blindness, pancreatitis, speech problems, short-term memory loss and Guillain-Barré syndrome. The documents are from the FDA's vaccine adverse event reporting systems.
We are all led to believe vaccines are safe and can be given without harm. If that is the case, why has the national vaccine injury compensation programme in the United States paid out almost $2 billion in damages to those who have suffered serious adverse reactions to vaccines? We cannot state that vaccines are safe when compensation is being paid to families. There are cases of girls who have died. Jessica Erickson died 40 hours after she received her third vaccine. Her parents came home from work to find her collapsed in her bathroom. She is not the only girl this has happened to. Those in authority are not listening to parents' concerns, however, and children have become very ill after administration of this vaccine. This is a disease that will lead to cancer in less than 1% of women, but we are submitting all our young children to a vaccine that carries such high risks. That is not very ethical.
Dr. Colette Bonner:
I thank the Chairman and members for the invitation to attend this meeting. Today I am joined by my colleagues Dr. Kevin Kelleher, Dr. Darina O'Flanagan, Dr. Brenda Corcoran and Dr. Joan Gilvarry. We look forward to working with the committee and extending co-operation and assistance to the Chairman and members in their work.
The committee requested information on specific issues prior to this meeting and will have already received the written information on these issues. Accordingly, I will comment briefly on some of the key issues regarding immunisation. Vaccines have saved more lives worldwide than any other public health intervention apart from the provision of clean water. A well-functioning national immunisation programme is essential for any country. The national immunisation programme, which is consistent with Government policy, aims to promote health by preventing death and disability from vaccine-preventable diseases. The programme provides infant and school immunisation free of charge to all children. Since September 2011, the national immunisation programme has administered a vaccination catch-up programme against HPV, which can lead to cervical cancer, for all girls in secondary school. This was one of the commitments given in the programme for Government and was achieved within the first 100 days, as promised.
The uptake of primary childhood immunisation - that is, the six-in-one vaccine - nationally at 24 months of age has increased from 83% in 2001 to the 95% uptake rate recommended by WHO since 2011. The national measles, mumps and rubella, MMR, vaccine uptake at 24 months has increased from 69% in 2001 to 93% in 2012. Since October 2012 a school-based MMR catch-up programme has been operated by the HSE to target those children who have not received the required two doses of MMR vaccine. This measure will assist in addressing the WHO target to achieve elimination of measles by 2015. In October 2000 the meningococcal C vaccine was introduced to the primary immunisation schedule. In 1999 there were 135 cases of meningococcal C infection and five associated deaths. In 2011 there were two cases of this illness. No deaths have been associated with meningococcal C infection since 2008. Pneumococcal vaccination has resulted in an 83% reduction in the number of cases of invasive pneumococcal disease in children under two years of age.
In spite of these achievements, it is important not to become complacent. The WHO is working towards the elimination of polio globally. In 2001, the European region was declared polio-free. However, in April 2010, a wild-type poliovirus type 1 outbreak was confirmed in Tajikistan, representing the first importation of a wild-type poliovirus into Europe since the region was certified polio-free in 2002. In January 2000, a large outbreak of measles in Dublin resulted in 100 children being hospitalised. Six cases required intensive care treatment and there were two measles-related deaths. It should be noted that the cost of treating a case of measles has been shown to be 23 times the cost of vaccinating one child against measles. Since early 2011 there has been an increase in the incidence of pertussis - that is, whooping cough. This year, up to 1 December 2012, 437 cases of pertussis have been notified to the Health Protection Surveillance Centre, and there have been two pertussis-related deaths.
These events underscore the importance of constant effort and commitment to ensure a high uptake of vaccination. In particular, hard-to-reach groups such as the Traveller community, ethnic minorities and those who object to immunisation on religious or moral grounds require diligent campaigns underpinned by unambiguous, simple, evidence-based information to highlight the importance of vaccination at both individual and population level. As many vaccine-preventable diseases have become so infrequent, parents may be unaware of the serious nature of some childhood illnesses. This makes it all the more important for all health care professionals involved in immunisation to explore new ways of communicating the benefits and risks of immunisation to parents. The national immunisation office has already commenced a number of worthwhile initiatives in this area.
Pharmaceutical companies continue to develop new vaccines, which may be added to our national immunisation schedule. This is beneficial in that it protects our population from an increasing number of illnesses, but on the other hand it is challenging due the increased complexity and costs of our immunisation programmes. Prior to the introduction of any new vaccine, a health technology assessment is performed, including a cost-benefit analysis, to help inform policy decisions. New models of vaccine delivery continue to be explored in order to increase efficiency within a sustainable budgetary framework. The Minister for Health, Deputy Reilly, the Department of Health and the Health Service Executive all remain committed to providing a first-class national immunisation service. I thank the committee for the opportunity to address it and will answer any questions from members.
We have conflicting opinions. It is a matter of major importance that we try to get to the facts.
I have a number of question on the Gardasil vaccine. Up to the end of last month, we were advised that the Irish Medical Board received 650 reports of adverse reactions associated with this vaccine. Is it possible to elaborate on the monitoring mechanism for identifying adverse reactions? What is the range of adverse reactions presenting? Have there been unanticipated adverse reactions? Is there a question mark as to their association with the Gardasil vaccine? What supports have been put in place for those who have presented with adverse reactions? The last question is the most pertinent. We have heard the argument as to why Gardasil should not be employed as it is, but will Ms Byrne or another witness elaborate on its understood success? Can we point to a reduction in cervical cancer cases as a consequence of its application across the cohort of young women to whom it has been given? That is critical information which would be of interest and help to the committee.
I will try to contain myself. Uniquely, I am probably the only person in this room who has ever had to tell somebody that she had cervical cancer and might die from it or might never have children again as a result of treatment. Uniquely in this room, I have heard people with tear-streaked eyes question whether they had this disease because they were infected with the virus. I would do all in my power to save any one of those people from having cancer, provided the safety benefit ratio showed it was effective. Clearly, the safety benefit ratio shows that vaccination is effective.
I apologise but I will be a little less diplomatic than I normally would be because of the reaction to vaccination. In the way that honey attracts bees, there is something about the issue of vaccines that attracts people from a paranoid fringe who will blindly and obliviously cocoon themselves away from facts in pursuit of prejudices. It has come to light on this issue.
Let us have a few facts. Members have heard about the rarity of cervical cancer in Ireland. We have 75 to 100 deaths a year from cervical cancer in Ireland. These deaths occur at a younger average age than deaths from other cancers. This is primarily a disease of the younger middle-aged woman. It is also a disease we see in women in their 20s and 30s.
While the witnesses may argue that between 75 and 100 deaths per annum is not enough to justify vaccinating 30,000 girls, I believe they do justify vaccination. Even if that were not the case, what about the other women who get cervical cancer but are cured? At this point, the cure for cervix cancer involves the use of less mutilating surgery in a tiny number of cases. For most people, however, there is a choice. They can have surgery to remove the womb, ovaries, fallopian tubes and part of the vagina. For many of the women in question, their reproductive ambitions will be no more and in addition to the physical and psychological stigmata of surgery, they will live with the knowledge that they will not become parents. For most others, they can have radiotherapy and, increasingly, chemotherapy. This will involve having the entire pelvis radiated, that is, the vagina, uterus and part of the rectum and bladder. I do not want to frighten people who are going through this treatment because it often cures people who would otherwise die. However, any woman who has this treatment will always know she has had it because it is life-changing. It is not like having a small growth removed from the skin. It is a treatment that will likely leave the person with profound sexual issues and probably bladder issues and issues relating to discomfort in the rectum, etc. The treatment also has a small but finite risk of causing one to get a second cancer such as leukemia later in life. We should seek to do anything that will preclude 300 women from having to get this treatment, of whom between 75 and 100 will die despite it.
There are another few nuances to this issue. It has been shown in trials, although the witnesses may be dispute the figures if they wish, that the vaccine that is widely used here decreases the incidence of the very early cervical cancer lesions. While these will not proceed to cancer in some cases, in many cases they will proceed to cancer. In every case of advanced cervical cancer, these lesions are the first warning that the cancer will occur. Nobody skips straight to advanced cancer by never having an early stage cervical cancer. Again, a large amount of nonsense has been spoken on this matter.
Many hundreds of women, probably thousands of them, have lesser degrees of surgery and surgical interventions and treatments such as laser treatment performed for other pre-cancerous lesions that have the potential to develop into cancer. For these reasons, I had my two beloved daughters vaccinated when they were young teenagers approximately ten years ago and before a national programme was introduced. I did so because the data were so compelling. Harold zur Hausen is one of the saints of modern medicine and one of the few people who goes to bed every night knowing that all around the world hundreds, if not thousands, of women are saved because of the research he did. I am old enough to remember when people believed cigarette smoking and herpes caused cervical cancer. To hear the name of this sainted genius who worked out the cause of cervical cancer being blemished and to have him misquoted in this room is highly irritating. Professor zur Hausen is a supporter of cervical cancer vaccination. On a previous occasion when a politician tried to raise spurious arguments against the vaccination, he demolished the arguments made on radio.
As to whether the vaccination works, the randomised trials clearly show that the incidence of early cervix cancer is dramatically decreased with vaccination. In addition, 80% rather than 100% of cervix cancers are caused by-----
I will make one final point given that we spend enough time in this room discussing raiméis. This issue is extremely important because if the wrong message is sent from this room, it could kill people. The argument is being advanced that we do not need vaccination because we have screening. This is a little like arguing that we do not need to prevent children from playing with matches or drunks from falling asleep with a cigarette in their hands because we have a fire department or that we do not need to wear seatbelts because we have neurosurgeons who will patch up one's brain if one receives a head injury. We need to waste as little time as possible on this issue. It is widely accepted that no jurisdiction in the world has discontinued the vaccine programme and no leading group of experts has stated we should stop vaccinating for cervical cancer. Furthermore, there are no proven cases - there are temporarily associated cases - of any deaths or serious life threatening injuries from this vaccine.
With respect to Senator Crown, members have been given an opportunity to hear the case put by our guests. If we have questions to pose to them, this is the appropriate forum for doing so. The Senator was not a witness, yet that is how he has behaved.
I thank all the witnesses for coming before the joint committee. As this meeting has shown, vaccines are an emotive issue. As Ms Paula Byrne noted, parents need to be given information to allow them to make an informed decision on whether to vaccinate. Sadly in this country, this basic requirement is ignored at times.
Ms Hogan pointed out that adverse reactions to the HPV vaccine have been recorded in Washington. How many such cases have been recorded and what is the ratio of adverse reactions to the number of vaccinations administered? It is important to have balance in this matter.
The officials from the Department will correct me if I am wrong but I understand that in respect of all vaccines, decisions must first be taken on the efficacy of the product in question, after which a cost-benefit analysis is carried out. Senator Crown highlighted the significant benefits associated with the HPV vaccine. One must weigh up the adverse reactions to the vaccine and their incidence and scale against the risk of not vaccinating.
It is frustrating that medical policy makers in this country ignore and are afraid to acknowledge that there are adverse reactions associated with vaccination. It is a medical fact that no vaccine is 100% safe, there are risks associated with vaccines and people are damaged by them. The number of adverse reactions to vaccines is probably higher here than elsewhere in Europe probably as a result of our limited genetic pool. The issue is the scale of adverse reactions, that is, whether they are minor or severe.
As Senator Crown noted, the issue of enlightenment arises in respect of vaccines and a full and open debate is needed on the issue. For the record, I have three children, all of whom have been vaccinated with all of the relevant vaccines. While I have no hesitation in having my children vaccinated, parents need to be given all of the information to allow them to weigh up the decision on vaccination. An issue arose recently in respect of a parent of a child who had an adverse reaction to the second administration of a particular vaccination. The child's general practitioner refused to administer the third dose and chose instead to refer the child to a specialist before a decision is made on the issue. The position is changing in this country regarding vaccines.
One of the reasons we invited departmental officials before the joint committee was to receive an update on what has been done since the committee reported on this issue in 2001. Its report stated that "in the light of the huge benefits of immunisation and the small number of children who experience serious adverse reactions a no-fault compensation scheme should be introduced in Ireland". Ireland is the only country in Europe that has not introduced such a compensation scheme. Most countries have had such a scheme in place for years, yet nothing has been done over the past 11 years to implement the joint committee's recommendation in this regard. In the United Kingdom, the maximum possible payment under a compensation scheme is £120,000 and the average payment is £3,800.
Anyway, there is a scheme in place and there is public acknowledgement that some children are damaged by vaccines. The reality is that the risks of having a vaccination programme rolled out are far less than the great benefit to children and to society as a whole. However, some acknowledgement must be given to this.
Previously, the committee made a recommendation to the effect that there should be a link developed between the birth registers in the country in order that the information technology system in place could trace children. At the moment there are four separate information technology systems with eight implementations throughout each of the former health boards. When will we get our act together and have one information technology system for a vaccination programme? When will we have a system in place whereby we can have traceability through the children's allowance system to know where children are or where they have slipped through the loop? Such traceability is not in place at the moment and it is undermining our vaccination programmes as a result.
I have one or two questions and I wish to reply to some of the things that have been said. I am not a medical expert, I am a politician but above all I am a parent. Like Senator Crown, I have four beautiful daughters, two of whom have gone through all the vaccination stages for cervical cancer. As a parent my issue is trust and who I trust. I trust my general practitioner. I have gone to my GP for the past 40 years. He has been with me at each stage. We went through all the various stages of illness, my pregnancies and so on. Therefore, a sense of trust has been built up. As Deputy Naughten has noted, with every vaccination a parent realises there is a small percentage or chance that something can go wrong. It is like having an operation. I have a beautiful granddaughter who has had all her vaccinations.
There is an issue about accountability and I wish to develop the point made by Deputy Naughten. When children go to school or start in a creche, there should be a format to ensure every child has received his or her vaccinations. Since she has started in the creche, my granddaughter has picked up everything going in the classroom. I believe many children are going to school, including, unfortunately, some children who are from other countries, who do not have the proper vaccinations. This is a real issue for many parents. I thank the delegations for the presentations. I found both of them very interesting. However, as a parent my trust lies with my GP. He is the medical expert and I am not. I am unsure whether it is naivety or blindness but at the level of being a parent there is a time to put the politician away for a while. I trust my GP when I go to see him and I trust the information and evidence he provides. This is the reason I go and I know that is the same for many parents throughout the country. They do it for the same reasons, because a trust has been built up with the general practitioner.
I thank the witnesses for coming here today and for presenting to us. Notwithstanding the differences of opinion, I agree with my colleague who said that parents have a choice. It is incumbent on all of us as parents to ensure we are best informed before we make a choice. That is part of parenting. I do not blindly accept other people's opinions because opinions differ. Anyway, it is incumbent on all of us as parents to ensure that we are as educated as possible with regard to what we are providing for our children and to make informed decisions in this regard. Against this backdrop we need to recognise that with every vaccine there is a slight risk.
I am sorry if this is not the appropriate venue but I have written many times to the Department of Health and to the Minister about it. Reports were commissioned by previous Governments on the whooping cough vaccinations scores of years ago. I genuinely believe they are sitting on shelves. What genuine consideration has been given to the recommendations of the previous Oireachtas committees and the reports issued by previous Ministers with regard to setting up a no-fault compensation scheme for children who were damaged by vaccines? This does not relate to cases that might arise in ten years' time or perhaps next year. It relates to children who were genuinely damaged by previous vaccines. The responsibility on the State is to address this issue and it is nothing short of a disgrace that we have had children who were inflicted with this in an awful way in the 1970s and 1980s. It is now 2012 and we still have not addressed these issues. I would be grateful if the delegations could address these points.
I thank everyone who has come in. I have one question which is mainly directed at the Department of Health. To what extent are children who come to the country from outside vaccinated, in the same way as vaccinations are available to Irish children? What attempts have been made to ensure that such vaccinations are made available to such children?
I thank everyone for their contributions. I wish address some of the points raised by Ms Hogan and Ms Byrne, especially those Ms Byrne made about the information leaflets. I am concerned and I am keen to hear from the Department of Health. Ms Byrne used rather inflammatory language in her description of the information. Much has been said about trust. Politicians may not often garner much trust but Deputy Byrne captured rather well the point that the medics capture a good deal of trust. We need to be clear that mixed messages do not come out of this committee meeting. I have great confidence in the Department of Health and the information it publishes. I am keen to hear a rebuttal from the Department of Health of the allegations made about the information that has been distributed to people. As someone who campaigned for a cervical cancer vaccination in a former life, before I entered here, I believe it should be rebutted strongly because this is a breakthrough for young women. As a young woman and as the mother of a young girl, I believe it is integral that we rebut such inflammatory language which has been used here to refer to the promotional material.
Ms Byrne summed it up well. Is the vaccine necessary? Is it effective? Is it safe? A large audience is looking at this programme at the moment and like myself it is made up of people who are rather confused. If I was a gambling person I would recommend going for the vaccine because we push hard. I am a firm believer in the views expressed by Senator John Crown, given all his experience. My questions are for Ms Byrne and Ms Colette Bonner and I call on them to give me their best shot. Why is it necessary? Why is effective? Why is it safe? Perhaps Ms Byrne will answer the question first and then Ms Colette Bonner could answer after that.
Ms Paula Byrne:
I will concentrate on my main point, which relates to the information given in the brochure. I accept that it is the opinion of many scientists and clinicians throughout the world that the vaccine is a good idea. However, I wish to point out that there are many other scientists and clinicians throughout the world who have examined the same evidence and come to the opposite conclusion. I have supplied supplementary information to the committee quoting from the medical journals. I offer one recent example from the Annals of Medicine. The article is entitled "Human papilloma virus (HPV) vaccine policy and evidence-based medicine: Are they at odds?" and it states: "Current worldwide HPV immunization practices with either of the two HPV vaccines (Gardasil or Cervarix) appear to be neither justified by long-term health benefits nor economically viable, nor is there any evidence that HPV vaccination (even if proven effective against cervical cancer) would reduce the rate of cervical cancer beyond what Pap screening has already achieved."
Ms Paula Byrne:
Yes, that is an opinion. I wish to go back to the base material and licensing information.
It was given to the FDA by the manufacturers of this vaccine. The final conclusions on this brought together all the trial results. The combined impact of Gardasil in the incidence of CIN - the precancerous lesions - irrespective of HPV type, range from a high of 45.5% to a low of 11.2%. In my view, as a parent, this leaflet says that it gives 100% protection from cervical cancer. It also concludes I am protected now for life. From a parent's perspective this is not 45% or 11%, but rather it is 100% protection. My biggest problem is with the data from the trials.
Ms Jacqueline Hogan:
He said that the vast majority of women clear through their own immunological system, that about 1% or so remain with persistent infection and that these are the ones at risk from cervical cancer. The HPV vaccine targets just two elements of the virus, 16 and 18. There are 13 others that it does not target. Maybe some of the ones referred to by Professor Crown - the cervical cancer - are not even the 16 and the 18 because there are other viruses that cause cervical cancer but this vaccine only addresses two of them. With the permission of the committee I wish to read from a very important research paper by Lucija Tomljenovic and Christopher A. Shaw, entitled "Death after Quadrivalent Human Papillomavirus (HPV) Vaccination: Causal or Coincidental?":
Background:The proper understanding of a true risk from vaccines is crucial for avoiding unnecessary adverse reactions (ADRs). However, to this date no solid tests or criteria have been established to determine whether adverse events are causally linked to vaccinations.
Objectives:This research was carried out to determine whether or not some serious autoimmune and neurological ADRs following HPV vaccination are causal or merely coincidental and to validate a biomarker-based immunohistochemical (IHC) protocol for assessing causality in case of vaccination-suspected serious adverse neurological outcomes.
Ms Jacqueline Hogan:
Thank you, Professor Crown. Perhaps Professor Crown will help me with other words. The paper continues:
Methods: Post-mortem brain tissue specimens from two young women who suffered from cerebral vasculitis-type symptoms following vaccination with the HPV vaccine Gardasil were analysed by IHC for various immuno-inflammatory markers. Brain sections were also stained for antibodies recognizing HPV-16L1 and HPV-18L1 antigen which are present in Gardasil.
Results:In both cases, the autopsy revealed no anatomical, microbiological nor toxicological findings that might have explained the death of the individuals. In contrast, our IHC analysis showed evidence of an autoimmune vasculitis potentially triggered by the cross-reactive HPV-16L1 antibodies binding to the wall of cerebral blood vessels in all examined brain samples. We also detected the presence of HPV-16L1 particles within the cerebral vasculature with some HPV-16L1 particles adhering to the blood vessel walls. HPV-18L1 antibodies did not bind to cerebral blood vessels nor any other neural tissues. IHC also showed increased T-cell signalling and marked activation of the classical antibody-dependent complement pathway in cerebral vascular tissues from both cases. This pattern of complement activation in the absence of an active brain infection indicates an abnormal triggering of the immune response in which the immune attack is directed towards self-tissue.
Dr. Colette Bonner:
I thank the politicians for their general support of our vaccination programme. However, I will try to reassure Ms Paula Byrne and Ms Jacqueline Hogan as to the safety of Gardasil. I will ask Dr. Kevin Kelleher from the HSE to talk about the general information about Gardasil. Dr. Joan Gilvarry will talk about adverse events and how these are notified and reported. I will deal with the question about the no-fault compensation.
Dr. Kevin Kelleher:
Over the past 15 years I have been very involved in both immunisation and screening programmes here in Ireland. I was the person who introduced the cervical screening programme first in the mid-west as part of the national campaign. All public health programmes such as screening and immunisation have both benefits and risks. The screening programme equally has risks as much as vaccination has risks. Both programmes happen because the benefits greatly outweigh the risks. That is the fundamental decision made before any other decision about money or cost-benefit analysis. The first decision is whether the benefits far outweigh - not even outweigh - the risks. Senator Professor Crown has left the room but it is different even from how he would try to treat somebody. It is a very different decision. It is not just that it is better but it actually far outweighs the risk. It is carried out on people who do not have the disease or are unlikely to get the disease so one must be very careful. That is the first fundamental decision which is made with regard to all these programmes. However, I agree that both screening and immunisation programmes cause problems. We are very upfront about all of that in all our literature, both in hard copy and in greater detail on the Internet. We accept that all Internet information is not available to everybody but the hard copy literature shows that clearly.
We state very clearly in that document that the HPV vaccine only prevents 70% of cervical cancers. It does not prevent all cervical cancers, just as much as the cervical cancer screening programme does not prevent all cervical cancers. Neither programme does this. We are clear that these are preventative programmes. The information booklet took quite some time to be produced because we went through a very detailed process. We asked people to review the booklet with regard to the language and content used. We were told whether there was too much or too little information in the document. It is regularly revised and re-examined, as is all our immunisation documentation. We seek to present that information to everybody in so far as possible.
Whether these programmes are necessary is one of those fundamental decisions. To be clear, the HPV vaccine does not just prevent cervical cancer. It prevents the precursor to it but it also prevents another disease which is extremely common, anal-genital warts. We will not see the explicit impact of the vaccine on cervical cancer for quite some time because like all cancers it takes a time to come about. It takes ten to 20 years to occur.
In Australia, which was one of the first countries in the world to have a systematic programme of HPV vaccination, there has been quite a significant reduction in the number of people under the ages of 20 and 25 who have anal-genital warts. We know that anal-genital warts and cervical cancer are caused by HPV infection. That gives us a very strong indication that we will see a reduction in the incidence of cervical cancer, but we have not seen it yet.
One aspect of immunisation is that the vaccines are tested in a slightly different way. Other witnesses such as Dr. O'Flanagan could speak on this. In a sense one is saying that it will prevent something, which is always very difficult to prove. Most drugs are for a disease that exists and they stop that disease. With immunisation, we are saying that the disease does not come about. That is a problem for us because some people want to know why they are still being vaccinated against diphtheria and typhoid when we do not see those diseases. People ask why they are being vaccinated against polio when they do not see that disease. However, these are still extremely important diseases.
An expert committee, the national immunisation advisory committee, has examined the issue of how to deal with children coming from different countries with different schedules of vaccines. We have provided in the documentation advice that is given to the various doctors and also to parents on what they need to do. There are different schedules of vaccines. Most countries in Europe have pretty much the same immunisation programmes. We try to make sure that children complete the programmes they have started and also get the vaccines that are given in this country that they may not have got in their own countries. There is literature on that in the documentation, and that literature is given to all GPs and other people who give immunisations. It is available on our website, the website of the national immunisation office and the website of the Royal College of Physicians of Ireland.
Dr. Kevin Kelleher:
That is done primarily via general practitioners. In addition, when such children arrive in school, we have school immunisation teams which will pick up on that. It is done at that stage when the child comes in contact with the system, primarily via general practitioners. I cannot say every general practitioner will do so, but virtually every general practitioner will ask a parent who brings in a one, two or three year old child what vaccinations the child has received if they have come here from abroad and, on noting what the child needs, the general practitioner will provide it. The State provides for that and also pays for it. It is not a major difficulty.
I find it slightly problematic when people suggest that we do not talk about the problems. We have repeatedly spoken about the problems concerning immunisation. I recognise as much as anybody that the programmes have risks, and we are very clear about this. I spoke to the committee when the report on immunisation was published in 2001; one of the recommendations made by the health boards at that time was that a vaccine damage scheme should be introduced. We were strongly of that view. We believe that to support the programme, something of that nature needs to be put in place. The provision of such a scheme is very important. Even without such a scheme at present, we have made great strides in rates of immunisation. We have hit the target set for the HPV; the immunisation rate has gone over 80%, which is the desired level. It is an amazing rate to have achieved quite rapidly and in quite a short period. We have made those changes.
We are currently in the process of putting together a single IT system for the country. It is quite complex but incredibly necessary. One of our difficulties has been that during the past five years a number of short-term projects, such as the introduction of new vaccines for pneumococcus, pandemic influenza and HPV, have diverted us from such longer-term projects. We are very clear that we will not introduce any vaccine in this country unless the benefits totally outweigh the risks at the population level. My colleague Dr. Gilvarry will speak about the issue of adverse events.
Dr. Joan Gilvarry:
I will give a few facts on the licensing of the vaccine worldwide before I go into the adverse events. Gardasil has been licensed across the European Union since 2006 and is used in most of the 27 member states in their immunisation programmes. It is also approved in about 130 countries worldwide, including by the FDA, the TGA in Australia and Health Canada. More than 110 million doses have been distributed, which equates to the vaccination of around 33 million children or adolescents with the three-dose schedule. When a vaccine comes to market there must be evidence that it works. A licence is given for the vaccine on the basis of the benefits versus the risks. The benefits of Gardasil, and the licensed indications, are the prevention of pre-malignant genital lesions and cervical cancer. That licence is based on evidence across the European Union. I have said it a hundred times, and we have heard it here today, that no medicine or vaccine is without risks. That is why we have an extensive post-marketing monitoring programme at the Irish Medicines Board, across the European Union and worldwide. When the vaccine was first introduced into the immunisation programme in 2010 the Irish Medicines Board issued a special drug safety newsletter advising of the benefits but also of the risks and the adverse reactions we knew of at that time, and it asked health care professionals to report any adverse reactions they were seeing. In terms of transparency, as the programme proceeded every month we updated our website to indicate the reactions we were seeing and the number of such reactions. In the first year of the programme we saw more than 450 reactions, while in the second year of the programme the number decreased to 150. The vast majority of the adverse reactions we saw were as expected and were non-serious. They were syncopes and faints in young girls in school, sometimes before the injection rather than after it, headaches, malaise, muscle pains and gastrointestinal upset - nothing that was extremely worrying.
To answer one of the questions posed, when 33 million children are vaccinated worldwide with three doses of the vaccine, one will see unexpected side effects with a temporal association with the vaccine but not necessarily a causal relationship. To date across the European Union and worldwide we have identified no risks additional to those that were known when the vaccine was licensed, and the benefits still far outweigh any risks to this vaccine.
Dr. Colette Bonner:
In regard to a national vaccine injury compensation scheme, an expert group was set up and has reported. However, the Department is still looking at that report and trying to decide whether to establish a vaccine injury compensation scheme or a system to deal with other adverse health care events. We believe those two things cannot be separate from one another. It is quite a complex area. We are having discussions and negotiations but to date we have not provided any legislation for a national vaccine injury compensation scheme. However, that does not mean it will not be part of our plan into the future.
I do not mean this to be disrespectful in any way, shape or form, and I am just trying to understand the issue, but what does it mean when a representative of a Department says that the Department has been looking at something for three years? I have asked previously for details of the occasions this matter has come up and been discussed and how it has been further advanced in the past three years, but I have got nothing in response. I am left in a vacuum, thinking this report is sitting on a shelf somewhere. What does it mean that the Department is looking at it?
Dr. Colette Bonner:
Just as Dr. Kelleher explained, we have all been involved in other things to do with immunisation programmes for the past three years. We had the flu pandemic vaccine, which took up a good deal of time and resources, we introduced the HPV vaccine and we have made other changes to the schedule. It is something that is still under consideration and we will get to it.
Dr. Darina O'Flanagan:
I want to address some of the concepts Ms Jacqueline Hogan raised. She stated that many women will be exposed and infected but just 1% will get the disease. She seemed to jump from that to the idea that we should not vaccinate everybody.
The difficulty, of course, is that we do not know which 1% will get the disease. The only way to protect people from a serious and fatal illness is to ensure that we vaccinate everyone. This occurs for many vaccine-preventable diseases. We have universal vaccination programmes not because these diseases kill everyone but because they kill some. This is the only way in which we can prevent these fatalities from occurring.
The other comment I wish to make pertains to Ms Paula Byrne's concern about the information and literature provided in Ireland and the statement that the vaccine prevents cervical cancer. Similar literature that is provided in many other countries. For example, I have to hand the vaccination statement of the Centers for Disease Control and Prevention, CDC, which is handed out to parents in the United States. It states precisely the same thing - that is, that the vaccine can prevent most cases of cervical cancer in females. It is known that the vaccine prevents the precursors of cancer and that this is the way to prevent cancer. This is well accepted internationally, including by all major health organisations such as the CDC and the WHO. Consequently, I do not consider our information to be in any way unusual or different from information supplied by other health organisations.
I thank the witnesses for the information they have shared with members in response to the questions posed. With regard to adverse reactions, have situations arisen in which particular supports were necessary? Apart altogether from the compensation issue about which Dr. Bonner spoke, what is the position in respect of supports? Has this issue presented and has this arisen?
I thank the witnesses for their responses and thank Dr. Kelleher in particular for his response. I put it to him that he is correct in that the aforementioned recommendation regarding a no-fault compensation scheme was made 11 years ago. As he is aware, every other country in Europe and every other developed country in the world has put in place such a system. Nevertheless, Ireland still has not done so. It must be acknowledged publicly that in a limited number of cases there are severe adverse reactions to vaccines, and those children and their families should be treated in a humane manner. To revert to the point made by Deputy Ó Caoláin, is it not true that in many cases parents have been obliged to fight and are still fighting for a public acknowledgement that their children were damaged by the vaccine or may have been damaged by the vaccine? Is it not the case that they are subsequently obliged to fight for even the most basic of services? Dr. Kelleher is aware the State has acknowledged 16 cases. An ex gratia payment of £10,000, with a confidentially clause tied into it, was made to those particular families when Dr. Woods was Minister for Health. Does Dr. Kelleher not think this matter should be getting a far higher priority within the Department and that there should be public acknowledgement that these children and their parents should be treated in a humane manner where, in all probability, they have been damaged by the vaccine? This pertains to very small numbers and Dr. Kelleher's point regarding proportion is correct. However, while the benefits far outweigh the risks, this does not mean one should shove the risks under the carpet or ignore those families and parents. This issue has been considered and navel-gazed within the Department since 2001. I met the Minister in April 2002 on this subject. A report was produced, followed by an expert group report, which now is gathering further dust, although the Department has stated consistently since 2009 that it is considering it. It took a long time even to get the aforementioned report published. When will actual action be taken in this area?
I apologise for being obliged to step outside but I needed to raise an issue on the Order of Business relating to the charging of public patients. Perhaps Dr. Kelleher can explain a point to me. Other than cases in which the benefit of the doubt has been given, how many confirmed cases of serious life-changing damage from vaccines have really been proven in Ireland? I mean causally proven and not simply temporally associated cases of damage from any vaccine in Ireland. Second, what vaccine is considered to be the most risky in this regard?
I wish to make two brief points. A highly inaccurate statement was made again about the level of coverage of the HPV vaccine. The currently used vaccine is Gardasil, which prevents four subtypes of HPV, including two subtypes which are incriminated in the great majority of viral cervical cancers and virtually all cases of genital warts. The alternative product only covers the two cervical cancer-causing subtypes. That product did not win the bidding competition in Ireland at the time. All of the many other subtypes of HPV have in most cases not been clearly shown to be associated with any health risk. It is a virus that passes through and passes out. The subtypes that cause cancer or warts or result in greater morbidity are those that are well covered by the vaccine.
To put some perspective on this matter, everyone should realise what happened when the really spurious paranoia-driven scare about the MMR vaccine occurred in England and vaccination rates dropped below the level that would give herd immunity. There was a colossal increase in all of the diseases that are protected against by the MMR vaccine, which resulted in many cases of brain damage and many deaths. I ask Dr. Kelleher to answer that question for me.
Ms Paula Byrne:
We have talked a lot about the risk-benefit ratio and obviously, this is the key point in all the decisions that parents must make. My main point is that parents are not being given correct information and therefore the benefits are being exaggerated. If one is clear that this vaccine will prevent one's child from cervical cancer, one will take risks that one might not take if one understood that the benefits were not quite so clear-cut.
I am studying health economics at present and as part of my studies, we looked into various cost-effective analyses that were conducted around the world. The results one gets at the end of a cost-effective analysis depend on the inputs, and they vary hugely. For example, one of the main points that varies in those analyses was the effectiveness of the vaccine. In Ireland, the vaccine's cost effectiveness was assumed to be 95%. However, "assumed" is the key word, as it is stated quite clearly in documentation from the National Centre for Pharmacoeconomics, NCPE, that assumptions were made that the vaccines were 90% or 95% effective - I forget which. However, the Belgians took the efficacy to be down at approximately 40%, which changed the results entirely.
I wish to make one quick comment, taken from an article in the journal Preventative Medicine. The article, entitled "Economic evaluations of massive HPV vaccination: within-study and between study variations in incremental cost per QALY gained", states: "The launching of the HPV vaccine in 2006 carried a sequence of decisions concerning its use, in the context of both pressure from the population - induced by the pharmaceutical industry - and uncertainty on long term vaccine efficacy and cost effectiveness".
Ms Jacqueline Hogan:
In respect of adverse reactions to the HPV vaccine, on 18 August 2011, an article in the Evening Herald stated: "Reports of 'adverse events' after giving the vaccination included six cases of anaphylactic shock in patients and five reports of seizures," so cases of seizures and anaphylactic shock have been recorded within Ireland. Moreover, in a study published in the Journal of Law, Medicine & Ethics in 2012, it was found that compared with all other vaccines, Gardasil alone was associated with 61% of all serious adverse reactions, including 63.8% of all deaths and 81.2% of cases of permanent disability in females younger than 30 years of age. Moreover, the adverse reactions had a consistent pattern, with a lot of neurological, nervous system and autoimmune disorders.
Dr. Kevin Kelleher:
As my identifying label has fallen, I should clarify to Deputy Naughten that I am from the HSE and not from the Department of Health. I totally agree and have always stated that there should be a vaccine damage scheme in place in Ireland. It is absolutely essential to the provision of an immunisation programme. I have no doubts whatsoever about that and have said so repeatedly. As the Deputy is aware, I made this point ten years ago and repeat that it is an absolutely essential part of any immunisation programme to provide that sort of thing.
Most of our vaccines are now incredibly safe and most of the history is there. I only came to the country in 1995, but I was involved in the UK prior to that and we were probably not dissimilar. Historically, we may not have dealt with people as well as we should have done. I hope we are now dealing much better with people who have got problems. Historically, some of our vaccines were very problematic. The vaccine we had for smallpox did not just cause people problems, it also had a mortality rate.
Dr. Kevin Kelleher:
That was back in the 1960s or 1970s in this country. It had a mortality rate but things have changed dramatically. That is why some of the vaccines have changed and we have seen some of those things.
The most recent example is shown by a report that Dr. O'Flanagan has produced and which is in the public domain. When we used the H1N1 pandemic vaccine during the flu pandemic, it would appear that adverse reactions were associated with a very small number of people. The numbers at the moment appear to be around 30 to 40, although that could grow. Unfortunately, they developed a severe form of narcolepsy. We are providing as much support as possible to those people at the moment. We are paying for treatment and for them to visit non-public services where appropriate. We are giving them support in different ways. Where they request medical cards they are being given the discretionary medical cards. We are also giving other costs. We have been working with our colleagues in the Department of Education and Skills to provide educational support for them. Therefore we are clearly committed to trying to support such individuals. As the committee has heard, however, the vast majority of problems that happen with immunisation are minor.
Having said that, we have heard that some people get anaphylactic shock. It is uncommon but all our staff are regularly trained in how to deal with anaphylactic shock. All of those are now dealt with immediately by the staff. They are resuscitated immediately and looked after. We are careful about all these issues.
With regard to Deputy Ó Caoláin's question, we have tried to give as much support as possible to the people who seem to have been affected by the H1N1 vaccine. I am not saying that we have done everything because that is never possible, but we have made every effort to try to help them. We have brought in colleagues from other Government Departments to support us as well. They have been very helpful.
The Minister is well aware that I gave evidence to the expert group, but we need action on this. Senator Crown is right to say that the vast majority of these cases are historic, but there needs to be an acknowledgement given to the families concerned. Most of those children are now in their 30s and 40s. Their elderly parents have fought for even the most basic acknowledgement from the State that anything adverse happened to their children. This matter should be expedited before it is too late for some of the families involved.
I would like to thank everybody for their contributions. I would like to hear a clear rebuttal to the allegation that has been made about the HSE's information campaign. I would like to know that that information is safe and that we are not misleading people.
Dr. Kevin Kelleher:
To add to what Dr. O'Flanagan said, our information is based on science and our interpretation of that science. It is based on evidence from all over the world. As Dr. O'Flanagan said, it is similar to what is provided in virtually every other country in the world that provides this vaccine to the population. It is the very same. Our difficulty is that, as with all parts of life, in science there are opposing views. However, I would ask the committee to accept my version, which is that 80%, 90% or 95% of the scientists concur with what we are saying. That is all I can say. I find it somewhat offensive that anyone would believe that I would put out information that is not correct. I certainly feel offended for my staff by that.
I thank everyone for coming in this morning. I wish to thank Ms Byrne and Ms Hogan for attending the committee for highlighting an important issue. They are welcome to stay, but may leave if they wish.
The second part of our meeting will deal with the Meningitis Research Foundation. I wish to thank the foundation's representatives for their patience in waiting to be called. I will now ask Ms Andy Cochrane to make her opening remarks.
Ms Andy Cochrane:
I thank the Chairman and other members of the joint committee for welcoming us here. Unfortunately, some people have had to leave. Hopefully, we will have some less controversial information to pass on to members of the committee for their consideration. I will now pass over to my colleague Ms Linda Glennie who will make the presentation. She has some slides so I hope that can be facilitated.
Ms Linda Glennie:
I thank the committee for the opportunity to make this presentation. The Meningitis Research Foundation represents around 1,200 families in Ireland that have been affected by meningitis and septicaemia. I am here to talk about meningococcal infection which is the leading cause of meningitis in Ireland. As members of the committee can see from the first slide, the people of Ireland suffer far more from this illness than anywhere else in Europe.
The next slide tells us a bit more about the disease. It is a deadly, disabling and disfiguring disease. Meningitis happens when bacteria inflame the protective covering of the brain, resulting in swelling. This can cause damage to brain tissue which can be irreversible. Septicaemia happens when bacteria attack the lining of the blood vessels leading to shock, which is rapidly fatal in 20% to 50% of cases. Widespread clotting throughout the body can cause amputations and damage to organs.
The second photos shows that is what is happening to the little girl's tissues. Unfortunately, that little girl went on to lose both legs and parts of both her hands to meningococcal septicaemia. It is the leading infectious cause of death of children in Ireland. There are long-term after-effects for about one in three survivors. For obvious reasons, it is top among illnesses feared by parents. This is because it is so devastating and because it strikes so suddenly, mainly at healthy children, so one cannot predict who will be affected. The onset is so rapid that there is only a brief window for effective medical treatment. Because the effects are so dire, the cost can be staggering.
The third slides deals with the after effects, which differ depending on whether the person has been affected by meningitis where the damage is mainly neurological or due to damage to the ear. In the case of septicaemia, the damage is obviously down to tissue and organs. The effects range from very damaging and permanent effects, in the worst cases where children have such severe brain damage that they are never able to lead an independent life.
Even children who are less severely affected can have the sort of subtle cognitive and psycho-social problems that will have an educational impact and will limit their educational attainment. This will have a major impact on their quality of life and the lives of those around them.
I will touch briefly on the fourth slide, which deals with work done in the United Kingdom which examined very severe cases of meningitis and septicaemia. One can see that the cost - not only the cost of the distress caused but also the cost of treating these children, plus the long-term medical costs to the State of specialist equipment and specialist education as well as direct social care costs - can amount to more than €5 million over a lifetime for a child severely affected by meningitis or up to €4 million for a child affected by septicaemia. There are also high costs with regard to litigation. Fortunately, this is rare, but it is a disproportionately high cost both in terms of the number of cases brought and, even more so, in terms of the payouts.
Early diagnosis and treatment are vitally important. Major advances are not likely through improvements in this area because it is so difficult. With regard to early symptoms, people know about the rash. We have done a great deal of work over the years to draw attention to and educate the public about the symptoms so that people can get help early if they think that they or their children have the illness, but the early symptoms resemble milder illnesses. Even the best-trained general practitioners will miss cases. Some 50% of cases are sent home the first time they present to their general practitioner. There is only a short window for effective intervention and it is difficult to improve matters based only on earlier diagnosis and better treatment. Hopefully, the guidelines put out by the Health Protection Surveillance Centre earlier this year will make a big difference in enabling better diagnosis and better treatment, but in terms of making major advances, the solution is prevention.
The seventh slide shows the impact that the Hib, Haemophilus influenzaetype b, vaccine has had over the years. The record of meningitis vaccines in Ireland shows what immunisation can achieve. Hib, which was once the leading childhood cause of meningitis, has now been almost eliminated.
The following slide shows the incidence of meningococcal disease in Ireland when the MenC vaccine was introduced. Meningitis C was once nearly as common as meningitis B and it has now dwindled to only a handful of cases. As Dr. Bonner stated earlier, there have been no deaths from meningitis C since 2008. That has been a triumph. It is fantastic. Pneumococcal vaccination has also had an impact. It has reduced the number of cases of pneumococcal meningitis in young children, which is great.
For decades group B streptococcus has been the leading cause of meningitis and although cases, coincidentally, are at a fairly low point, the disease circulates unchecked. There is nothing to control it - we have 100 cases this year and we could have 200 cases next year. One can see that over the past decade, we have seen 100 to 200 cases a year resulting in five to 15 deaths, and probably 30 to 60 persons with long-term effects that can prevent them growing into adults who can have a reasonable quality of life, contribute to the economy, etc. In this report from the Health Protection Surveillance Centre, the author stated that meningitis will remain a major public health problem until a MenB vaccine that is effective in children is available. However, we are actually at this point at last. Last month the European Medicines Agency announced a positive opinion on the first ever MenB vaccine, and a licence is due next month or in February. We are hopeful that at last the means exist to put an end to this terrible disease. We have high hopes for it and we urge the Government to ensure that the vaccine is introduced without delay. The committee has seen how fantastic the MenC vaccine was.
It took seven years from the time that the pneumococcal vaccine was licensed for it to be introduced.
Ms Linda Glennie:
Even a delay of a year would mean deaths and cases of brain damage, deafness and amputation that could be prevented. We urge that the Government help to ensure this vaccine is introduced as soon as possible. We just do not want to see any more children die from a disease that is now preventable.
I welcome the groups, especially the Meningitis Research Foundation. I apologise for the wait they have had. It is unfortunate. That is something we must address in the committee. We had a lengthy private session earlier.
I have personal experience as a member of a community that was directly affected by meningitis when a tragedy presented some years ago. I cannot remember exactly, but I have some notion in my head that Dr. O'Flanagan attended at the time. I could be wrong. I do not know if she did but it is in my memory that she might have. One young boy was lost and the other survived - two incidents simultaneously. Of course, the tragedy is that a surviving child's potential is seriously affected. There are many similar instances. It is welcome that in the fourth slide Ms Glennie presented the holistic in-the-round cost or real cost. The cost does not include only the treatment or whatever. Perhaps Ms Glennie has been a little conservative in terms of a lifetime's projection in real terms.
What is the likely time for completion of the work of the national immunisation advisory committee, NIAC, on Bexsero? I understand it is a matter of determining Bexsero's application and suitability and obtaining confidence to proceed with it here in Ireland. When will the NIAC report and when can we expect certainty in this regard? Would the HSE, the Department of Health and the IMB representatives like to comment as to their understanding of the potential of Bexsero to have an impact on meningitis B? Does it have the same potential impact as the MenC vaccine has already demonstrated? The graph on the eighth slide shows a significant decrease in incidence as a result of the introduction of the MenC vaccine. Can we expect a similar impact with the introduction of Bexsero? What data support this claim? If it is indeed the case that those with the professional competence to make that assessment so recommend, how promptly can we expect it to be introduced?
Is there any explanation for the incidence of meningococcal disease across Europe and Ireland? In regard to the impact of the Hib vaccination, I gave birth to one of my children when that campaign was beginning. We trust that we are vaccinating our children for their overall good and the data before us clearly show that is the case.
Like Deputy Ó Caoláin, my neighbours lost their 18 year granddaughter to meningitis. She came home from school one day feeling unwell, was in intensive care by the same evening and, sadly, passed away the next morning. Her death had a huge impact on her parents, family and extended community. I recently heard the hopeful news that a prevention or cure may have been found. It would be a shame to think that costs or failure to get our act together could mean we do not help these people. The numbers may be small but for someone in that 1% or 2% cohort, life is changed forever. I am a very cautious mother. As soon as my children cough I bring them to the doctor because meningitis is every parents' worst nightmare.
I commend the Meningitis Research Foundation on the powerful presentation it gave in Buswells Hotel several weeks ago. Representatives from the foundation gave powerful testimony on the work that was being done. I was especially struck by Liam Mulvihill's story about his daughter. One gentlemen who was originally from Dublin came from the UK to describe the effects and incidence of the disease. I regret that the briefing was not attended by more Members of the Oireachtas. It was from that session that Deputy Troy, Deputy Ó Caoláin and I decided to arrange this morning's meeting.
Dr. Kevin Kelleher:
In regard to the timeline, the national immunisation advisory committee, NIAC, will first consider the vaccine's effectiveness and the next stage will be to consider how best to introduce it. When we introduced the meningococcal C vaccine, we also rolled out a catch-up campaign to vaccinate a larger group in the more susceptible population against the disease. This is the type of decision that needs to be made. The next stage is to ask the pharmacology economics unit at St. James's Hospital to conduct a cost-benefit analysis of whether it is appropriate to introduce it as a routine vaccine or to include a catch-up campaign for children under the age of two, under the age of five or primary or secondary school going age. The meningococcal C vaccine included all young adults under the age of 20. Issues also arise in respect of logistics and whether the system is able to achieve some of these objectives. We are also in the middle of other campaigns at present, including the HPV campaign and the HPV catch-up campaign for girls in secondary school. We also face a problem with both measles and pertussis and we are trying to increase vaccination rates for those diseases. The final decision on introducing the vaccine will be up to the Department of Health and the Government. Some of that will be reflected in the cost-benefit analysis. Depending on what is proposed, the administration costs may be high or relatively low. It will be simply be a matter of performing two tasks at the same time but if we ask people to do something de novo we could incur additional costs.
We are all medical practitioners. I spent my clinical time in paediatrics in the early 1980s. The changes we have seen in terms of meningococcal C, Hib and the pneumococcal vaccine have been immense. I used to have immense fears for children coming in with these diseases because they presented in a very poor condition and our ability to treat them was problematic, even in terms of inserting a needle. Changing methods of treatment but also the vaccines have made a big difference. Current medical students have no idea what Hib is. When I was a junior doctor croup was one of the most frightening diseases I saw. We have experienced difficulties recently with pertussis, or whooping cough, but many doctors do not recognise its symptoms. It is a dreadful disease and is especially problematic for young children.
Unfortunately there have been two deaths in this country in the last year from whooping cough in babies who could not take the vaccine. This is one of the fundamental issues in terms of vaccination. Immunisation is not only a question of protecting oneself. As a society we also have an obligation to protect the vulnerable. In these circumstances, vulnerable members of society include babies under the age of three months who have not started their vaccination programmes. These programmes put an onus on us as a community to protect the vulnerable. Vaccinating one's child also protects those babies who cannot yet take the vaccine and one's own baby until he or she is one or two months old. If this vaccine is seen to be effective we will have what is known as herd immunity and the incidence of disease will drop down to one or two because infection cannot spread. Some of these vaccines also impact on the elderly. The pneumococcal vaccine is only given to children but evidence from elsewhere in the world indicates that it helps to reduce the incidence of the disease among elderly people because it is not as widespread in the community.
Dr. Colette Bonner:
I thank the Meningitis Research Foundation for its balanced and considered presentation. We concur with the figures which show a considerable reduction in the incidence of meningococcal disease related to many organisms as a result of our vaccination campaign. In regard to the meningococcal B vaccine, Dr. Kelleher explained how the process involves NIAC. If the vaccine proves effective we will do everything in our power to introduce it into our immunisation schedule.
However, we will do everything in our power to ensure that if it is proved to be an effective vaccine to introduce into our immunisation schedule, we will do as much as we can to get it introduced as early as possible into our vaccination programme.
I appreciate all the details shared and Dr. Kelleher's extended commentary. Regarding the timeline, is it possible to give us some sense of all the evaluation work? From all he said, I do not get the sense that there is immediacy or that this is imminent. When will a positive decision be reached?
Dr. Kevin Kelleher:
It is not licensed yet. We need to wait for it to be licensed. NIAC needs to consider it, which it is doing to a degree. NIAC would take three to six months to get through some of that because it also needs to seek an external evaluation. NIAC is a classic health committee within Ireland. It comprises a group of people who have totally different day jobs. They meet every month or every other month in their own time in the evenings to consider this work. We are asking people to do this outside their working lives. We are not trying to move away. Everyone present hopes this vaccine turns out to be as good as MenC and we firmly hope we can introduce it like we introduced MenC. However, there are some other issues. As I have said we are also in the throes of other immunisation issues. The staff concerned are dealing with three or four times the number of vaccines compared with five years ago and there are not any more of them.
Dr. Kevin Kelleher:
I am saying it is of that nature. If this vaccine turns out to be like MenC, we would want it in as soon as possible. However, I am saying there are some issues. In reality, it took us a year or so to plan for MenC after the decision for us to introduce it. We need time to make some of those plans, to produce the literature and all those matters we discussed earlier.
I thank everyone for attending and I apologise sincerely for the delay. I thank the witnesses for the quality of the presentation and the answers. I wish members, witnesses, the clerk and other officials a very happy and prosperous Christmas, and a safe journey home.