Dr. Kevin Connolly:

I am here in my capacity as the chairman of the National Immunisation Advisory Committee. I will offer some background or additional helpful information. Up to last year, I was the Irish representative on the expert committee of the European Medicines Agency known as the paediatric committee. One of the functions of the committee is to stipulate in detail the contents and timelines of all trials by any company for any vaccine intended for use in Europe. These plans include a large emphasis on safety monitoring during the trials and after the vaccine is introduced. The companies must comply with these conditions or they will not get a licence.

I have been a member of the advisory committee of the Health Products Regulatory Agency for over 20 years. I worked as a paediatrician for 32 years up to 2010, dealing with children with chronic ongoing debilitating conditions. I am a parent of four children. One of my children had chronic fatigue following infection with glandular fever, a well-recognised cause of chronic fatigue.

I am keen to make clear that I strongly empathise with the children and families represented by the Reactions and Effects of Gardasil Resulting in Extreme Trauma support group. Chronic fatigue syndrome can be a debilitating chronic condition, and no one who has listened to the stories could fail to recognise that. I have met and spoken with representatives of REGRET. Any person in Ireland with a chronic condition should have ready access to services that can, in a timely fashion, appropriately assess, investigate and manage their problems on an individual basis. If that is assured, the main aim of REGRET. will be achieved.

I will address four areas to help inform the committee and to answer some of the questions put by the representatives of REGRET. First, I will set out some information about the immunisation advisory committee. Second, I will outline some facts about the infection and disease caused by HPV. Third, I will outline some information about the vaccine. Fourth, I will try to tease out the differences between adverse events and adverse reactions.

The immunisation advisory committee is an independent committee of the Royal College of Physicians of Ireland. Members include members of the college of physicians, the Royal College of Surgeons in Ireland, the Irish College of General Practitioners and the faculties of paediatrics, occupational medicine and public health medicine in universities. There are also representatives from the national virus reference laboratory as well as the Travel Medicine Society of Ireland and nursing and midwifery experts. The committee also includes representatives of the Health Protection Surveillance Centre, which gives us information about the incidence and pattern of diseases. A representative of the Health Products Regulatory Authority is on the committee because the licensing and legality of particular decisions must be ensured. Finally, there are representatives from the Department of Health and the national immunisation office as well as another observer from the HSE.

I will set out the relevant responsibilities of the immunisation committee. I call it NIAC for short because it is easier to say. First, the function of the committee is to review new licensed vaccines to see whether they are suitable for inclusion in the Irish vaccine schedule. Second, its role is to give advice or make recommendations to the Department of Health with regard to vaccines.

I will set out the main criteria we consider when we are considering new vaccines. First, the availability of a safe and effective vaccine. Second, knowledge of the incidence of the disease or infection in Ireland. Third, whether there is a significant disease burden. In other words, a mild infection such as a cold does not really require a vaccine whereas a significant infection like the cancer-causing HPV would. Fourth, we consider whether the recommended vaccine can be easily added to the current vaccine schedule. This is why the national immunisation office is represented on the committee. We also consider the experience in different countries that may have already introduced the vaccine and an economic analysis to see whether the vaccine is cost-effective. Then we provide advice or recommendations to the Department.

Another function of the committee is just as important as making the decision. This is the ongoing review of all available information regarding the vaccines, including the safety and their effectiveness. I will set out why this is relevant to the infection caused by the human papillomavirus. HPV infection is the commonest sexually-transmitted infection and it is very contagious.

It is estimated that up to 80% of males and females will have contracted the infection by the time they are 50. It is known that it causes cancers of the cervix, vagina, vulva, penis, anus, mouth and throat. It also causes anogenital warts. Without the screening mentioned by REGRET, the lifetime risk of sexually active people developing cancer from this virus is about one in 30, which is very appreciable.

Most HPV infections of the cervix and the anus have no symptoms and more than 90% of infections are cleared naturally within two years. Early infections in both sexes may be accompanied by mild changes at the site of infection and for females these changes can be identified in cervical smears, which is part of the cervical screening programme. The term given is cervical intraepithelial neoplasia, which to me means abnormal cells in the cervix, and this can go on to cause cancer. As the infection persists, the cancer precursors are noticed. This means that if these remain untreated they have a high chance of leading to cancer. It can take ten years or longer for the cancer to show; there is a very long incubation period.

Cervical cancer is the second most common cancer in females and the virus is estimated to result in nearly all of the approximately 250,000 deaths from cervical cancer. In Ireland each year there are more than 300 cases of cancer of the cervix and 100 deaths.

No vaccine is 100% safe or 100% effective, but they are very safe and very effective. The trials of drugs normally involve hundreds or thousands of subjects. In the case of vaccines, the trials involve tens of thousands of subjects, as they are given mainly to people who are well and the bar is set much higher. This safety is monitored both in the trials carried out before licensing and in follow-up reports. The clinical part of the trials on the HPV vaccines in Europe lasted more than four years and not the six months that was stated in the United States. So they happened for appreciably longer.