Dr. Colette Bonner:

In 2009, the national immunisation advisory committee recommended the HPV vaccination for all 12 year old girls, and in September 2010 the programme started for all girls in first year of second level schools.

My colleague, Dr. Kevin Connolly, is chairman of the National Immunisation Advisory Committee. He will give the committee examples of how NIAC makes recommendations for inclusion of new vaccines in the primary childhood immunisation schedule and school immunisation programme.

Gardasil is the vaccine used by the HSE in the school immunisation programme and is provided free of charge. My colleague, Dr. Brenda Corcoran, will give details of the school immunisation programme and discuss the information given to parents.

Why did we introduce the human papillomavirus vaccine? The reason is that it protects against HPV types 16 and 18, which are known to cause over 70% of cervical cancers. In Ireland, approximately 300 cases of cervical cancer are diagnosed each year. Up to 60% of women diagnosed with cervical cancer are under 50 years of age and there are approximately 100 deaths each year. This vaccine could save up to 70% of these women's lives.

What happens when a new vaccine or medicine is introduced to the market? All medicinal products, including vaccines, are required to go through extensive trials before they are reviewed by the European Medicines Agency and licensed by the European Commission. Even after any products are licensed, the EMA, the Health Products Regulatory Agency and all EU competent authorities continue to monitor them to ensure they continue to be safe and effective. My colleague, Dr. Joan Gilvarry, will explain the regulatory regime in greater detail.

I am aware of reports of serious health problems alleged to have occurred following HPV vaccination and I have great sympathy for any family caring for a sick child. However, I emphasise that this does not mean the symptoms have been caused by the HPV vaccine. Over 170,000 girls in Ireland and up to 63 million girls worldwide have received this important cancer-preventing vaccine. The vast majority of reported side-effects have been consistent with the expected pattern of short-term adverse side effects for the vaccine.

Two reported conditions have recently been examined by the European Medicines Agency. These are complex regional pain syndrome, a chronic pain condition affecting the limbs, and postural orthostatic tachycardia syndrome, a condition causing symptoms such as dizziness, fainting, headaches, chest pain and weakness. It should be noted that these two syndromes are recognised to occur in the general population, including adolescents, regardless of whether those affected have had the HPV vaccine. The EMA review confirms that the evidence does not support a causal link between the HPV vaccine and the development of CRPS and POTS. Therefore, there is no reason to change the way the vaccines are used or amend the current product information. My colleagues will give the committee further details of these reviews.

Anyone in Ireland who is experiencing ill-health is eligible to seek medical attention and access appropriate health and social services, irrespective of the cause of the symptoms. I strongly advise any girls and their families in this situation to seek medical advice from their doctors and be guided by that advice, so that they can have an opportunity to return to full health as soon as possible.