Maureen O'Sullivan (Dublin Central, Independent)
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584. To ask the Minister for Health his plans to sanction an independent investigation of the causation of the symptoms affecting young girls as a result of the human papilloma virus, HPV, vaccine and for a treatment plan to be put in place to facilitate their needs [37481/16]

Simon Harris (Wicklow, Fine Gael)
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Each year in Ireland around 300 women are diagnosed with cervical cancer. The HPV vaccine protects against two high risk types of HPV (16 & 18) that cause 73% of all cervical cancers. Vaccinated women and girls will still be at risk from other high risk types of HPV that can cause cervical cancer and will therefore need to continue to have regular cervical smear tests. NIAC recommended that the human papillomavirus (HPV) vaccine be given to all girls aged 12-13 in 2009 and in September 2010 the HPV vaccination programme was introduced for all girls in first year of second level schools.

By January 2016, over 200 million doses of Gardasil had been distributed worldwide. In Ireland over 580,000 doses of Gardasil have been administered and over 220,000 girls have been fully vaccinated against HPV since it was introduced in 2010.

No medicine, including vaccines, is entirely without risk, there is therefore on-going pharmacovigilance and monitoring of medicinal products once they are authorised for use. The safety profile of Gardasil has been continuously monitored since it was first authorised both nationally and at EU level. In Ireland, the Health Products Regulatory Authority (HPRA) is the statutory regulatory authority for medicines in Ireland.

In November 2015 the European Medicines Agency (EMA) completed a detailed scientific review of the HPV vaccine. The review, in which the HPRA participated, focused on two conditions, complex regional pain syndrome and postural orthostatic tachycardia syndrome. The review found no evidence of a causal link between the vaccine and the two conditions. On 12 January 2016 the European Commission endorsed the conclusion of the EMA stating that there is no need to change the way HPV vaccines are used or to amend the product information which is now binding in all member states.

I am aware of claims of an association between HPV vaccination and a number of conditions experienced by a group of young women. It appears that some girls first suffered symptoms around the time they received the HPV vaccine, and understandably some parents have connected the vaccine to their daughter’s condition. It is important to reassure people that anyone who is suffering ill health is eligible to seek medical attention, and to access appropriate health and social care services, irrespective of the cause of their symptoms. The individual nature of the needs of some children may require access to specialist services. The HSE are currently working to put in place a clinical care pathway appropriate to the medical needs of this group.

I encourage the parents of all eligible girls to ensure that their daughters receive this important cancer preventing vaccine.