Bobby Aylward (Carlow-Kilkenny, Fianna Fail)
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318. To ask the Minister for Health the details of research undertaken to date by his Department to ensure the safety of the Gardasil vaccine; his plans to engage with the advocacy groups and families representing the 628 persons who claim to have suffered adverse health effects shortly after having received the vaccine; and if he will make a statement on the matter. [48734/17]

Simon Harris (Wicklow, Fine Gael)
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All medicines, including vaccines are subject to ongoing review and evaluation of all available data from a range of sources, including systematic scientific literature review, to consider any impact that their data may have on the overall assessment of the benefits and risks of a medicinal product. Taking into account the totality of the available information, the benefits of the HPV vaccines continue to outweigh their risks. The safety of these vaccines continues to be monitored at EU level through the European Medicines Agency (EMA) and its expert committees, which includes representatives from member state competent authorities such as the Health Products Regulatory Authority (HPRA).

The HPRA is responsible for monitoring the safety and quality of all medicines including vaccines that are licensed in Ireland and operates a national adverse reaction reporting system, which members of the public and healthcare professionals are encouraged to submit any suspected adverse reactions through this system. All Reports received by the HPRA are routinely transmitted to the EMA's adverse reaction database for inclusion in global signal detection and monitoring activities.

I am aware of claims of an association between HPV vaccination and a number of conditions experienced by a group of young women. An illness that occurs around the time a vaccine is given and is already known to be common in adolescence does not imply the vaccine caused the problem. 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. As there is no scientific evidence that the vaccine causes long term illnesses, the HPV vaccine cannot be held responsible for these illnesses.

The individual nature of the needs of some children may require access to specialist services and the Health Service Executive are currently working to put in place a clinical care pathway appropriate to the medical needs of this group.