Martin Kenny (Sligo-Leitrim, Sinn Fein)
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1241. To ask the Minister for Health if his attention has been drawn to a situation where some persons claim that a vaccine (details supplied) has had an adverse affect on their health; if he received correspondence on this issue; if he or officials from his Department met with any of the persons affected; and if he will make a statement on the matter. [25389/16]

Simon Harris (Wicklow, Fine Gael)
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As part of Ireland’s response to the pandemic (H1N1) 2009 the National Public Health Emergency Team, following advice from the Pandemic Influenza Expert Group recommended that vaccination against pandemic influenza would be provided to all citizens.

Following reports of narcolepsy among children and adolescents who were vaccinated with Pandemrix in Ireland, a National Narcolepsy Study Steering Committee was established to conduct a retrospective population based study in relation to the Irish data. This Committee comprised expertise in the areas of epidemiology, neurology, paediatrics and paediatric neurology.

The study found that there was a 13 fold higher risk of narcolepsy in children/adolescents vaccinated with the pandemic (H1N1) 2009 vaccine compared with unvaccinated children/adolescents.

The development of narcolepsy following pandemic vaccination is not a uniquely Irish issue. The results from the Irish data concur with those observed in Finland and Sweden.

All of the studies confirm a strong association between the pandemic vaccine and the development of narcolepsy in the 5 to 19 year age group. However, this is not evidence of causation and further studies are required in order to seek explanations of the increased risk of narcolepsy in children and adolescents in certain countries.

As of 7 September 2016, the Health Products Regulatory Authority (HPRA) has received 81 reports with clinical information confirming a diagnosis of narcolepsy in individuals who were vaccinated with Pandemrix (80) and Celvapan (1). The majority of these reports relate to children/adolescents.

Pandemrix accounted for 88% of pandemic influenza vaccine received and 22.5% of the population received at least one dose of Pandemrix vaccine (0.95 million out of a total population of 4.2 million). The 5-19 age group had a significantly higher uptake with 39.8% (339,312) of that age group receiving at least one dose of Pandemrix® (0.34 million out of 0.85 million).

My Department, the HSE and the Department of Education and Skills continue to work together to provide a wide range of services and supports for those affected by narcolepsy following the administration of pandemic influenza vaccine.

The HSE’s Advocacy Unit acts as liaison with service and support providers and other Government Departments to facilitate access to required services. It is in regular contact with individuals affected and regularly meets with representatives of the SOUND (sufferers of unique narcolepsy disorder). Regional co-ordinators have been appointed to assist individuals by providing advice, information and access to local services.

The ex-gratia health supports include clinical care pathways to ensure access to rapid diagnosis and treatment, multi-disciplinary assessments led by clinical experts, counselling services for both the individuals and their families, discretionary medical cards for those who have been diagnosed have been provided to allow unlimited access to GP care and any prescribed medication, ex-gratia reimbursement of vouched expenses incurred in the process of diagnosis and treatment, including travel expenses for attending medical appointments; physiotherapy, occupational therapy assessments, dental assessments and dietary services all on a needs basis.

As of 12 September 2016, legal proceedings against the Minister, the Health Services Executive and GlaxoSmithKline Biological SA have been initiated by 50 individuals. The plaintiffs allege personal injury in which they claim the development of narcolepsy (cataplexy) resulted from the administration of the H1N1 pandemic vaccine.