Róisín Shortall (Dublin North West, Labour)

I thank the Senator for raising this matter as it provides me with an opportunity to outline to the House its importance. Epidemiological studies in Finland and Sweden show an association between immunisation against H1N1 with Pandemrix and narcolepsy. Narcolepsy is a disabling chronic neurological disorder characterised by recurrent episodes of excessive daytime sleepiness. A multi-factorial aetiology has been suggested for narcolepsy, involving a genetic predisposition in combination with environmental risk factors. Researchers have proposed an autoimmune involvement. A Chinese study points to an upper respiratory tract infection as a possible determining factor.

The Health Protection and Surveillance Centre estimates that approximately 250,000 children and adolescents between the ages of five and 19 years received Pandemrix vaccine. The Department's chief medical officer's office and the Health Protection and Surveillance Centre are working with the Irish Medicines Board and clinical experts in narcolepsy to examine the Irish data. However, the number of cases in Ireland is relatively small and may not allow causality to be determined. The results of the study are expected in early 2012. We are also awaiting the outcome of a multi-country vaccine adverse events monitoring and communication, VAESCO, study undertaken in conjunction with the European Centre for Disease Control. Results from this study are expected in spring 2012.

The Health Protection and Surveillance Centre is investigating 32 cases that meet the case definition for narcolepsy which had onset of symptoms between April 2009 and December 2010 and in which people have consented to participate in the study. Of these 32 validated cases, 25 had received a vaccination before the recalled onset of the first narcolepsy symptom, 24 with Pandemrix and one with Celvapan. A small number of cases had received vaccination after the onset of the first symptom. Three cases did not receive any vaccination. The Health Protection Surveillance Centre is aware of a further 15 potential cases at varying stages of investigation. These may or may not meet the case definition, and one of them has declined to participate in the study.

Relevant health care professionals, including GPs, paediatricians, psychiatrists, clinical psychologists and public health nurses, have been advised on the possible association between Pandemrix vaccination and narcolepsy and the referral process for suspect cases for diagnosis. A group called Sufferers of Unique Narcolepsy Disorder, SOUND, has been set up by parents of those affected. The Minister has met the group which is actively engaged with the HSE through two representatives on the HSE serious incident alert group which is managing the issue.

Medical cards have been granted for diagnosed cases and expenses incurred by parents are being met by the HSE. Representatives of SOUND also met the Department of Education and Skills recently. The Department has advised on how educational support services available can be accessed to assist the children concerned in continuing their education. Everything possible will continue to be done by the health and education services to address the concerns of parents whose children have developed narcolepsy.