Wednesday, 3 May 2017
Department of Health
21. To ask the Minister for Health if he will provide the detail of the information held by his Department after November 2009 regarding the safety profile of the Pandemrix vaccine compared to other vaccines for swine flu; and if his Department was briefed by the Irish Medicines Board as to the heightened risk of serious adverse drug reactions associated with the drug. [20206/17]
As you are aware this matter is the subject of litigation in which plaintiffs allege personal injury in which they claim the development of narcolepsy (cataplexy) resulted from the administration of the H1N1 pandemic vaccine. An Order requiring the defendants to make Discovery was made in the High Court on 28 November 2016 in the most advanced case. Discovery is a legal process which must be carried out in accordance with Orders made by the Courts and both the Department of Health and the HSE are working to comply with the Order made in this case. However, the size and complexity of the Discovery means that this is not a trivial or quick process and, to date, the HSE has identified 300,000 records, and the Department over 465,000 records, all which must be examined and scheduled by Counsel. Consequently, I am currently not in a position to provide the detailed information requested in this question.
Nevertheless, it is important to remember the context in which vaccination against influenza type A (H1N1) was introduced. On 11 June 2009, following consideration by its Emergency Committee, the WHO raised the Influenza type A (H1N1) alert to Pandemic level 6 which officially declares a pandemic. My Department activated the National Plan for pandemic influenza and, based on the advices of the National Immunisation Advisory Committee, ‘at risk’ groups were prioritised for vaccination. Vaccination of children was prioritised as the rates of influenza were highest in those groups at that time. The public pandemic vaccination campaign ended on 31 March 2010.
The first reports of a link between pandemic influenza vaccination and narcolepsy came in the second half of 2010. In August 2010, the Swedish pharmacovigilance authority reported that it was investigating six cases of narcolepsy reported by health care professionals as a possible adverse event following the use of Pandemrix vaccine during the pandemic. This was followed later that month by reports from the Finnish National Institute for Health and Welfare noting there had been a more than expected number of cases of narcolepsy in children and adolescents that year. On 23 September 2010, the Committee on Human Medicinal Products of the European Medicines Agency concluded in its initial review of available data that the available evidence did not confirm a link but that more research was needed. By the end of March 2011 the Irish Medicines Board, now the Health Products Regulatory Authority, had received reports of two confirmed cases of narcolepsy following vaccination with pandemic vaccines. My Department and the HSE agreed that the Health Protection Surveillance Centre would work with the Irish Medicines Board and Irish clinical experts in narcolepsy to examine the Irish data and report back the findings. The Final Report of National Narcolepsy Study Steering Committee was published on 19 April 2012. It found a 13-fold higher risk of narcolepsy in vaccinated compared to unvaccinated individuals and the absolute increased risk associated with the vaccine was five narcolepsy cases per 100,000 vaccinated children and adolescents.