Tuesday, 2 May 2017
Department of Health
871. To ask the Minister for Health further to Parliamentary Question No. 611 of 11 April 2017, the reason pandemrix continued to be used after 2009 when the Irish Medicines Board was in possession of facts that showed it had a far greater likelihood of adverse reactions. [19463/17]
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, used during the H1N1 2009 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 (CHMP) of the EMA 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 (IMB), now the Health Products Regulatory Authority (HPRA) had received reports of two confirmed cases of narcolepsy following vaccination with pandemic vaccines. The Department of Health and the HSE agreed that the HSE Health Protection Surveillance Centre would work with the IMB 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.
The vaccination programme in Ireland was based on the advices of the National Immunisation Advisory Committee. A number of "at risk" groups were defined and prioritised for vaccination commencing in October 2009. Over 1.1 million pandemic vaccinations were recorded, giving a 25% uptake for the total population. The vaccine uptakes among the priority groups were 50% for those medically at risk, 32% for pregnant women (it was 45% during early part of programme), 31% for health care workers, 60% for children aged 6 months to 4 years, 39% for children aged 5-14 years and 25% for those aged 65 years and older. The public pandemic vaccination campaign ended on 31 March 2010. However, following a full assessment of the situation at that time the vaccine continued to be made available free of charge to the “at risk” groups through General Practice and Maternity Units until September 2010.
Since the 2010/2011 influenza season H1N1 has been incorporated in the seasonal flu vaccine used in Ireland. Pandemrix was distributed to GPs in January 2011 with a recommendation that it be used for those in at risk groups for a three week period when there was a temporary shortage of seasonal influenza vaccine. All sites were asked to return any unused vaccine and it has not been recommended for use since then.