Tuesday, 18 September 2018
Department of Health
364. To ask the Minister for Health if concerns regarding the link between Pandemrix and narcolepsy were ever brought to his attention; if so, the details of same; and the measures he took to have the matter addressed [35867/18]
I cannot comment on individual cases or matters that are the subject of litigation but I can provide background information on this litigation and clarify matters that are already in the public domain.
The Final Report of National Narcolepsy Study Steering Committee, “Investigation of an increase in the incidence of narcolepsy in children and adolescents in 2009 and 2010”, published on 19 April 2012, set out the facts concerning when knowledge of possible side effects from the pandemic influenza vaccine came to the attention of health authorities. The first reported case of narcolepsy as a possible consequence of the Pandemrix vaccination was identified by the Swedish pharmacovigilance authority in August 2010. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), being the relevant regulatory authority for Pandemrix, continually monitored the reported adverse reactions of Pandemrix and advised member states accordingly.
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. In Ireland, children and young adults were the most affected groups. Eighty percent of cases were less than 35 years of age. More than 1,000 cases of confirmed Pandemic (H1N1) 2009 influenza were hospitalised and 100 people were admitted to Intensive Care Units. There were 29 deaths, all but two of which were in ‘at risk’ groups and most had other significant underlying medical conditions.
The Department of Health 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. Over 1.1 million pandemic vaccinations were recorded giving a 25% uptake for the total population. Since the 2010/2011 influenza season H1N1 has been incorporated in the seasonal flu vaccine used in Ireland.
A copy of the report can be found on my Department’s website: health.gov.ie/blog/publications/final-report-of-the-national-narcolepsy-study-steering-committee-2/.