ECDC – VAESCO investigation into narcolepsyArchived
This initiative was taken following the indication of a potential association between the 2009 pandemic influenza A(H1N1) monvalent vaccine and the occurrence of narcolepsy following reports, especially in children from Finland and Sweden.
Reports of cases of narcolepsy and cataplexy in children and adolescents in Finland, Iceland, and SwedenArchived
In February 2011, ECDC published a report concerning a rise in narcolepsy in children and adolescents in some northern countries.
Swedish MPA publishes interim results of a cohort study assessing the risk of narcolepsy after vaccination with Pandemic influenza vaccine Pandemrix®Archived
A four-fold increased incidence of narcolepsy in vaccinated children/adolescents compared to unvaccinated children was observed in this register-based cohort study.
Narcolepsy following pandemic influenza A H1N1 2009 vaccination - ECDC update: the European Medicines Agency interim measures for PandemrixArchived
In late March, 2011 ECDC reported that the Swedish Medical Product Agency published preliminary results from an on-going cohort study involving 5.3 million people, where 67% of children and adolescents and 51.0% of adults were vaccinated with Pandemrix.
European Medicines Agency (EMA) 2009 Influenza Pandemic EvaluationArchived
The European Medicines Agency (EMA) was key in the Europe during the 2009 pandemic concerning the authorisation and the benefit – risk assessment of the novel pandemic vaccines.
Case inventory study from Sweden concerning association of Pandemrix vaccination and reports of narcolepsy with cataplexy in children and adolescentsArchived
ECDC has previously summarised information concerning the appearance of narcolepsy following the use of a specific pandemic vaccine (Pandemrix®) in children and adolescents in three European Countries.
EMA's Committee for Medicinal Products for Human Use (CHMP) issues opinion on narcolepsy and vaccination with Pandemrix®Archived
On 21 July 2011 the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued its opinion on the review of Pandemrix® and reports on narcolepsy. The CHMP recommended that in persons under 20 years of age Pandemrix® may only be used if the recommended seasonal trivalent influenza vaccine is not available and if immunisation against H1N1 is still needed (e.g. in persons at risk of the complications of infection).
Recommendation by the European Medicines Agency concerning Pandemrix vaccination and reports of narcolepsy in children and adolescentsArchived
EMA recommends restricting use in persons under 20 years of age Pandemrix to be used only in the absence of seasonal trivalent influenza vaccines, following link to very rare cases of narcolepsy in young people. Overall benefit-risk remains positive.
Association of childhood narcolepsy and cataplexy and receipt of a pandemic influenza vaccine in Finland in 2009-10 – First papers in a peer review journalArchived
A pair of linked papers from Finland concerning the above topic, one epidemiological and the second combining both clinical and epidemiological were published on March 28th in the open access journal, PLoS One.(1,2).