Narcolepsy in association with pandemic influenza vaccination – a multi-country European epidemiological investigation
This report summarises the results from two epidemiological studies conducted by the Vaccine Adverse Event Surveillance and Communication (VAESCO) Consortium undertaken in eight European Union (EU)/European Economic Area (EEA) countries in order to investigate a possible association between an unexpected increase in narcolepsy cases following the use of influenza A(H1N1)pdm09 vaccines. Narcolepsy is an underdiagnosed disease of widely unknown etiology.
Understanding the association between narcolepsy and one of the 2009 adjuvanted influenza A (H1N1) vaccines
This meeting was designed to offer a place to exchange the latest information on into the development of narcolepsy following vaccination with one of the 2009 adjuvanted influenza A(H1N1) vaccines.
European Parliament resolution on the evaluation of the management of H1N1 influenza in 2009-2010 in the EUArchived
The European Parliament adopted a resolution on the evaluation of the pandemic in its sitting on the 8th March 2011.
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.
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).