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.

​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).

Investigation of an increase in the incidence of narcolepsy in children and adolescents in 2009 and 2010 - Final Report of National Narcolepsy Study Steering Committee, Department of Health, Ireland

​In September 2010 Sweden and Finland noted a number of children had developed narcolepsy seemingly in association with having received the pandemic vaccine used almost exclusively in those countries (Pandemrix)

This is the first published study where an attempt has been made to understand the possible biological mechanisms behind development of narcolepsy following vaccination with Pandemrix™.

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).