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.
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).
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.
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.
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.
In recent years there have been a series of arguments and findings suggesting that Statins (HMG-CoA reductase inhibitors) which used widely to lower cholesterol levels may also be important in reducing the risk associated with severe infective conditions.
A four-fold increased incidence of narcolepsy in vaccinated children/adolescents compared to unvaccinated children was observed in this register-based cohort study.
Each year in February WHO convenes a meeting with advisers from the WHO Influenza Collaborating Centres and Essential Reference laboratories in order to achieve consensus and advise WHO on the optimal formulation of seasonal influenza vaccines for the next influenza season.