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.
No association found between pandemic influenza vaccination and Guillain-Barre Syndrome in EuropeArchived
Due to an association that was observed in the United States between a swine-flu based human influenza vaccine developed in 1976 and the disease acute polyneuropathy Guillain-Barré syndrome (GBS) (1,2), GBS was one of the adverse events that was monitored in Europe and North America (3) following the 2009 influenza pandemic vaccination campaigns.
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.
Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine in Children Previously Immunized With 7-valent Pneumococcal Conjugate VaccineArchived
This study demonstrates that PCV13 is immunogenic and safe in children previously vaccinated with PCV7. By eliciting high antibacterial immune responses to the additional serotypes, PCV13 provides protection against these serotypes, which are important causes of pneumococcal disease globally.