Technical report In Brief: Narcolepsy in association with pandemic influenza vaccination
This report summarises the results from two epidemiological studies to investigate a possible association between an unexpected increase in narcolepsy cases following the use of the influenza A(H1N1)pdm09 vaccines. The studies were conducted by the Vaccine Adverse Event Surveillance and Communication (VAESCO) Consortium under the auspices of ECDC and undertaken in Denmark, Finland, France, Italy, the Netherlands, Norway, Sweden and the United Kingdom. This Technical Report In Brief accompanies the full Report ‘Narcolepsy in association with pandemic influenza vaccination- A multi-country European epidemiological investigation’.
European Commission: Influenza
Vaccination policy is a competence of national authorities however, the European Commission supports EU countries to coordinate their policies and programmes. To support EU countries in maintaining or increasing rates of vaccination, the EU Commission promotes seasonal flu vaccination to at risk groups.
Vaccine hesitancy among healthcare workers and their patients in Europe
The aim of this research project is to have a better understanding of vaccine hesitancy and safety concerns among healthcare vaccine providers and their patients in Europe and to explore the link and potential influence between the two groups.
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.
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.
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.
Safety, Reactogenicity and Immunogenicity of the Human Rotavirus Vaccine in Pre-Term European Infants: A Randomized Phase IIIb StudyArchived
Results of this study demonstrated that the RIX4414 vaccine was well tolerated and immunogenic in pre-term European infants: more than 75% of infants had seroconverted 30-83 days after dose 2.
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).