title: Where are we in our understanding of the association between narcolepsy and one of the 2009 adjuvanted influenza A (H1N1) vaccines?
abstract: Evaluating new rare serious vaccine safety signals is difficult and complex work. To further assess the observed increase in narcolepsy cases seen in Europe with the 2009 pandemic H1N1 influenza vaccine, the International Alliance for Biological Standardization (IABS) invited a wide range of experts to a one day meeting in Geneva in October 2015 to present data and to discuss the implications. The presentations covered the following topics: clinical picture of childhood narcolepsy following the 2009 H1N1 pandemic vaccination campaigns; epidemiological studies conducted to assess the risk of narcolepsy, other neurological and immune-related diseases following 2009 pandemic H1N1 influenza vaccine; potential biases influencing the different epidemiological study designs; potential genetic contribution to the development of narcolepsy; potential biological mechanisms for development of narcolepsy in this setting including the role of the virus itself, antigenic differences between the vaccines and differences in AS03-adjuvanted vaccines. The presentations were followed by fulsome roundtable discussions. Members from affected families also attended and made informal comments to round out the day's deliberations. This meeting emphasized the value added in bringing together in a neutral setting a wide range of experts and vaccine producers to discuss such a complex new serious adverse event following immunization.
authors.affiliation: Influenza and other Respiratory Viruses Disease Programme, Office of the Chief Scientist, European Centre for Disease Prevention and Control, Stockholm, Sweden.
authors.forename: K
authors.initials: K
authors.lastname: Johansen
authors.affiliation: Department of Paediatrics, Free University Brussels (ULB), Brussels, Belgium.
authors.forename: D
authors.initials: D
authors.lastname: Brasseur
authors.affiliation: Dalhousie University, IWK Health Center, Halifax, Nova Scotia, Canada.
authors.forename: N
authors.initials: N
authors.lastname: MacDonald
authors.affiliation: Vaccine Programme Development Team, Vaccine Programme Unit, National Institute for Health and Welfare, Helsinki, Finland.
authors.forename: H
authors.initials: H
authors.lastname: Nohynek
authors.affiliation: International Alliance on Biological Standards, Switzerland.
authors.forename: J
authors.initials: J
authors.lastname: Vandeputte
authors.affiliation: Technologies Standards and Norms, Essential Medicines and Health Products Department, World Health Organization, Geneva, Switzerland.
authors.forename: D
authors.initials: D
authors.lastname: Wood
authors.affiliation: International Alliance on Biological Standards, Switzerland; Vaccine-Advice BVBA, University of Namur, Zoersel, Belgium. Electronic address: iabs@iabs.org.
authors.forename: P
authors.initials: P
authors.lastname: Neels
mesh_terms: D000293:Adolescent; D002648:Child; D005060:Europe / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000009:adverse effects / Q000276:immunology* / Q000592:standards; D007251:Influenza, Human / Q000276:immunology* / Q000517:prevention & control; D009290:Narcolepsy / Q000453:epidemiology / Q000209:etiology / Q000276:immunology*; D058873:Pandemics / Q000517:prevention & control; D014611:Vaccination / Q000009:adverse effects / Q000379:methods / Q000592:standards; D055815:Young Adult
chemical_list: D007252:Influenza Vaccines
keywords: Adverse event; Narcolepsy; Pandemic; Signal detection; Vaccination; Vaccine