title: The Safety of Adjuvanted Vaccines Revisited: Vaccine-Induced Narcolepsy.
abstract: Despite the very high benefit-to-risk ratio of vaccines, the fear of negative side effects has discouraged many people from getting vaccinated, resulting in the reemergence of previously controlled diseases such as measles, pertussis and diphtheria. This fear has been amplified more recently by multiple epidemiologic studies that confirmed the link of an AS03-adjuvanted pandemic influenza vaccine (Pandemrix, GlaxoSmithKline Biologicals, Germany) used in Europe during the 2009 H1N1 influenza pandemic [A(H1N1) pdm09] with the development of narcolepsy, a chronic sleep disorder, in children and adolescents. However, public misperceptions of what adjuvants are and why they are used in vaccines has created in some individuals a closed "black box" attitude towards all vaccines. The focus of this review article is to revisit this "black box" using the example of narcolepsy associated with the European AS03-adjuvanted pandemic influenza vaccine.
authors.forename: S Sohail
authors.initials: SS
authors.lastname: Ahmed
authors.forename: Emanuele
authors.initials: E
authors.lastname: Montomoli
authors.forename: Franco Laghi
authors.initials: FL
authors.lastname: Pasini
authors.forename: Lawrence
authors.initials: L
authors.lastname: Steinman
mesh_terms: D000276:Adjuvants, Immunologic / Q000494:pharmacology; D000293:Adolescent; D002648:Child; D004338:Drug Combinations; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000502:physiology*; D007252:Influenza Vaccines / Q000494:pharmacology*; D007251:Influenza, Human / Q000517:prevention & control / Q000821:virology; D009290:Narcolepsy / Q000209:etiology / Q000276:immunology; D009698:Nucleoproteins / Q000276:immunology; D016017:Odds Ratio; D064446:Orexin Receptors / Q000276:immunology; D011136:Polysorbates / Q000494:pharmacology*; D018570:Risk Assessment; D012938:Social Perception; D013185:Squalene / Q000494:pharmacology*; D014611:Vaccination / Q000009:adverse effects / Q000523:psychology; D024502:alpha-Tocopherol / Q000494:pharmacology*
chemical_list: D000276:Adjuvants, Immunologic; D004338:Drug Combinations; D007252:Influenza Vaccines; D009698:Nucleoproteins; D064446:Orexin Receptors; D011136:Polysorbates; C556153:pandemrix; D013185:Squalene; C550253:AS03 adjuvant; D024502:alpha-Tocopherol