Increased childhood incidence of narcolepsy in western Sweden after H1NI influenza vaccination

and Department of Pediatrics (A.S., N.D., T.H.), Institute of Clinical Sciences, University of Gothenburg, The Queen Silvia Children's Hospital, Göteborg, Sweden.
Neurology (Impact Factor: 8.3). 03/2013; 80(14). DOI: 10.1212/WNL.0b013e31828ab26f
Source: PubMed

ABSTRACT OBJECTIVES: To assess the incidence of narcolepsy between January 2000 and December 2010 in children in western Sweden and its relationship to the Pandemrix vaccination, and to compare the clinical and laboratory features of these children. METHODS: The children were identified from all local and regional pediatric hospitals, child rehabilitation centers, outpatient pediatric clinics, and regional departments of neurophysiology. Data collection was performed with the aid of a standardized data collection form, from medical records and telephone interviews with patients and parents. The laboratory and investigational data were carefully scrutinized. RESULTS: We identified 37 children with narcolepsy. Nine of them had onset of symptoms before the H1N1 vaccination and 28 had onset of symptoms in relationship to the vaccination. The median age at onset was 10 years. All patients in the postvaccination group were positive for human leukocyte antigen (HLA)-DQB1*0602. Nineteen patients in the postvaccination group, compared with one in the prevaccination group, had a clinical onset that could be dated within 12 weeks. CONCLUSION: Pandemrix vaccination is a precipitating factor for narcolepsy, especially in combination with HLA-DQB1*0602. The incidence of narcolepsy was 25 times higher after the vaccination compared with the time period before. The children in the postvaccination group had a lower age at onset and a more sudden onset than that generally seen.

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    • "Animal narcolepsy models and optogenetic device studies have shown that hypocretin maintains wakefulness, increases arousal, and suppresses REM and non-REM sleep [8] [9]. The observed association of narcolepsy with streptococcal [10] and H1N1 [11] infections and with H1N1 vaccination [12] [13] [14] [15] further supports the concept that narcolepsy is an immune-mediated disease. "
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    ABSTRACT: Despite published treatment recommendations and the availability of approved and off-label pharmacologic therapies for narcolepsy, clinical management of this incurable, chronic neurologic disorder remains challenging. While treatment is generally symptomatically driven, decisions regarding which drug(s) to use need to take into account a variety of factors that may affect adherence, efficacy, and tolerability. Type 1 narcolepsy (predominantly excessive daytime sleepiness with cataplexy) or type 2 narcolepsy (excessive daytime sleepiness without cataplexy) may drive treatment decisions, with consideration given either to a single drug that targets multiple symptoms or multiple drugs that each treat a specific symptom. Other drug-related characteristics that affect drug choice are dosing regimens, tolerability, and potential drug-drug interactions. Additionally, the patient should be an active participant in treatment decisions, and the main symptomatic complaints, treatment goals, psychosocial setting, and use of lifestyle substances (i.e., alcohol, nicotine, caffeine, cannabis) need to be discussed with respect to treatment decisions. Although there is a lack of narcolepsy-specific instruments for monitoring therapeutic effects, clinically relevant subjective and objective measures of daytime sleepiness (e.g., Epworth Sleepiness Scale, Maintenance of Wakefulness Test) can be used to provide guidance on whether treatment goals are being met. These considerations are discussed with the objective of providing clinically relevant recommendations for making treatment decisions that can enhance effective management of patients with narcolepsy.
    Sleep Medicine 10/2014; 16(1). DOI:10.1016/j.sleep.2014.10.002 · 3.10 Impact Factor
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    • "One Swedish report concluded that the Pandemrix-vaccination was the precipitating factor for narcolepsy due to a sudden onset of symptoms with a lower age of onset. There was also an association with HLA-DQB1*06:02 found in the majority of patients vaccinated with Pandemrix Ò [23]. "
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    ABSTRACT: Narcolepsy is a lifelong sleep disorder related to hypocretin deficiency resulting from a specific loss of hypocretin-producing neurons in the lateral hypothalamic area. The disease is thought to be autoimmune due to a strong association with HLA-DQB1*06:02. In 2009 the World Health Organization (WHO) declared the H1N1 2009 flu pandemic (A/H1N1PDM09). In response to this, the Swedish vaccination campaign began in October of the same year, using the influenza vaccine Pandemrix®. A few months later an excess of narcolepsy cases was observed. It is still unclear to what extent the vaccination campaign affected humoral autoimmunity associated with narcolepsy.
    Journal of Autoimmunity 01/2014; 50. DOI:10.1016/j.jaut.2014.01.031 · 7.02 Impact Factor
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    ABSTRACT: After the beginning of the influenza A (H1N1 pdm09) pandemic in 2009, several monovalent pandemic H1N1 vaccines were licensed using fast track procedures, with limited safety data in children and adolescents.(1) Nonadjuvant monovalent vaccines were used in the United States and Australia, and on a limited scale, in Europe (France, Spain) and other countries. Within the European Union (EU), 2 different vaccines with adjuvant were licensed, both containing a new generation of squalene-based adjuvant: Focetria (Novartis, Philadelphia, PA), with the MF59 adjuvant, and Pandemrix (GSK, Philadelphia, PA), containing AS03 (squalene and α-tocopherol). Arepanrix, similar to Pandemrix, was used in Canada and Brazil. The vaccine program started in the EU by September 2009; concurrently, the European Center for Disease Prevention & Control (ECDC), Vaccine Adverse Event Surveillance and Communication, and other agencies initiated an active surveillance program to monitor safety and adverse events associated with this vaccine.
    Neurology 03/2013; 80(14). DOI:10.1212/WNL.0b013e31828ab382 · 8.30 Impact Factor
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