| dc.description.abstract | Background
In 2010, a safety signal was detected for narcolepsy following vaccination with Pandemrix, an AS03-adjuvanted monovalent pandemic H1N1 influenza (pH1N1) vaccine. To further assess a possible association and inform policy on future use of adjuvants, we conducted a multi-country study of narcolepsy and adjuvanted pH1N1 vaccines.
Methods
We used electronic health databases to conduct a dynamic retrospective cohort study to assess narcolepsy incidence rates (IR) before and during pH1N1 virus circulation, and after pH1N1 vaccination campaigns in Canada, Denmark, Spain, Sweden, Taiwan, the Netherlands, and the United Kingdom. Using a case-control study design, we evaluated the risk of narcolepsy following AS03- and MF59-adjuvanted pH1N1 vaccines in Argentina, Canada, Spain, Switzerland, Taiwan, and the Netherlands. In the Netherlands, we also conducted a case-coverage study in children born between 2004 and 2009.
Results
No changes in narcolepsy IRs were observed in any periods in single study sites except Sweden and Taiwan; in Taiwan incidence increased after wild-type pH1N1 virus circulation and in Sweden (a previously identified signaling country), incidence increased after the start of pH1N1 vaccination. No association was observed for Arepanrix-AS03 or Focetria-MF59 adjuvanted pH1N1 vaccines and narcolepsy in children or adults in the case-control study nor for children born between 2004 and 2009 in the Netherlands case-coverage study for Pandemrix-AS03.
Conclusions
Other than elevated narcolepsy IRs in the period after vaccination campaigns in Sweden, we did not find an association between AS03- or MF59-adjuvanted pH1N1 vaccines and narcolepsy in children or adults in the sites studied, although power to evaluate the AS03-adjuvanted Pandemrix brand vaccine was limited in our study. |
| dc.contributor.authoraffiliation | [Weibel D, de Ridder M, Dodd C, Vanrolleghem A, Perez-Vilar S] Medical Informatics Department, Erasmus Medical Center, Rotterdam, The Netherlands. [Sturkenboom M] Julius Global Health, University Utrecht Medical Center, Utrecht, The Netherlands. [Black S] Cincinnati Children’s Hospital, Cincinnati, OH, USA. [Bonhoeffer J] Infectiology and Vaccinology University Children’s Hospital, Basel, Switzerland. Brighton Collaboration Foundation, Basel, Switzerland. [van der Maas N] Dept. Epidemiology and Surveillance, National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands. [Lammers GJ] Leiden University Medical Centre, Leiden, The Netherlands. Sleep-Wake Center SEIN, Heemstede, The Netherlands. [Overeem S] Sleep Medicine Centre Kempenhaeghe, Heeze, The Netherlands. [Gentile A, Giglio N, Castellano V] Hospital de Niños Ricardo Gutiérrez, Ciudad Autónoma de Buenos Aires, Argentina. [Kwong JC, Cauch-Dudek K, Juhasz D, Campitelli M] Institute for Clinical Evaluative Sciences (ICES), Ontario, Canada. [Murray BJ] Division of Neurology, Department of Medicine, Sunnybrook Health Sciences Centre, University of Toronto, Canada. [Datta AN] University Hospital Basel, Basel, Switzerland. [Kallweit U] Bern University Hospital and University of Bern, Bern, Switzerland. Witten/Herdecke University, Department of Rehabilitation, Witten/Herdecke, Germany. [Huang WT] Taiwan Centers for Disease Control, Taipei, Taiwan. [Huang YS] Department of Child Psychiatry and Sleep Center, Chang Gung Memorial Hospital and University, Taoyuan, Taiwan. [Hsu CY] Department of Neurology and Sleep Disorders Center, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan. [Chen HC] Department of Psychiatry and Center of Sleep Disorders, National Taiwan University Hospital, Taipei, Taiwan. [Giner-Soriano M, Morros R] Institut Universitari d’Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), Barcelona, Spain. [Gaig C] Neurology Service and Multidisciplinary Sleep Disorders Unit, Hospital Clinic of Barcelona, Barcelona, Spain. [Tió E] Althaia Xarxa Assistencial Universitària de Manresa, Neurology Service, Manresa, Barcelona, Spain. [Perez-Vilar S, Diez-Domingo J] Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat (FISABIO), Vaccine Research, Valencia, Spain. [Puertas FJ] Servicio de Neurofisiologia, Hospital Universitari de la Ribera, Valencia, Spain. [Svenson LW] Division of Preventive Medicine, University of Alberta, Alberta, Canada. [Mahmud SM] Vaccine and Drug Evaluation Centre, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Manitoba, Canada. [Carleton B] Faculty of Medicine, University of British Columbia, British Columbia, Canada. [Arnheim-Dahlström L] Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden. [Pedersen L] Clinical Medicine/Epidemiology, Aarhus University, Aarhus, Denmark. [DeStefano F, Shimabukuro TT] Centers for Disease Control and Prevention (CDC), Immunization Safety Office, Atlanta, USA |
