Narcolepsy and adjuvanted pandemic influenza A (H1N1) 2009 vaccines - Multi-country assessment
Weibel, Daniel (Erasmus Medical Center (Rotterdam, Països Baixos))
Sturkenboom, Miriam (University Utrecht Medical Center)
Black, Steven (Cincinnati Children's Hospital Medical Center)
de Ridder, Maria A. J. (Erasmus Medical Center (Rotterdam, Països Baixos))
Dodd, Caitlin (Erasmus Medical Center (Rotterdam, Països Baixos))
Bonhoeffer, Jan (Brighton Collaboration Foundation (Basilea, Suïssa))
Vanrolleghem, Ann (Erasmus Medical Center (Rotterdam, Països Baixos))
van der Maas, Nicoline (National Institute for Public Health and the Environment (Bilthoven, Països Baixos))
Lammers, Gert Jan (Sleep-Wake Center SEIN (Heemstede, Països Baixos))
Overeem, Sebastiaan (Sleep Medicine Centre Kempenhaeghe (Heeze, Països Baixos))
Gentile, Angela (Hospital de Niños Ricardo Gutiérrez (Buenos Aires, Argentina))
Giglio, Norberto (Hospital de Niños Ricardo Gutiérrez (Buenos Aires, Argentina))
Castellano, Vanesa (Hospital de Niños Ricardo Gutiérrez (Buenos Aires, Argentina))
Kwong, Jeffrey C. (Institute for Clinical Evaluative Sciences-ICES (Ontario, Canada))
Murray, Brian J. (University of Toronto)
Cauch-Dudek, Karen (Institute for Clinical Evaluative Sciences-ICES (Ontario, Canada))
Juhasz, Diana (Institute for Clinical Evaluative Sciences-ICES (Ontario, Canada))
Campitelli, Michael (Institute for Clinical Evaluative Sciences-ICES (Ontario, Canada))
Datta, Alexandre N. (University Hospital Basel (Basilea, Suïssa))
Kallweit, Ulf (Witten/Herdecke University)
Huang, Wan-Ting (Taiwan Centers for Disease Control)
Huang, Yu-Shu (Chang Gung Memorial Hospital (Taiwan). Department of Child Psychiatry and Sleep Center)
Hsu, Chung-Yao (Kaohsiung Medical University Hospital (Kaohsiung, Taiwan))
Chen, Hsi-Chung (National Taiwan University Hospital (Taipei, Taiwan))
Giner-Soriano, Maria (Institut Universitari d'Investigació en Atenció Primària Jordi Gol)
Morros, Rosa (Institut Universitari d'Investigació en Atenció Primària Jordi Gol)
Gaig, Carles (Hospital Clínic i Provincial de Barcelona)
Tió, Ester (Althaia Xarxa Assistencial Universitària de Manresa (Manresa, Catalunya))
Perez-Vilar, Silvia (Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat -FISABIO (València))
Diez-Domingo, Javier (Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat (València))
Puertas, Francisco Javier (Hospital Universitari de la Ribera (València))
Svenson, Lawrence W. (University of Alberta (Alberta, Canada). Division of Preventive Medicine)
Mahmud, Salaheddin M. (University of Manitoba (Manitoba, Canada). Rady Faculty of Health Sciences)
Carleton, Bruce (University of British Columbia. Faculty of Medicine)
Naus, Monika (University of British Columbia. Faculty of Medicine)
Arnheim-Dahlström, Lisen (Karolinska Institutet (Estocolm, Suècia). Department of Medical Epidemiology and Biostatistics)
Pedersen, Lars (Aarhus University (Aarhus, Dinamarca))
DeStefano, Frank (Centers for Disease Control and Prevention-CDC (Atlanta, Estats Units d'Amèrica))
Shimabukuro, Tom T. (Centers for Disease Control and Prevention-CDC (Atlanta, Estats Units d'Amèrica))
Universitat Autònoma de Barcelona

Data:	2018
Resum:	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. 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. 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. 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.
Nota:	Altres ajuts: This study was funded by the Centers for Disease Control and Prevention (CDC), Atlanta, USA, under CDC contract number 200-2012-53425_addendum 0001. This study was also supported by Public Health Ontario (PHO) and the Institute for Clinical Evaluative Sciences (ICES), which is funded by an annual grant from the Ontario Ministry of Health and Long-Term Care (MOHLTC).
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Narcolepsy ; Pandemic H1N1 influenza ; Adjuvant ; AS03 ; MF59
Publicat a:	Vaccine, Vol. 36 (august 2018) , p. 6202-6211, ISSN 1873-2518

DOI: 10.1016/j.vaccine.2018.08.008
PMID: 30122647

22 p, 620.6 KB

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