Format

Send to

Choose Destination
Vaccine. 2018 Oct 1;36(41):6202-6211. doi: 10.1016/j.vaccine.2018.08.008. Epub 2018 Aug 16.

Narcolepsy and adjuvanted pandemic influenza A (H1N1) 2009 vaccines - Multi-country assessment.

Author information

1
Medical Informatics Department, Erasmus Medical Center, Rotterdam, The Netherlands. Electronic address: weibeldaniel@gmail.com.
2
Julius Global Health, University Utrecht Medical Center, Utrecht, The Netherlands.
3
Cincinnati Children's Hospital, Cincinnati, OH, USA.
4
Medical Informatics Department, Erasmus Medical Center, Rotterdam, The Netherlands.
5
Infectiology and Vaccinology University Children's Hospital, Basel, Switzerland; Brighton Collaboration Foundation, Basel, Switzerland.
6
Dept. Epidemiology and Surveillance, National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands.
7
Leiden University Medical Centre, Leiden, The Netherlands; Sleep-Wake Center SEIN, Heemstede, The Netherlands.
8
Sleep Medicine Centre Kempenhaeghe, Heeze, The Netherlands.
9
Hospital de Niños Ricardo Gutiérrez, Ciudad Autónoma de Buenos Aires, Argentina.
10
Institute for Clinical Evaluative Sciences (ICES), Ontario, Canada.
11
Division of Neurology, Department of Medicine, Sunnybrook Health Sciences Centre, University of Toronto, Canada.
12
University Hospital Basel, Basel, Switzerland.
13
Bern University Hospital and University of Bern, Bern, Switzerland; Witten/Herdecke University, Department of Rehabilitation, Witten/Herdecke, Germany.
14
Taiwan Centers for Disease Control, Taipei, Taiwan.
15
Department of Child Psychiatry and Sleep Center, Chang Gung Memorial Hospital and University, Taoyuan, Taiwan.
16
Department of Neurology and Sleep Disorders Center, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
17
Department of Psychiatry and Center of Sleep Disorders, National Taiwan University Hospital, Taipei, Taiwan.
18
Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), Barcelona, Spain.
19
Neurology Service and Multidisciplinary Sleep Disorders Unit, Hospital Clinic of Barcelona, Barcelona, Spain.
20
Althaia Xarxa Assistencial Universitària de Manresa, Neurology Service, Manresa, Barcelona, Spain.
21
Medical Informatics Department, Erasmus Medical Center, Rotterdam, The Netherlands; Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat (FISABIO), Vaccine Research, Valencia, Spain.
22
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat (FISABIO), Vaccine Research, Valencia, Spain.
23
Servicio de Neurofisiologia, Hospital Universitari de la Ribera, Valencia, Spain.
24
Division of Preventive Medicine, University of Alberta, Alberta, Canada.
25
Vaccine and Drug Evaluation Centre, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Manitoba, Canada.
26
Faculty of Medicine, University of British Columbia, British Columbia, Canada.
27
Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.
28
Clinical Medicine/Epidemiology, Aarhus University, Aarhus, Denmark.
29
Centers for Disease Control and Prevention (CDC), Immunization Safety Office, Atlanta, USA.

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.

KEYWORDS:

AS03; Adjuvant; MF59; Narcolepsy; Pandemic H1N1 influenza

PMID:
30122647
DOI:
10.1016/j.vaccine.2018.08.008
[Indexed for MEDLINE]
Free full text

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center