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Diabetologia. 2018 Jan;61(1):193-202. doi: 10.1007/s00125-017-4448-3. Epub 2017 Oct 9.

Pandemrix® vaccination is not associated with increased risk of islet autoimmunity or type 1 diabetes in the TEDDY study children.

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Department of Clinical Sciences Malmö, Lund University CRC, Skåne University Hospital SUS, Jan Waldenströms gata 35; 60:11, 20502, Malmö, Sweden.
Health Informatics Institute, Morsani College of Medicine, University of South Florida, Tampa, FL, USA.
Faculty of Medicine and Life Sciences, University of Tampere, Tampere, Finland.
Department of Dermatology, Tampere University Hospital, Tampere, Finland.
Department of Pediatrics, University of Florida, Gainesville, FL, USA.
Department of Clinical Sciences Malmö, Lund University CRC, Skåne University Hospital SUS, Jan Waldenströms gata 35; 60:11, 20502, Malmö, Sweden.
Pacific Northwest Diabetes Research Institute, Seattle, WA, USA.
Center for Biotechnology and Genomic Medicine, Medical College of Georgia, Augusta University, Augusta, GA, USA.
Department of Pediatrics, Turku University Hospital, Turku, Finland.
Department of Physiology, Institute of Biomedicine, University of Turku, Turku, Finland.
Institute of Diabetes Research, Helmholtz Zentrum München, and Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
Forschergruppe Diabetes e.V., Neuherberg, Germany.
National Institute of Diabetes & Digestive & Kidney Diseases, Bethesda, MD, USA.
Barbara Davis Center for Childhood Diabetes, University of Colorado, Aurora, CO, USA.
Fimlab Laboratories, Pirkanmaa Hospital District, Tampere, Finland.



During the A/H1N1 2009 (A/California/04/2009) pandemic, mass vaccination with a squalene-containing vaccine, Pandemrix®, was performed in Sweden and Finland. The vaccination was found to cause narcolepsy in children and young adults with the HLA-DQ 6.2 haplotype. The aim of this study was to investigate if exposure to Pandemrix® similarly increased the risk of islet autoimmunity or type 1 diabetes.


In The Environmental Determinants of Diabetes in the Young (TEDDY) study, children are followed prospectively for the development of islet autoimmunity and type 1 diabetes. In October 2009, when the mass vaccination began, 3401 children at risk for islet autoimmunity and type 1 diabetes were followed in Sweden and Finland. Vaccinations were recorded and autoantibodies against insulin, GAD65 and insulinoma-associated protein 2 were ascertained quarterly before the age of 4 years and semi-annually thereafter.


By 5 August 2010, 2413 of the 3401 (71%) children observed as at risk for an islet autoantibody or type 1 diabetes on 1 October 2009 had been vaccinated with Pandemrix®. By 31 July 2016, 232 children had at least one islet autoantibody before 10 years of age, 148 had multiple islet autoantibodies and 96 had developed type 1 diabetes. The risk of islet autoimmunity was not increased among vaccinated children. The HR (95% CI) for the appearance of at least one islet autoantibody was 0.75 (0.55, 1.03), at least two autoantibodies was 0.85 (0.57, 1.26) and type 1 diabetes was 0.67 (0.42, 1.07). In Finland, but not in Sweden, vaccinated children had a lower risk of islet autoimmunity (0.47 [0.29, 0.75]), multiple autoantibodies (0.50 [0.28, 0.90]) and type 1 diabetes (0.38 [0.20, 0.72]) compared with those who did not receive Pandemrix®. The analyses were adjusted for confounding factors.


Children with an increased genetic risk for type 1 diabetes who received the Pandemrix® vaccine during the A/H1N1 2009 pandemic had no increased risk of islet autoimmunity, multiple islet autoantibodies or type 1 diabetes. In Finland, the vaccine was associated with a reduced risk of islet autoimmunity and type 1 diabetes.


Influenza vaccine; Islet autoimmunity; Pandemrix; Squalene; Swine flu; Type 1 diabetes; Vaccination

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