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

Aims/hypothesis 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 stud...

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Published in:Diabetologia Vol. 61; no. 1; pp. 193 - 202
Main Authors: Elding Larsson, Helena, Lynch, Kristian F., Lönnrot, Maria, Haller, Michael J., Lernmark, Åke, Hagopian, William A., She, Jin-Xiong, Simell, Olli, Toppari, Jorma, Ziegler, Anette-G., Akolkar, Beena, Krischer, Jeffrey P., Rewers, Marian J., Hyöty, Heikki
Format: Journal Article
Language:English
Published: Berlin/Heidelberg Springer Berlin Heidelberg 01.01.2018
Springer Nature B.V
Subjects:
Autoantibodies
Autoantibodies - immunology
Autoantibodies - metabolism
Autoimmunity
Autoimmunity - physiology
Children
Clinical Medicine
Diabetes
Diabetes mellitus
Diabetes Mellitus, Type 1 - metabolism
Endocrinology and Diabetes
Endokrinologi och diabetes
Female
Finland
Histocompatibility antigen HLA
Human Physiology
Humans
Immunization
Influenza A Virus, H1N1 Subtype - drug effects
Influenza Vaccines - adverse effects
Insulin
Insulinoma
Internal Medicine
Klinisk medicin
Male
Medical and Health Sciences
Medicin och hälsovetenskap
Medicine
Medicine & Public Health
Metabolic Diseases
Narcolepsy
Neuroendocrine tumors
Pandemics
Sleep disorders
Squalene
Squalene - chemistry
Vaccination
Vaccines
Sweden
Finland
Swine flu
Type 1 diabetes
Vaccination
Islet autoimmunity
Squalene
Pandemrix
Influenza vaccine
ISSN:0012-186X, 1432-0428, 1432-0428
Online Access:Get full text
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Summary:Aims/hypothesis 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. Methods 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. Results 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. Conclusions/interpretation 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.
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ISSN:0012-186X
1432-0428
1432-0428
DOI:10.1007/s00125-017-4448-3