792. The Risk of Narcolepsy following receipt of adjuvanted pandemic 2009 H1N1 vaccines – Results of the SOMNIA Global Collaborative Study
Session: Poster Abstract Session: Vaccines: Safety and Adverse Events
Thursday, October 27, 2016
Room: Poster Hall
Posters
  • 09.19.16_IDSA SOMNIA Poster final Sept 19 .pdf (765.1 kB)
  • Background: An increased risk of narcolepsy following AS03-adjuvanted 2009 pandemic H1N1 influenza vaccine was observed in children in some countries in Europe, but the impact of media attention bias could not be excluded. The SOMNIA study was an international investigation of the association between AS03- and MF-59-adjuvanted monovalent pandemic H1N1 vaccines and narcolepsy.

    Methods: Objectives: To assess trends in narcolepsy incidence rates (IRs) before, during, and after the pandemic influenza (A)H1N1 vaccination campaigns and to perform a case-control study to estimate the relative risk of narcolepsy in children and adults for both MF-59 and AS03 adjuvanted pandemic (H1N1) 2009 vaccines. A dynamic retrospective cohort study was conducted to estimate incidence rates of narcolepsy diagnoses using a common protocol on electronic data in 7 countries during 2003-2013. For the case control study, conducted according to a common protocol in 6 countries, cases were identified from sleep center records. The referral date for the sleep latency test was the index date. Controls were matched for country, age, sex, and index date. Conditional logistic regression was used to estimate the odds ratio of narcolepsy with AS03 and MF59 containing H1N1 vaccines.

    Results: No changes in incidence rates of narcolepsy diagnoses were observed between the period after the start of AS03- or MF-59-containing H1N1 vaccination programs and the period before H1N1 circulation, in any of the age groups or countries except for Sweden, where a steep increase was observed in children 5-19 years in 2010.

    In the primary case control analysis, no association was observed for AS03-containing vaccines in children or adults. Based on three exposed cases, an association with MF-59 vaccine was observed in Argentina in the primary analysis in children, but no association was found when cases from Europe were included.

    Conclusion:

    Overall, our results do not support an association between receipt of AS03-adjuvanted 2009 H1N1 vaccine and narcolepsy although our results are based almost exclusively on Arepanrix® use in Ontario. Power to assess risk following MF-59 vaccine was limited.

    The study is funded by the Centers for Disease Control and Prevention (CDC), Atlanta, USA, under CDC contract number 200-2012-53425_addendum 0001.

    Steven Black, MD1, Miriam Sturkenboom, Ph.D.2, Jan Bonhoeffer, MD3, Frank Destefano, MD, MPH4, Tom Shimabukuro, MD, MPH, MBA5, Caitlin Dodd, M.S.6, Maria De Ridder, MS7, Daniel Weibel, Ph.D.8, Angela Gentile, MD9, Norberto Giglio, MD10, Salah Mahmud, Ph.D.11, Larry Svenson, Ph.D.12, Bruce Carleton, Ph.D.13, Monika Naus, MD, FRCPC14, Jeffrey C. Kwong, MD15, Brian Murray, MD, FRCPC16, Lisen Arnheim Dahlstrom, Ph.D.17, Lars Pedersen, MD, FRCPC18, Wan-Ting Huang, MD19, Maria Goner-Soriano, MS20, Silvia Perez-Vilar, MS8, Gert Jan Lammers, M.D.8, Sebastian Overeem, MD8, Alexandre Datta, M.D.21, Ulf Kallweit, MD21 and SOMNIA Collaborative Study Group, (1)Center for Global Health, Cincinnati Children's Hospital, Cincinnati, OH, (2)Professor, Erasmus University, Rotterdam, Netherlands, (3)University Children's Hospital, Basel, Switzerland, (4)Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, (5)Immunization Safety Office, CDC, Atlanta, GA, (6)Division of Infectious Diseases, Global Health Center, Erasmus University, Rotterdam, Netherlands, (7)Erasmus University, rotterdam, Netherlands, (8)Erasmus University, Rotterdam, Netherlands, (9)Ricardo Gutierrez Childrens Hospital, Buenos Aires, Argentina, (10)Epidemiology, Hospital de Niños Ricardo Gutierrez, Buenos Aires, Argentina, (11)University of Manitoba, Winnepeg, MB, Canada, (12)Alberta Ministry of Health, Edmonton, AB, Canada, (13)University of British Columbia, Vancouver, BC, Canada, (14)Epidemiology Services, British Columbia Centre for Disease Control, Vancouver, BC, Canada, (15)Institute for Clinical Evaluative Sciences, Toronto, ON, Canada, (16)Sunny brook Health Sciences Center, Toronto, ON, Canada, (17)Karolinska Institute, Solna, Sweden, (18)Aarhus University, Aarhus, Denmark, (19)Epidemic Intelligence Center, Taiwan Centers for Disease Control, Taipei City, Taiwan, (20)Institut Jordi Gol, Barcelona, Spain, (21)University of Bern Hospital, Bern, Switzerland

    Disclosures:

    S. Black, GSK Vaccines: Scientific Advisor , Consulting fee

    M. Sturkenboom, None

    J. Bonhoeffer, None

    F. Destefano, None

    T. Shimabukuro, None

    C. Dodd, None

    M. De Ridder, None

    D. Weibel, None

    A. Gentile, None

    N. Giglio, None

    S. Mahmud, None

    L. Svenson, None

    B. Carleton, None

    M. Naus, None

    J. C. Kwong, None

    B. Murray, None

    L. A. Dahlstrom, None

    L. Pedersen, None

    W. T. Huang, None

    M. Goner-Soriano, None

    S. Perez-Vilar, None

    G. J. Lammers, None

    S. Overeem, None

    A. Datta, None

    U. Kallweit, None

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