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Responding to Vaccine Safety Signals during Pandemic Influenza: A Modeling Study

    Basic Details
    Health Outcome(s)
    Guillain-Barré syndrome
    febrile seizure

    This article describes a multi-criteria decision analysis model developed to explore regulatory decision-making in the context of emerging vaccine safety signals during a pandemic. The authors simulated vaccine safety surveillance system capabilities and used an age-structured compartmental model to develop potential pandemic scenarios. The authors also used an expert-derived multi-attribute utility function to evaluate potential regulatory responses by combining four outcome measures into a single measure of interest: 1) expected vaccination benefit from averted influenza; 2) expected vaccination risk from vaccine-associated febrile seizures; 3) expected vaccination risk from vaccine-associated Guillain-Barre Syndrome; and 4) expected change in vaccine-seeking behavior in future influenza seasons.


    Judith C. Maro PhD, Dennis G. Fryback PhD, Tracy A. Lieu MD, MPH, Grace M. Lee MD, MPH, David B. Martin MD, MPH

    Corresponding Author

    J. C. Maro, Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, 401 Park Drive, Suite 401 East, Boston, MA. Email: