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

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.