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About the Authors:
Judith C. Maro
* E-mail: [email protected]
Affiliation: Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, United States of America
Dennis G. Fryback
Affiliation: Department of Population Health Sciences, University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin, United States of America
Tracy A. Lieu
Affiliation: Division of Research, Kaiser Permanente Northern California, Oakland, California, United States of America
Grace M. Lee
Affiliation: Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, United States of America
David B. Martin
Affiliation: Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, United States of America
Introduction
Responding to influenza vaccine safety signals experienced during a pandemic is a scientific and public policy challenge. Not only must federal decision-makers balance the immediate consequences of pandemic disease against uncertain vaccine risks, they also must weigh how federal actions might affect future vaccine-seeking behavior. For instance, in 1976, after initiating a National Influenza Immunization Program in response to a localized swine flu outbreak, federal authorities suspended vaccination after ten weeks because preliminary surveillance suggested that the incidence of Guillain-Barre Syndrome was approximately seven-fold greater among vaccinees [1].
Given that this particular swine flu virus was never isolated outside of Fort Dix [2], the benefit-risk calculus appears simple in hindsight. However, the decision to initiate and then withdraw a mass vaccination campaign was regarded by some as a public health failure [3], resulting in sustained and unforeseen consequences on vaccine-seeking behavior, and loss of public confidence in decision-making. Firsthand accounts [4]–[8] and historical assessments [9], [10] have emphasized the difficulty of compressed decision-making under conditions of uncertainty. While improvements in near real-time vaccine safety surveillance now allow earlier detection of vaccine safety signals [11], [12], the need to act in the context of scientific uncertainty has not changed.
These circumstances are ripe for simulation and decision models. Recent pandemic threats and the pandemic potential of H5N1 and H7N9 viruses have stimulated multiple preparedness efforts [13]–[15] including scenario-based mathematical modeling [16], [17]. Prior models have focused on influenza transmission [18], [19], optimal vaccine allocation [20]–[26], social distancing [27]–[29], antivirals [30], and layered interventions [31]–[33]. However, none have considered regulatory responses to...