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NBSB Pandemic Influenza Working Group Detailed Report overconfidence in theories based on meager evidence, conviction fueled by a personal agenda, zeal by health professionals to make their lay superiors do the right thing, failure to address uncertainties or allow for reconsideration, insufficient questioning of the scientific logic, and insensitivity to media relations, public perception, and long-term credibility of institutions. Current decision-making must consider at least two scenarios: 1) a rapid epidemic for which limited information is available from the Southern Hemisphere, for which there is no real information on variants, and against which it may be possible to use novel adjuvants under an EUA; and 2) a mild epidemic for which there is not enough vaccine to cover the entire population but against which vaccination of high-risk populations could be initiated. Dr. Korch identified all the parties that both contribute to and benefit from the decisionmaking process, noting that all are equal. He asked participants to consider whether a vaccine program is a foregone conclusion, given the following challenges: It will cost a lot. It will disrupt the medical and public health infrastructure. It will have significant political costs if it is seen as wasteful or untimely. It will have a long-term impact on vaccine programs if adverse events occur. In addition, there are uncertainties about the availability of vaccine and whether the vaccine will match the strain. Moreover, Dr. Korch asked whether the decision to use vaccine will be made in advance of the event. It is imperative that the decision-making process be transparent and vetted; relies on the best available evidence; allows for flexibility; ensures that rules are in place for starting and stopping a vaccination campaign; and makes certain that vaccination meets the needs of the end-user. The elements of a decision plan are as follows: Identify all the sequential output decisions. Identify critical data needs and inputs for those decisions. Identify stopping rules, if needed. Evaluate other factors that mitigate or exacerbate the vaccine plan. List key assumptions. Enunciate decisions that may be made “at-risk” and their cost/benefit impacts. Among the important variables are the need for patient tracking, a coordinated startup with State and local governments, and clear communication. If the decision is made to vaccinate, the overall objective should be defined: Reduce number of overall deaths to seasonal or below levels 44
NBSB Pandemic Influenza Working Group Detailed Report Reduce number of deaths in young age group to seasonal or below level Reduce proportion of severe cases to ameliorate surge in hospitalized cases Reduce transmission rate in general population Protect critical infrastructure Comprehensive control of infection in population The decision tree under consideration by ASPR identifies probabilities at each node as well as the expected values, risks, and effect on the overall strategy. CDC coordinates a lot of the data elements. The relationship of risks to benefits varies depending on the scenario, so biologic and epidemiologic data are critical. Dr. Korch identified a number of questions about the decision-making process that must be considered: Is it a reasonable approach to address the decision? Are there important decision points left out? Is there a different sequencing or priority of decision points? Are there assumptions or mitigating factors that must be additionally identified? What additional questions need to be posed? Are there other “decisions at risk” that must be posed? What is the minimal set of decision nodes that produce a reasoned and defensible outcome? What are the appropriate data requirements for each node? Are the data required achievable in the time scale needed? How much parsimony is tolerable for the data requirements? What is the preferred decision methodology for this level of complexity? He then posed a series of broader questions: What alternative decision schema would the NBSB propose? What is the best method to define risk vs. benefit for the decision-maker? What is the reality of having the data that we believe we need? What should be the acceptable (defensible) level of risk to proceed on a decision? If you were the President or the Secretary, what would you want to see, know, or have to make this decision? How sensitive will the decision process be to different scenarios? How engaged will the NBSB want to be during the process leading up to a decision, and thereafter? Dr. Korch noted that the decision tree he presented informs those at the highest levels, and some elements are the same as for the pandemic influenza strategy. He added that vaccine is not the only mitigation tool and BARDA has looked exhaustively at other tools that might mitigate or exacerbate the vaccine strategy. 45
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