H1N1 COUNTERMEASURES STRATEGY AND ... - PHE Home

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
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