H1N1 COUNTERMEASURES STRATEGY AND ... - PHE Home

NBSB Pandemic Influenza Working Group
Detailed Report
RADM Vanderwagen noted that preparedness is a broad enterprise with a wide variety of
partners. For example, the National Institutes of Health (NIH) works on discovery
research; the Biomedical Advanced Research and Development Authority (BARDA)
translates that research into products to counter threats, e.g., a novel virus; the Food and
Drug Administration (FDA) ensures the products are safe and effective; and the Centers
for Disease Control and Prevention (CDC) conducts epidemiologic and scientific studies
and facilitates implementation through distribution of products. Successful
implementation, however, all comes down to State and local colleagues: Will they be
able to use the tools we develop? How can we support them? How can we encourage
them to take advantage of the tools available? Ultimately, their communities, families,
and friends receive the countermeasures we develop. Therefore, no single Federal
agency acts alone, nor does the Federal government act alone as one entity. Rather,
partnership reaches all the way down to the level of the individual patient.
RADM Vanderwagen displayed the decision tree his office is using to facilitate its
efforts. Among the issues to consider for H1N1 influenza, he said, is the availability of a
vaccine and how a vaccine would be used—both of which are affected by the severity,
spread, and timing of the disease, as well as special populations or target groups affected
by the disease. The potential use of adjuvants should also be considered. RADM
Vanderwagen reiterated the need for outside experts to provide input on the decisionmaking
process. Specifically, the meeting participants should explore what we know
about the science of countermeasures (vaccines, diagnostics, and therapeutics) and how
to use them. No timeline has yet been identified, but it is believed that we are
experiencing the first wave of H1N1 influenza now and anticipate a second wave in the
fall. If a vaccine is to be used, many of the questions about what to use, when, and for
who must be answered within the next 90 days.
RADM Vanderwagen said the effort represents a worthy challenge, in which public
health and preparedness experts must come together to create tools that will ensure
resilience, should there be a severe resurgence in the fall. He emphasized that the health
and well-being of society at large are the central concerns as the United States gears up to
address not only the threat of H1N1 virus, but also the fall hurricane season. He thanked
the participants for their time and input.
NOVEL H1N1 VACCINE STRATEGY
H1N1 Vaccine Strategy—Robin Robinson, Ph.D., BARDA
Dr. Robinson said a convergence of events led to the development of the National
Strategy for Pandemic Influenza: the H5N1 virus reemerged, and surprising results from
clinical studies showed that the H5 vaccine developed would not protect 90% of the
people. Hurricane Katrina exposed significant gaps in disaster response planning and
capacity. Having only one manufacturer to produce seasonal influenza vaccine (for the
2004–2005 season) demonstrated what a vaccine shortage would be like. With all of
these events happening in the early part of the decade, and 29 years after the 1976 swine
influenza epidemic, Congress passed PAHPA and established BARDA to develop
3