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“Exercise Only” Emerging Infection Scenario, Afternoon Session

“Exercise Only” Emerging Infection Scenario, Afternoon Session. FDA Workshop “Data and Data Needs to Advance Risk Assessment for Emerging Infectious Diseases for Blood and Blood Products” November 29, 2011, Gaithersburg MD. “Exercise Only” Viral Hemorrhagic Fever Outbreak.

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“Exercise Only” Emerging Infection Scenario, Afternoon Session

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  1. “Exercise Only” Emerging Infection Scenario, Afternoon Session FDA Workshop “Data and Data Needs to Advance Risk Assessment for Emerging Infectious Diseases for Blood and Blood Products” November 29, 2011, Gaithersburg MD

  2. “Exercise Only” Viral Hemorrhagic Fever Outbreak • The new Viral Hemorrhagic Fever is now called Mississippi Valley Fever. Previous efforts to contain the virus have failed • National State of Emergency has been declared by CDC, death toll passed 5,000 • Ban on unnecessary travel within the US, schools are closed in affected areas, essential services only in affected areas Emerging Infection Scenario, Afternoon Session

  3. “Exercise Only” Current Blood Safety Concerns • A blood test has been established and validated for MVF. The test is sensitive and specific but has not been submitted for FDA review/approval • Test performance, pre-symptom test window period and asymptomatic viremia are not yet established • New TTIs continue to be reported to CDC, nationwide. Emerging Infection Scenario, Afternoon Session

  4. “Exercise Only” Current and Pending Actions • Some donors may be deferred. Possibly those who: • have traveled or lived in the original affected area • close contacts of cases • disease symptoms Emerging Infection Scenario, Afternoon Session

  5. “Exercise Only” Questions to the Panel • What information is critical to managing this outbreak with respect to transfusion safety and blood supply? • What are the major barriers you see for conducting new donor prevalence surveys? • For example, is new ethical review board approval necessary for you to be able to add questionnaire items? • Which steps would take the most time? • Should a nation wide test be instituted under IND? • How can the FDA expedite solutions? Emerging Infection Scenario, Afternoon Session

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