Nuclear/Biological/Chemical (NBC) Defense - Federation of ...
Nuclear/Biological/Chemical (NBC) Defense - Federation of ...
Nuclear/Biological/Chemical (NBC) Defense - Federation of ...
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<strong>NBC</strong> <strong>Defense</strong> Annual Report<br />
D-24<br />
• Reviewed historical records and identified technical and regulatory issues to form the<br />
basis for a scientifically sound, feasible plan for the advanced development <strong>of</strong> a Q-fever<br />
vaccine.<br />
• Met with a potential manufacturing subcontractor to discuss how their product meets<br />
our user’s requirement.<br />
• JVAP has received concurrence from our user about the suitability <strong>of</strong> this vaccine<br />
candidate.<br />
D.2.4.5 Advanced Development <strong>of</strong> the Smallpox Virus Vaccine (Vaccinia Virus)<br />
• Reviewed historical records and identified technical and regulatory issues to form the<br />
basis for a scientifically sound, feasible plan for the advanced development <strong>of</strong> a cell<br />
culture vaccinia vaccine for smallpox.<br />
• Prepared a clinical protocol to evaluate the candidate vaccines administered by<br />
scarification.<br />
• Guided protocol through all internal review boards and FDA review.<br />
• Initiated process definition studies to evaluate large-scale production methods.<br />
• Began discussions with the Department <strong>of</strong> Health and Human Services about the<br />
feasibility <strong>of</strong> scale-up production for the DoD vaccine to obtain for a civilian stockpile.<br />
• Clinical protocol has stalled due to regulatory concerns about Vaccinia Immune<br />
Globulin, which is required before immunizations can take place.<br />
• Baxter, current license holder for VIG, no longer plans to manufacture this product.<br />
JVAP market survey information from potential manufactures is being forwarded to<br />
DynPort to manage a new manufacturing and licensure effort for this product.<br />
D.2.4.6 International Cooperative Research and Development<br />
• The JVAP-Project Management Office conducted technical discussions with<br />
representatives <strong>of</strong> the United Kingdom and Canada about cooperative research and<br />
development agreements for <strong>Biological</strong> <strong>Defense</strong> vaccine products. A conceptual<br />
approach to tri-national cooperative research and development has been developed and is<br />
under review by the JPO-BD.<br />
• Proposed recombinant plague vaccine candidates from the U.S. and United Kingdom<br />
recently underwent a pre-IND review at the FDA. This collaborative approach between<br />
the two countries leverages tech-base and advanced development efforts to provide a<br />
safe and effective vaccine protecting against aerosol exposure to Yersinia pestis.
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