Instructions for Providing Input on Priorities for Vaccines and Diagnostics for
Transboundary Animal Diseases
Introduction
The primary objective of the Vaccines and Diagnostics for Transboundary Animal Diseases meeting is to
discuss “State of the Art” measures that the Department of Homeland Security (and it’s University
Centers of Excellence) and the USDA can take to better position themselves to serve U.S. and
international needs related to development of vaccine and diagnostic tools for significant transboundary
diseases. An overview of cutting-edge research on vaccines and diagnostics for high priority
transboundary animal diseases will be presented to help inform the decision making process. The intent
is to primarily focus on selected diseases of high priority interest to the National Veterinary Stockpile,
and on recently emerging diseases. A second objective is to present information to academic scientists
to help them focus on translational research which can result in novel vaccines and diagnostics for high
priority transboundary animal diseases. In addition, an important purpose of the meeting is to give
government officials from each agency working in this area an opportunity to convey their roles,
responsibilities, and needs to a broad audience.
Homeland Security Presidential Directive 9 (2004) directed the Secretary of Agriculture to establish the
National Veterinary Stockpile. The NVS is a national repository of critical veterinary supplies,
equipment, and services capable of deploying within 24 hours “sufficient amounts of animal vaccine,
antiviral, or therapeutic products to appropriately respond to the most damaging animal diseases
affecting human health and the economy.” The intent of this workshop is to identify knowledge gaps
and research priorities and produce a way forward for vaccine and diagnostic test development for
selected transboundary animal diseases.
We are asking the Scientific Advisory Board and meeting participants to provide input during the
meeting. This input will be summarized, reviewed by the Scientific Advisory Board, and sent to DHS
within 30 days after the meeting, and a more thorough analysis will be prepared within 90 days after the
meeting.
Vaccines and diagnostics for emergency use in an outbreak of a high priority transboundary animal
disease may require unique characteristics compared to vaccines and diagnostics for endemic animal
diseases and may be unique for each disease. We ask that the following potentially important
characteristics be considered when providing input on recommendations for research and development
priorities for vaccines and diagnostics for each of the diseases covered in this workshop. Safety and
efficacy of a vaccine or sensitivity and specificity for a diagnostic test are only a few of the important
characteristics needed for effective tools for emergency use in an outbreak of a transboundary animal
disease.
Please fill out one form for each disease noting that the forms for input on vaccines and diagnostics
are different. Return the forms via email to iicab@iastate.edu by Friday, September 21, 2012.
The following is a list of potentially important characteristics for vaccines. When providing input on
recommendations for research and development priorities for each of the diseases covered in this
conference, please consider which of these characteristics are most important for an emergency use
vaccine:
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Rapid onset of immunity
Long duration of immunity
Safe for manufacturing under BL2 conditions in a disease-free country
Broad protection for multiple strains or serotypes. Induction of heterosubtypic immunity
Induction of:
o Serum neutralizing antibody
o TH 1 cytokine response
o Cytotoxic T cells
o Mucosal IgA
o T cell mediated immunity at mucosal surface
Desirable characteristics for stockpiling for emergency use
o Ongoing manufacture and sale in endemic countries which enables indefinite
delivery/indefinite quantity (IDIQ) contracts for just in time delivery
o Stable when stored as bulk antigen
o Long shelf-life of finished vaccine
o Likelihood that it will protect against future strains/serotypes of pathogen
Companion diagnostic test to detect infection in vaccinated animal (DIVA)
Positive marker to detect vaccinated animals
Capability to meet 9 CFR regulatory requirements for purity, potency, safety, and efficacy
Capability to meet requirements for cost effective manufacturing and all proprietary rights to
vaccine antigen, vectors, and/or adjuvants
Safe for use in food producing animals with no, or reasonably short, withdrawal time for animal
products for human consumption
Not hazardous for humans accidentally exposed to the vaccine
Suitable for mass vaccination strategies (eg. oral delivery)
Safety and efficacy in multiple species affected by the pathogen
Vaccine capable of being delivered to wildlife (eg. in baits)
Knowledge of level of herd immunity needed to stop transmission in a population (Reproduction
ratio)
Thermostability to maintain efficacy in absence of a reliable cold chain
Compatible with World Organization for Animal Health (OIE) requirements for safety and
efficacy of vaccines for international trade
Other:
The following is a list of potentially important characteristics for diagnostics tests. When providing
input on recommendations for research and development priorities for each of the diseases covered
in this conference, please consider which of these characteristics are most important for an
emergency use diagnostic test:
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Rapid results (minutes to hours)
Animal side test – Field deployable
High throughput assay to detect agent or antibody
Safe under BL2 laboratory conditions
Bulk reagents, and/or finished kits, are stable and have a long self-life.
Diagnostic reagents or kits are routinely used in other countries which enables IDIQ contract for
just in time delivery
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Detection of all serotypes or strains of organism
Detection of specific serotype or strain
Detect infection in vaccinated animals (DIVA) (compatible with a negative marker vaccine)
Detect animals which have been vaccinated (compatible with a positive marker vaccine)
High sensitivity
High specificity
Validation for specific sample types:
o Serum
o Whole blood
o Oral fluids
o Nasal secretions
o Tissue samples
o Milk
o Semen
o Meat juice
o Feces
o Other
Validation for sensitivity/specificity in specific species (list species)
Capability to meet 9 CFR regulatory requirements for diagnostic test kits
Fit for the purpose of detection of infection
o Herd level
o Individual animal level
Fit for the purpose of proof of freedom from infection and pathogen circulation
o Herd level
o Individual animal level
o Region or country level
Compatible with World Organization for Animal Health (OIE) requirements for validated
diagnostic test for international trade
Other: