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Joint Vaccine Acquisition Program JVAP Overview

Agenda. What is JVAP?How does JVAP do business?Where is JVAP in accomplishing its mission?. JVAP Mission . Develop, Produce, and Stockpile FDA Licensed Vaccines and Antisera to Protect the Warfighter in a Biological Warfare Environment. . What is JVAP? A Chartered Product Management Office. FUNDING.

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Joint Vaccine Acquisition Program JVAP Overview

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    1. Joint Vaccine Acquisition Program (JVAP) Overview Presented to: Armed Forces Epidemiology Board (AFEB) Presented by: LTC Edward T. Clayson Acting Joint Product Manager edward.clayson@det.amedd.army.mil 301-619-7083 20 May 2003

    2. Agenda What is JVAP? How does JVAP do business? Where is JVAP in accomplishing its mission?

    3. JVAP Mission Develop, Produce, and Stockpile FDA Licensed Vaccines and Antisera to Protect the Warfighter in a Biological Warfare Environment Vision: Eliminate the threat of biological warfare by protecting the individual warfighter with safe and effective medical products Become the DoDs Merck operation Vision: Eliminate the threat of biological warfare by protecting the individual warfighter with safe and effective medical products Become the DoDs Merck operation

    4. What is JVAP? A Chartered Product Management Office

    5. What is JVAP? A Relatively New Program!

    6. JVAP Organizational Chart

    7. How does JVAP do business?

    8. The Vaccine System

    9. Dynport Vaccine Company (DVC) BD Vaccine Prime Contractor Company Contract uses commercial biotech to meet DoD requirements Award in 1997, started in 1998, duration 10 years Type: Vaccine development Cost Plus Award Fee Vaccine production Firm Fixed Price Able to pass indemnification to subcontractors with Government approval Contract Options - develop and produce vaccines/antisera against 18 BWA BD Vaccine Manufacturer responsible for obtaining and maintaining FDA licenses. Business representative to other agencies and organizations EVMS first use for medical product development. In place and extended to subcontractors Integrated Digital Environment capability to meet DoD and FDA regs for secure data storage and transfer (electronic submission) Special Studies allows contractor to evaluate and integrate emerging technologies into vaccine systems Storage and Maintenance protects older vaccines, seed stocks, and data while new products are being developed

    10. JVAP Management

    11. JVAP Planning Processes

    12. Where is JVAP in accomplishing its mission?

    13. Anthrax Licensed and Approved Biothrax Pre exposure only Ciprofloxacin, Doxycycline, Penicillin IND for Contingency Use Biothrax Post exposure Developmental CDC protocol for Biothrax reduced immunizations JVAP/DVC protocol for recombinant (r)PA vaccine NIAID new contracts with VaxiGen and Avicia for rPA vaccines Others DNA vaccines, conjugated vaccines, mono and polyclonal human antibodies

    14. Smallpox Licensed DryVax Pre exposure INDs for Contingency Use Vaccinia Immune Globulin (Cangene and DVC) Cidofovir DryVax Post exposure Aventis Pasteur vaccine 1:5 dilution Developmental JVAP/DVC contract for Cell-Culture Smallpox Vaccine DHHS contracts with Acambis for ACAM2000 and MVA and with Vaxigen for LC18M8 USAMRIID/NIAID oral Cidofovir

    15. Botulism Licensed Products None Contingency INDs Botulinum Pentavalent Toxoid vaccine Botulinum Immune Globulins (BIG): human and equine Products in Development Recombinant Botulinum (A/B) Vaccine. Phase I Clinical Trial FY04 BIG: equine, ovine, human, transgenic, MAB

    16. Plague FDA-licensed No vaccine Gentamicin, Doxycycline, Ciprofloxacin Contingency Protocols None Products in Development Recombinant F1 V vaccine. Phase I clinical trial FY04-05

    17. Equine Encephalitis Viruses (VEE, WEE, EEE) Licensed Products None INDs for At-Risk Personnel VEE Live and Inactivated EEE Inactivated WEE Inactivated Product in Development VEE infectious clone. Phase I Clinical Trial FY04

    18. Tularemia Licensed Products No vaccine Gentamicin, Ciprofloxacin, Doxycycline IND for At-Risk Personnel LVS vaccine (clinical hold) New Product LVS vaccine. Phase I Clinical Trial FY04

    19. Current Status of BD Vaccines

    20. Industry Benchmarks For EACH Vaccine Reaching FDA Licensure* Invention Licensure 8-12 Years Industry Invests > $500M DoD Invests < $100M

    21. BD Vaccine Development Schedule

    22. Questions?

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