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CDC Smallpox Vaccine Production

CDC Smallpox Vaccine Production . ACIP May 8, 2002 . Smallpox Vaccine Products. Overview . Wyeth Dryvax (1:1 & 1:5) Acambis Vaccinia Vaccine in MRC5 Cells (Acam1000) Acambis Vaccinia Vaccine in Vero Cells (Acam2000) Aventis Pasteur Vaccine. ~54 million doses . Acam 1000.

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CDC Smallpox Vaccine Production

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  1. CDC Smallpox Vaccine Production ACIP May 8, 2002

  2. Smallpox Vaccine Products Overview • Wyeth Dryvax (1:1 & 1:5) • Acambis Vaccinia Vaccine in MRC5 Cells (Acam1000) • Acambis Vaccinia Vaccine in Vero Cells (Acam2000) • Aventis Pasteur Vaccine

  3. ~54 million doses Acam 1000 ~155 million doses Acam 2000 Dryvax AvP Vaccine 15 million doses – undiluted 75 million @ 1:5 dilution 70-90 million doses Smallpox Vaccine Supply and Production 2001 2002 2003 2004 2005 1983

  4. Smallpox Vaccine Related Supplies Overview Provides for: • Bifurcated Needles • 15 million for original Dryvax stock • 60 million for 1:5 dilution Dryvax supplies • Diluent for 1:5 Dryvax • Protocols • Storage & Distribution • VIG

  5. ACAM2000 Development

  6. Passage History

  7. ACAM2000 Manufacturing Overview

  8. Acam 1000/2000 Stockpile

  9. Acam 1000 Human Clinical Trial

  10. group group # of subjects # of subjects vaccination vaccination completion completion 1 20 5-Mar-02 19-Apr-02 2 16 13-Mar-02 27-Apr-02 3 24 26-Mar-02 10-May-02 Acam1000 Phase I Clinical Trial

  11. SMALLPOX VACCINE PRODUCTION Summary • Vaccine for “All Americans” by end of 2002 • All vaccines now under IND • Clinical trials through Phase 2 done by end of 2002; licensure late 2003 or 2004 • Production includes bifurcated needles, dil. • VIG contract under negotiations now • NPS storage site for rapid deployment

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