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Downselect Status

Downselect Status. National Vaccine Advisory Committee June 3, 2003. Downselect Decision. Secretary signed Decision Memo March 11, 2003 ACAM1000 – contract terminated -- process development suspended -- clinical trials to be completed ACAM2000 -- contract renegotiated

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Downselect Status

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  1. Downselect Status National Vaccine Advisory Committee June 3, 2003

  2. Downselect Decision Secretary signed Decision Memo March 11, 2003 ACAM1000 – contract terminated -- process development suspended -- clinical trials to be completed ACAM2000 -- contract renegotiated -- additional 54 million doses -- annual warm base production

  3. ACAM 2000 UPDATE 90 M doses kitted and delivered to SNS Delivery of 155 M doses to SNS by Aug 03 Additional 54 M doses delivered in 1Q04

  4. ACAM 2000 UPDATE Clinical Trials Phase 2 dose-range study in final stages End of Phase 2 meeting --- early July Phase 3 study to begin – late Aug / early Sept BLA submission targeted for 2Q04

  5. SNS STOCKPILE SMALLPOX VACCINE Wyeth Dryvax: 9.8 M doses ( Licensed) Aventis-Pasteur Wetvax: 85 M doses (425 M at 1:5) (IND) ACAM2000: 90 M doses (IND)

  6. Downselect Joint Working Group CLINICAL REVIEW JULY 24, 2003

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