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National Vaccine Advisory Committee's Decision on ACAM 2000: Updates and Progress

Updates on the ACAM 2000 smallpox vaccine, including contract negotiations, production status, clinical trials progress, and stockpile information from the Joint Working Group. Stay informed about the latest developments.

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National Vaccine Advisory Committee's Decision on ACAM 2000: Updates and Progress

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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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