CDC Smallpox Vaccine Production

1
CDC Smallpox Vaccine Production

• ACIP
• May 8, 2002

2
Smallpox Vaccine Products
Overview

• Wyeth Dryvax (11 15)
• Acambis Vaccinia Vaccine in MRC5 Cells (Acam1000)
  
• Acambis Vaccinia Vaccine in Vero Cells (Acam2000)
• Aventis Pasteur Vaccine

3
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 15 dilution Dryvax supplies
• Diluent for 15 Dryvax
• Protocols
• Storage Distribution
• VIG

5
ACAM2000 Development
Milestone Start Start Start End
Vero cell Master file 12 Mar 12 Mar 12 Mar 12 Mar
ACAM2000 Master file 15 May 15 May 15 May 15 May
IND 31 May 31 May 31 May 31 May
Remaining release tests 1 July 1 July 1 July 1 July
Phase I/II trial 15 July 31 Aug 31 Aug 31 Aug
End of Phase II mtg 10 Oct 10 Oct 10 Oct 10 Oct
Phase III trial 16 Nov 16 Nov 6 Apr 03 6 Apr 03
BLA Sept 03 Sept 03 Sept 03 Sept 03
6
Passage History
7
ACAM2000 Manufacturing Overview
8
Acam 1000/2000 Stockpile
9
Acam 1000 Human Clinical Trial
10
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