1. HHS Smallpox Vaccine Program & ACAM2000 Briefing for VRBPAC 17 May 2007 Dr. Gerald Parker Principal Deputy Assistant Secretary for Preparedness and Response

2. 1 Briefing Overview DHHS Smallpox Program Requirement for Smallpox Vaccine ACAM2000 Smallpox Vaccine Utilization Policy Public Health Response Planning at Federal, State, and Local Levels Training and Education programs Summary

3. 2 Requirement for Smallpox Vaccine Eradication of Smallpox –Vaccination and manufacturing programs halted ~25 years ago –Approximately one half of the US population has no immunity to smallpox Pre 9/11 – USG Discussion of Potential Biological Warfare Threat Using Smallpox –Evaluated public health response capabilities –Evaluated existing stockpile of vaccine (15 M doses) –Consensus reached for new licensed smallpox vaccine Post 9/11 – USG Requirement for Smallpox Vaccine Increased –Utilization policies and preparedness programs were put in place

4. 3 ACAM2000 USG Requirements –Strain v New York City Board of Health strain of vaccinia (derived from licensed Dryvax® vaccine) v Used successfully during eradication period –Manufacturing and Immunogenicity v Grown in qualified cell substrate – Vero bioreactors v Clonal isolate – well characterized v Free of adventitious agents v Elicitation of immune response analogous to current licensed Dryvax® vaccine Contractor –Acambis met all the public health, regulatory, and contractual requirements of the USG and was awarded its first contract (40M doses) in 2000, second contract (250M doses) in 2001 –Acambis has delivered 192 M doses to the Strategic National Stockpile

5. 4 Utilization of Vaccine Under Different Outbreak Scenarios POPULATIONPRE-EVENTOUTBREAK OUTSIDE US OUTBREAK IN US Low Risk AreaHigh Risk Area LaboratoriansRecommended Health Care Workers AvailableRecommended First Responders Available Recommended ContactsN/A Recommended Community-wide Vaccination No AvailableRecommended Balances Risk/Benefit Ratio with Potential Public Demands

6. 5 HHS—Public Health Response Planning at the Federal Level HHS/ASPR Participation in Preparedness Activities –Tabletop exercises and other activities v Catastrophic Assessment Task Force (2006) v Atlantic Storm (2005) v NJ TTX (Fierce Squall) (2005) v Global Mercury (2003) v Dark Winter (2001) ASPR/OPEO – Playbooks for national level federal public health response planning ASPR/BARDA – Developing next-generation vaccines and therapeutics for smallpox

7. 6 CDC—Public Health Response Planning at Federal, State, and Local Levels Working with HHS/ASPR to Coordinate Preparedness and Response Enhancing Collaboration with State and Local Governments Providing Grants for Preparedness Planning and Exercises Conducting Exercises with State and Local Partners to Ensure Readiness and Response for Multiple Threat Scenarios Including a Smallpox Event Managing the Strategic National Stockpile

8. 7 CDC—Training for Smallpox Vaccination Training of Health Care Workers, Clinicians, and Laboratorians  To recognize the disease and symptoms  To understand how the vaccine works and potential side effects  To effectively administer the vaccine using a bifurcated needle Training for Smallpox Response Teams (Federal and State) Training Products and Detailed Information Available in a Variety of Media Formats  CDC website  Video and CD  Telephone  Classroom setting

9. 8 Summary ACAM2000 –NYCBH-derived vaccine –Delivered to Strategic National Stockpile –Replenishment/Warm-base Response Planning and Utilization Policy –ASPR and CDC – Federal/State/Local plans –Pre-Event v Civilian—limited distribution and use v DOD program – to be discussed v Surveillance/reporting systems –Post-Event v Recommendations for low vs. high risk populations v AE/SAE reporting