# Presentation: 339829

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

## 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

## 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

## ACAM2000

**USG Requirements**
**Strain**
- New York City Board of Health strain of vaccinia (derived from licensed Dryvax®  vaccine)
- Used successfully during eradication period
**Manufacturing and Immunogenicity**
- Grown in qualified cell substrate – Vero bioreactors
- Clonal isolate – well characterized
- Free of adventitious agents
- 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

## Utilization of Vaccine Under Different Outbreak Scenarios

| POPULATION | PRE-EVENT | OUTBREAK
OUTSIDE US | OUTBREAK IN US |  |
| --- | --- | --- | --- | --- |
|  |  |  | Low Risk Area | High Risk Area |
| Laboratorians | Recommended | Recommended | Recommended | Recommended |
| Health 
Care Workers | Available | Recommended | Recommended | Recommended |
| First
Responders | Available | Available | Available | Recommended |
| Contacts | N/A | N/A | N/A | Recommended |
| Community-wide 
Vaccination | No | No | Available | Recommended |

**Balances Risk/Benefit Ratio with Potential Public Demands**

## HHS—Public Health Response Planning at the Federal Level

**HHS/ASPR Participation in Preparedness Activities**
- Tabletop exercises and other activities
- Catastrophic Assessment Task Force (2006)
- Atlantic Storm (2005)
- NJ TTX (Fierce Squall) (2005)
- Global Mercury (2003)
- Dark Winter (2001)
**ASPR/OPEO – **Playbooks for national level federal public health response planning
**ASPR/BARDA** – Developing next-generation vaccines and therapeutics for smallpox

## 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

## 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

## 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
- Civilian—limited distribution and use
- DOD program – to be discussed
- Surveillance/reporting systems
- Post-Event
-  Recommendations for low vs. high risk populations
-  AE/SAE reporting