# Presentation: 627349

## HHS Pandemic Influenza 

**Vaccine Program**
**for VRBPAC Meeting**
**February 27, 2007**

**By: Dr. Robin Robinson**
**Acting Assoc. Director **
**HHS/ASPR/OPHEMC              **

## Overview

**Strategic Plans & Goals**
**Program Portfolio Matrix**
**H5N1 Vaccine Stockpile Requirements**
**H5N1 Vaccine Production**
**Summary**

## National Strategy for Pandemic Influenza

**Notes:**
On November 1, 2005, the President requested $7.1 billion in emergency funding for the National Strategy for Pandemic Influenza, of which $6.7 billion was designated for HHS.  Congress appropriated $3.8 billion in December 2005 as the first installment of the President’s request to begin these priority activities, and of this amount, $3.3 billion was provided to HHS. The second appropriation in June 2006 provided HHS with $2.3 billion. 

## Implementation Plan for the National Strategy

- Contains over 300 actions for Federal Departments and Agencies
- Provides guidance on implementation of the *Strategy*, the development of Department-specific plans, and outlines specific roles and responsibilities of Departments and Agencies in pandemic preparedness and response.
- Communicates expectations of non-Federal entities (State and local governments, the private sector, critical infrastructure entities, and individuals).
**USE LICENSED VACCINES & ANTIVIRALS WHERE POSSIBLE**

**Implementation Plan for the National Strategy**

## Strategic Goals 

- Vaccine
**Goal #1: Establish & maintain dynamic pre-pandemic influenza vaccine stockpiles available for 20 M persons in critical workforce **
**Goal #2: Provide pandemic vaccine to all U.S. citizens within 6 months of a pandemic declaration: pandemic vaccine (600 M doses)**
- Antivirals
**Goal #1**: Provide influenza antiviral drug stockpiles for pandemic treatment of 25% of U.S. population (75 M treatment courses)
**Goal #2**: Provide influenza antiviral drug stockpiles for strategic limited containment at onset of pandemic (6 M treatment courses)
- Diagnostics
**Goal #1**: Develop new high-throughput laboratory & point-of-care (POC)  influenza diagnostics for pandemic virus detection
*National Strategy for Pandemic Influenza* (Nov 2005) and *HHS Pandemic Influenza Plan* (Nov 2005)
_**www.pandemicflu.gov**_

## Program Portfolio Matrix

|  | Vaccines | Antivirals | Diagnostics |
| --- | --- | --- | --- |
| Advanced Development |  Cell-based   
 Antigen-sparing
 Next Generation
 Egg-based Supply | Peramivir | Rapid
Diagnostics
Point-of-Care |
| Acquisitions | H5N1 Vaccine Stockpiles | Tamiflu & Relenza
Federal Stockpiles State Stockpiles |  |
| Infrastructure Building |  Retrofit Existing  Mfg Facilities   
 Build New Cell-based Mfg Facilities  |  |  |

## H5N1 Vaccine Stockpile Requirements

- Establish and maintain pre-pandemic influenza vaccine stockpiles
- For 20 million persons in the critical workforce including first responders
- For usage at the onset of a H5N1 influenza virus pandemic prior to release of a well-matched pandemic vaccine
- Without disrupting seasonal influenza vaccine manufacturing campaigns
- Usage of apathogenic reassortants of high risk virus strains as virus reference seeds
- At U.S.-licensed influenza vaccine manufacturers using commercial scale manufacturing process for licensed inactivated split monovalent influenza vaccines – “strain change” for antigen-alone vaccine
- Vaccine stored & stability tested on-site at manufacturers
- Option to formulate final container vaccine as antigen alone or with adjuvant as directed by safety, immunogenicity, and cross-protection studies
- Liability relief – PREP Act issued Feb. 1, 2007
- Secure U.S.-licensed vaccine product prior to usage where possible

## H5N1 Vaccine Production

## U.S. Pandemic Influenza Vaccine Summary

- Today represents the cooperative leveraging of resources throughout HHS (NIH, CDC, FDA & ASPR) with industry to develop, manufacture, and test a H5N1 vaccine candidate most similar to U.S.-licensed seasonal influenza vaccines
- Today is a discussion of the first H5N1 vaccine candidate that could be licensed for immediate usage if a H5N1 virus pandemic emerges this year