# Presentation: 572098

- HHS Influenza
- Vaccine Projects
- for NVAC Meeting
- November 29-30, 2005

**By: Dr. Robin Robinson **
**Sr. Project Officer**
**ORDC/OPHEP/DHHS              **
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## Overview

- Key Summer/Fall Events
- H5N1 Vaccine: Pre-Pandemic Vaccine Stockpile
- H5N1 + Alum Adjuvant Vaccine Candidates
- Egg-based Influenza Vaccine Contract: Egg Supply & H7N7 Vaccine
- Cell-based Influenza Vaccine Contract: PER.C6 Cell Line
- RFP 05-04 Cell- & Recombinant-based Influenza Vaccines
- RFP 05-08 Optimization of Influenza Vaccine Antigen

## Key Summer/Fall Influenza Events

- Results of NIAID/NIH clinical studies with H5N1 vaccine (antigen alone)
- Origin of 1918 pandemic influenza virus
- Emergence of H5N1 virus clade 2 isolates in Eurasia
- Emergence of drug-resistant H5N1 virus mutants to oseltamivir
- U.S. Pandemic Plan & Budget release
- U.S. pandemic models presented
- 2006 Preview: Year of the Adjuvant

## H5N1 Vaccine: Pre-Pandemic Vaccine Stockpile 

- HHS Pandemic Plan goal: establish & maintain pre-pandemic vaccine stockpile for 20 M persons in critical workforce & high priority groups
- Contracts awarded for commercial scale production of egg-based inactivated monovalent split H5N1 bulk vaccine during seasonal vaccine manufacturing off-season to establish stockpile
- SP: 0.33 M doses @ 90 ug HA/dose Sept. 04; _**completed Nov. 04**_
- SP: ~ 5.5 M doses @ 90 ug HA/dose Sept. 05; _**completion Dec. 05**_
- Chiron: 2.0 M doses @ 90 ug HA/dose Oct. 05; _**completion Feb. 06**_
- Manufacturing virus reference strain: reverse genetics reassortant avian influenza A/H5N1/Vietnam/2004/1203 x PR8 (St. Jude)
- Indemnification issued to St. Jude and SP in summer 2005
- Formulation and fill finish of H5N1 + adjuvant vaccines await results of NIAID/NIH clinical studies in 2006

## H5N1 + Alum Adjuvant Vaccine Candidates 

- Binding studies of H5N1 vaccine antigen to aluminum hydroxide indicate tight and rapid binding
- Formulation of commercial scale H5N1 bulk vaccine with aluminum hydroxide completed in Nov. 05
- Fill finish mfg. of six formulations of H5N1 +/- alum vaccine completed in Nov. 05
- NIAID/NIH expected to commence clinical studies with H5N1 +/- alum vaccine in early 2006 for safety and immunogenicity

## Egg-based Influenza Vaccine Contract: Egg Supply & H7N7 Vaccine 

- Contract awarded Sept. 2004 to Sanofi Pasteur for establishment of secure, year-round embryonated hen’s eggs and other essential supplies for five years
- Transition from 9-month egg production cycle to year-round egg supply completed successfully Apr. 2005
- Other essential supplies stockpiled in 2005
- Establishment of contingency flocks in 2006
- Production of pilot investigational lots of H7N7 + alum adjuvant vaccine in progress for safety & immunogenicity evaluation in clinical trials by NIAID/NIH VTEUs in 2006

## Cell-based Influenza Vaccine Contract: PER.C6 Cell Line

- Contract awarded Apr. 2005 to sanofi pasteur over five years to facilitate advanced development of a PER.C6 human cell-based influenza vaccine U.S. towards U.S. licensure in U.S. mfg facilities with surge capacity of 300 M monovalent doses of pandemic vaccine (15 ug/dose)
- Manufacturing of pilot investigational lots near completion in France for safety & immunogenicity clinical evaluation in U.S.
- Phase I studies scheduled for 2006

## RFP 05-04 Cell- & Recombinant-based Influenza Vaccines

- Goal: Expansion and acceleration of influenza vaccine surge capacity & diversification of influenza vaccine
- Solicitation for contract proposals to facilitate development of cell- or recombinant-based seasonal and pandemic influenza vaccines towards U.S. licensure and manufacturing
- Surge capacity of 150 M doses of pandemic vaccine
- RFP issued April 29, 2005
- Proposals evaluated for technical merit
- Contracts under negotiation with Offerors
- Contract awards awaiting pending U.S. Congressional approval of Pandemic Appropriation Bill

## RFP 05-08 Optimization of Influenza Vaccine Antigen 

- Solicitation for contract proposals to facilitate development of adjuvant and biological products, medical devices, and/or methods that optimize influenza HA antigen in vaccines to stretch the influenza vaccine supply
- Scope includes:
- Adjuvants
- Immune cytokines
- Alternative delivery devices
- Other delivery methods
- Synopsis issued March 17, 2005
- RFP issuance expected December 2005
- Contract awarding expected in 2Q06