# Presentation: 506896

- HHS Influenza
- Vaccine Projects
- for NVAC Meeting
- June 7-8, 2005

**By: Dr. Robin Robinson (HHS/OPHEP)              **
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## Overview

- HHS Influenza Vaccine Program
- H5N1 Vaccine: Commercial Scale Production Contract
- Egg-based Influenza Vaccine Contract: Secure, Year-round Egg & Other Supplies
- Egg-based Influenza Vaccine Contract: H7N7 Vaccine
- Cell-based Influenza Vaccine Contract: PER.C6 Cell Line
- RFP 05-04 Cell- & Recombinant-based Influenza Vaccines
- RFP 05-07 Improved Influenza Vaccine Manufacturing
- RFP 05-08 Optimization of Influenza Vaccine Antigen

## HHS Influenza Vaccine Program

- Program Goals
- Secure vaccine supply
- Expand and stretch vaccine supply base
- Diversify vaccine supply base and type
- Provide vaccine stockpiles for pandemic preparedness
- Establish necessary vaccine supply and surge capacity for pandemic response and seasonal vaccine shortages
- Coordinators
- National Vaccine Program Office
- Office of Public Health Emergency Preparedness
- Stakeholders:
- NIAID/NIH
- NCID/CDC
- CBER/FDA

## H5N1 Vaccine: Commercial Scale Production Contract

- Contract awarded Sept. 2004 to Sanofi Pasteur for egg-based commercial scale production of inactivated monovalent H5N1 vaccine (2M doses @ 15 ug HA/dose)
- Manufacturing used virus reassortant rg avian influenza A/H5N1/Vietnam/2004/1203 x PR8 (St. Jude)
- Manufacturing and testing of H5N1 bulk vaccine concentrates completed successfully in Nov. 2004
- Formulation and fill finish of H5N1 antigen alone and alum adjuvant vaccines await results of NIAID/NIH Phase I (Stage I) clinical results and indemnification issuance in 2005-06
- Plans for more production

## Egg-based Influenza Vaccine Contract: Secure, Year-round Egg & Other Supplies 

- 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

## Egg-based Influenza Vaccine Contract: H7N7 Vaccine 

- Contract awarded Sept. 2004 to Sanofi Pasteur to manufacture at least one pandemic-like influenza vaccine candidate per year for five years
- Manufacturing of pilot investigational lots of an H7N7 vaccine (3000 doses) scheduled at Sanofi Pasteur in 2005
- H7N7 virus reference seed derived by classical reassortant techniques by NCID/CDC (Nancy Cox)
- NIAID/NIH will conduct safety and immunogenicity clinical studies with H7N7 vaccine in 2006

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

- Contract awarded Apr. 2005 to Sanofi Pasteur to facilitate development of a cell-based influenza vaccine towards licensure and manufacturing in the U.S. over five years with a surge capacity of 300 M monovalent doses of pandemic vaccine
- Manufacturing of pilot investigational lots in France and clinical evaluation in U.S.
- SP employing PER.C6 human cell line for influenza vaccine manufacturing
- U.S. – based manufacturing site

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

- 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 due June 21, 2005
- Contract awarding expected in 4Q05

## RFP 05-07 Improved Influenza Vaccine Manufacturing

- Solicitation for contract proposals to improve manufacturing yield and efficiency of U.S. license or near licensure influenza vaccines to expand influenza vaccine supply
- Scope includes:
- Raw materials
- Upstream processing
- Downstream processing
- Formulation
- Synopsis issued March 17, 2005
- RFP issuance expected June 2005
- Contract awarding expected in 4Q05

## 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 June 2005
- Contract awarding expected in 4Q05