1. 0 HHS Influenza Vaccine Projects for NVAC Meeting June 7-8, 2005 By: Dr. Robin Robinson (HHS/OPHEP)

2. 1 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

3. 2 HHS Influenza Vaccine Program Program Goals oSecure vaccine supply oExpand and stretch vaccine supply base oDiversify vaccine supply base and type oProvide vaccine stockpiles for pandemic preparedness oEstablish necessary vaccine supply and surge capacity for pandemic response and seasonal vaccine shortages Coordinators oNational Vaccine Program Office oOffice of Public Health Emergency Preparedness Stakeholders: oNIAID/NIH oNCID/CDC oCBER/FDA

4. 3 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

5. 4 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

6. 5 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

7. 6 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

8. 7 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

9. 8 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: oRaw materials oUpstream processing oDownstream processing oFormulation Synopsis issued March 17, 2005 RFP issuance expected June 2005 Contract awarding expected in 4Q05

10. 9 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: oAdjuvants oImmune cytokines oAlternative delivery devices oOther delivery methods Synopsis issued March 17, 2005 RFP issuance expected June 2005 Contract awarding expected in 4Q05