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1
HHS Influenza Vaccine Projects
for NVAC MeetingJune 7-8, 2005
By: Dr. Robin Robinson (HHS/OPHEP) 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
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HHS Influenza Vaccine Program
Program Goals o Secure vaccine supply
o Expand and stretch vaccine supply base
o Diversify vaccine supply base and type
o Provide vaccine stockpiles for pandemic preparedness
o Establish necessary vaccine supply and surge capacity for pandemic response and seasonal vaccine shortages
Coordinatorso National Vaccine Program Office
o Office of Public Health Emergency Preparedness
Stakeholders: o NIAID/NIH
o NCID/CDC
o CBER/FDA
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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
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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
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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
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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
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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
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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: o Raw materialso Upstream processingo Downstream processingo Formulation
Synopsis issued March 17, 2005
RFP issuance expected June 2005
Contract awarding expected in 4Q05
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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: o Adjuvantso Immune cytokineso Alternative delivery deviceso Other delivery methods
Synopsis issued March 17, 2005
RFP issuance expected June 2005
Contract awarding expected in 4Q05