0. HHS Pandemic Influenza Vaccine Program VRBPAC Meeting
Robin Robinson, Ph.D.
Director, BARDA
Deputy Assistant Secretary, ASPR
February 29, 2012

1. Pre-2003 Pandemic Influenza Vaccine Goal & Strategy
4/15/2017
Pre-2003 Pandemic Influenza Vaccine Goal & Strategy
Egg-based Vaccines
This is a good point to make the case for addressing the gap in countermeasures and medical materiel. This gap can be addressed by increasing the supply of these essential goods (by either stockpiling these goods in advance and/or increasing manufacturing before pandemic or increasing surge production capability during the event) and by reshaping the demand for these essential goods by decreasing the need for these goods (by limiting disease transmission and limiting illness and hospitalization). The most prudent approach is to do both and increase supply while also decreasing demand.
Demand for Healthcare Services
weeks 1 1

2. U.S. Pandemic Influenza Plans

3. Vaccine Strategic Goals
4/15/2017
Goal #1: Establish & maintain dynamic pre-pandemic influenza vaccine stockpiles available for 20 M persons (2 doses/person): H5N1 stockpiles
Goal #2: Provide pandemic vaccine to all U.S. citizens within 6 months of a pandemic declaration: pandemic vaccine (600 M doses)
National Strategy for Pandemic Influenza (Nov 2005) and HHS Pandemic Influenza Plan (Nov 2005)

4. Pandemic Influenza Preparedness Preparedness Seasonal Influenza
4/15/2017
Seasonal Influenza
Preparedness
Pandemic Influenza
Preparedness
Preparedness
for other
hazards

5. Influenza Vaccine Implementation Goals - 2006
Fortify existing influenza vaccine capabilities
Support development of modern influenza vaccine technologies
Cell-based Vaccines
Recombinant and Molecular Vaccines
Adjuvants for Dose- and Antigen-sparing
Universal Influenza Vaccines
Establish pre-pandemic influenza vaccine stockpile
Expand domestic manufacturing capacity
Retrofit existing facilities
Establish new facilities

6. BARDA Pandemic Influenza MCM Integrated Portfolio Matrix
Diagnostics/ Respiratory Devices
Vaccines
Antivirals
Advanced Development
Diagnostics Point of Care Clinical Lab Next Generation Ventilators
Cell-based Antigen-sparing Recombinant & Molecular
Peramivir Laninamivir
Federal & State Stockpiles
IV Antivirals: EUA
Stockpiling & Acquisitions
H5N1 Pre-Pandemic Vaccine
H1N1 Vaccines
Masks & Respirators
Infrastructure Building
Retrofit Existing Mfg Facilities
Build New Mfg Facilities
Egg-based Supply

7. Cell-based Influenza Vaccines
Provide more robust, flexible, and scalable process, while being less vulnerable
manufacturing platform for flu vaccines
Awarded 6 contracts in for advanced
development of cell-based seasonal &
pandemic influenza vaccines towards US-licensure with commitment for domestic manufacturing surge capacity of 150 M doses in 6 mos. of pandemic onset
Novartis, Baxter, sanofi pasteur, GSK, Solvay, MedImmune
Two manufacturers completed pivotal Phase 3 clinical studies & expected to submit BLAs in
Two manufacturers in early stage development
Two manufacturers down selected in 2009

8. Antigen-sparing Adjuvant Technologies
Adjuvants, immunostimulatory molecules, provide dose-sparing effects, cross-strain protection, and prolonged prime-boost
immunity.
Awarded 4 contracts in (H5N1) & contracts in 2009 (H1N1) for advanced development of pandemic influenza vaccines with adjuvants towards US-licensure
Novartis, GSK, Intercell, sanofi pasteur
Two manufacturers completing pivotal Phase 3 clinical studies & expected to submit BLAs in 2012
Two manufacturers in early stage development

9. Mix-N-Match Vaccine – Adjuvant Studies
Combine vaccine antigen from one manufacturer with adjuvant from another manufacturer
Conduct a series of laboratory, animal, and clinical studies for H5N1 & H1N1 vaccines (2008  2011)
Physicochemical analyses
Murine immunogenicity studies
Rabbit toxicology studies
Ferret challenge studies
Phase I clinical study: dosage-ranging study for safety, immunogenicity, & cross-reactivity
Adjuvant
H5N1 A/Indonesia/05/2005
ASO3 GSK
sanofi pasteur
MF59 Novartis

10. 2004-2009 Pandemic Influenza Vaccine Goal & Strategy
4/15/2017
Pandemic Influenza Vaccine Goal & Strategy
Cell-based Vaccines + Adjuvants
H5N1
Pre-Pandemic Vaccines
Egg-based Vaccines
This is a good point to make the case for addressing the gap in countermeasures and medical materiel. This gap can be addressed by increasing the supply of these essential goods (by either stockpiling these goods in advance and/or increasing manufacturing before pandemic or increasing surge production capability during the event) and by reshaping the demand for these essential goods by decreasing the need for these goods (by limiting disease transmission and limiting illness and hospitalization). The most prudent approach is to do both and increase supply while also decreasing demand.
Demand for Healthcare Services
weeks 10 10

11. 2009 Pandemic Influenza MCM Supply-Demand Gap
4/15/2017
2009 Pandemic Influenza MCM Supply-Demand Gap
Reduce Demand: Pre-Pandemic Vaccines, Community Mitigation, Antivirals, Vaccines, Masks
Increase Capacity: Ventilators, Oxygen, Antivirals, Pandemic Vaccines, Masks,
Adjuvants Considered
H5N1
Pre-Pandemic Vaccines
Egg-based Vaccines
This is a good point to make the case for addressing the gap in countermeasures and medical materiel. This gap can be addressed by increasing the supply of these essential goods (by either stockpiling these goods in advance and/or increasing manufacturing before pandemic or increasing surge production capability during the event) and by reshaping the demand for these essential goods by decreasing the need for these goods (by limiting disease transmission and limiting illness and hospitalization). The most prudent approach is to do both and increase supply while also decreasing demand.
Demand for Healthcare Services
weeks 11 11

12. H1N1 Pandemic Reports 2010

13. New Influenza Vaccine Implementation Goals
Fortify existing influenza vaccine capabilities
Support development of modern influenza vaccine technologies
Greater focus on Recombinant and Molecular Vaccines
Maintain pre-pandemic influenza vaccine stockpile
Build domestic manufacturing capacity
Retrofit existing facilities
Establish new facilities
Centers for Innovation in Advanced Development & Manufacturing
Improve influenza vaccine manufacturing
High production yield seed strains
Potency assays
Sterility assays

14. Recombinant & Molecular Vaccine Technologies
Recombinant & molecular technologies may
provide vaccine sooner with less dependence
on influenza virus strain properties
Awarded contracts in 2009 & 2011 to for advanced development of recombinant- based seasonal & pandemic influenza vaccines towards US-licensure with commitment for domestic manufacturing surge capacity of 50 M doses in 6 mos. of pandemic onset & initial lot release in 12 wks
Protein Sciences, Novavax, & VaxInnate
One manufacturer completed Phase 3 clinical trials & BLA submitted
Two manufacturers in Phase 2 clinical studies

15. Pandemic Influenza Vaccine Gap Closure Goals - 2012
4/15/2017
Egg- & Cell-based Vaccines + Adjuvants
Pre-Pandemic Vaccines
Recombinant Vaccines + Adjuvants
This is a good point to make the case for addressing the gap in countermeasures and medical materiel. This gap can be addressed by increasing the supply of these essential goods (by either stockpiling these goods in advance and/or increasing manufacturing before pandemic or increasing surge production capability during the event) and by reshaping the demand for these essential goods by decreasing the need for these goods (by limiting disease transmission and limiting illness and hospitalization). The most prudent approach is to do both and increase supply while also decreasing demand.
Demand for Healthcare Services
weeks
16-20 weeks 15 15