0 H1N1 Vaccines VRBPAC Meeting Robin Robinson, Ph.D. HHS/ASPR/BARDA Director July 23, 2009
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- Slide 1
- 0 H1N1 Vaccines VRBPAC Meeting Robin Robinson, Ph.D.
HHS/ASPR/BARDA Director July 23, 2009
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- 1 National Pandemic Influenza Plans
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- 2 U.S. Strategic Pan Flu Vaccine Goals Vaccines Goal #1:
Establish and maintain a dynamic pre-pandemic influenza vaccine
stockpile available for 20 M persons (2 doses/person) 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)
http://www.pandemicflu.govhttp://www.pandemicflu.gov
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- 3 Integrated Pandemic Influenza Product Portfolio Approach
VaccinesAntiviralsDiagnostics/ Respiratory Devices Advanced
Development Cell-based Antigen-sparing Next Generation Recombinant
Peramivir AV MedKits Diagnostics Point of Care Clinical Lab Simple
Ventilators Next Generation Stockpile Acquisitions H5N1
Pre-Pandemic Vaccine Stockpiles Tamiflu & Relenza Federal
Stockpiles State Stockpiles Masks & Respirators Infrastructure
Building Retrofit Existing Mfg Facilities Build New Cell-based Mfg
Facilities Egg-based Supply Intl. Vaccine Cap.
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- 4 H5N1 Vaccine Stockpile Inventory: 2008 *Adjusted number for
usage and potency loss Most vaccine is stored in the US as bulk
concentrates H5N1 Vaccine StrainClade20042005200620072008Totals
A/VTN/1203/0410.232.860.79 1.165.04 A/Indo/05/052.1
6.252.250.0418.54 A/BHG/QL/1A/052.2 6.32 A/Anhui/1/052.3 2.56
Totals Ag-Alone Formulation (90 ug/dose) 0.2 M2.9 M7.0 M11.1
M1.222.5* M AdjuvantAS035.25.2 M Totals Oil-in- Water Adjuvant
Formulation (7.5 ug/dose) 2.7 M34.3 M84 M133.2 M14.4 M268 M *
Adjusted for usage and potency
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- 5 U.S. Pandemic Influenza Vaccine Capacity Forecast: The
Promise of Adjuvants
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- 6 H1N1 Vaccine Strategy
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- 7 H1N1 Vaccines National Strategy for Pandemic Influenza (Nov.
2005) goal is to provide vaccine to everyone in U.S. within 6
months of pandemic onset H1N1 Vaccine Strategy follows pandemic
playbook for vaccine development, production, and administration
with multiple decisions and on/off ramps Clinical studies will
inform vaccine formulation and safety profile Licensure of
antigen-alone formulations may be afforded as strain changes
Emergency Usage Authorization may afford vaccine administration
with adjuvant Scenario-sensitive vaccine production &
administration approach Disease severity affects selection of
vaccine type Virus antigenicity as compared to vaccine
immunogenicity (well-matched?) Key decision issues: Prioritization
of vaccine for special populations (e.g., children, etc. ) Vaccine
type Thimerosal preservative Oil-in-water adjuvant
Post-immunization adverse event safety monitoring
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- 8 H1N1 Vaccine Products Novartis Multi-dose vial Scenario A
Standard vaccine U.S.-licensed CSL sanofi pastuer MedImmune GSK GSK
3.4% Scenario B Standard vaccine U.S.-licensed Vaccine + adjuvant -
EUA MedImmune sanofi pastuer CSL Novartis GSK Novartis CSL sanofi
pastuer
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- 9 H1N1 Vaccine Production Options
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- 10 H1N1 Vaccine Production Options
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- 11 H1N1 Vaccine Procurements to Date
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- 12 H1N1 Vaccine Distribution Options LOCALS STATES CDC BARDA
General PublicPrivate ProvidersCSL ElderlyOther Public
SitesMedImmune Healthcare Workers County Public Health Depts
McKesson and othersGlaxoSmithKline Critical WorkforcePODsNovartis
ChildrenState Health Deptssanofi pasteur 300 million40,000 -
90,00030-50 distrb. sites5 American PublicStates & Locals Sites
Wholesale Distributors Vaccine Manufacturers! ! !
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- 13 H1N1 Pandemic Influenza Medical Countermeasure Supply-Demand
Gap Closure Reduce Demand: Pandemic Vaccines, Community Mitigation,
Antivirals, Masks Increase Capacity: Ventilators, Oxygen,
Antivirals, Pandemic Vaccines, Masks Egg- based Vaccines +
Adjuvants? Increase Supplies of Critical Materiel Demand for
Healthcare Services Current Healthcare Capacity ? ? ? ? ? ? WHEN?
PATHOGENICITY? ANTIGENICITY?