hhs pandemic influenza vaccine program vrbpac meeting robin robinson, ph.d. director, barda deputy...
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![Page 1: HHS Pandemic Influenza Vaccine Program VRBPAC Meeting Robin Robinson, Ph.D. Director, BARDA Deputy Assistant Secretary, ASPR November 14, 2012](https://reader030.vdocument.in/reader030/viewer/2022032702/56649cb15503460f94976e01/html5/thumbnails/1.jpg)
HHS Pandemic Influenza Vaccine Program
VRBPAC Meeting
Robin Robinson, Ph.D.
Director, BARDA
Deputy Assistant Secretary, ASPR
November 14, 2012
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U.S. Pandemic Influenza Plans Laid the Pathway for Pandemic Vaccines
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Vaccine Strategic Goals Were Specific on Expectations
• 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)
www.pandemicflu.gov
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Seasonal Influenza
Preparedness
Pandemic InfluenzaPreparedness
Preparedness
for other
hazards
Vaccine Development, Planning, & Infrastructure Must Address Both Seasonal and Pandemic Influenza
Unifying Principle
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Pandemic Influenza Vaccine Implementation Goals
• Fortify existing influenza vaccine capabilities• Support development of better influenza vaccines that
afford greater surge manufacturing capacity ─ 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
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National Pandemic Influenza Vaccine Development Strategy Is Multi-Step & Integrated Approach
Cell-based Vaccines
Egg-based Vaccines
Recombinant-based Vaccines
Universal Vaccines
Antigen-Sparing Vaccine Technology
“More and better vaccines sooner”
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2009 Pandemic Influenza Scenario Relied on Existing Capabilities
Antigen-Alone Egg-based Vaccines
Pan
Flu
Ill
nes
ses
22-24
weeks
Unabated Pandemic Wave
Idealized Pandemic Wave
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New Vaccines & Domestic Facilities Will Help Close the U.S.
Pan Flu Vaccine Gap this Decade
Egg- & Cell-based Vaccines with Adjuvants
Recombinant Vaccines with Adjuvants
Pre-pandemic Vaccines
16-20 week
s
12 -16
weeksP
an F
lu I
lln
esse
s
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Universal Flu Vaccines Will Transform Seasonal & Pandemic Influenza Preparedness
Egg- & Cell-based Vaccines with Adjuvants
Recombinant Vaccines with Adjuvants
Universal Vaccines
16-20 week
s
12 -16
weeks
“Priming Dose”
“BoosterDose”
Pan
Flu
Ill
nes
ses
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HHS Has Supported Development of Multiple Antigen-sparing Flu Vaccine Adjuvant
Technologies
• Supported multiple projects in 2007-09 (H5N1) & in 2009 (H1N1) for advanced development of pandemic influenza vaccines with adjuvants towards US-licensure
• Vaccine candidates are at various stages of development with Q-Pan representing one mature vaccine candidate
• Multiple study results (academia, USG, & vax mfg.) have shown that different oil-in-water emulsion adjuvants confer additional properties onto flu vaccines─ antigen- & dose-sparing effects─ cross-strain protection─ prolonged prime-boost immunity
• Mix-N-Match studies showed that H1 and H5 vaccine antigens from one manufacturer combined with adjuvants from other manufacturers are immunogenic
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HHS Has Established H5N1 Vaccine Stockpile Available for Deployment
• HHS/BARDA established & manages H5N1 vaccine antigen (4 strains) and adjuvant (2) stockpiles stored and routinely tested at domestic vaccine manufacturing sites
• U.S. pan flu preparedness stockpiling goal met in 2008• Stockpile needs evaluated annually using CDC’S
Influenza Risk Assessment Tool (e.g., H3N2v – 2012)• Potency of bulk vaccine antigen lots remains >75% after
5-8 years & bulk adjuvant lots near 100% after 4-5 years• Pre-EUA packages submitted by BARDA in 2012 to FDA
for stockpiled vaccines with adjuvants• Vaccine distribution through central distribution system
managed by CDC
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Licensure of H5N1 Vaccine with Adjuvant Caps Development & Initiates Further Partnering
• Milestone achievement for U.S. pandemic preparedness realized with licensure of H5N1 vaccine with adjuvant
• USG (CDC, FDA, BARDA, DoD, & others) and flu vaccine manufacturers will continue partnering on post-licensure activities for seasonal and H5N1 flu vaccines.
─ seasonal flu vaccine safety & performance tracking─ planning future U.S. tracking systems for influenza vaccine
safety and effectiveness ─ executing these tracking systems during inter-pandemic
periods and influenza pandemics