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HHS Pandemic Influenza Vaccine Program VRBPAC Meeting. Robin Robinson, Ph.D. Director, BARDA Deputy Assistant Secretary, ASPR November 14, 2012. U.S. Pandemic Influenza Plans Laid the Pathway for Pandemic Vaccines . Vaccine Strategic Goals Were Specific on Expectations .

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Hhs pandemic influenza vaccine program vrbpac meeting

HHS Pandemic Influenza Vaccine ProgramVRBPAC Meeting

Robin Robinson, Ph.D.

Director, BARDA

Deputy Assistant Secretary, ASPR

November 14, 2012

Vaccine strategic goals were specific on expectations
Vaccine Strategic Goals Were Specific on Expectations Vaccines

  • 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)


Vaccine Development, Planning, & Infrastructure Must Address Both

Seasonal and Pandemic Influenza


for other


Pandemic Influenza


Seasonal Influenza


Unifying Principle

Pandemic influenza vaccine implementation goals
Pandemic Influenza Vaccine Implementation Goals Both

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

National pandemic influenza vaccine development strategy is multi step integrated approach
National Pandemic Influenza Both Vaccine Development Strategy Is Multi-Step & Integrated Approach

Universal Vaccines

Antigen-Sparing Vaccine Technology

Recombinant-based Vaccines

Cell-based Vaccines

Egg-based Vaccines

“More and better vaccines sooner”


2009 pandemic influenza scenario relied on existing capabilities
2009 Pandemic Influenza Scenario Both Relied on Existing Capabilities

Antigen-Alone Egg-based Vaccines


Pandemic Wave

Pan Flu Illnesses


Pandemic Wave

22-24 weeks


New vaccines domestic facilities will help close the u s pan flu vaccine gap this decade
New Vaccines & Domestic Facilities Both Will Help Close the U.S. Pan Flu Vaccine Gap this Decade

Egg- & Cell-based Vaccines with Adjuvants

Pre-pandemic Vaccines

Recombinant Vaccines with Adjuvants

Pan Flu Illnesses

12 -16 weeks

16-20 weeks


Universal flu vaccines will transform seasonal pandemic influenza preparedness
Universal Flu Vaccines Will Transform Both Seasonal & Pandemic Influenza Preparedness



  • “Booster

  • Dose”

Egg- & Cell-based Vaccines with Adjuvants

Universal Vaccines

Recombinant Vaccines with Adjuvants

Pan Flu Illnesses

12 -16 weeks

16-20 weeks


Hhs has supported development of multiple antigen sparing flu vaccine adjuvant technologies
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

Hhs has established h5n1 vaccine stockpile available for deployment
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

Licensure of h5n1 vaccine with adjuvant caps development initiates further partnering
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