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H1N1 Vaccines VRBPAC Meeting Robin Robinson, Ph.D. HHS/ASPR/BARDA Director July 23, 2009 PowerPoint Presentation
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H1N1 Vaccines VRBPAC Meeting Robin Robinson, Ph.D. HHS/ASPR/BARDA Director July 23, 2009. National Pandemic Influenza Plans. U.S. Strategic Pan Flu Vaccine Goals. Vaccines

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slide1
H1N1 Vaccines

VRBPAC Meeting

Robin Robinson, Ph.D.

HHS/ASPR/BARDA Director

July 23, 2009

u s strategic pan flu vaccine goals
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.gov

slide5

H5N1 Vaccine Stockpile Inventory: 2008

  • *Adjusted number for usage and potency loss
  • Most vaccine is stored in the US as bulk concentrates

* Adjusted for usage and potency

h1n1 vaccines
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
h1n1 vaccine products
H1N1 Vaccine Products

Scenario A

Standard vaccine – U.S.-licensed

Multi-dose vial

sanofi pastuer

MedImmune

CSL

GSK

Scenario B

Standard vaccine – U.S.-licensed

Vaccine + adjuvant - EUA

GSK 3.4%

GSK

Novartis

sanofi pastuer

Novartis

MedImmune

CSL

sanofi pastuer

CSL

Novartis

h1n1 vaccine distribution options
H1N1 Vaccine Distribution Options

Vaccine Manufacturers

Wholesale Distributors

States & Locals Sites

American Public

5

30-50 distrb. sites

40,000 - 90,000

300 million

sanofi pasteur

State Health Depts

Children

Novartis

PODs

Critical Workforce

GlaxoSmithKline

McKesson

and others

County Public Health Depts

Healthcare Workers

!

!

!

MedImmune

Other Public Sites

Elderly

CSL

Private Providers

General Public

BARDA

CDC

STATES

LOCALS

h1n1 pandemic influenza medical countermeasure supply demand gap closure
H1N1 Pandemic InfluenzaMedical 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?

WHEN? PATHOGENICITY? ANTIGENICITY?

Demand for Healthcare Services

Increase Supplies of Critical Materiel

? ? ?

Current Healthcare Capacity