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

3

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

4

Seasonal Influenza

Preparedness

Pandemic InfluenzaPreparedness

Preparedness

for other

hazards

Vaccine Development, Planning, & Infrastructure Must Address Both Seasonal and Pandemic Influenza

Unifying Principle

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

6

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”

7

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

8

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

9

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

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/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

• 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