barda international influenza program – bridging the gap · barda mission • the mission of...

United States Department of

Health & Human ServicesOffice of the Assistant Secretary for Preparedness and Response

BARDA International Influenza Program –Bridging the GAP

Biomedical Advanced Research and Development Authority

(BARDA)

Rick Bright, PhD

Acting Deputy Director

ASPR/BARDA/ID

WHO Partners Meeting

March 28 2012

ASPR: Resilient People. Healthy Communities. A Nation Prepared. 2

Insufficient global vaccine

manufacturing capacity to respond to

an influenza pandemic

The Problem


WHO Global Action Plan (GAP)

• GAP for Pandemic Preparedness

recognized three strategies:

1. To promote seasonal vaccination

programmes as a driver of

increased market and production

capacity;

2. To expand manufacturing

capabilities in both industrialized

and developing countries; and

3. To promote influenza vaccine

research and development


BARDA Mission

• The mission of BARDA is to develop and procure medical

countermeasures that address the public health and medical

consequences of chemical, biological, radiological, and nuclear

(CBRN) accidents, incidents and attacks, pandemic influenza,

and emerging infectious diseases

BARDA fulfills its mission by:

• Supporting advanced research and development of needed

medical countermeasures;

• Working in collaboration with manufacturers, governmental

and non-governmental agencies;

• Supporting technology innovation through strategic initiatives


BARDA International Program

• BARDA is uniquely positioned to lead an effort to build

sustainable influenza vaccine production capacity worldwide,

with:

─ Technical expertise

─ Procurement (contractual) and financial assistance (grants &

cooperative agreements) expertise

─ Established relationships with multinational pharmaceutical

companies, international government and non-government

organizations

─ Utilize internal matrix teams of subject matter experts and core

services to accomplish program goals


BARDA Core Service Assistance

ASPR: Resilient People. Healthy Communities. A Nation Prepared.

BARDA International Program Objectives

• Protect Americans by reducing the global risk of

influenza

• Develop and sustain influenza vaccine manufacturing

capabilities and capacity for pandemic readiness:

promote international investment, diplomacy and

partnerships

• Achieve sustainable influenza vaccine production

capacity worldwide by leveraging BARDA’s unique

resources

7


BARDA International Program Timeline & Funding Activities

FY2005 2006 2007 2008 2009 2010 2011

$1M $10M $14.4M $15M $10.9M $9.4M TOTAL $60.7M

WHO

EgyptVACSERA

RomaniaCantacuzino

SerbiaTorklak

VietnamVABIOTECH

US & SEAPOC Test

VietnamPATH

RussiaIEM

WHO

USAdvanced Biomanu-facturingTraining Program

WHO

US & Switzerland

Adjuvant Development & Technical

Transfer

South AfricaBiovac

KazakhstanRIBSP

WHO

CDC-BARDA LAIV Trial

Setup

CDC-BARDA LAIV Ref.Facility

WHO GAP

VietnamIVAC

ThailandGPO

IndonesiaBio Farma

MexicoBIRMEX

IndiaSIIL

BrazilButantan

South KoreaGreen Cross

2012

International Workshops

Multi-productFeasibility

Study


BARDA International Program Funding Activities FY2005 - 2011

20102008 20092007 2011

PATH

USU

IDRI

EgyptVASERA

RomaniaCantacuzino

Institute

SerbiaTorlak

Institute

RussiaIEM

SwitzerlandUNIL

South AfricaBiovac

VABIOTECH

Vietnam

FY2005 2006

IndonesiaBio Farma

Bangladesh

India Serum

Institute

ThailandGPO

IVAC

MexicoBirmex

BrazilInstituto Butantan


BTEC

KazakhstanRIBSP


Licensed Influenza Vaccine Producers in 2006

Geographical Distribution of Influenza Vaccine Production in 2006


Licensed/Active Influenza Vaccine Producers

BARDA/WHO Cooperative Agreement Grantees


KazakhstanRIBSP

RomaniaCantacuzino

Institute

MexicoBirmex

BrazilInstituto Butantan South

AfricaBiovac

India Serum

Institute

VietnamIVAC

VABIOTECHPATH

ThailandGPO

IndonesiaBio Farma

EgyptVASERA


SerbiaTorlak

Institute


Licensed/Active Influenza Vaccine Producers

BARDA/WHO Cooperative Agreement Grantees


KazakhstanRIBSP

RomaniaCantacuzino

Institute

2012

MexicoBirmex

BrazilInstituto Butantan South

AfricaBiovac

India Serum

Institute

VietnamIVAC

VABIOTECHPATH

ThailandGPO

IndonesiaBio Farma

EgyptVASERA


SerbiaTorlak

Institute

BARDA/WHO Licensed Pandemic Vaccine for Human Use


Program Accomplishments

>1M doses (2005)

7 international partners

14 grantees in 13 countries

4 countries have licensed pandemic vaccine for human use (Brazil in April 2012)

146 scientists trained in advanced biomanufacturing skills

$60.7M ($30M to countries - $495M leveraged)

13 publications in 2011 and 4 publications projected in 2012

10 International Workshops/Partner Meetings

7 countries have initiated human clinical trials (2 companies in Vietnam in 2012)

2 countries have adjuvant production capability (clinical trials 2013)

500M+ doses pandemic vaccine projected from BARDA supported International Program (2015)


Benefits to the US and the World

• Reduced burden on the US to produce and distribute limited vaccine

─ More efficient to produce vaccine locally/regionally

• International/biological diplomacy

• Minimal investment has yielded significant ROI

─ Virus/Sample sharing benefits

─ Rapid notification of emerging threats

─ Enhanced surveillance and disease burden data

• Enhanced global capability to respond to an influenza pandemic

─ More equitable and geographical distribution of vaccine


Challenges

• Manufacturing capacity building cannot happen in a vacuum

─ Technical training

─ Regulatory development

─ Clinical capacity

─ Policy (pandemic and seasonal vaccine use)

─ Business models for sustainability

─ Data (disease burden, vaccine effectiveness)

• Local government support

• Close collaboration and communication with partners

• Need for flexibility in approach, models, pace, funding

• Need for broader international support

• Need for multiple and diverse funding sources

15


Goals for FY2012-13

• Support WHO GAP 1 & 2 objectives (WHO)

• Initiate clinical trials in Vietnam (PATH)

• Support biomanufacturing training (US-based)

• Initiate clinical trials of adjuvanted vaccines (BioFarma, Cantacuzino)

• Support for international workshops (WHO, OGA)

• Initiate clinical studies for LAIV produced by SIIL (US CDC)


IDRI & Cantacuzino Institute


First Adjuvant Production - Cantacuzino


BARDA/PATH Cooperative Agreement: Enhancing Influenza Vaccine Manufacturing Capacity in Vietnam


Adjuvant Technology Transfer Training: UNIL - BioFarma


In Summary…

Global Partnerships = Make More Vaccine, Faster and Better

BARDA International Program Strategies

Increase Influenza Vaccine Global

Manufacturing Capacity

International Partnerships

Rick Bright, PhDActing Deputy DirectorInfluenza DivisionUS DHHS/ASPR/BARDA

[email protected]

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