Lesson Learnt on GPO Flu

Vaccine Development

28 March 2012

The 5th Meeting Partnerships IV Technology Transfer

Belgrade, Serbia

Sit Thirapakpoomanunt

The Government Pharmaceutical Organization(GPO)

Thailand and background

• Location: Mainland of

SEA(a member of ASEAN)

• Area: 513,115 sq. km.(50th

world largest size)

• Economy: 30th of the world

• Population:64 million(20th

global population)

• Birth rate: 1.25%

• GDP: USD 5,174/capita

(PPP 9,598 in 2011)

The

Government• 1st Strategic plan on AI/PI(2005-2007)

•2nd Strategic plan on AI/PI(2008-2010)

•3rd Strategic plan on Avian Influenza and Influenza Pandemic Preparedness (2012-2016)

National AI / PI preparedness planning

The Government

Pharmaceutical

Organization,under

MoPH

Thai Cabinet

WHO GMP Standard Plant for Influenza Vaccine Production Approved $42 Million Approved $42 Million Approved $42 Million Approved $42 Million

for Flu Plant Project for Flu Plant Project for Flu Plant Project for Flu Plant Project 22 May 200722 May 200722 May 200722 May 2007

WHO GMP Standard Plant for Influenza Vaccine Production

www.themegallery.com

(a) Pilot Plant : at Silapakorn UniversityPurpose : R&D and Clinical lot production of IIV and LAIVSupported by

1. WHO: 4 million USD2. GPO : 150,000 USD + management and labor

(b) Industrial-scale Plant (2009-2014)Purpose : Capacity for 2-10 million doses of Trivalent IIV/yr Capital investment - Thai Government - 42 million USD

Flu Vaccine Development Project for Industrial Capacity

6

Flu Vaccine Project: Objectives and targets

Objective - To build the Sustainable

Capacity on R&D and production of seasonal

IIV and LAIV to respond to pandemic

Targets

Adequate R&D and production capacity

Pilot plant and Industrial Scale plant

2-10 million doses of seasonal IIV and

LAIV.

Key Achievement on LAIV

7

May 2009

Jun 2009

Jul 2009

…Oct

2009…

Dec 2009

…Jul

2011Aug 2011

…Oct 2011

(1) 2nd WHO Grant (2.064 million

USD)

(2) Renovate BSL3 Complying

to WHO-cGMP standard

(4) Clinical Study Phase I on GPO H1N1 LAIV

(5) GPO H1N1 LAIV Licensed

with Thai FDA

(3) Successfully Developed

LAIV Production Process (pilot scale)

(6) Immunogenicity & Efficacy

of GPO H5N2 LAIV in ferrets

Challenge test

(7) EC approved CT Protocol

of GPO H5N2 LAIV

& WHO approved grant of 0.5 million

USD

Summary of key lessons learnt

� Be opportunistic to ensure public investment to increase supply

based on National Security not competitive business model, so

don’t assure lower price!!!!

� Ensure adequate demand based on BOD, CEA or cost comparison –

anything that works based on situation

� Be opportunistic to use the pandemic situation to mobilize

supports from international partners to speed up the learning

curve and to earn confidence from policy makers and public

� Capacity Building must be comprehensive based on INNE model

and include at least the manufacturers, NDRA, and Disease Control

agencies

� Public confidence and cooperation is crucial and the media

education and management will be important to encourage .

Challenges• We still do not have the best answer where to produce

our seasonal LAIV and use it for the pandemic capacity.

We know that it is very difficult to produce in the same

place as IIV, except may be during pandemic.

• We need more evidence to convince the users

(NVIC/NEDLC/NHSO) on which seasonal flu vaccine to be

used in which age group, which will affect the future

production capacity.

• There are still many technical challenges lying ahead,

including stability, optimization of production processes,

etc.

Thank you for your kind attention