1. Influenza vaccine production capacity in the
South-East Asia Region(SEAR)
Dr. Pushpa Ranjan Wijesinghe
Medical Officer ( Emerging VPD Surveilance )
1
Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
1
Global Action Plan (GAP) for influenza vaccines
A comprehensive strategy to reduce the present global shortage of
seasonal and pandemic Influenza vaccines
Development of GAP 1 in 2006 in a wide consultation
Transition from GAP 1 to GAP 2
based on lessons from H1N1pdm 2009 and H5N1 epidemic
to ensure access, affordability and effective deployment
Three major objectives
Increase in seasonal vaccine use
Increase in vaccine production capacity
Research and development
2
Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
2
1

2. Objective 1 : Increase in seasonal vaccine use
A win-win relationship for public-private partnership
Demand generation for investment by manufacturers
Trigger for industry to develop a greater capacity for influenza vaccines
production
Opportunity to express social responsibility for greater well being of the
global community
Helps
Project the demand to meet with the adequate future supply of
seasonal influenza vaccines
Determine the potential demand of pandemic influenza vaccines
Prepare countries to effectively respond to an eventual pandemic
3
Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
3
Regional update on seasonal influenza vaccine use -SEARO
Identified as a “priority” new and underutilized vaccine for
the SEAR region
Recommendations of the South East Asia Regional vaccine
priority workshop – 11-13 May , 2009
Feasibility assessment of introducing for high risk groups in
SEAR recommended
SEAR Immunization Technical Advisory Group (2012)
Systematic vaccination of high risk groups only in Thailand
Haj and Umra pilgrims targeted in Maldives , (Indonesia )
Potential benefits are not delivered to public in other
member states
4
Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
4
2

3. Is the seasonal influenza vaccine use in SEARO adequate to
sustain a reasonable regional influenza vaccine production?
Year
Thailand
(Doses in millions)
2008
2009
2010
2011
2012
Maldives
(Doses in Millions)
0.52
2.2
2.4
2.8
2.9
0.001
0.003
0.0032
0.0035
0.0037
Source : WHO/UNICEF Joint Reporting Form (JRF)
Objective 2 : Increase in vaccine production capacity
Increase vaccine production capacity through
New production facilities
Higher yielding technologies (Live Attenuated Influenza Vaccines (LAIV),adjuvants)
Sustaining it in the inter-pandemic period
Short term goal (2015) :
Produce enough pandemic vaccine to immunize two billion people 6 months after
transfer of the vaccine prototype strain to vaccine manufacturers
Increase seasonal flu vaccine capacity by 280 million doses in 2016 (1700 m)
relative to 2011 capacity ( 1420 m)
Long term goal :
Produce enough vaccine to immunize the world's population in 6 months
after transfer of the vaccine prototype strain to vaccine manufacturers ( 6.7
billion doses)
6
Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
6
3

4. Influenza vaccine production capacity since 2006
7
Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
7
Monovalent pandemic – base case ( 3 X) = 5.1 b doses / annum
Monovalent Pandemic – best case (11X )-18.6 b doses / annum
8
Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
8
4

5. Vaccine production targets (GAP) by 2015
Target 1 (Herd immunity target) – 70% of SEAR population with 2
doses within 6 months of availability of pandemic strain= 2.7
billion doses (global target -10 billion doses/6 months )
Seasonal influenza vaccine production capacity per 6 months
– Base (3X)=900 million doses ,
– Best case (11X)= 245 million doses
Target 2 ( equity target ) - 100% of SEAR population with 2 doses
within 6 months of availability of pandemic strain = 3.8 billion
doses (global target 14 billon doses/6 months)
Seasonal influenza vaccine production capacity per 6 months
– Base (3X)= 1.3 billion doses ,
– Best case (11X)= 345 million doses
Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
9
9
Influenza vaccine production capacity in SEARO
company
Product
Current annual
capacity
Bharat biotech
HNVAC R pandemic
(H1N1)vaccine
Pandemic-5 million
Cell derived inactivated
( Target 10-12 million) using Madin Darby
Canine Kidney (MDCK)
Panacea biotec
PandyFLU R pandemic Pandemic-11.5 million Egg based (Inactivated
H1N1 vaccine
(target - 45 million)
Split Virion)
Seasonal -10 million
Technique
Availability of a
licensed product
Licensed
Licensed
Egg Based (Live
attenuated influenza
vaccine)
License under
process
Nasovac R pandemic Pandemic(H1N1) nasal vaccine Plan A -30 million
Plan B – 50 million
Egg Based (Live
attenuated influenza
vaccine)
Licensed/ WHO pre
qualified
FluBiO*
Egg based
NADFC market
authorization
Serum Institute
PT Biofarma ,
Indonesia
GPO Thailand
Target : pandemic -20
million doses
Target : seasonal -10
Egg based ( Live
million doses , PIIV-30 attenuated influenza
, PLAIV 300-500 m
vaccine)
Licensed with Thai
FDA
Seventh meeting of the NICs and Influenza surveillance in the Western
1 st license product of the WHO technology transfer initiative South-East Asia region ,
Pacific and
10
Beijing, China 12-15 November 2013
10
5

6. 11
Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
11
Role of SEARO manufacturers in meeting projected scale-up
from 2011- 2016
25M China
106M-AsiapacificDifference between seasonal flu vaccine production capacity between 2011 and 2016
12
Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
12
6

7. New patents in the globe
13
Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
13
Achievements in SEAR
Recognizing self-reliance of domestic vaccine production as a
means of ensuring health security and economic stability
Government contributions for industrial scale influenza vaccine
manufacturing facilities
Being grantees of the WHO initiative supporting pandemic
influenza vaccines
Establishment and expansion of vaccine production capacity
Building staff capacity in
management, production and quality control
14
Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
14
7

8. Achievements in SEAR
Technology transfer via
(a) “technology transfer hub” (b) bi-lateral agreements
Acquiring egg based and cell based technology
Shifting to higher yielding technologies
to enable surge capacity in a pandemic
Bio Farma -the first beneficiary of the initiative “Vaccine
Formulation Laboratory”
transferred the generic oil in water adjuvant technology
Initial investments to secure sufficient quantities of quality
eggs
15
Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
15
Achievements in SEAR
Industrial scale capacity development for trivalent seasonal
influenza vaccines (IIV,LAIV)
to ensure immediate
(PLAIV,PIV)
surge capacity for pandemic vaccines
3 countries manufacturing vaccines having a licensed vaccine
in the market
Ability to contribute to meeting regional and global pandemic
influenza needs
Development of H5N1 vaccines based on the experience
acquired from H1N1 vaccine production
Relative strengthening of the National Regulatory Authorities
16
Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
16
8

9. Achievements in SEAR
17
Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
17
Regional challenges
Securing and sustaining policy support and government
commitment
Preventing the reduction of the number of manufacturers
due to low return in investment
drop from 7 to 5 in SEAR
Ensuring sufficient domestic market by increased use of
seasonal influenza vaccines in the region
Further expanding and sustain superior yield technology
to increase production capacity in a pandemic
Optimization and scaling up of the quality control methods
18
Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
18
9

10. Regional challenges
Establishing an effective and sustainable supply of premaster seeds with other necessary reagents for LAIV
Optimizing processes to obtain high virus yields and
volumes of harvested allantoic fluids by providing quality
eggs
Inculcating better management capacity with new high
yielding technology based production
Enhancing the capacity of NRAs in relation to approving
LAIV
Ensuring the public confidence in quality and efficacy of
vaccine produced in the region by new manufacturers
19
Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
19
Way forward
Maintaining industrial scale production through regular use of
seasonal influenza vaccines to serve as a reserve for pandemic
response
Mobilizing additional financial support for industrial-scale
production
Developing extensive domestic, regional and international
networking
Improving capacity through comprehensive collaborative
programmes with partners including WHO and its TAG
Establishing effective research and production management
capacity through in-house and external training
20
Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
20
10

11. Way forward
Investments on clean egg supply, negotiations with local
producers and international suppliers of embryonated eggs
While pursuing the egg based technology, capitalizing on cell
based technology ( R&D)
Strengthening regulatory capacity for timely processing
production, GMP approval, product registration and market
authorization
Institutional structures and coordination mechanisms
Applying for WHO prequalification as a means of ensuring
public and media confidence on the safety and efficacy
21
Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
21
Summary
Recognizing investment in domestic production capacity
as a health security and economic stability measure by
member states with vaccine production potential
Competitive private sector business model and public
sector national security model
Significant expansion of the regional capacity since 2006
following the GAP
Need for sustaining the production capacity through
regular use of seasonal influenza vaccination as a reserve
for pandemic response
Insufficient use of seasonal influenza vaccines – an
impediment for this strategy
22
Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
22
11

12. Thailand – A role model for the SEAR
“Investing in domestic
seasonal
influenza vaccine production with a
readiness to convert to pandemic
vaccines is like investment in fighter
air-crafts, missiles
tanks and
submarines “
Public investment for national security
Strategic sustenance of the local
capacity
Evidence based demand generation
Capacity for the local and regional
support

23
Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
23
Acknowledgement
Some global slides - courtesy presentations of Marie-Paule
Kieny of WHO
Some information – courtesy presentations of
Dr. Suwit Wibulpolpresert – MOPH Thailand
GPO Thailand
Dr.Opart Kankawinpong –MOPH Thailand
Mr.Stephan Guichard – RA , Vaccine Safety and Quality for
his inputs
Coordinator and other colleagues of the IVD for their
guidance and comments
24
Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
24
12