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1 Seventh meeting of the NICs and Influenza surveillance in the Western

Pacific and South-East Asia region ,

Beijing, China 12-15 November 2013

Influenza vaccine production capacity in the South-East Asia Region(SEAR)

Dr. Pushpa Ranjan Wijesinghe Medical Officer ( Emerging VPD Surveilance )

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2 Seventh meeting of the NICs and Influenza surveillance in the Western

Pacific and South-East Asia region ,

Beijing, China 12-15 November 2013

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

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3 Seventh meeting of the NICs and Influenza surveillance in the Western

Pacific and South-East Asia region ,

Beijing, China 12-15 November 2013

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

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4 Seventh meeting of the NICs and Influenza surveillance in the Western

Pacific and South-East Asia region ,

Beijing, China 12-15 November 2013

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

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Year Thailand

(Doses in millions)

Maldives

(Doses in Millions)

2008 0.52 0.001

2009 2.2 0.003

2010 2.4 0.0032

2011 2.8 0.0035

2012 2.9 0.0037

Is the seasonal influenza vaccine use in SEARO adequate to sustain a reasonable regional influenza vaccine production?

Source : WHO/UNICEF Joint Reporting Form (JRF)

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6 Seventh meeting of the NICs and Influenza surveillance in the Western

Pacific and South-East Asia region ,

Beijing, China 12-15 November 2013

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)

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7 Seventh meeting of the NICs and Influenza surveillance in the Western

Pacific and South-East Asia region ,

Beijing, China 12-15 November 2013

Influenza vaccine production capacity since 2006

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8 Seventh meeting of the NICs and Influenza surveillance in the Western

Pacific and South-East Asia region ,

Beijing, China 12-15 November 2013

Monovalent pandemic – base case ( 3 X) = 5.1 b doses / annum Monovalent Pandemic – best case (11X )-18.6 b doses / annum

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9 Seventh meeting of the NICs and Influenza surveillance in the Western

Pacific and South-East Asia region ,

Beijing, China 12-15 November 2013

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

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10 Seventh meeting of the NICs and Influenza surveillance in the Western

Pacific and South-East Asia region ,

Beijing, China 12-15 November 2013

Influenza vaccine production capacity in SEARO

company Product Current annual

capacity

Technique Availability of a

licensed product

Bharat biotech HNVAC R pandemic (H1N1)vaccine

Pandemic-5 million ( Target 10-12 million)

Cell derived inactivated using Madin Darby Canine Kidney (MDCK)

Licensed

Panacea biotec PandyFLU R pandemic H1N1 vaccine

Pandemic-11.5 million (target - 45 million)

Egg based (Inactivated Split Virion)

Licensed

Serum Institute

Seasonal -10 million Egg Based (Live attenuated influenza vaccine)

License under process

Nasovac R pandemic (H1N1) nasal vaccine

Pandemic- Plan A -30 million Plan B – 50 million

Egg Based (Live attenuated influenza vaccine)

Licensed/ WHO pre qualified

PT Biofarma , Indonesia

FluBiO* Target : pandemic -20 million doses

Egg based NADFC market authorization

GPO Thailand Target : seasonal -10 million doses , PIIV-30 , PLAIV 300-500 m

Egg based ( Live attenuated influenza vaccine)

Licensed with Thai FDA

1st license product of the WHO technology transfer initiative

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11 Seventh meeting of the NICs and Influenza surveillance in the Western

Pacific and South-East Asia region ,

Beijing, China 12-15 November 2013

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12 Seventh meeting of the NICs and Influenza surveillance in the Western

Pacific and South-East Asia region ,

Beijing, China 12-15 November 2013

Role of SEARO manufacturers in meeting projected scale-up from 2011- 2016

Difference between seasonal flu vaccine production capacity between 2011 and 2016

106M-Asia-

pacific-

25M China

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13 Seventh meeting of the NICs and Influenza surveillance in the Western

Pacific and South-East Asia region ,

Beijing, China 12-15 November 2013

New patents in the globe

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14 Seventh meeting of the NICs and Influenza surveillance in the Western

Pacific and South-East Asia region ,

Beijing, China 12-15 November 2013

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

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15 Seventh meeting of the NICs and Influenza surveillance in the Western

Pacific and South-East Asia region ,

Beijing, China 12-15 November 2013

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

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16 Seventh meeting of the NICs and Influenza surveillance in the Western

Pacific and South-East Asia region ,

Beijing, China 12-15 November 2013

Achievements in SEAR

Industrial scale capacity development for trivalent seasonal influenza vaccines (IIV,LAIV)

to ensure immediate surge capacity for pandemic vaccines (PLAIV,PIV)

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

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17 Seventh meeting of the NICs and Influenza surveillance in the Western

Pacific and South-East Asia region ,

Beijing, China 12-15 November 2013

Achievements in SEAR

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18 Seventh meeting of the NICs and Influenza surveillance in the Western

Pacific and South-East Asia region ,

Beijing, China 12-15 November 2013

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

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19 Seventh meeting of the NICs and Influenza surveillance in the Western

Pacific and South-East Asia region ,

Beijing, China 12-15 November 2013

Regional challenges

Establishing an effective and sustainable supply of pre-master 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

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20 Seventh meeting of the NICs and Influenza surveillance in the Western

Pacific and South-East Asia region ,

Beijing, China 12-15 November 2013

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

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21 Seventh meeting of the NICs and Influenza surveillance in the Western

Pacific and South-East Asia region ,

Beijing, China 12-15 November 2013

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

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22 Seventh meeting of the NICs and Influenza surveillance in the Western

Pacific and South-East Asia region ,

Beijing, China 12-15 November 2013

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

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23 Seventh meeting of the NICs and Influenza surveillance in the Western

Pacific and South-East Asia region ,

Beijing, China 12-15 November 2013

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

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24 Seventh meeting of the NICs and Influenza surveillance in the Western

Pacific and South-East Asia region ,

Beijing, China 12-15 November 2013

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