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2.11 influenza vaccine production capacity in the sear (dr pushpa wijesinghe)

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  • 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