1. www.evm-vaccines.org www.evm-vaccines.org www.evm-vaccines.org www.evm-vaccines.org www.evm-vaccines.org The industry contribution to the equitable availability of vaccines in a pandemic situation Luc Hessel, M.D. Influenza Pandemic Working Group European Vaccine Manufacturers Vilamoura (Portugal),16 September 2008 ESWI Third European influenza Conference

2. 2 Hessel – TEIC Vilamoura 16 September 2008 Deliver as much pandemic vaccine as quickly as possible after the pandemic has been declared and/or in anticipation of the first wave Timely R & DRegulatory Sufficient Production Adapt Flu vaccine productionDevelop prototype vaccines The priority challenge of pandemic preparedness

3. 3 Hessel – TEIC Vilamoura 16 September 2008  Industry has developed antigen dose-sparing strategies and adjuvant technology that could potentially solve the pandemic supply issue and make pre-pandemic strategies a reality  Industry has planned significant increase in production capacity for trivalent seasonal influenza vaccines by 2010, assuming continued growth in seasonal vaccine usage  This means that monovalent pandemic dose capacity could be sufficient to cover most of the global population by 2010 2008 industry’s achievements* * IFPMA / IVS WHO GAP advisory group meeting, 19 October 2007

4. 4 Hessel – TEIC Vilamoura 16 September 2008 Key priorities and challenges for the industry*  Optimise vaccine performance – Define optimal formulations – Vaccination schedules – Duration of the protection – Cross-reactivity/protection with new mutated strains – Booster with homologous and heterologous strains – Develop appropriate and standardised immunological tools and animal challenge models  Complete development and licensing process  Address technical issues of the supply and logistics – filling and packaging (multidose vials) – Stability, storage, supply chain … * IFPMA / IVS WHO GAP advisory group meeting, 19 October 2007

5. 5 Hessel – TEIC Vilamoura 16 September 2008 Key priorities and challenges for Member States and International organisations*  Ensure implementation of seasonal influenza vaccination policies as appropriate  Define pre-pandemic and pandemic vaccination strategies  Define allocation and procurement processes for all countries  Develop and/or strengthen critical health systems and infrastructure for vaccine distribution and delivery * IFPMA / IVS WHO GAP advisory group meeting, 19 October 2007

6. 6 Hessel – TEIC Vilamoura 16 September 2008  Finalise vaccination strategies  Establish reasonable vaccine forecasts accordingly  Ensure regulatory processes are in place  Ensure public health infrastructures are in place  Develop appropriate contractual agreements for the procurement and deployment of vaccines – Stockpile of pre-pandemic vaccines – Supply of pandemic vaccines Key success factors for ensuring equitable availability of vaccines in a pandemic situation

7. 7 Hessel – TEIC Vilamoura 16 September 2008  Key elements of the vaccine supply chain: – Shipment from manufacturing facility to inventory centers: transport infrastructure, cold chain … – Distribution of vaccines to vaccinators: central management, robust area deployment and systems, monitoring and tracking processes… – Adequate communication – Management and distribution of ancillary medical supplies needed to administer the vaccines General considerations on vaccine supply and deployment in an emergency situation

8. 8 Hessel – TEIC Vilamoura 16 September 2008  Define the optimal process of moving large amounts of vaccines from the producer to those in charge of their administration  Public health infrastructures must be able to collect, stock, distribute and deliver vaccines to targeted (entire?) population  Volume of medical device needed to deliver pandemic vaccines  Adapt delivery processes to the populations and health care systems: – multiple strategies and tactics must be considered – specific procedures must be applied to each country / local levels  Anticipate communication systems and well-defined procedures to address a wide range of likely and unexpected situations  Planning, simulation models* and exercises are needed General considerations on vaccine administration in an emergency situation *Aaby et al. J Public Health Management Practice 2006;12(4),365-372

9. 9 Hessel – TEIC Vilamoura 16 September 2008  Prioritization policies: who should receive pandemic or pre-pandemic vaccines, especially in the early stage of a pandemic ?  Conflict between mass vaccination programmes and need to limit disease transmission (social distancing, quarantine): consider alternative “points of dispensing” (local schools)  Learn from experience in disaster preparedness and response in other regions (Red Cross, UNICEF, MSF …)  Special consideration for extemporaneous adjuvanted vaccines and administration of a second dose  Protection of supply chain’s effective and safe operations  Counterfeit vaccines Specific issues related to vaccine supply and deployment in a pandemic situation

10. 10 Hessel – TEIC Vilamoura 16 September 2008 Delivery and administration of pre- and pandemic vaccines: programmatic and logistical aspects for industry*  Regulatory aspects – Registration process: Cannot become a barrier, particularly for developing countries Fast-track WHO pre-qualification process – Batch release process – Generic / harmonized labeling across all countries  Flexibility to maximize speed of delivery – Either bulk or finished product – Both mono and multidose presentations – Use of local fill & finish facilities  Liability issues  Deployment and delivery – Inter-governmental agreements on free circulation of vaccines – Robust delivery systems to ensure rapid vaccination * IFPMA / IVS WHO GAP advisory group meeting, 19 October 2007

11. 11 Hessel – TEIC Vilamoura 16 September 2008 Specific considerations on stockpiling of pre-pandemic vaccines  Stockpiling of H5N1 vaccines already adopted by WHO and several countries (Australia, Finland, France, Italy, UK, Switzerland, Japan and USA)  Relies on a positive benefit / risk assessment of cross-reactivity between avian and human strains  Contributes to Pandemic Preparedness – Offers the potential for early protection during the period when the pandemic vaccine is being manufactured (3-4 months) – Contributes to improved logistics of pandemic vaccine distribution  Appropriate logistical systems must be established

12. 12 Hessel – TEIC Vilamoura 16 September 2008 Specific considerations on stockpiling of pre-pandemic vaccines: logistics for vaccines and material  Several suppliers: presentation, packaging, product identification  Logistics for warehouses: qualified building & operations, security, protection.  Maintenance / update over time: stock replacement (of different types of material)  Stockpile of medical supply: syringes*, needles*, packaging materials for distribution * For one multidose vial of H5N1 vaccine (10 doses with ex-temporaneous adjuvant): 11 syringes and 12 needles

13. 13 Hessel – TEIC Vilamoura 16 September 2008  Equitable availability of vaccines in a pandemic situation relies on: – Consolidation of vaccination strategies which allow to anticipate needs and define delivery processes – Adaptation of vaccine delivery systems to efficient distribution and administration of pre- and pandemic vaccines in an emergency situation  These issues require significant coordination and guidelines with all partners across the globe Conclusion (1)

14. 14 Hessel – TEIC Vilamoura 16 September 2008  Securing vaccine supply and distribution is an urgent concern, which must be part of national preparedness plans and WHO guidance on pandemic preparedness  Appropriate contractual agreements are the best way to address such challenges and allow vaccine manufacturers to meet national and international demands – in accordance with global public health needs – based on reasonable forecasts – relevant to specific vaccination strategies, existing infrastructures and regulatory aspects Conclusion (2)

15. 15 Hessel – TEIC Vilamoura 16 September 2008  The IFPMA Influenza Vaccine Supply international task force Acknowledgments