The industry contribution to the equitable availability of vaccines in a pandemic situation

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

2. Timely Sufficient R & D Regulatory Production Develop prototype vaccines Adapt Flu vaccine production The priority challenge of pandemic preparedness Deliver as much pandemic vaccine as quickly as possible after the pandemic has been declared and/or in anticipation of the first wave

3. 2008 industry’s achievements* • 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 * IFPMA / IVS WHO GAP advisory group meeting, 19 October 2007

4. 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. 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. Key success factors for ensuring equitable availability of vaccines in a pandemic situation • 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

7. General considerations on vaccine supply and deployment in an emergency situation • 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

8. General considerations on vaccine administration in an emergency situation • 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 *Aaby et al. J Public Health Management Practice 2006;12(4),365-372

9. Specific issues related to vaccine supply and deployment in apandemic situation • 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

10. 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. Specific considerations onstockpiling 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. 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. Conclusion (1) • 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

14. Conclusion (2) • 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

15. Acknowledgments • The IFPMA Influenza Vaccine Supply international task force