Www.evm-vaccines.org The industry contribution to the equitable availability.

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

situation

Luc Hessel, M.D.Influenza Pandemic Working GroupEuropean Vaccine Manufacturers

Vilamoura (Portugal),16 September 2008ESWI Third European influenza Conference

2Hessel – 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 & D Regulatory

Sufficient

Production

Adapt Flu vaccine production Develop prototype vaccines

The priority challenge of pandemic preparedness


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


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 …



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



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


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


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


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


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



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


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


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)


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)


The IFPMA Influenza Vaccine Supply international task force

Acknowledgments

Www.evm-vaccines.org The industry contribution to the equitable availability.

Documents

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