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Looking Ahead: Strategies for Building a Platform

Pandemic Influenza Vaccines: Building a Platform for Global Collaboration

David Nabarro

January 30th 2007

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Pandemic Vaccines have

• Potentially a high public health value and huge social and economic benefits,

• low commercial value for developers and manufacturers

There is not agreement on the optimal product

The market is uncertain

There are risks for manufacturers in scaling up production

Regulatory, Intellectual Property challenges lie ahead

There are deep concerns about equity of access: there will be public pressure for equity of predictable and prompt access to vaccines

Pandemic vaccines do not have the potential to result in sustained multi-billion dollar markets

Pandemic Influenza VaccinesNot an easy prospect for Manufacturers

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Need for faster research and development to develop better vaccine production technologies

Need to shorten lead times and manufacturing cycles of existing vaccines

Need to factor in the inevitable redundancy in the product – short shelf life, reduction in potency due to antigenic drift

Need for global coverage

And so on….

To respond manufacturers and researchers will need adequate incentives

Finance for strategic R and D; finance to reduce manufacturers’ risks

Are there Investors convinced that the cost is worthwhile?

Pandemic Influenza VaccinesThe Public Health Imperative

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Potential Stakeholders:– R and D groups– Manufacturers– Regulators– Governments– International Bodies

Potential value of a global platform– A meeting place where open (and critical) dialogue is

possible– An opportunity for structured exchanges to tackle difficult

issues (strategies to find solutions, together)– A grouping of committed partners determined to move

forward in synergy: an INITIATIVE

Pandemic Influenza VaccinesWhy a global platform might help

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An Initiative for Action means having– Common Vision and Goal– Agreed Strategy (product, development,

manufacture, distribution, administration, control) – An Implementation Process– Attention to Access and Distribution Issues– Backing to make it happen

Pandemic Influenza VaccinesPlatform for Talk or Initiative for Action: which way to go?

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Components– Increase use of seasonal influenza vaccine – Increase production capacity for pandemic

vaccines, independent of seasonal vaccine use

– Research and develop new technologies and new vaccines

comprehensive analyses of existing problems; global overview of generic solutions; strategic basis for a new initiative

Pandemic Influenza VaccinesWHO Global Action Plan to Increase Access to Pandemic Vaccines

Strategy for a New Initiative

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Challenge 1: Ensuring there is worldwide political support for international attention to pandemic vaccines (funding follows a political wind)

Challenge 2: Selection of technology : Speed and cost of production, streamlined regulatory review. safety and intellectual property issues, administration route

Challenge 3: Establishing the demand : Need for developing as well as developed countries to agree on potential demand in a context of uncertainty: willingness to stockpile, to vaccinate before a pandemic, to “guarantee” supply to poor countries

Challenge 4: Clarifying the supply potential – specifically the potential for steady state manufacture, for surge in the event of pandmeic: determining the risks that industry will face

Challenge 5: Preparing an initiative: Options for different partners to work together on (a) Demand analysis, (b) R and D, (c) Intellectual Property Protection, (d) Production, (e) Regulation and PMS, (e) Distribution issues, (f) Advance Purchase

Challenge 6: Structure and programme for the Initiative

Pandemic Influenza VaccinesEstablishing an Initiative: Challenges to be addressed