Pandemic Vaccine 143

3.Mock-up vaccines must be developed and tested in clinical trials to determine the most antigen sparing formulation and the best vaccination schedule (Fedson 2005, Kilbourne 2005).

4.Newer vaccine technology needs to be developed, e.g. reverse genetics, and knowledge of epitopes in influenza to design more effective vaccines.

Controversies

A number of controversies surrounding the development of a new influenza vaccine need to be dealt with (Fedson 2005, Osterholm 2005).

Financial – patents exist for the plasmid-based methods of making virus in cell culture and the legal implications in various countries need to be examined and addressed. Will the owners of the intellectual property benefit in any way? Mock vaccines need to be made, but will probably never be sold and used. Who will fund this endeavour?

Rationing – in the event of vaccine shortage, higher risk groups will need vaccination first, along with those working on the front lines to control the pandemic. In such an event, the definition of “high risk group” may need to be revised – will it include children, for instance? Who will get the vaccine first – there is already tension over this issue in the UK: poultry farmers or healthcare workers? (Day 2005)

Equitable access will need to be ensured – countries without vaccine production, poorer countries, and developing countries will all want to have their share of the vaccine supply.

Liability issues – due to increased vaccination with current vaccines, greater attention must be paid to liability. Several countries have legislation that limits and/or covers certain liability for vaccine companies – encouraging such legislation will make vaccine companies feel more free to develop new vaccines, and increase the supply of current vaccines. When the time comes for rapid entry of pandemic vaccines into general use, such legislation will be important.

Organising

Barnett employs a Haddon Matrix to show what sort of planning needs to be done at different stages of the pandemic, from pre-pandemic to post-pandemic (Barnett 2005).

The WHO will play an important role in the process. In 2001, the Global Agenda for Influenza Surveillance and Control was established (Webby 2003, Stohr 2005). Its role is to enhance our surveillance abilities, in order to better detect a pandemic, and prepare for influenza seasons until then. It is also charged with the task of increasing our knowledge of influenza, and enhancing vaccine acceptance and use, in order to prepare us for a pandemic (WHO 2005j).

The WHO also needs to lead the address of the problems of production capacity, legislation and expedited vaccine availability, and research that needs to be done in order to reach the point where these are possible. It needs to help solve the controversies over financing, patents and intellectual property, equity for developing countries and countries not producing vaccine, and rationing of vaccine when supplies do not meet the demands of a population of more than 6 billion people.