Immediate And Sustained Action Required To Sharply Increase Pandemic Influenza Vaccine Supply

"We are presently several billion doses short of the amount of pandemic influenza vaccine we would need to protect the global population. This situation could lead to a public health crisis," said Dr Marie-Paule Kieny, Director, WHO Initiative for Vaccine Research. "The Global Action Plan sets the course for what needs to be done, starting now, to increase vaccine production capacity and close the gap. In just three to five years we could begin to see results that could save many lives in case of a pandemic."

The Global Action Plan is the product of the advice of more than 120 scientific experts from national immunization programmes, national regulatory authorities, scientists and vaccine manufacturers in both industrialized and developing countries.

It identifies and prioritizes practical solutions for reducing the potential pandemic influenza vaccine supply gap; these are contained in eight strategies with activities for the short (tangible results in less than five years), medium (five to ten years) and long (more than ten years) terms. Activities need to be undertaken simultaneously.

"Immunization is a critical control strategy for limiting the impact of an influenza pandemic. Immediate, collaborative action to increase vaccine supply could have a massive payoff," said Dr David L. Heymann, acting Assistant Director-General, Communicable Diseases, WHO. "In addition, continued participation of countries in the timely sharing of their influenza viruses and sequence data is vital to support global vaccination efforts," he added.

The three main approaches to closing the vaccine supply gap are identified in the Global Action Plan as:

• an increase in seasonal influenza vaccine use to provide protection against seasonal influenza and at the same time use the increased demand to stimulate industry to produce more;
• an increase in production capacity through measures such as improving vaccine production yields and building new plants; and
• further research and development to:
  • design more potent and effective vaccines that would induce protection after one dose and/or broad spectrum and long-lasting immunity, and
  • produce vaccines more efficiently and quickly.

Relying on market-driven forces alone, it is estimated that by 2008-2009 the production of pandemic influenza vaccine will not exceed 2.34 billion doses per year. At present, the production capacity for seasonal influenza vaccine stands at 350 million doses. Such quantities fall far short of the expected demand for vaccine during an influenza pandemic when there will likely be calls to vaccinate the entire 6.7 billion world population. The anticipated shortage is, in particular, due to the expectation that a two-dose course of vaccine will be needed to protect each person.

New technologies will play an important role in developing the best possible pandemic influenza vaccine. The ideal vaccine would be safe and highly protective in all target groups (including infants, the elderly, etc.) for at least one year with only a single dose. It would require just a small amount of virus antigen and could be stored without refrigeration. Finally, the vaccine would be easily and inexpensively produced on a large scale.

Implementation of the Global Action Plan requires the sustained, joint efforts of countries, industry and the global health community and will require substantial funding. Capital investment for the establishment of new production facilities, alone, is estimated at US$ 1.00 per dose. Investments made in relation to the Global Action Plan will substantially benefit the production and utilization of vaccines for seasonal influenza, which results, on an annual basis, in an estimated 3-5 million cases of severe illness and 250 000 to 500 000 deaths worldwide.

Dr Peter Salama, Chief, Child Survival and Immunization Unit, UNICEF, said: “Our agency is pleased to support the Global Action Plan. We are working with WHO to make sure that developing countries have the capacity to effectively and rapidly use the pandemic vaccine when it becomes available, so that the most vulnerable children and their families can be protected.”

Assistance to developing countries is critical. In particular, they will need help to assess the impact of influenza on their populations; and to develop and implement seasonal influenza vaccination programmes including the purchase of seasonal influenza vaccine which currently costs approximately US$ 3.00-7.00 per dose.

Earlier this month, the United States announced a US$ 10 million contribution to WHO to support influenza vaccine development and manufacturing infrastructure in other countries.

Leveraging its experience with domestic vaccine production, Canada is also supporting the Global Action Plan. “Canada has placed a high priority on its own capacity to manufacture a pandemic influenza vaccine but we can’t just focus on our needs. The global community has a responsibility to work together to narrow the supply gap,” said Canada’s Health Minister, Tony Clement.