NEWS - July 2002
Partners back new approach to fast-track vaccine development
WITH a concerted effort, vaccines against two major killers, pneumococcus and rotavirus, could be developed and introduced into the countries that need them most within around five years a fraction of the time it took for hepatitis B vaccine to reach low-income countries after its licensure. The GAVI Board has approved an entirely new approach to coordinate the remaining R&D on these vaccines and to ensure that manufacturers will invest in producing them.
To support the new approach, the Board authorised use of the Vaccine Funds third "window", or sub-account, up to a maximum of $90 million over the next three years, subject to regular review. Until now, only the first two sub-accounts, for new vaccines and the strengthening of immunization services, have been opened.
A key aim is to overcome what appears to be the biggest barrier to the development of new vaccines for use in developing countries: a lack of clear, credible evidence that the vaccines will be bought. This lack of evidence has in the past left industry reluctant to invest in building up the capacity to produce these vaccines. Prices have stayed high, and in turn, the public sector has been unable to afford the vaccines, keeping demand low. And so the vicious cycle has continued.
The new approach, developed with the help of the consultancy firm McKinsey & Company, uses "accelerated development and introduction plans" (ADIPs) for each vaccine. With support from the Gates Foundation and the World Bank, draft ADIPs for the two vaccines have been created. One important finding is that ensuring the uptake of new vaccines is not just a matter of access to immediate financing. So the plans set out clear goals for establishing the value of the vaccines, communicating their value and delivering them. If successful, the plans could bring forward the introduction of the vaccines in developing countries by as much as six years, preventing many deaths.
"This is an incredibly important moment in time for us," said James Christopher Lovelace, director of health, nutrition and population at the World Bank, and a member of the Board, when the decision was taken on 20 June.
The ADIPs set out the key steps, timelines, players and budgets needed to deliver a specific number of doses of vaccine by a specific date. For example, the preliminary targets are to immunize some 10 million children per year against pneumococcus and some 30 million children per year against rotavirus between 2006 and 2012. Plans will be open to revision as development proceeds.
Each ADIP will be implemented by small teams of four or five people. The teams will be overseen by a steering group appointed by the Board, and will also seek regular advice from a scientific and technical review panel. Details of how and where the teams will work have yet to be decided.
Among the key tasks facing the teams is to get better estimates of the burdens of these diseases in different regions and countries, as well as wider evidence of the efficacy of the vaccines in clinical trials (see Update, next page). Decision makers who will ultimately pay for the vaccines governments in countries and their international partners are usually unwilling to invest in vaccines without solid evidence about how many lives they can save.
To avoid the possibility of conflicts of interest over individual vaccine products, industry representatives will be prevented from serving on review panels where specific products are being discussed. Board members also warned of the need to make sure that, while industry has a right to protect its intellectual property, GAVI would need to be explicit about what it expected in return for Vaccine Fund money invested towards product development.
Immunization Focus July 2002 - Contents