Malaria drug and vaccine research is booming. According to a new report launched in the UK by Australian researchers at The George Institute for International Health, 16 new malaria vaccine candidates are now in clinical trials; six new malaria drugs are about to reach the market; and by 2011 we will have up to 12 new anti-malarial drug product registered.
However, this unprecedented level of malaria R&D activity is not necessarily all good news. The report's authors found that the high number of malaria vaccine candidates was the result of scientific and technical gaps and lacking policy coordination rather than a reflection of cohesive global activity. Lack of coordination and planning mean that invested funding and efforts are not delivering as much as they should, and may be costing donors tens of millions of dollars.
According to Dr Mary Moran, the report's lead author, improved vaccine research co-ordination and investment decisions could save more than USD20 million over 5 years and prevent up to 3,000 unnecessary test vaccinations in African children. "The most tantalizing finding was that these high-impact policy interventions -- and the resulting savings - are well within reach if donors and developers can work together", said Dr Moran. "We need a system to ensure that fewer and better vaccine candidates enter clinical trials in Africa."
On the drug front, the report welcomed the arrival of new anti-malarials after a dearth of many decades, but noted that this meant donors, purchasers and developing countries are now faced with the challenge of working out which of the many competing products offer the best cost-benefit for African populations, and the funding of very large and expensive studies which are needed to determine this. Post-registration trials of tens to hundreds of thousands of patients will be needed to ensure that these new drugs are appropriately absorbed by already strained health systems and appropriately delivered to malaria patients.
Over the past year, Dr Mary Moran and her team from The George Institute, supported by the Global Forum for Health Research through World Bank funding, engaged with main stakeholders in the malaria field to provide donors with a 5-year map of the future, including what malaria products are in the pipeline, how much donors will need to spend to move them towards success, and where this spending should focus. Key findings were:
- The additional cost for clinical development of the global malaria vaccine and drug portfolio over the next 5 years is likely to be around $US 600 million
- A substantial proportion of this (e.g. up to 60% in the case of vaccine trials) will go to Africa. This represents a very large injection of business funding into Africa
- Up to US $250 million may go to small Western drug companies and Contract Research Organizations and to developing country manufacturers: again, a substantial injection of funds into desired growth areas.
The report also debunks some common beliefs about African capacity (or lack thereof). In particular, the notion that Africa needs investment to build new malaria trial sites, and that existing African trial sites could be sustainable if they were only more business-like.
"Sustainability is a myth", said Dr Moran, "at least under current conditions. Currently, many donors and developers strangle a site's ability to stay afloat because they routinely pay project overheads that are well below costs, and are resistant to providing core funding. No Western institution could survive under those conditions."
More encouragingly, the report noted that well-planned and sustained donor investment since 2000 means that, if well managed, we now have enough malaria trial sites in Africa to meet all likely future demand out to 2012 and probably well beyond. "Funders and trial sites can justly congratulate themselves on their site capacity-building efforts in Africa in the last 10 years", said Dr Moran. "However, this also means the time has come to move on from building new product trial sites in Africa to supporting current sites in a sustainable way."
"The key to success in the next five years will be providing the right amount of funding in the right places supported by the right policies," said Professor Stephen Matlin, Executive Director of the Global Forum for Health Research. "We hope this report helps donors and product developers reach that goal."
WHO estimates that 300 - 500 million new malaria infections occur per year, resulting in more than 1.2 million deaths annually. The overwhelming majority of these deaths are in children under five years of age and in pregnant women.
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