The world must increase collaboration to meet the pressing need for a malaria vaccine, argue Carter Diggs, Sarah Ewart and Melinda Moree.
A wide range of public- and private-sector stakeholders currently drive the search for a malaria vaccine. This diversity is an asset because a range of imaginative approaches will be needed to produce a vaccine against a foe as formidable as the malaria parasite. But many of the institutions and individuals involved have different motivations. The prospect of a vaccine that could prevent the deaths of more than one million children every year should bring the community together around common goals.
In vaccine development, the private sector usually has a focusing effect, uniting the multiplicity of actors needed to develop, test, regulate, manufacture and introduce new vaccines. Unfortunately, this driving force has been absent in malaria vaccine development due to the perception that profits from an eventual product would be small. As a result, many of the efforts take place in government or academic laboratories, or in industry heavily subsidized by philanthropic organizations or governments.
Despite this, an increasing number of vaccine candidates are now moving into clinical trials and progressing through the product-development pipeline. A more coordinated effort to address the key scientific, technical and introduction issues is now needed to accelerate this progress and ensure that a vaccine, when available, will be taken up without delay by immunization programmes in disease-endemic countries.
The World Health Organization (WHO) lists some 75 malaria vaccines or vaccine concepts that are under development, most of them funded by a small number of agencies. The advantage of this loose structure is that there is competition to pursue innovative and diverse approaches. The disadvantage is that there can be gaps in some parts of the research base and unnecessary repetition in others.
Although active networks exist within the community, there is no single driving force towards an effective, licensed vaccine, nor is there a global plan to maximize progress and minimize unnecessary duplication of work. To overcome this, the malaria vaccine community should strengthen its networks and increase collaboration to ensure that all of the diverse activities it is pursuing will lead to a successful malaria vaccine.
The community will face some difficult choices. The experience of vaccine research is that few promising candidates move through the pipeline to advanced development. With limited resources available for funding research, the community will have to decide which vaccine concepts to pursue. When making these decisions, the challenge will be to broaden institutional and individual interests to emphasize the global health consequences and make the most of available resources.
Funding has gradually increased in recent years. Total annual expenditures for malaria vaccine development worldwide rose from US$42 million in 1999 to $65 million in 2003. A single new donor, the Bill & Melinda Gates Foundation, can account for most of this new infusion of funding. At current levels, however, if a candidate in phase II clinical trials demonstrated sufficient efficacy, there would be insufficient funding available to proceed to phase III trials.
In 2001, the Commission on Macroeconomics and Health called for $1.5 billion to go to targeted research and development for new drugs, vaccines, diagnostics and intervention strategies against HIV/AIDS, malaria, tuberculosis, reproductive health and other health conditions of the poor. Increased funding would considerably accelerate progress, especially by enabling parallel efforts that currently have to take place serially. But in the midst of the clamour of competing priorities, few international organizations or donors have responded to this call and new resources have been difficult to attain.
Once the efficacy of a vaccine has been determined, further increases in expenditure will be necessary to fund final process development, pivotal trials, installation of a manufacturing capability and introduction of the product.
The decision over whether to assume such an effort will be approached differently by the various groups involved. A vaccine manufacturer would necessarily emphasize business considerations, including projected profits or losses.
Aid organizations and private donors, on the other hand, will no doubt assess the cost-effectiveness of a malaria vaccine compared with other control measures. Ideally, vaccines will prove to be so effective that new funding will be provided to introduce immunization as an additional modality along with pre-existing interventions. Otherwise, difficult decisions on which of the several alternatives offers the most promise will be necessary. Aid organizations and donors would also consider long-term sustainability issues, for example the likelihood that funds would be available for vaccine purchase and distribution. The development of new tools that offer promise for success in fighting malaria, however, should generate new funding.
Ministers of finance and health in malaria-endemic countries would have to make their decision on whether to fund the distribution and delivery of a new vaccine in the context of the myriad other health interventions competing for the same limited pot of funding.
A coordinated and coherent message from the malaria community as to the role and value of interventions against malaria, including a vaccine when available, will be critical to international and national-level policy-makers. An existing umbrella organization, the Roll Back Malaria Partnership, could strengthen the ties between the different players in the malaria community, present a coherent message and aid the decision-making process for policies on malaria control as new tools become available.
United against a common foe, those involved in research and development and those working to control the disease in the field could come together to tell the compelling story of the impact of malaria on the lives of people in developing countries and so motivate funders to do more to fight malaria. There can be little doubt that this coordinated approach towards major policy issues will accelerate the introduction of a malaria vaccine. Those responsible must vigorously take up the challenge.
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The views expressed by the authors do not necessarily reflect the views of the US Agency for International Development and the US government generally.