Strength in unity
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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 institu- tions and individuals involved have differ- ent 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 sec- tor 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 develop- ment due to the perception that profits from an eventual product would be small. As a result, many of the efforts take place in gov- ernment 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 scien- tific,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 pro- grammes 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 agen- cies. The advantage of this loose structure is that there is competition to pursue innova- tive and diverse approaches. The disadvan- tage 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 candi- dates 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 con- sequences and make the most of available resources. Cash shortfall 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 suffi- cient efficacy, there would be insufficient funding available to proceed to phase III trials. In 2001, the Commission on Macro- economics 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 accel- erate progress, especially by enabling parallel efforts that currently have to take place serially. But in the midst of the clamour of competing priori- ties, few international organiza- tions 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 devel- opment, pivotal trials, installation of a man- ufacturing 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, vac- cines will prove to be so effective that new funding will be provided to introduce immunization as an additional modality 938 NATURE | VOL 430 | 19 AUGUST 2004 | www.nature.com/nature Strength in unity The world must increase collaboration to meet the pressing need for a malaria vaccine, argue Carter Diggs, Sarah Ewart and Melinda Moree. malaria “Ideally, vaccines will prove to be so effective that new funding will be provided to introduce immunization in addition to pre-existing interventions.” Raising the game: technicians look after Anopheles mosquitoes bred for research. SANARIA ©2004 Nature Publishing Group
Transcript of Strength in unity
Awide range of public- and private-sectorstakeholders currently drive the search
for a malaria vaccine. This diversity is anasset because a range of imaginativeapproaches will be needed to produce a vaccine against a foe as formidable as themalaria parasite. But many of the institu-tions and individuals involved have differ-ent motivations. The prospect of a vaccinethat could prevent the deaths of more thanone million children every year shouldbring the community together aroundcommon goals.
In vaccine development, the private sec-tor usually has a focusing effect, uniting themultiplicity of actors needed to develop, test,regulate, manufacture and introduce newvaccines. Unfortunately, this driving forcehas been absent in malaria vaccine develop-ment due to the perception that profits froman eventual product would be small. As aresult, many of the efforts take place in gov-ernment or academic laboratories, or inindustry heavily subsidized by philanthropicorganizations or governments.
Despite this, an increasing number ofvaccine candidates are now moving intoclinical trials and progressing through the product-development pipeline. A morecoordinated effort to address the key scien-tific,technical and introduction issues is nowneeded to accelerate this progress and ensurethat a vaccine, when available, will be takenup without delay by immunization pro-grammes in disease-endemic countries.
The World Health Organization (WHO)lists some 75 malaria vaccines or vaccineconcepts that are under development, mostof them funded by a small number of agen-cies. The advantage of this loose structure is
that there is competition to pursue innova-tive and diverse approaches. The disadvan-tage is that there can be gaps in some parts ofthe research base and unnecessary repetitionin others.
Although active networks exist within thecommunity, there is no single driving forcetowards an effective, licensed vaccine, nor isthere a global plan to maximize progress and minimize unnecessary duplication of work.To overcome this, the malaria vaccine community should strengthen its networksand increase collaboration toensure that all of the diverseactivities it is pursuing will leadto a successful malaria vaccine.
The community will facesome difficult choices. Theexperience of vaccine researchis that few promising candi-dates move through thepipeline to advanced development. Withlimited resources available for fundingresearch, the community will have to decidewhich vaccine concepts to pursue. Whenmaking these decisions, the challenge will beto broaden institutional and individualinterests to emphasize the global health con-sequences and make the most of availableresources.
Cash shortfallFunding has gradually increased in recentyears. Total annual expenditures for malariavaccine development worldwide rose fromUS$42 million in 1999 to $65 million in2003. A single new donor, the Bill &Melinda Gates Foundation, can account formost of this new infusion of funding. Atcurrent levels, however, if a candidate in
phase II clinical trials demonstrated suffi-cient efficacy, there would be insufficientfunding available to proceed to phase III trials.
In 2001, the Commission on Macro-economics and Health called for $1.5 billionto go to targeted research and developmentfor new drugs, vaccines, diagnostics andintervention strategies against HIV/AIDS,malaria, tuberculosis, reproductive healthand other health conditions of the poor.Increased funding would considerably accel-
erate progress, especially byenabling parallel efforts thatcurrently have to take placeserially. But in the midst of theclamour of competing priori-ties, few international organiza-tions or donors have respondedto this call and new resourceshave been difficult to attain.
Once the efficacy of a vaccine has beendetermined,further increases in expenditurewill be necessary to fund final process devel-opment, pivotal trials, installation of a man-ufacturing capability and introduction ofthe product.
The decision over whether to assumesuch an effort will be approached differentlyby the various groups involved. A vaccinemanufacturer would necessarily emphasizebusiness considerations, including projectedprofits or losses.
Aid organizations and private donors, onthe other hand, will no doubt assess the cost-effectiveness of a malaria vaccine comparedwith other control measures. Ideally, vac-cines will prove to be so effective that newfunding will be provided to introduceimmunization as an additional modality
938 NATURE | VOL 430 | 19 AUGUST 2004 | www.nature.com/nature
Strength in unityThe world must increasecollaboration to meet thepressing need for a malariavaccine, argue CarterDiggs, Sarah Ewart andMelinda Moree.
malaria
“Ideally, vaccines willprove to be so effectivethat new funding will beprovided to introduceimmunization inaddition to pre-existinginterventions.”
Raising the game: technicians look after Anopheles mosquitoes bred for research.
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along with pre-existing interventions.Otherwise, difficult decisions on which ofthe several alternatives offers the mostpromise will be necessary. Aid organizationsand donors would also consider long-termsustainability issues, for example the likeli-hood that funds would be available for vaccine purchase and distribution. Thedevelopment of new tools that offer promisefor success in fighting malaria, however,should generate new funding.
Ministers of finance and health inmalaria-endemic countries would have tomake their decision on whether to fund thedistribution and delivery of a new vaccine inthe context of the myriad other health inter-ventions competing for the same limited potof funding.
A coordinated and coherent messagefrom the malaria community as to the roleand value of interventions against malaria,including a vaccine when available, will be
critical to international and national-levelpolicy-makers.An existing umbrella organi-zation, the Roll Back Malaria Partnership,could strengthen the ties between the differ-ent players in the malaria community,present a coherent message and aid the deci-
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sion-making process for policies on malariacontrol as new tools become available.
United against a common foe, thoseinvolved in research and development andthose working to control the disease in thefield could come together to tell the com-pelling story of the impact of malaria on thelives of people in developing countries andso motivate funders to do more to fightmalaria. There can be little doubt that thiscoordinated approach towards major policyissues will accelerate the introduction of amalaria vaccine.Those responsible must vig-orously take up the challenge. ■
Melinda Moree is director of, and Sarah Ewart a policy
analyst at, the Malaria Vaccine Initiative. Carter Diggs is
senior technical advisor at the USAID Malaria Vaccine
Development Program.
The views expressed by the authors do not necessarily reflect the
views of the US Agency for International Development and the US
government generally.
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malaria
Mosquitoes feed on blood infected withPlasmodium as part of vaccine research.
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