opening the gates for vaccine development in the real world

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EDITORIAL Opening the Gates for vaccine development in the real world ‘‘In 100 years it will be clear that the ‘sea change’ in global health interest that took place in the early twenty-first century could be traced to two people: Bill and Melinda Gates’’. The quote above is taken from the winner of the 2001 Lasker Award for Public Service [1]. The Bill and Melinda Gates’ Foundation has certainly made major contributions to vaccine development including 126.5 million dollars given to the Inter- national AIDS Vaccine Initiative to help the search for an HIV vaccine. This is extremely welcome for the inherent, self-evident value of trying to pre- vent transmission of HIV; it is also remarkable for the way the award has been structured. As with other awards from the Gates Foundation (http://www.gatesfoundation.org/), such as the $750 million 5-year grant to the Global Fund for Children’s Vaccines, this latest award aims to create a market incentive for vaccine develop- ment [2]. Why is this concept so innovative and so necessary? Successful vaccines have been developed through the actions of individual investigators who understand the specific disease, government agencies who fund the basic science aspects, and public companies who develop the candidate preparations into practical vaccines. It would be misleading to present this chain of responsibility as a process of handing over a baton from one member of a team to another; in practice, the process is haphazard, discontinuous, and only maintained by the enthusiasms of individuals within each organisation. What are the incentives which drive key individuals to proselytise, often at the expense of popularity within their organisa- tions? For the investigator, there is the knowledge that their ‘‘favourite’’ virus is truly recognised as an important pathogen and that disease could be brought under control within a professional life-time. For government agencies, there is the prospect that a vaccine could reduce the public health burden of disease and probably save health costs overall. For public companies, there is the prospect of making financial returns for stock- holders while helping to prevent disease. A recent report from the Institute of Medicine shows that some vaccines could save money in the long-term, and many would be cost-neutral, yet large sums are needed up-front for their develop- ment costs [3]. Clinicians continue to expend vast resources on sub-optimal management of con- ditions which could be prevented, so there is a need to divert some of these funds into preven- tion, while maintaining care for individuals. The problem is thus one of cash-flow coupled with sharing of financial risk among the various stakeholders. As we have discussed previously, the cost can be considered a one-off revenue to capital transfer [4], with a short time of repayment due to reduction in the costs of caring for infected individuals. However, these obvious financial benefits are mis-represented by accountants who insist on discounting future savings. This occurs even though such standard cost accounting prac- tices are inappropriate and intellectually unjusti- fied for the health-care sector [5]. This is why the multi-million dollar award from the Gates Foundation is so welcome. It recognises the realities of vaccine development, and aims to use philanthropic funds to kick-start scientifically promising development programmes stalled for lack of support. Thus, in the HIV example, it will provide millions of dollars in each of five consecu- tive years to provide the cash-flow, confidence and continuity necessary for the International AIDS Vaccine Initiative to maintain a sustained scientific effort. Furthermore, the award is a ‘‘Challenge Grant’’ aiming to stimulate other donors to join an active development programme. In this way, a large guaranteed investment can provide financial leverage to create a ‘‘market incentive’’ to justify further investments. The return on the investment is not equity but a commitment that a successful vaccine preparation will be made available to the poorest of develop- ing countries at an affordable price. This concept Reviews in Medical Virology Rev. Med. Virol. 2002; 12: 67–68. Published online in Wiley InterScience (www.interscience.wiley.com). DOI: 10.1002/rmv.349 Copyright # 2002 John Wiley & Sons, Ltd.

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Page 1: Opening the Gates for vaccine development in the real world

EDITORIAL Opening the Gates for vaccine development inthe real world

‘‘In 100 years it will be clear that the ‘sea change’ inglobal health interest that took place in the earlytwenty-first century could be traced to two people: Billand Melinda Gates’’.

The quote above is taken from the winner of the2001 Lasker Award for Public Service [1]. The Billand Melinda Gates’ Foundation has certainlymade major contributions to vaccine developmentincluding 126.5 million dollars given to the Inter-national AIDS Vaccine Initiative to help the searchfor an HIV vaccine. This is extremely welcomefor the inherent, self-evident value of trying to pre-vent transmission of HIV; it is also remarkablefor the way the award has been structured. Aswith other awards from the Gates Foundation(http://www.gatesfoundation.org/), such as the$750 million 5-year grant to the Global Fund forChildren’s Vaccines, this latest award aims tocreate a market incentive for vaccine develop-ment [2]. Why is this concept so innovative andso necessary?

Successful vaccines have been developedthrough the actions of individual investigatorswho understand the specific disease, governmentagencies who fund the basic science aspects, andpublic companies who develop the candidatepreparations into practical vaccines. It would bemisleading to present this chain of responsibilityas a process of handing over a baton from onemember of a team to another; in practice, theprocess is haphazard, discontinuous, and onlymaintained by the enthusiasms of individualswithin each organisation. What are the incentiveswhich drive key individuals to proselytise, oftenat the expense of popularity within their organisa-tions? For the investigator, there is the knowledgethat their ‘‘favourite’’ virus is truly recognised asan important pathogen and that disease couldbe brought under control within a professionallife-time. For government agencies, there is theprospect that a vaccine could reduce the publichealth burden of disease and probably save healthcosts overall. For public companies, there is the

prospect of making financial returns for stock-holders while helping to prevent disease.

A recent report from the Institute of Medicineshows that some vaccines could save money in thelong-term, and many would be cost-neutral, yetlarge sums are needed up-front for their develop-ment costs [3]. Clinicians continue to expend vastresources on sub-optimal management of con-ditions which could be prevented, so there is aneed to divert some of these funds into preven-tion, while maintaining care for individuals. Theproblem is thus one of cash-flow coupled withsharing of financial risk among the variousstakeholders. As we have discussed previously,the cost can be considered a one-off revenue tocapital transfer [4], with a short time of repaymentdue to reduction in the costs of caring for infectedindividuals. However, these obvious financialbenefits are mis-represented by accountants whoinsist on discounting future savings. This occurseven though such standard cost accounting prac-tices are inappropriate and intellectually unjusti-fied for the health-care sector [5].

This is why the multi-million dollar award fromthe Gates Foundation is so welcome. It recognisesthe realities of vaccine development, and aims touse philanthropic funds to kick-start scientificallypromising development programmes stalled forlack of support. Thus, in the HIV example, it willprovide millions of dollars in each of five consecu-tive years to provide the cash-flow, confidenceand continuity necessary for the InternationalAIDS Vaccine Initiative to maintain a sustainedscientific effort. Furthermore, the award is a‘‘Challenge Grant’’ aiming to stimulate otherdonors to join an active development programme.In this way, a large guaranteed investment canprovide financial leverage to create a ‘‘marketincentive’’ to justify further investments. Thereturn on the investment is not equity but acommitment that a successful vaccine preparationwill be made available to the poorest of develop-ing countries at an affordable price. This concept

Reviews in Medical Virology

Rev. Med. Virol. 2002; 12: 67–68.Published online in Wiley InterScience (www.interscience.wiley.com).

DOI: 10.1002/rmv.349

Copyright # 2002 John Wiley & Sons, Ltd.

Page 2: Opening the Gates for vaccine development in the real world

of ‘‘social venture capital’’ (www.iavi.org) offers anew paradigm for funding the initial costs ofnovel vaccines. If other donors can be persuadedto rise to the ‘‘venture philanthropy’’ challenge,[6] the opening quote may yet turn into reality.

P. D. Griffiths

REFERENCES1. Foege WH. The wonder that is global health. Nat Med

2001; 7: 1095–6.

2. Brandt R. Philanthropy. Gates gives booster shot toAIDS vaccines. Science 2001; 291: 809–11.

3. Stratton KR, Durch JS, Lawrence RS. Vaccines for the21st Century. Washington, DC.: National AcademyPress., 2000

4. Griffiths P. Vaccination policies and accountants. RevMed Virol 1998; 8: 59–60.

5. West RR. Economic rate of discount and estimatingcost benefit of viral immunisation programmes. RevMed Virol 1999; 9: 51–5.

6. Gura T. Biomedical philanthropy, Silicon Valleystyle. Nature 2001; 410: 140–3.

68 Editorial

Copyright # 2002 John Wiley & Sons, Ltd. Rev. Med. Virol. 2002; 12: 67–68.