Issue Briefs • Vaccination Requirements and Exemptions • Informed Consent in Vaccination • The Vaccine Industry - An Overview • The Rationing of Vaccines Against Pandemic Influenza Evaluating Risk, Benefits, and Safety in Vaccine Policy • Risk-Benefit Analyses and Vaccine Safety Monitoring • Risk Communication and Related Ethical Considerations Vaccines against Potential Agents of Bioterrorism • Bioterror Threats and Vaccines against Anthrax and Smallpox • Obstacles Facing Bioterror Vaccine Development Vaccines for Tropical Diseases and Global Research Priorities • Neglected Tropical Disease Vaccine Candidates and Financing • Vaccine Research Priorities and Obstacles to Access The Quest for an HIV Vaccine • Challenges in HIV Vaccine Development - An Overview • Logistical and Ethical Considerations of HIV Vaccine Clinical Trials • HIV Vaccine Clinical Trials: The Standard of Care Debate

Vaccines for Tropical Diseases and Global Research Priorities
II. Vaccine Research Priorities and Obstacles to Access

Global Priority Setting for Vaccine Development

Advances in genomic sequencing have enhanced baseline understanding of many neglected tropical diseases; physician-researchers Peter Hotez and Meghan Ferris argue that technical hurdles no longer limit vaccine development. Rather, "the social and political will needed to translate scientific discoveries into products" is lagging.¹ This necessary social and political will is related to global priority setting. The poverty diseases have historically ranked low in the priority hierarchy, with the most attention and dollars focused on HIV/AIDS, malaria, and tuberculosis (often dubbed the "Big 3").² In addition, the poverty diseases have not had the high profile champions of more generously funded diseases. Because of geographic overlap and the synergistic effect that poverty diseases have on the 'Big 3,' many argue that neglected tropical disease control should be directly linked with other vaccine development efforts: the International AIDS Vaccine Initiative, the Malaria Vaccine Initiative, and the Aeras Global Tuberculosis Vaccine Foundation.³ Opportunities and associated benefits from reductions in anemia; worm burdens; and susceptibility to HIV/AIDS, malaria, and tuberculosis morbidity have largely been ignored.⁴

Even with two million annual deaths resulting from inadequate vaccine access, resource allocation decisions are incredibly difficult.⁵ Yet while vaccination greatly reduces disease, disability, death, and inequity worldwide, as isolated interventions, vaccines often are not considered urgent priorities.^6,7 In areas where vaccines could be most helpful, there are often major shortcomings in basic necessities, including food, shelter, water, and sanitation.⁸ Furthermore, developing countries' public health infrastructures, including research and delivery systems, are inadequate for large-scale vaccination campaigns. While vaccines may be cost-effective, the cost of the systems required to deliver them must also be accounted for.⁹

Moreover, global and local priorities often come into conflict. Large PPPs struggle to balance "top-down" and "bottom-up" approaches in their relationships with developing countries.¹⁰ Historian William Muraskin explains that top-down globalism has a powerful role in moving the public health community forward, but without true bottom-up support and enthusiasm, initiatives falter.¹¹ Public health decisions around vaccination should take epidemiological data and demand forecasts into account, as well as closely examine the local population's concerns. Yet a key stakeholder group - the millions of people suffering in rural developing countries - lacks the voice to call their priorities to the global agenda. Along with tremendous power disparities, poor communication among stakeholders is consistently highlighted as a major problem.

The Ethics of Poverty and Inadequate Vaccine Access

These poverty diseases have widespread effects on the societal, economic, and political infrastructures of developing countries. Public health scholar Lawrence Gostin asserts that "[s]tates with exceptionally unhealthy populations are often in crisis, fragmented, and governed poorly."¹² He further contends that societal disaffection, political instability, civil unrest, mass migrations, and human rights abuses are linked to extreme poor health.¹³ Poor health and economic decline are also inescapably interwoven. The economist-philosopher Amartya Sen describes how health interventions like vaccines function in an "autocatalytic process" connecting health and development.¹⁴ Improving health through direct means, like vaccines, facilitates school attendance as well as worker productivity - and thus economic growth.^15,16 Moreover, good health improves economic dividends by advancing development, building the workforce, and enhancing business.¹⁷ Unless endemic health problems like the neglected tropical diseases are addressed, poverty will continue to cycle in developing countries.

The prevalence and neglect of poverty diseases indicate that ethical arguments and calls to action have not been heeded by the international community. Gostin suggests that the theory of human functioning may make the strongest claim that health disparities are unethical.¹⁸ The global burden of disease falls on the poor disproportionately and drastically alters both life expectancy and quality; these disparities are indeed a defining issue of modern society.¹⁹ Health impacts an individual's opportunities and is essential for engagement in society, whether that be social interactions, political participation, generation of wealth, or security. The poverty diseases' high incidence in children, an inherently vulnerable population, amplifies the argument that poor health prohibits individuals from living the lives they wish, thereby reducing the ability to function and the broader capacity for human agency.²⁰

Justice is another ethical concern in discussing the poverty diseases. The philosopher Thomas Nagel explains that "[j]ustice as ordinarily understood requires more than mere humanitarian assistance to those in desperate need."²¹ Until the deep-rooted causes of inequality are remedied, justice concerns persist. Social contract, the political theory describing the implicit agreements by which individuals form nations and maintain order, holds that states have basic obligations to promote the health their citizens, but that contract is often impossible to execute in the midst of poverty and violence. Furthermore, while the international community may be moving toward a global health compact, there is no consensus on the duty that wealthy countries owe to poorer ones.²²

Perhaps the most compelling ethical issue comes down to a fundamental question: are all lives of equal worth? The very nature of a sovereign country's social contract questions affirmations of human equality. Philosopher Peter Singer asks, "To what extent should political leaders see their role narrowly, in terms of promoting the interests of their citizens, and to what extent should they be concerned with the welfare of people everywhere?"²³ In prioritizing the needs of one's own citizens over those of other sovereign countries, world leaders make inevitable value judgments every day. As explained by journalist Thomas Friedman, the integration of information, capital, and technology across national markets has increased the fluidity of our borders.²⁴ The growing interconnectedness of the global community challenges us to reassess the very way in which we conceive value. An examination of global health disparities, the poverty diseases' prevalence and their place on the global agenda highlights key ethical concerns that contemporary society must grapple with and ultimately address.

-- By Katelin Hoskins, University of Pennsylvania (hoskinsk@nursing.upenn.edu)

¹Hotez PJ & Ferris MT. (2006). The antipoverty vaccines. Vaccine, 24:5787-5799.
²Hotez PJ, Molyneux DH, Fenwick A, Ottesen E, Sachs E & Sachs JD. (2006). Incorporating a rapid-impact package for neglected tropical disease with programs for HIV/AIDS, tuberculosis, and malaria. PLoS Medicine, 3(5): e102 doi:10.1371/journal/pmed./0030102.
³Ibid.
⁴Ibid.
⁵Chokshi DA & Kesselhiem AS. (2008). Rethinking global access to vaccines. BMJ, 336: 750-753.
⁶Andre FE, Booy R, Bock HL, Clemens J, Datta SK, John TJ, Lee BW, Lolekha S, Peltola H, Ruff TA, Santosham M & Schmitt HJ. (2008). Vaccination greatly reduces disease, disability, death, and inequity worldwide. Bulletin of the World Health Organization, 86(2): 140-146.
⁷Muraskin W. (2004). The Global Alliance for Vaccines and Immunization: is it a new model for effective public-private cooperating in international public health? American Journal of Public Health, 94(11): 1922-1925.
⁸Mittal O. (2008). Vaccine requirements compete with basic needs of poor people. BMJ, 336:975.
⁹Ibid.
¹⁰Muraskin W. (2004). The Global Alliance for Vaccines and Immunization: is it a new model for effective public-private cooperating in international public health? American Journal of Public Health, 94(11): 1922-1925.
¹¹Ibid.
¹²Gostin LO. (2007). Why rich countries should care about the world's least healthy people. JAMA, 298(1): 89-92.
¹³Ibid.
¹⁴Sen AK. (1999). Development as freedom. New York: Knopf. in Chokshi DA & Kesselhiem AS. (2008). Rethinking global access to vaccines. BMJ, 336: 750-753.
¹⁵Ibid.
¹⁶Hotez PJ, Molyneux DH, Fenwick A, Ottesen E, Sachs E & Sachs JD. (2006). Incorporating a rapid-impact package for neglected tropical disease with programs for HIV/AIDS, tuberculosis, and malaria. PLoS Medicine, 3(5): e102 doi:10.1371/journal/pmed./0030102.
¹⁷Eiss RB & Glass RI. (2007). Bridging the coverage gap in global health. JAMA, 298(16): 1940-1942.
¹⁸Ibid.
¹⁹Gostin LO. (2007). Why rich countries should care about the world's least healthy people. JAMA, 298(1): 89-92.
²⁰Ibid.
²¹Ibid.
²²Gostin LO. (2007). Why rich countries should care about the world's least healthy people. JAMA, 298(1): 89-92.
²³Singer P. (2002). One World, The Ethics of Globalization. Yale University Press: United States.
²⁴Friedman T. (1999). The Lexus and the Olive Tree. Farrar, Strauss & Giroux: New York.