Issue Briefs • Vaccination Requirements and Exemptions • Informed Consent in Vaccination • The Vaccine Industry - An Overview • The Allocation of Vaccines during an Influenza Pandemic Evaluating Risk, Benefits, and Safety in Vaccine Policy • Risk-Benefit Analyses and Vaccine Safety Monitoring • Risk Communication and Related Ethical Considerations Vaccines and Bioterrorism • Bioterror Threats and Vaccines for Anthrax and Smallpox • Obstacles to 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 the understanding of many neglected tropical diseases (NTDs). 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, they argue.¹ This "social and political will" refers principally to global development priorities. NTDs have historically ranked low in research priority, with most attention and funding devoted to HIV/AIDS, malaria, and tuberculosis (often dubbed the "Big 3").² In addition, NTDs have lacked the high-profile champions of these other diseases that can drive attention and resources to research programs. Because of geographic overlap and the synergistic effect that NTDs have on the 'Big 3,' many argue that neglected tropical disease control should be directly linked with other vaccine development efforts, such as the International AIDS Vaccine Initiative, the Malaria Vaccine Initiative, and the Aeras Global Tuberculosis Vaccine Foundation.³ By failing to do so, opportunities and associated benefits from reductions in anemia, worm burdens, and susceptibility to HIV/AIDS, malaria, and tuberculosis morbidity have largely been missed thus far.⁴

Even while two million annual deaths result from inadequate vaccine access, resource allocation decisions remain incredibly difficult.⁵ While vaccination has been proven to reduce disease rates, disability, and death worldwide, vaccines often are not often considered urgent priorities.^6,7 In areas where vaccines could be most helpful, there are often major shortcomings in basic necessities of daily life, including food, shelter, water, and sanitation.⁸ Furthermore, developing countries' public health infrastructures, including storage and delivery systems, are inadequate for large-scale vaccination campaigns. While vaccines themselves may be cost-effective, the cost and complexity of the networks required to deliver them often present tremendous challenges for the developing world.⁹

Moreover, global, national, and local priorities often conflict with one another. 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 local support and enthusiasm, initiatives falter.¹¹ Public health decisions regarding vaccination clearly must combine epidemiological and clinical data with demand forecasts and the concerns of the local population. Yet a key stakeholder group--the millions of people suffering in developing countries--often lacks channels to express priorities and concerns. Along with tremendous power disparities, poor communication among stakeholders is consistently highlighted as a major challenge.

The Ethics of Poverty and Inadequate Vaccine Access

Tropical diseases have widespread effects on the societal, economic, and political infrastructures of developing countries. Georgetown University's Lawrence Gostin writes that "[s]tates with exceptionally unhealthy populations are often in crisis, fragmented, and governed poorly."¹² He adds 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 such as vaccines function in an "autocatalytic process" connecting health and development.¹⁴ Improving health through direct means such as vaccination facilitates school attendance as well as worker productivity and thus contributes to 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, the poverty cycle in developing countries will continue, Sen argues.

The relative lack of attention to the prevention of NTDs indicates that the international community has not been sufficiently swayed by ethical arguments. Gostin suggests that the theory of human functioning reveals that health disparities are inherently unethical.¹⁸ The global burden of disease falls on the poor disproportionately, drastically altering both life expectancy and quality. These disparities are indeed a defining characteristic of modern society.¹⁹ Health impacts an individual's opportunities and is essential for engagement in society, including social interactions, political participation, generation of wealth, and personal security. The NTDs' high incidence in children, an inherently vulnerable population, underscores the argument that poor health prohibits individuals from living as they wish to, reducing their ability to function and their broader capacity for human agency.²⁰

Justice is another ethical concern relevant to discussions of neglected tropical 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 fundamental causes of inequality are remedied, justice concerns will persist. Social contract theory, which posits the existence of implicit agreements through which individuals form nations and maintain order, holds that states have basic obligations to promote the health of their citizens. Such a contract is often impossible to uphold amid poverty and violence. While the international community may be moving toward a global health contract, there is no consensus on the duty that wealthy countries have to poorer ones.²²

These ethical concerns can be distilled into one fundamental question: are all lives of equal worth? The very nature of a sovereign country's social contract may undermine the notion of human equality, commentators argue. 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 countries, world leaders inevitably make value judgments every day. The recent global integration of information, capital, and technology has increased the fluidity of our social borders.²⁴ The interconnectedness of the global community challenges us to reassess the way in which we conceive of national responsibility. An examination of global health disparities, including the prevalence of the neglected tropical diseases and the international attention they receive, highlights key ethical concerns that contemporary society must confront.

-- By Katelin Hoskins, University of Pennsylvania (hoskinsk@nursing.upenn.edu); Updated July 2010

¹ Hotez PJ & Ferris MT. (2006). The antipoverty vaccines. Vaccine, 24:5787-5799.
² Hotez 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.
³ Ibid.
⁴ Ibid.
⁵ Chokshi DA & Kesselhiem AS. (2008). Rethinking global access to vaccines. BMJ, 336: 750-753.
⁶ Andre 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.
⁷ Muraskin 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.
⁸ Mittal O. (2008). Vaccine requirements compete with basic needs of poor people. BMJ, 336:975.
⁹ Ibid.
¹⁰ Muraskin 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.
¹¹ Ibid.
¹² Gostin LO. (2007). Why rich countries should care about the world's least healthy people. JAMA, 298(1): 89-92.
¹³ Ibid.
¹⁴ Sen AK. (1999). Development as freedom. New York: Knopf.
¹⁵ Ibid.
¹⁶ Hotez 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.
¹⁷ Eiss RB & Glass RI. (2007). Bridging the coverage gap in global health. JAMA, 298(16): 1940-1942.
¹⁸ Ibid.
¹⁹ Gostin LO. (2007). Why rich countries should care about the world's least healthy people. JAMA, 298(1): 89-92.
²⁰ Ibid.
²¹ Ibid.
²² Gostin LO. (2007). Why rich countries should care about the world's least healthy people. JAMA, 298(1): 89-92.
²³ Singer P. (2002). One World, The Ethics of Globalization. Yale University Press.
²⁴ Friedman T. (1999). The Lexus and the Olive Tree. Farrar, Strauss & Giroux: New York.