HIV vaccine development: infrastructure, funding, and global commitment

HIV Vaccine

It Takes a Village

Advances in medical treatment follow two paths more or less simultaneously. The first of these is the basic and directed scientific research that is needed to provide the concepts and solutions that may be channeled into particular treatments or cures. The second is equally important in terms of the ways in which medicine is conducted in the current age: The infrastructure to fund medical developments, to guide them through the approval process, and to distribute them to the medical professionals and patients who will be able to use them is a complicated and extremely expensive process. This paper examines the current state and possible future directions of the process of developing a vaccine for AIDS, focusing on the latter of these two pathways while touching on the current state of the science of such a vaccine (Shilts, 1987).

The quest for a vaccine for AIDS (that is, for the human immune-deficiency virus that causes AIDS) began not long after the disease was recognized. While the disease is now believed to have origins in the late 19th century (a date based on genetic techniques), AIDS was not recognized by Western medical authorities until 1981, when the Centers for Disease Control and Prevention officially named it. The cause of the disease -- HIV -- was recognized soon afterward and soon after that HIV was linked to the older, closely related disease simian immunodeficiency virus (Sepkowitz, 2001, p. 1765.)

In the initial years after the disease came to the attention of Western medical officials and of the populations that were initially the hardest hit (including gay men and IV-drug users) AIDS was a terribly efficient killer, with individuals on average dying about a year after symptoms began to appear. The lethality of the disease made a vaccine initially highly attractive, although the fact that the populations most affected initially were highly socially stigmatized reduced support for such an enterprise. While the doctors who treated the first AIDS patients were generally highly compassionate (as well as intellectually curious about the new disease), the other players and stakeholders in the process were reluctant to begin to funnel the resources needed into the medical infrastructure to begin to explore possibilities for treatments and a vaccination for AIDS.

The commitment of public health services, governments, NGOs and other non-profits, along with research programs and drug companies, has shifted dramatically since those first days of the AIDS pandemic. That shift has occurred because the disease has become a pandemic: While it was relatively easy for governments and other funding sources to ignore or dismiss the importance of developing a vaccine or treatments for a disease that seemed to affect only drug users and gay men, it is impossible for them to ignore children left orphans as their parents died and the children themselves dying by the thousands.

AIDS is now a pandemic. The AIDS research organization (which also advocates for the rights of those affected with the disease) estimated that worldwide as of 2009 there are 33.3 million people with HIV / AIDS (Worldwide AIDS and HIV statistics, AVERT.org). The same organization also estimates that there are 2.6 million new HIV infections each year and the world sees 1.8 million deaths each year due to complications from AIDS. Disease and death on this scale are impossible for governments to ignore.

However there remain some substantial roadblocks to AIDS treatments and vaccine production. Primary among these is that fact that most of the people who are currently infected and those who are dying of AIDS live in sub-Saharan Africa. According to the World Health Organization, over three-quarters of recent AIDS victims are from this fundamentally impoverished region of the world that, along with lacking economic power, also lacks political power. (These two facts are, of course, related to each other.) The WHO also estimates that hundreds of thousands of children are dying of AIDS each year, many of these in sub-Saharan Africa (WHO, 2007 AIDS epidemic update.)

Public health authorities, medical clinicians, and others engaged in the business of trying to put an end to the AIDS pandemic generally agree on the fact that an effective vaccine might well be the only way to halt the pandemic (Bentwich, Kalinkovich, & Weisman, 1995). Treatments exist that reduce the viral load that an infected person has (in large measure the viral load is a proxy for both how sick someone is from AIDS and how infectious he or she is) to such a low level that that individual is highly unlikely to be able to infect anyone else (Kaleebu et alia, 2002).

However, such a treatment is both complicated and expensive requiring numerous medications taken at precise times for years. Such a drug regimen is simply not feasible for many of the people living in sub-Saharan Africa (Morgan, et al., 2002). Thus the kinds of treatments that significantly improve the quality of life for AIDS patients, dramatically increase their potential lifespan, and reduce their degree of infectiousness is simply not available to the majority of those who have HIV / AIDS. This makes a vaccine for AIDS even more important to develop. And yet, despite the urgency of the need for this vaccine, and despite the fact that researchers have been working to create a vaccine for three decades, the possibility of an AIDS vaccine remains distant.

Economics of a Vaccine

The fact that a single vaccine would be able to protect individuals against all (or at least most) of the current strains of AIDS substantially changes the ways in which an AIDS vaccine could be developed, marketed, and distributed. Just a decade into the pandemic, careful analyses of an effective AIDS vaccine demonstrated that it would be financially worthwhile (e.g. Cowley, 1993). For governments, who will have to shoulder much of the cost of AIDS treatment in the countries in which the disease is the most common, the cost of a vaccine must be weighed against the cost of the disease. This is of course, a terrible calculation that government officials have to make (Harmon, 2009). But for poor governments, a vaccine is not worth supporting if it will not be effective (Song & Ostrom, 2007).

The primary costs for governments are not the cost of the development of the vaccine itself. This cost is being borne primarily by Western research facilities as well as pharmaceutical companies. These two have their own reasons for promoting an AIDS vaccine. The former are motivated by a number of factors, including the prestige that would accompany a successful vaccine, humanitarian values, and in some cases the potential for financial gain (Nabel, 2001). The latter, being for-profit corporations, are motivated by the potential for profit, although one should not therefore presume that they are not also interested in the humanitarian aspects of a vaccine.

Governments along with NGOs and non-profits are responsible for building the public health system that can distribute any new vaccine (Letvin, 2002). Such a distribution system includes everything from maintaining roads to staffing clinics to supporting law enforcement efforts to keep the vaccine from being stolen and resold and the substitution of fake vaccines for real ones. Governments must also take on the cost of educating the public so that they will participate in any vaccination program (Kim, Elizaga & Duerr, 2007). Government officials can be helped in such efforts by large non-profits such as the Bill and Melinda Gates Foundation as well as small local non-profits working to integrate local cultural and social norms into national and international public health efforts.

The complexity of the process of creating an AIDS vaccine and the ways in which the actions and motivations of different stakeholders in the process must be integrated are summarized below:

Good science will produce a vaccine against HIV. However, good science in and of itself will not be enough. A promising vaccine candidate without the volunteers needed to test it, or a vaccine that is not trusted by the people it is meant to benefit, will impair long-term success. To succeed, researchers must collaborate with policymakers and public health officials to engage the public in the pursuit of an effective HIV vaccine.

The goal of all of the stakeholders involved in the development of an AIDS vaccine must be to do better than previous efforts to vaccinate adult populations in vulnerable areas of the world.

To achieve effective and equitable distribution of the HIV vaccine once it is available, governments and international organizations will require both adequate supplies of the vaccines from manufacturers and the infrastructure to deliver the vaccine quickly. Developing countries now wait an average of twenty years after a vaccine is licensed in industrialized countries before it begins to reach their own populations. Hepatitis B vaccine uptake and policies provide insight into the enormous challenges of adult immunization in industrialized countries. Although the vaccine has been available for more than twenty years, financial barriers -- as well as a lack of awareness -- have prevented many people at risk for infection from receiving an immunization.

Previous efforts have failed to bring together all of the partners that must talk with each other to create the social, political, and economic conditions that will allow for the successful implementation of an AIDS vaccine. The risks for all of the parties are substantial, from the economic costs involved in creating a new antiviral vaccine to the cultural risks that a government would face if people believed that a vaccine is harmful. But the benefits of a truly effective AIDS vaccine would offer benefits that would more than compensate for such risks.