Our monkeypox vaccination plan is an experiment. It requires better care.
To deal with both the uncertain effectiveness and the scarcity of vaccine supplies, federal health authorities have put in place a plan to maximize the number of people with a certain level of protection. Instead of being injected into fatty tissue, the Jynneos smallpox vaccine will now be injected intradermally – under the top layers of the skin – and in a much smaller amount, stretching one dose into five doses. This technique, called “fractional dosing” or “sparing dose”, has been used in other vaccination campaigns, particularly against influenza.
The Biden administration’s split-dose monkeypox vaccination plan is based on the results of a single study and remains subject to scientific and clinical debate. This may yield useful data on how intradermal vaccination produces an immune response. However, it also adds to the experimental nature of the vaccine rollout.
Past health crises help illustrate how medical shortages and government neglect can lead people to participate in medical and public health projects with uncertain outcomes. The monkeypox vaccination is the final chapter in this story of health experiments – a story that links biomedical uncertainty to social marginalization.
The growing influence of bioethics in the mid-twentieth century, particularly after the horrors of Nazi medicine and the Tuskegee study of syphilis, normalized informed consent in research. Consent to participate in medical research sometimes gave access to treatment. However, this research did not always address the inequality of access to health care.
Such was the case in experiments in treating tuberculosis among the Navajo people in the 1950s. White researchers learned of an epidemic of tuberculosis in the Many Farms community of the Navajo Nation in the northeast of the United States. ‘Arizona (Dá’ák’eh Halani). The researchers hoped to test the effectiveness of treating tuberculosis with the antibiotic isoniazid. But to understand isoniazid’s unique effectiveness, they needed to test it in a population that didn’t have access to additional antibiotics for tuberculosis. If other antibiotics were used, it would be difficult to show the individual effects of isoniazid. Due to years of neglect by the US government, the people living at Many Farms met these criteria and therefore seemed ideal for studying isoniazid. The community accepted the research.
The drug helped fight the tuberculosis epidemic, but the focus on the effectiveness of isoniazid meant that the intervention did not address underlying inequalities in healthcare. Without investments in broader community health, mortality has remained high and medical researchers have undermined community trust in healthcare workers. The experience was extractive. He built knowledge but denied care.
In the 1960s and 1970s, conversations about addressing the root causes of disease and disparities in access to health care through research design were increasingly common. Activists have become more involved in debates about who can participate in new medical and public health research, particularly in the areas of women’s health and cancer.
For example, women’s health groups such as the Boston Women’s Health Collective have sought to change the longstanding reluctance of clinical trials to recruit women.
HIV/AIDS drug trials in the 1980s marked another major turning point when activists denounced the links between research and access to health care. The impact of AIDS on gay men in the 1980s in the United States meant that gay activists created movements that demanded access to experimental antiretroviral drugs. When scientists conducted a clinical trial of AZT (azidothymidine) and concluded that it could reduce HIV transmission and mortality among people with AIDS, the drug quickly became a rallying point for some activists in the AIDS. Being part of drug efficacy testing has become a desperately desired chance for many HIV-positive people to continue living.
But some activists and doctors have questioned the disparities among AZT trial participants. They noted that trial participants who had higher survival rates and fewer adverse effects were also more likely to have health insurance and access to their own doctors. Regular medical support and follow-up was critically important to prevent death. At trial sites where participants did not have consistent access to health care, more deaths occurred. The AZT trials illustrated the challenges of ignoring potentially significant differences in participants’ access to health care.
HIV drug clinical trials also often underrepresented black and Latino participants and overrepresented white gay men.
Campaigners have pointed out that efficacy actually has two components – the effectiveness of the drug and access to care.
The AIDS activist coalitions of the 1990s made this last issue the basis of their advocacy with public health officials and medical professionals. This was especially the case for African American activist groups focused on improving HIV care in black communities.
By connecting to global campaigns on issues such as drug pricing, patents and the availability of cheaper generic drugs, these groups have linked biomedical innovation with reducing inequalities in access to health care. Activists also challenged the pharmaceutical industry, questioning how its profit motives shaped experimental priorities. Bodies could prove much more than biological truths; they were a playground for social and economic dilemmas.
The effectiveness of preventive measures took a different turn in the 2010s, during debates on the development of pre-exposure prophylaxis, or PrEP, which helps prevent HIV transmission. The drug known as Truvada, taken once a day and now available in generic form, can reduce the possibility of HIV transmission by up to 99%. It was approved by the FDA in 2004 as a treatment for people living with HIV and in 2012 as pre-exposure prophylaxis in HIV-negative people.
Despite the effectiveness of the drug, some early public reactions to the drug nonetheless portrayed it in terms of uncertainty. Instead of asking if the drug worked, discussions often focused on how people would behave if they had access to the drug. While PrEP’s effectiveness was clear, some health authorities raised concerns that the drug would lead to increased condomless sex and higher risk of STI prevalence.
Arguments about morality have hampered the drug’s rollout, leaving some of those most at risk of contracting HIV less able to access the drug. Meanwhile, pharmaceutical marketing tended to target white gay men. Indeed, this has resulted in unequal access to PrEP among black men and women.
These stories show that beyond the critical question of “does this drug work?” an additional question is crucial: how to ensure the care of people participating in uncertain biomedical projects, in particular due to government failure?
Monkeypox illustrates the stakes of these two questions. Activists argue that the new split dosing plan may increase the number of doses, but does not necessarily guarantee access for black and Latino men at a time when test positivity is increasingly concentrated in communities of color.
There are also global inequalities. To date, not a single Jynneos vaccine has been made available in West and Central Africa, where monkeypox has caused many more deaths than in countries with access to the vaccine.
Still, in places where vaccines have been distributed, there is reason to be cautiously optimistic about the sprint to contain and treat monkeypox. Recently published data from Britain, Canada, Germany and New York suggest that the incidence of new cases of monkeypox may be declining. It is likely that alongside vaccines, changing sexual practices and community-based research work by health advocates are contributing to this decline.
The past teaches us that efficiency is always both a scientific and a social problem. As health experiments continue, it’s crucial to remember which bodies make certainty possible – and at what cost.