Posted on June 11, 2020 at 9:00 AM
by R. Thomas Day, Bradley S. Guidry, Brian C. Drolet, Ellen W. Clayton
The United States has never experienced the grim realities of a resource-limited healthcare environment like that brought by Covid-19. Dire projections of overwhelmed ICUs introduced the public to novel concepts such as flattening the curve, triaging, and resource allocation. In response, hospitals and states moved quickly to update resource scarcity protocols to preserve ventilators and personal protective equipment.
Fortunately, massive public health efforts were able to slow viral spreading enough that medical systems were only overwhelmed in a few locations. Accordingly, scarcity protocols were not widely implemented. However, the discussion is still germane. Although much of the ethical conversation on resource allocation has focused on ventilators, the more important subject going forward is likely to be another equally limited resource – vaccines.
The international research community, supported by both public and private investors, is racing to produce safe and effective novel coronavirus vaccines. However, despite widespread enthusiasm around vaccine development, there has been little discussion about how to fairly allocate and distribute a Covid-19 vaccine once it is produced. Although vaccine allocation frameworks have been widely discussed in the past, these discussions have been mostly hypothetical and have not occurred in the setting of this current pandemic.
To date, most ethical conversations regarding SARS-CoV-2 have focused on how to transition from business as usual to resource-limited care. After similar questions arose during the 2009 H1N1 influenza pandemic, the Crisis Standards of Care model was created to provide a framework to shift from conventional to contingency to crisis scenarios. In effect, this model shifts the emphasis of care from the clinical ethical principles of autonomy, shared decision making, and clinical reasoning to a framework that combines principles from both clinical and public health ethics. This blended approach is reflected in contemporary guidelines that emphasize the utilitarian aims of maximizing lives saved with limited resources as well as the values of addressing medical neediness and equity.
Ventilators provide a compelling illustration of how these frameworks can alter clinical decision-making. Under normal circumstances, judgments about reasonable ventilator use follow clinical ethical guidelines. The physician and patient (or surrogate) make decisions based on the medical indications for treatment, patient preferences and other contextual factors. However, once ventilators become scarce, utilization decisions change because each ventilator can typically only support one critically ill patient at a time. This forces healthcare teams to make painful, zero-sum choices in an attempt to maximize lives saved. In some cases, it can even justify removing one patient from a ventilator in order to redistribute it to another patient with a better prognosis.
In contrast, vaccines differ from ventilators in several important ways, which limit the relevance of the crisis standards of care model. Unlike the ability of a ventilator to help one person, vaccines benefit many people simultaneously. A single dose protects both the recipient and the community by preventing viral spread as herd immunity develops. Furthermore, vaccine allocation is not an immediate life-or-death dilemma. It is focused on prevention rather than life-sustaining intervention, which allows for strategies that target systemic inequities.
These qualitative differences call for distinct sets of ethical values. In ventilator allocation, utilitarian principles typically prevail over the pursuit of equity. For example, prioritizing a patient with a good prognosis over another with many comorbidities favors maximizing lives saved over the principle of priority to the neediest. Furthermore, these utilitarian frameworks have a limited ability to address systemic inequities. For instance, seemingly objective prognostic data, such as a patient’s comorbidities, may perpetuate pre-existing disparities since comorbidities are disproportionately present in underserved populations. In contrast, vaccine allocation allows for the promotion of equity as resources can be devoted to those most at risk, while at the same time conferring population benefit.
Clearly, vaccines need a separate allocation framework. Vaccines provide the quintessential public good because of their population-level effects on herd immunity. They require an ethical framework for allocation that shifts from the crisis standards of care model’s blend of clinical and public health ethics to one informed predominately by public health principles. Previous work around the ethics of vaccine allocation relies on the public health principles of interdependent population health, transparent community engagement, and equitable resource management. Therefore, in addition to vaccinating the medically neediest individuals, an ethically sound vaccine allocation strategy should include the following considerations:
Consideration #1: Community Engagement
Local community engagement is of the utmost importance. Public trust and cooperation are paramount in achieving herd immunity, which must be considered a primary goal of any vaccination strategy. Transparent distribution guidelines based on community values may reduce vaccine hesitancy and minimize hoarding by increasing local buy-in. One potential tool for creating these guidelines is deliberative democracy, which facilitates engagement from diverse stakeholders and educates participants about scarcity protocols. Although varied protocols allow for opportunities to introduce bias, local communities may be able to create trusted distribution guidelines that better reflect local values, rather than relying on a single comprehensive national protocol. Since a coronavirus vaccine will not be ready for distribution for months to years, we have both an opportunity and an obligation to begin working with local communities now to develop trusted allocation processes.
Consideration #2: Individual and Population-Level Approaches
Allocation strategies must also reflect vaccines’ dual benefits of protecting both individuals and communities. Clinical ethics and the principle of meeting medical need should dictate which individuals receive priority, while public health ethics and the principles of health equity and reciprocity should inform strategies to reduce community spread. For example, a strategy that seeks to reduce viral transmission in severely affected communities would champion utility and equity in two ways. First, it would prioritize the hardest-hit communities. Second, in order to reduce transmission, it would prioritize those who cannot social distance, such as those living in high-occupancy conditions and others who must work outside the home in essential occupations. These groups are potentially at a greater risk of acquiring and transmitting the virus. Therefore, vaccinating them protects both individual and population health. Ultimately, allocation policies will guide difficult decisions about who gets the first vaccines, and part of those decisions should rely on data about transmission and susceptibility that is only now being understood.
This is only the beginning of the conversation. Juxtaposing ventilators and vaccines highlights broad differences between utilitarian and equity-based frameworks. Specific ethical questions demonstrate practical challenges with implementation. For example, immunocompromised patients are vulnerable but may not mount an adequate immune response for a vaccine dose to be effective. Similarly, low- and middle-income countries should be prioritized based on equity, but their public health infrastructure may compromise their ability to deliver vaccines effectively. More data and ethical deliberations are needed to answer these and other outstanding questions. However, if we start now, we have the opportunity to develop an ethically sound and politically acceptable allocation framework before novel coronavirus vaccines are produced, a day we hope will be here soon.