On December 11, 2020, the US Food and Drug Administration (FDA) announced it is sued an emergency use authorization (EUA) for the Pfizer-BioNTech coronavirus disease 2019 (COVID-19) vaccine (1); a week later, on December 18, the FDA announced it had granted an EUA for the Moderna vaccine. (2) (See related article on p26 of this issue--Ed.) Investigators overcame unprecedented scientific obstacles to develop these 2 vaccines and reach governmental authorization. (3) Yet the ethical challenges of vaccine allocation may be even more daunting.
Since at least 1962, when the FDA first grappled with the conundrum of who should get access to the novel dialysis machine, (4) health care professionals, bioethicists, and public health leaders have wrestled with how to justly distribute the angel of life-saving resources when the devil is in the details precisely because the resource is scarce. Sadly, not everyone who needs and could benefit from life-saving care can receive it. Allocation decisions for COVID-19 vaccines are especially weighty, given that the virus has thwarted most other therapeutics, besieged the health care system, collapsed the economy, and caused widespread social disruption.
There are many vexing ethical issues surrounding COVID-19 vaccine allocation. Fortunately, we are not alone in navigating this moral labyrinth. In the past few months, several of the most respected public health institutions in the world have published reports that provide ethical frameworks for allocating the COVID-19 vaccine (Table (1-3,5,6)). Any ethical framework must consider those with serious mental illness, and the hundreds of members of our specialty who are on the front line delivering COVID-19 care. (Note: future Psychiatric Times[TM] articles will consider exactly where individuals with mental health illness should fall in the vaccine prioritization queue.)
Several observations about the ethics of COVID-19 vaccine allocation in the United States can be drawn from these summaries. First, the 3 American frameworks summarized in the Table contain principles of distributive and procedural justice. (7) In the context of allocating scarce resources, "distributive justice" concerns the outcomes that are sought when competing ethical values, principles, and interests must be balanced. For example, ethical vaccine prioritization must balance utility in maximizing the reduction of severe disease and mortality from COVID-19, ensuring groups with health disparities have fair access to the vaccine and promoting respect for the dignity of vulnerable populations, such as those with disabilities.
"Procedural justice" concerns the process of specifying and weighing these many values, principles, and interests. For vaccine allocation planning and execution, an ethical process requires wide stakeholder input, transparent decision-making, and a clear mechanism for adjusting criteria in response to new scientific data and logistic developments.
The Table also illustrates the critical difference between the clinical ethics most of us practice, in which the preferences and needs of the individual patient are the locus of decision-making, and...