By Sarah de Guia and Nicolas Terry
The U.S. Food and Drug Administration (FDA) is poised to decide soon whether to authorize the emergency use of COVID-19 vaccines. While this is positive news, critical decisions remain about the equitable allocation of the vaccine.
On December 10, 2020, the FDA will hold a meeting of its vaccine advisory committee to consider an emergency use authorization (EUA) sought by Pfizer/BioNTech for its COVID-19 vaccine candidate. A week later, the committee likely will consider a similar request from Moderna for its candidate. The UK is moving on an even more aggressive timeline and has already approved the Pfizer/BioNTech candidate.
In 2020, it is expected that doses will be ready for only 20 million Americans; there will not be general availability until the second quarter of 2021.
So, who will get the vaccine soonest, and will those decisions be based on equitable criteria?
Equity is an important consideration in the distribution of the vaccine, given the disproportionate impact COVID-19.
Black, Latinx and Native American populations have had case rates at 2.6 and 2.8 times higher than whites (respectively) and hospitalization rates that were 4.7 times higher, while Pacific Islander communities experienced mortality rates that were five times higher than their proportion to the general population.
Recognizing these disparities, the National Academies of Science, Engineering, and Medicine convened experts to develop the Framework for Equitable Allocation of the COVID-19 Vaccine, with the overarching goal of reducing “severe morbidity and mortality and negative societal impact” due to COVID-19.
One of the three ethical principles for distribution includes “mitigation of health inequities,” which attempts to consider the impacts of systemic racism and other disparities that are associated with an increased likelihood of acquiring the infection, such as being an essential worker, having limited access to personal protective equipment, living in crowded conditions, and not being able to work from home. These conditions are rooted in fundamental drivers of inequity, including poverty, lack of power, disparities in opportunity, structural discrimination, and societal failure to address these longstanding inequities. Wrapped into this is the additional challenge of gaining trust within Black, Indigenous and People of Color to ensure uptake of the vaccines, given the country’s long history of discrimination, inhumane practices, and lack of access to health care, generally.
Another key consideration is intergovernmental coordination and decision-making. Overall coordination resides with the Centers for Disease Control and Prevention (CDC), which issued an Interim Playbook for Vaccine Distribution in October 2020. The playbook, based on assumptions about vaccine availability, breaks down probable distribution into three phases that will roughly correspond to distribution in the remainder of 2020, first quarter of 2021, and second quarter of 2021.
The playbook also identifies critical populations, specifically: the essential infrastructure workforce; persons at increased risk for severe COVID-19 illness; people at increased risk of acquiring or transmitting the virus; and those with limited access to routine vaccination services.
Given that Phase 1 supplies will be insufficient to vaccinate all of these critical populations, the playbook suggests the need for a priority system. For example, Phase 1a could be healthcare workers, while Phase 1b could include first responders, essential workers, teachers, cohorts with high-risk conditions, or those over 65 years of age (including long-term care residents).
Last week, the CDC’s Advisory Committee on Immunization Practices (ACIP) met and recommended healthcare workers and nursing home residents and staff as the cohorts to receive the vaccination under Phase 1a.
Interestingly (and controversially), the UK, which will receive only 800,000 doses in December, has elected to prioritize persons over 80 years of age and nursing home caregivers over healthcare workers.
In the U.S., the choices regarding Phase 1b may be even more controversial, potentially pitting saving the lives of elderly Americans against reducing infection by vaccinating essential workers; the latter cohort clearly encompassing large numbers of people of color and/or low-income.
The National Academies’ suggested distribution phases are similar to that of the CDC’s. Their framework suggests prioritizing communities or individuals considered vulnerable by the CDC’s Social Vulnerability Index or the COVID-19 Community Vulnerability Index. Doing so would further specify that the most vulnerable within those groups are the primary recipients of the vaccine in the first waves.
Equity principles must be applied not only to the distribution criteria, but also to their implementation.
Legally, the CDC is only making recommendations. In our heavily fragmented health care and public health systems, the actual decisions about distribution will lie with state governors, territorial, tribal, local health departments, or even health care systems, although most are likely to follow the CDC guidance. It is vital that they respect equity in practice, ensuring that vulnerable populations are identified and sought out. The fact that initial shipments of the vaccine to states are smaller than expected places a premium on transparent, equitable distribution.
It is indisputable that the societal, personal, and financial costs of COVID-19 – the cases, the mental and physical suffering, and deaths – have been inequitably distributed.
As policy makers consider the phases of vaccine distribution ahead, they must not only avoid exacerbating the conditions that led to infection, but also aggressively highlight equitable principles.
As the National Academies writes in their framework, “Inequities in health have always existed, but at this moment there is an awakening to the power of racism, poverty, and bias in amplifying the health and economic pain and hardship imposed by this pandemic.” Equitable vaccine distribution is an opportunity to make amends.
Sarah de Guia, JD is Chief Executive Officer, ChangeLab Solutions.
Nicolas Terry, LLM is Executive Director, Hall Center for Law and Health, Robert H. McKinney School of Law, Indiana University.