R. Alta Charo is the Warren P. Knowles Professor of Law and Bioethics at the University of Wisconsin. She was a member of the National Academies of Sciences, Engineering and Medicine committee that recently drafted “Framework for Equitable Allocation of Vaccine for the Novel Coronavirus,” and she was a member of the Vaccine Ethics Subcommittee of the Wisconsin State Disaster Medical Advisory Committee.
The U.S. Department of Health and Human Services recently had a plan to spend $250 million of its COVID-19 budget to give Santa Claus a first shot at getting a coronavirus vaccine. Around Christmas time, many Santas around the country offer a lap to children, whose parents are close by, putting Santas at enhanced risk of exposure. Plus, of course, Santas are essential to public morale.
Though it has since been abandoned, the Santa plan did address some challenges and even some ethical principles underlying the more realistic plans for vaccine distribution. First, it highlighted the need to identify role models who could persuade increasingly skeptical members of the public to get the vaccine once available. Second, it highlighted the need to prioritize during the early months of limited supply by offering vaccination to the medically vulnerable and to “essential workers,” of whom Santas were thought to be among.
The chairman of the Fraternal Order of Real Bearded Santas was disappointed by the cancellation: “This was our greatest hope for Christmas 2020, and now it looks like it won’t happen.”
The uncertainties around COVID-19 vaccine development and availability are many, but vaccines are coming. A few have reached Phase 3 trials, with thousands of research subjects.
In early October, a National Academies of Sciences, Engineering and Medicine committee presented its recommendations for a best approximation of an equitable framework for distributing vaccines against COVID-19. Built on widely accepted principles and guided by evidence to achieve the goal of reducing severe morbidity and mortality and negative societal impact, the study laid out a four-phase plan for federal, state, tribal and local governments to use when making decisions about precisely where vaccine supplies should go, to whom and in what order.
One important aspect of the committee’s work was outreach. It held weekly virtual meetings through late summer and early fall, invited outside speakers and held a virtual hearing with over 50 presentations by individuals and organizations. In addition, it released a draft of its report for the public’s consideration and received over 1,400 written comments, which helped to shape the final report and recommendations.
The committee recognized that its proposed framework must not only be equitable but also be perceived as such by audiences who are socioeconomically, culturally and educationally diverse and who have distinct historical experiences with the health system. Toward that end, the framework includes both ethical and procedural principles embedded in U.S. social institutions and culture.
The framework starts with frontline healthcare workers and those at high risk of exposure to patients exhibiting symptoms of COVID-19, as they are at risk themselves and could transmit the virus to others. The phases then progress through groups at decreasing levels of risk for exposure, morbidity and mortality. The framework also tries to address inequities suffered by communities of color. For each group included in each phase, the committee recommended that special efforts are made to deliver vaccines to residents of high-vulnerability areas by using, for example, the C.D.C.’s Social Vulnerability Index.
The recommended series of distributions begins with a “jump-start” phase, when there is not expected to be a large supply of vaccines available. Health workers in high-risk settings with extensive exposure to infected or potentially infected patients — doctors, nurses, orderlies and cleaning staff — are included in Phase 1a, as well as first responders like police, because they are central for ensuring that people with medical emergencies receive necessary immediate care.
It’s worth noting that among the high-risk health workers are caregivers in nursing homes, who not only risk their own health but also are a potential source of transmission to residents, whose age and health problems make them more vulnerable. Demographically, such caregivers, as well as other high-risk health workers such as cleaning staff and orderlies in COVID-care hospital wards, are disproportionately members of minority groups, which have suffered infection and death rates up to five times higher than the general population. Prioritizing these high-risk workers has the effect of addressing this disparate impact of the pandemic, as well as conforming to traditional priorities during public health emergencies.
In Phase 1b, priority is given to people whose underlying medical conditions put them at significantly increased risk of serious morbidity and mortality, again a population in which minorities are disproportionately represented. Priority is given as well to older adults if they live in congregate settings such as nursing homes, where evidence shows the infection tends to spread widely and rapidly. Since age is associated with an accumulation of underlying medical problems, particularly among those in need of nursing home care, these two groups have considerable overlap.
Workers in critical industries and who are in settings that pose a high risk of exposure would be offered a vaccine in Phase 2, along with people at moderately increased vulnerability due to comorbidities and those in congregate settings such as group homes and prisons. Here, yet again, minorities are over-represented, due to their employment patterns and underlying medical conditions.
Some might question the political acceptability of giving people in prisons and jails priority in Phase 2. The criteria and phases were developed based on estimates of risk, primarily of risk to the individual, and secondarily of risk of transmission (given that there is no good data yet on how well vaccination prevents transmission). People in prisons and jails face increased risk of acquisition and transmission due to their living settings, in which they have limited opportunity to follow public health measures such as maintaining physical distance. Furthermore, it is well-established in public health practice that those who are in custody or control of public authorities are entitled to receive protection from those authorities, given their own relative helplessness.
K-12 teachers, school staff and childcare workers are also in Phase 2. Across the nation, states and localities are placing a high priority on reopening schools and expanding childcare programs to promote children’s educational and social development and to facilitate parents’ employment. Exposure is difficult to control in these institutions, especially for those providing care or education to young children.
At the same time, children and young adults between the ages of 18 and 30 are less likely to become severely ill or die due to COVID-19, so until vaccine supplies expand or data demonstrates efficacy at reducing transmission (and clinical trial data demonstrates safety and efficacy for the younger children), they would fall into Phase 3. The rest of the population would be offered vaccines in Phase 4.
To help improve vaccine acceptance, the committee recommended that the C.D.C. rapidly develop and launch a national, multidimensional COVID-19 vaccine promotion campaign, using rigorous, evidence-informed techniques from risk and health communication, social marketing and behavioral science. It should find partners like community-based and faith-based organizations to help promote the vaccine to people of color and other communities that are hesitant toward vaccines.
Crucial to uptake is ensuring that there is no out-of-pocket cost for those being vaccinated, regardless of their social and economic resources or their employment, immigration or insurance status. Also vital is providing financial support to the hospitals, clinics, pharmacies and individual providers who will be administering vaccines to literally millions of people. Equitable access requires a financial commitment.
That financial — and moral — commitment is needed at the global level as well. We are a part of the global community, and this is a global pandemic. We should commit to a global leadership role by opting into efforts led by the World Health Organization and various non-governmental organizations to develop, manufacture, share and deliver vaccines to optimize the fair and equitable allocation of vaccine, regardless of a given country’s wealth.
It is inevitable that early phases of vaccine rollout will be dogged by hesitancy and even refusal by some people. For others, there will be confusion over whether to take the first vaccine offered or to wait until several vaccines are available and see which might be best tailored to their particular age, health status or other traits. There will be logistical challenges, particularly for the vaccines that require storage and transport in extraordinarily cold environments. And of course, vaccines will be only one part of the public health response to this pandemic, alongside infection control and hygiene practices.
But the vaccine will nonetheless be a key element in our collective effort, not only to protect ourselves personally, but to do right by our parents, our children and our neighbors. At the core of public health philosophy is the recognition that we are all in this together.
Disclosure: Opinions expressed here do not necessarily represent the views of either the National Academies of Sciences, Engineering and Medicine or the Wisconsin Vaccine Ethics Subcommittee.