Coronavirus disease 2019 (COVID-19) has disproportionately affected racial minorities in the United States resulting in higher rates of infection, hospitalization, and death. With a limited supply after the initial approval of a safe and effective vaccine, difficult legal and ethical choices will have to be made on priority access for individuals. The National Academies of Sciences, Engineering, and Medicine (NASEM) has recommended prioritization of racial minorities who are “worse off” socioeconomically and epidemiologically. TheWorld Health Organization (WHO) similarly cautioned that “colorblind” allocation frameworks could perpetuate or exacerbate existing injustices. Both NASEM and WHO urge policy makers to allocate vaccines in ways that reduce unjust health disparities. The ethics and legality of race-based policies in the United States have been fraught with controversy. This Viewpoint considers how COVID-19 vaccine priority allocations could be implemented ethically and legally

Gostin, Lawrence O.

Schmidt, Harald

Williams, Michelle A.

English

Georgetown Law Scholarly Commons

Georgetown University Law Center Scholarship @ GEORGETOWN LAW 2020 Is It Lawful and Ethical to Prioritize Racial Minorities for COVID-19 Vaccines? Harald Schmidt Perelman School of Medicine, University of Pennsylvania Lawrence O. Gostin Georgetown University - Law Center - O'Neill Institute for National and Global Health Law, gostin@law.georgetown.edu Michelle A. Williams Harvard T.H. Chan School of Public Health, Harvard University   This paper can be downloaded free of charge from: https://scholarship.law.georgetown.edu/facpub/2316 https://ssrn.com/abstract=3716515  The Journal of the American Medical Association, published online October 14, 2020, at E1-E2. This open-access article is brought to you by the Georgetown Law Library. Posted with permission of the author. Follow this and additional works at: https://scholarship.law.georgetown.edu/facpub  Part of the Health Law and Policy Commons, International Humanitarian Law Commons, and the Law and Race Commons Is It Lawful and Ethical to Prioritize Racial Minoritiesfor COVID-19 Vaccines?Coronavirus disease 2019 (COVID-19) has dispropor-tionately affected racial minorities in the United States re-sulting in higher rates of infection, hospitalization, anddeath. With a limited supply after the initial approval of asafeandeffectivevaccine,difficult legalandethicalchoiceswill have to be made on priority access for individuals.The National Academies of Sciences, Engineering,and Medicine (NASEM) has recommended prioritiza-tion of racial minorities who are “worse off” socioeco-nomically and epidemiologically.1 The World Health Or-ganization (WHO) similarly cautioned that “colorblind”allocation frameworks could perpetuate or exacerbateexisting injustices. Both NASEM and WHO urge policymakers to allocate vaccines in ways that reduce unjusthealth disparities.2 The ethics and legality of race-based policies in the United States have been fraughtwith controversy.3 This Viewpoint considers howCOVID-19 vaccine priority allocations could be imple-mented ethically and legally.COVID-19 and Communities of ColorCompared with the rate of COVID-19–related deathsamong non-Hispanic White individuals (mortality rate,38/100 000) and adjusting for age, the mortality raterelative to population size is 3.4-fold higher among Blackindividuals (mortality rate, 131/100 000), 3.3-fold higheramong Indigenous and Latino communities (mortalityrate for both, 125/100 000), 2.9-fold higher among Pa-cific Islander individuals (mortality rate, 111/100 000),and 1.3 higher among Asian populations (mortality rate,50/100 000).4 These elevated death rates are unlikelyto be explained by biological differences1 but more likelyare influenced by social determinants of health, includ-ing economic privation and systemic bias. To avoid fur-ther compounding these disparities, the NASEM ex-pressly includes “mitigation of health inequities” as 1 ofthe 3 foundational principles of its framework.1The Ethical Case for Considering RaceThe ethical justification for prioritizing economicallyworse-off racial minorities rests on epidemiological, eco-nomic, and social justice grounds.1,2,5 Economically,worse-off groups are more dependent on regular in-come with little or no retirement or other savings, andless able to work remotely. Epidemiologically, worse-off groups are more likely to live with multiple genera-tions in close proximity and are typically less able tophysically distance at home, at work, and while com-muting to work (if they are employed), and therefore atgreater risk of contracting and spreading severe acuterespiratory syndrome coronavirus 2 (SARS-CoV-2).Social justice rationales are based on the disparateoutcomes that worse-off racial minorities, especiallyBlack persons in the United States, have experienced interms of higher rates of COVID-19–related unemploy-ment, housing evictions, and hospitalizations. Ignoringthese effects in allocating vaccines could exacerbatethese differences, with an influence lasting likely far be-yond the end of the pandemic.5NASEM FrameworkThe Centers for Disease Control and Prevention (CDC)and the National Institutes of Health (NIH) commis-sioned the NASEM to provide recommendations to theCDC’s Advisory Committee on Immunization Practices(ACIP). ACIP will issue national guidance, implementedby the states. ACIP has indicated it would be guided bythe NASEM framework, particularly the way in which mi-norities will be prioritized.The NASEM framework allocates vaccines in 4sequential phases, with distinct priority populations.Within each population group, vaccine access would beprioritized for geographic areas identified as vulnerablethrough a statistical measure called the Social Vulner-ability Index (SVI). The SVI (developed for public healthemergencies such as hurricanes or earthquakes) identi-fies geographic areas of vulnerability based on 15 cen-sus variables “most linked to the disproportionateimpact of COVID-19 on people of color and other vul-nerable populations.”1 The CDC advises state-level plan-ners to draw on the NASEM and the ACIP frameworks,instructing planners to begin identifying “critical popu-lations” including “people from racial and ethnic minor-ity groups.”6 Race, therefore, could be among theexplicit factors that health professionals will use to allo-cate scarce COVID-19 vaccines.Are Race-Based Allocation Criteria Lawful?The US Supreme Court uses a demanding legal stan-dard in reviewing race-based classifications. There is nodirect precedent in which courts have considered racein allocating scarce health care resources. The closest par-allels are found in rulings on school access and univer-sity admissions. The critical question is whether govern-ment is permitted to consider race when seeking toameliorate the effects of past and current discrimina-tion. Often called “reverse discrimination,” the policy de-liberately favors people of color.In a series of cases, the court has vacillated as towhether race can be an express criterion for achievinggreater equity and diversity. In striking down publicschool integration plans that explicitly included a stu-dent’s race, Chief Justice Roberts said, “The way to stopdiscrimination on the basis of race is to stop discrimi-nating on the basis of race” (Parents Involved in Com-munity Schools v Seattle School District No. 1, 551 US 701VIEWPOINTHarald Schmidt, PhDPerelman School ofMedicine, University ofPennsylvania,Philadelphia.Lawrence O. Gostin,JDO’Neill Institute forNational & GlobalHealth Law,Georgetown University,Washington, DC.Michelle A. Williams,ScDHarvard T.H. ChanSchool of Public Health,Harvard University,Boston, Massachusetts.Author AudioInterviewVideoCorrespondingAuthor: Lawrence O.Gostin, JD, O’NeillInstitute for National &Global Health Law,Georgetown University,600 New Jersey AveNW, McDonough 568,Washington, DC 20001(gostin@georgetown.edu).Opinionjama.com (Reprinted) JAMA Published online October 14, 2020 E1© 2020 American Medical Association. All rights reserved.Downloaded From: https://jamanetwork.com/ by a Georgetown University Medical Center User  on 10/21/2020[2007]). Yet the court has permitted race to be one of multiple fac-tors in ensuring diversity in universities.7The court has increasingly moved toward limiting the explicit con-sideration of race, requiring policies categorizing individuals by raceto meet a “strict scrutiny” standard. Under strict scrutiny, race-basedpolicies must be narrowly tailored to achieve a compelling govern-mental interest. Even if the court were to rule that promoting equityis a compelling state interest, it would still require government, wher-ever possible, to use means other than race to achieve equitable out-comes. Likewise, the future of race-based discrimination to remedypast and future disadvantage remains uncertain. The considerationof race in COVID-19 vaccine allocation could be a potentially attrac-tive test case for the court given its changing composition.7Strict judicial scrutiny would not permit 2 vaccine priority strate-gies. First, a health care worker could not give priority to vaccinatingpersons from minority groups, for instance, by skipping White peoplewaiting in line at a health care facility. Second, public health agenciescouldnotprovidevaccinesexclusively,or inlargershares,togeographicareas identified by race alone. This would not preclude distribution inproportion to the population of a vaccine through community healthcenters, many of which serve largely urban minority populations.For strategies that would increase the allocation ratio above thatproportionate to the population, the Supreme Court is likely to upholdracially neutral vaccine allocation criteria, which are designed to cap-ture worse-off minorities but not explicitly. A vaccine distribution for-mula, therefore, could lawfully prioritize populations based on factorslike geography, socioeconomic status, and housing density that wouldfavor racial minorities de facto, but not explicitly include race.An example of such a legally permissible approach would be touse a measure called the Area Deprivation Index (ADI), which is simi-lar to the SVI, but does not explicitly prioritize on the basis of race.The ADI reflects the level of socioeconomic deprivation of a geo-graphic area at the block-group level (600-3000 people) and is as-sociated with health outcomes.8 The index integrates income, edu-cation, employment, and housing quality. Although it does not userace as a variable, the ADI still captures structural disadvantage andsystemic racism because racial minorities are far more likely to beeconomically worse off.1,2 The ADI therefore closely tracks racial andethnic divides and significantly reduces potential legal concerns thatare associated with using the SVI.The methodological design of the SVI does not prescribe how its4 domains (socioeconomic status, household composition, race/ethnicity and language, and housing and transportation) that are fo-cused on the census tract level (1200-8000 people) should beweighed. Current guidance suggests that states will have considerablediscretion in allocations.1,6 Race could therefore account for as little asone-fifteenth of the overall SVI score (if all variables were consideredequally) or, depending on how the index is configured by a planner,could become far more prominent, if not determinative.It is not clear how the Supreme Court would rule on vaccine dis-tribution based on either the ADI or SVI, but it is likely that the ADIwould be more acceptable because it does not explicitly prioritizeon the basis of race.Race in the United StatesThe United States is experiencing an intense reckoning with struc-tural racism, both because of the disparate health effects of COVID-19on racial minorities and protests over police violence. Vaccine allo-cation strategies should not exacerbate racial divisions yet must con-sider socioeconomic and racial disadvantage. Protected litigationchallenging vaccine allocation plans could disrupt the implementa-tion of a COVID-19 vaccination plan. Before implementation, ACIPshould model the performance of the SVI against racially neutral stan-dards such as the ADI, in capturing vulnerable groups while mini-mizing legal and ethical risks.Policy makers should also model how many more vaccinesworse-off racial minorities should receive. NASEM suggests that 10%of all vaccines be reserved for the worst-off SVI quartile in each state.In addition, states should make “special efforts” to deliver vaccinesto these areas. The more intense the priority that might be given toracial minorities, the deeper the legal scrutiny will be. In addition, aseemingly arbitrary arithmetic cutoff point can invite further legalconcern. An equally pragmatic yet more meaningful approach wouldconsider COVID-19’s effects to date (for example, in terms of deathsan ADI region incurred) on worse-off racial minorities. Grounding pri-ority decisions in objective data help justify allocation formulas bothfor the general public and for the judiciary.Public health agencies will have considerable discretion in ra-tioning scarce COVID-19 vaccines. They could become agents ofchange toward improving social and racial justice. Or they can be-come complicit in allocation strategies that, once again, dispropor-tionately favor the better-off, White majority. Racially neutral ap-proaches must be implemented to advance social and racial justicein the United States.ARTICLE INFORMATIONPublished Online: October 14, 2020.doi:10.1001/jama.2020.20571Conflict of Interest Disclosures: None reported.REFERENCES1. Gayle H, Foege W, Brown L, Kahn B, eds.A Framework for Equitable Allocation of Vaccine forthe Novel Coronavirus. National Academy ofSciences, Engineering, and Medicine; August 2020.Accessed September 21, 2020. https://www.nationalacademies.org/our-work/a-framework-for-equitable-allocation-of-vaccine-for-the-novel-coronavirus2. World Health Organization Strategic AdvisoryGroup of Experts (WHO/SAGE). Values frameworkfor the allocation and prioritization of COVID-19vaccination. September 14, 2020. AccessedSeptember 14, 2020. https://apps.who.int/iris/bitstream/handle/10665/334299/WHO-2019-nCoV-SAGE_Framework-Allocation_and_prioritization-2020.1-eng.pdf?ua=13. Persad G, Peek ME, Emanuel EJ. Fairlyprioritizing groups for access to COVID-19 vaccines.JAMA. Published online September 10, 2020. doi:10.1001/jama.2020.185134. APM Research Lab Staff. The color ofcoronavirus: COVID-19 deaths by race and ethnicityin the US. Published September 16, 2020. AccessedSeptember 29, 2020. https://www.apmresearchlab.org/covid/deaths-by-race#age5. Schmidt H. Vaccine rationing and the urgency ofsocial justice in the COVID-19 response. HastingsCent Rep. 2020;50(3):46-49. doi:10.1002/hast.11136. Covid-19 vaccination program interim playbookfor jurisdiction operations. Centers for DiseaseControl and Prevention. September 16, 2020.Accessed September 16, 2020. https://www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination-Program-Interim_Playbook.pdf7. Persad G. Allocating medicine to addressdisparities. SSRN. Posted September 28, 2020. Lastrevised October 5, 2020. Accessed October 5,2020. http://ssrn.com/abstract=36997698. Kind AJH, Buckingham WR. Makingneighborhood-disadvantage metricsaccessible—the Neighorhood Atlas. N Engl J Med.2018;378(26):2456-2458. doi:10.1056/NEJMp1802313Opinion ViewpointE2 JAMA Published online October 14, 2020 (Reprinted) jama.com© 2020 American Medical Association. All rights reserved.Downloaded From: https://jamanetwork.com/ by a Georgetown University Medical Center User  on 10/21/2020

Is It Lawful and Ethical to Prioritize Racial Minorities for COVID-19 Vaccines?

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Is It Lawful and Ethical to Prioritize Racial Minorities for COVID-19 Vaccines?

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