Framework for Equitable Allocation of COVID-19 Vaccine (2020) / Chapter Skim
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3 A Framework for Equitable Allocation of COVID-19 Vaccine
3 A Framework for Equitable Allocation of COVID-19 Vaccine
Pages 89-144
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From page 89... ...
The committee recognizes that decisions about COVID-19 vaccine allocation must be made under conditions of uncertainty. These unknowns include the safety and efficacy of the vaccines in specific populations (such as children, pregnant women, older adults, and individuals previously infected with COVID-19)
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transmitting SARS-CoV-2 infection to others Foundational Principles Ethical Principles: Maximum Benefit; Equal Concern; Mitigation of Health Inequities Procedural Principles: Fairness; Transparency; Evidence-Based FIGURE 3-1 Major elements of the framework for equitable allocation of COVID-19 vaccine. state of the science, and the extent to which people are engaging in social distancing and other preventive measures.
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From page 91... ...
Therefore, the committee has designed the framework so that it: • Can be easily and equally well understood by the diverse audiences whose concerns the vaccine allocation framework must address; • Reflects widely accepted social and ethical principles; • Can be reliably translated into operational terms; • Distinguishes scientific and ethical judgments in their application; and • Does not perpetuate discrimination and inequities. Foundational Principles The foundational principles for the equitable allocation framework for COVID-19 vaccine include ethical and procedural principles embedded in U.S.
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In difficult choices about vaccine allocation, the principle of equal concern directs attention to the equal worth and value of every person, protecting each person from discrimination. The procedural principle of fairness requires the engagement and participation of affected populations in setting allocation criteria and determining priority groups.
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The overlaps are evident in comparisons with the several COVID-19 vaccine allocation frameworks discussed in Chapter 2 (see Table 3-1)
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The vaccine allocation framework thus seeks to reduce the risks of severe morbidity and mortality caused by transmission due to SARS-CoV-2 for those (a) most at risk of infection and serious outcomes, for example, those in congregate living arrangements with comorbid conditions; (b)
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From page 95... ...
Any vaccine allocation framework designed to reduce COVID-19 risk must explicitly address the higher burden of COVID-19 experienced by the populations affected most heavily, given their exposure and compounding health inequities. Mitigating those health inequities is, therefore, a moral imperative of an equitable vaccine allocation framework.
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From page 96... ...
The committee's allocation criteria do so in part by taking into account the "vulnerability" of • People at increased risk of infection because of social conditions, such as crowded workplaces and multigenerational homes;2 and • People at increased risk of severe outcomes because of comorbid con ditions associated with social factors, limited access to health care, etc. These allocation criteria identify people who are considered to be the most disadvantaged or the "worst off" because of conditions of ill health or social deprivation, or both, that could make them more susceptible to infection or severe illness or death.
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From page 97... ...
This is discussed further in Chapter 6. Fairness Procedural fairness or justice is vitally important for the legitimacy and public acceptance of the allocation criteria and prioritizations based on these ethical principles (Daniels, 1996, 2007)
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From page 98... ...
Second, such communication is essential to generating and sustaining public trust in the vaccine allocation criteria and program. Transparency should also extend to other aspects of procedural fairness.
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From page 99... ...
The ethical principles need to be specified and applied in the process of developing vaccine allocation criteria and phases to match the features of the pandemic, along with the characteristics, supply, safety, and efficacy of any available vaccines. For example, applying the ethical principle of maximum benefit for vaccine allocation requires determining how best to protect and promote the public's health and socioeconomic well-being, both immediate and long term, before the vaccine is available to everyone.
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From page 100... ...
The overall allocation framework reflects the committee's best judgment about how to balance sometimes conflicting aims as the pandemic evolves and vaccine becomes incrementally available over time. COVID-19 VACCINE ALLOCATION FRAMEWORK Goal of the Framework Previous proposals for allocation of scarce resources in pandemics and other settings articulate various overarching goals and also focus on reducing severe morbidity and mortality, reducing disease transmission, minimizing societal disruptions, maintaining national security, and mitigating health inequities.
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From page 101... ...
and there is little evidence of a social consensus around this approach in these situations, whereas reduction of number of deaths is a widely understood and accepted goal. Third, a YLL-focused approach is inconsistent with the committee's principles of equal concern and mitigating health inequities and could be viewed as discriminating on the basis of age and not addressing the disproportionate impact on older adults.
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From page 102... ...
The committee notes that the fidelity of the allocation process to these foundational principles and criteria depends on the availability of data regarding vaccine safety, efficacy, and distribution. Achieving this goal requires comprehensive, consistent, real-time data collection that includes variables needed to assess the program's success in mitigating health inequities, such as participants' race and ethnicity, age, sex, and social status.
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Compatibility of Allocation Criteria with Foundational Principles Maximum Benefit Each of these four types of risk reflects a threat to the public's health, social, and economic well-being. Reducing each risk would bring both short- and long-term benefits.
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The committee anticipates that the criteria will, in practice, tend to give higher priority to lower-income individuals (because they more frequently live in high-density settings, work in jobs that cannot be done without having personal contact with others, and have multiple comorbid conditions due to their circumstances and their relative lack of access to health care) and Black, Hispanic or Latinx, American Indian and Alaska Native, and Native Hawaiian and Pacific Islander communities, given the ways in which these risks disproportionately affect people in these groups.
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From page 105... ...
It should be noted that the guidance offered through the committee's allocation framework is intended to inform the work of the federal government, the Advisory Committee on Immunization Practices (ACIP) , STLT authorities, and potentially other countries in their COVID-19 vaccine allocation planning.
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From page 106... ...
Operationalizing the Criteria to Determine Allocation Phases Data will not be available to characterize each individual in terms of the framework's risk-based criteria. Even were such data available, an allocation scheme based on individual priority scores would be technically impractical for expeditiously delivering millions of courses of vaccine to geographically distributed individuals.
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From page 107... ...
Rather, the committee has set priorities by the groups' risk profiles, treating those within each phase equally and relying on the dedication and good judgment of STLT authorities to work out the details in keeping with the framework's guiding principles and the best available evidence. Discussion of the Allocation Phases The committee recommends a four-phased approach to COVID-19 vaccine allocation.
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1b People with significant M H M M Ability to maintain social distance and isolate. comorbid conditions (defined as having two or more)
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Lastly, the committee has elected not to use the designation "essential worker." Instead, the committee refer to these workers as critical workers in high-risk settings as they are both working in industries vital to the functioning of society and in occupations where they cannot avoid exposure risk by, for example, teleworking. This is described in additional detail later in this chapter.
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From page 110... ...
The expansion of vaccine supply would allow for the immunization of another cohort of individuals with comorbid and underlying conditions that put them at increased risk, as well as all older adults not already included in Phase 1. People who are incarcerated or detained and people who live in group homes and homeless shelters -- congregate settings -- are also included in Phase 2, along with the staff who work in such settings.
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From page 111... ...
STLT authorities must consider the cumulative effect of populations belonging to multiple groups and adhere to the stated foundational principles and apply the risk-based criteria to ensure that the implementation of the allocation phases meets the goal to reduce severe morbidity, mortality, and negative societal impact due to the transmission of the SARS-CoV-2. The committee's estimates of group size do not consider either the heterogeneity of the groups nor their overlap.
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From page 112... ...
112 Phase 1 Phase 2 Phase 3 Phase 4 Phase 1a "Jumpstart Phase" • K–12 teachers and school staff and • Young adults • Everyone residing • High-risk health child care workers • Children in the United States workers • Critical workers in high-risk who did not have • Workers in industries access to the • First responders settings -- workers who are in and occupations vaccine in previous industries essential to the function Phase 1b important to the phases ing of society and at substantially • People of all ages functioning of society higher risk of exposure with comorbid and and at increased risk of underlying conditions that • People of all ages with comorbid and exposure not included put them at underlying conditions that put them in Phase 1 or 2 significantly higher risk at moderately higher risk • People in homeless shelters or • Older adults living in group homes for individuals with congregate or overcrowd disabilities, including serious mental ed settings illness, developmental and intellec tual disabilities, and physical disabilities or in recovery, and staff who work in such settings • People in prisons, jails, detention centers, and similar facilities, and staff who work in such settings • All older adults not included in Phase 1 Equity is a In each population group, vaccine access should be prioritized crosscutting for geographic areas identified through CDC's Social Vulnerability consideration: Index or another more specific index. FIGURE 3-2 A phased approach to vaccine allocation for COVID-19.
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From page 113... ...
Phase 1a Population: High-Risk Health Workers This group includes frontline health care workers (who are in hospitals, nursing homes, or providing home care) who either (1)
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From page 114... ...
Frontline health workers are at significantly higher risk of becoming infected with SARS-CoV-2 compared to members of the general public. A recent cohort study using data from the United States and the United Kingdom found that frontline health care workers had nearly 12 times the risk of the general population of testing positive for COVID-19 (Nguyen et al., 2020)
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From page 115... ...
In considering those health care workers who are at an elevated risk of transmitting the infection to patients at higher risk of mortality and severe morbidity, it is also important to note that nursing home residents and staff have been at the center of the pandemic since the first reported cases. Nearly 80 percent of all COVID-19 deaths in the United States have occurred in people over the age of 65 (CDC, 2020g)
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From page 116... ...
There are also approximately 1,500,000 full-time nursing home employees, 432,000 health care practitioners who work in skilled nursing facilities, and 3,162,000 home health care workers (Baker et al., 2020; BLS, 2019d)
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From page 117... ...
In a highly constrained vaccine scenario, the initial group of recipients with comorbid and underlying conditions could focus specifically on individuals with two or more of these designated conditions. It should be noted that as the relationship between severe COVID-19 disease and certain comorbid conditions becomes clearer, this list should
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From page 118... ...
Estimated Group Size There are currently no clear data from which to accurately estimate the size of the population group with multiple select comorbid conditions, 10 The list of comorbid conditions assessed in COVID-NET differs slightly from CDC's current list of conditions that put individuals at "increased risk" of severe illness from COVID-19 disease. The COVID-NET list includes hypertension, obesity, diabetes, cardiovascular disease, neurologic disease, chronic lung disease, renal disease, asthma, immune suppression, gastrointestinal/liver disease, and autoimmune disease.
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Given that approximately 75 percent of those hospitalized for COVID-19 based on the COVID-NET data had multiple comorbid conditions, the committee estimates that the value of 19–20 million may approximate the number of individuals with multiple comorbid conditions (from the preceding CDC list)
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From page 120... ...
The combination of the risk of severe disease due to advanced age and the higher risk of acquiring infection and transmission among older adults included in this population group makes it among the highest priority groups for receiving the COVID-19 vaccine. Estimated Group Size There are approximately 1,347,000 nursing home residents in the United States and 811,000 individuals living in residential care facilities.
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From page 121... ...
Moving to Phase 2, it is important to note the overlap issue discussed earlier in this chapter. Individuals who fall within population groups in this phase may also be high-risk health workers or first responders, may have comorbid and underlying conditions that put them at significantly higher risk, or may be older and living in congregate or overcrowded settings and therefore should be vaccinated in Phase 1.
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. Thus, 11 See https://www.cisa.gov/publication/guidance-essential-critical-infrastructure-workforce (accessed September 15, 2020)
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Instead, the committee refers to these workers as critical workers in high-risk settings because they are both working in industries vital to the functioning of society and in occupations where they cannot avoid exposure risk. The industries in which these critical workers are employed are essential to keeping society and the economy functioning.
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From page 124... ...
There are many reasons why food system workers are at increased risk of infection and disease, including prolonged close workplace contact with coworkers, frequent community contact with fellow workers, mobility of the workforce (i.e., migrant workers) , shared transportation to and from the workplace, lack of paid sick leave, and congregate housing situations (including living in employer-furnished housing and shared living quarters, and living in crowded and multi-generational homes)
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From page 125... ...
Furthermore, it 12 The list of comorbid conditions assessed in COVID-NET differs slightly from CDC's current list of conditions that put individuals at "increased risk" of severe illness from COVID-19 disease. The COVID-NET list includes hypertension, obesity, diabetes, cardiovascular disease, neurologic disease, chronic lung disease, renal disease, asthma, immune suppression, gastrointestinal/liver disease, and autoimmune disease.
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From page 126... ...
. Individuals living in congregate settings face increased risk of exposure to COVID-19 if they have limited or shared bathroom facilities, share utensils and other personal items, and have limited ability to practice social distancing or hygiene, including frequent hand washing.
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From page 127... ...
Population: People in Prisons, Jails, Detention Centers, and Similar Facilities, and Staff Who Work in Such Settings Another group to be included in Phase 2 are staff members and people in prisons, jails, and detention centers, including immigration detention facilities. A prisoner is defined as anyone who is deprived of personal liberty against his or her will following conviction of a crime.
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Phase 3 Phase 3 includes the following groups: • Young adults; • Children; and • Workers in industries and occupations important to the functioning of society and at increased risk of exposure not included in Phases 1 or 2.
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From page 129... ...
, thus potentially putting them at heightened risk of both acquiring infection and transmission. In addition, this group includes college-aged individuals, who are more likely to be living in congregate settings -- such as college dormitories, house shares, and other communal living facilities -- and thus face increased risk of contracting SARS-CoV-2 infections.
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From page 130... ...
. Population: Workers in Industries and Occupations Important to the Functioning of Society and at Increased Risk of Exposure Not Included in Phases 1 or 2 The inclusion of workers in this category represents a social choice: beyond the workers designated in Phases 1 and 2, which jobs and industries
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From page 131... ...
The jobs of some of these workers are primarily in settings where distancing and other protective measures can be implemented without great difficulty, but who may still be at increased risk. There are others in this population group, like those employed in theater, sports, and other aspects of entertainment, who cannot easily socially distance or use PPE, but whose industry was not considered to be as essential to societal functioning and was therefore suspended at the beginning of the pandemic.
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From page 132... ...
have access to the vaccine. Ensuring Equity As discussed earlier in this chapter, the principles and allocation criteria underlying these phases explicitly avoid perpetuating health inequities, while implicitly valuing the essential social roles played by individuals in groups that have faced discrimination, as well as their greater risks due to health conditions reflecting inequities (Karaca-Mandic et al., 2020)
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, and increased risk of adverse COVID-19 outcomes (e.g., proportion aged 65 or older)
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From page 134... ...
If there are pockets of susceptibility among those who do not receive the vaccine, the risk of outbreaks is likely to increase for everyone -- including those who are legally present in the United States -- because no vaccine is 100 percent effective. Considerations for Pregnant Women Although data are uncertain regarding the risk of adverse outcomes associated with COVID-19 in pregnancy, current evidence suggests that pregnant women are more likely to be hospitalized with COVID-19 than are non-pregnant women, and infants born to women infected with SARS-CoV-2 during pregnancy appear to have increased risk for preterm birth and admission to
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From page 135... ...
naval ships) , and those with underlying comorbid conditions associated with an increased risk of severe COVID-19, among others.
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From page 136... ...
In doing so, they should refer to the principles and allocation criteria that guided the formulation of the phases. Unintended Consequences The committee acknowledges the risk of potential unintended consequences of the allocation framework and the need to assess prioritization based on operational and supply realities.
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From page 137... ...
authorities should adopt the eq uitable allocation framework set out in the committee's report in the development of national and local guidelines for COVID-19 vaccine allocation. The guidelines should adhere to the foundational principles, goal, allocation criteria, and allocation phases described in the com mittee's report and seek to maximize benefit, mitigate health inequities, manifest equal regard for all, be fair and transparent, and build on the best current evidence.
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From page 138... ...
. https://www.bls.gov/oes/current/ oes290000.htm#nat (accessed September 22, 2020)
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https://www.cdc.gov/ coronavirus/2019-ncov/covid-data/investigations-discovery/hospitalization-death-by-age. html (accessed September 22, 2020)
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From page 140... ...
2020. Global, regional, and national estimates of the population at increased risk of severe COVID-19 due to underlying health condi tions in 2020: A modelling study.
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2020. Epidemiology of individuals at increased risk of COVID-19 disease.
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2020. NCD comments to National Academies on pre liminary COVID-19 vaccine allocation framework.
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2020. COVID-19 in nursing homes: Calming the perfect storm.
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2020. Interim framework for COVID-19 vaccine allocation and distribution in the United States.
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