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Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2020. Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25917.
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Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2020. Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25917.
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Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2020. Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25917.
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Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2020. Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25917.
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Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2020. Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25917.
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Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2020. Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25917.
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Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2020. Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25917.
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Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2020. Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25917.
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Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2020. Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25917.
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Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2020. Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25917.
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Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2020. Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25917.
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Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2020. Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25917.
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Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2020. Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25917.
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Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2020. Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25917.
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Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2020. Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25917.
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Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2020. Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25917.
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Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2020. Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25917.
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Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2020. Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25917.
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Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2020. Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25917.
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Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2020. Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25917.
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Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2020. Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25917.
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Suggested Citation:"Summary." National Academies of Sciences, Engineering, and Medicine. 2020. Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25917.
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Summary1 In response to the coronavirus disease 2019 (COVID-19) pandemic and the societal disruption it has brought, national governments and the international community have invested billions of dollars and immense amounts of human resources to develop a safe and effective vaccine in an unprecedented time frame. Vaccination against this novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), offers the possibility of significantly reducing severe morbidity and mortality and transmission when deployed alongside other public health strategies (e.g., non-pharmaceutical interventions and better diagnostic tests) and improved therapies. According to the World Health Organization (WHO), 149 COVID-19 vaccines are currently in pre-clinical development and 38 candidate vaccines are undergoing evaluation in clinical trials in the United States, Europe, and China. Domestically, the U.S. government has homed in on six COVID-19 vaccine candidates, with four currently in Phase 3 tri- als: the Johnson & Johnson JNJ-78436735, the Moderna/NIAID mRNA 1273, the University of Oxford/AstraZeneca AZD1222, and the Pfizer and BioNTech BNT162. However, even if one or more safe and effective COVID-19 vaccines under development are authorized for use, they are very unlikely to be im- mediately available in amounts sufficient to vaccinate a large portion of the U.S. population, despite plans to begin large-scale production of promising vaccines even before trials are completed. Planning is urgently needed to 1  This Summary does not include references. Citations for the discussion presented in the Summary appear in the subsequent report chapters. 1

2 FRAMEWORK FOR EQUITABLE ALLOCATION OF COVID-19 VACCINE ensure equitable access to COVID-19 vaccine. To prepare for the inability to meet the anticipated high demand for COVID-19 vaccine in the early stages of availability, the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) asked the National Academies of Sciences, Engineering, and Medicine (the National Academies), in part- nership with the National Academy of Medicine, to convene an ad hoc committee to develop an overarching framework for vaccine allocation to assist policy makers in the domestic and global health community. The full charge to the committee is presented in Chapter 1. This report offers a framework for equitable allocation of COVID-19 vaccine. It is built on widely accepted foundational principles and rec- ognizes the distinctive characteristics of COVID-19 disease, including its rates of infection, its modes of transmission, the groups and individuals most susceptible to infection, and varying rates of severe illness and death among those groups. This report’s recommendations address the institu- tional and administrative commitments needed to implement equitable allocation policies. COVID-19 AND HEALTH EQUITY Race and ethnicity and health equity are intertwined with the impact of COVID-19 and there are certain populations that are at increased risk of se- vere illness or death from COVID-19. In the United States and worldwide, the COVID-19 pandemic has shed light on the pervasive impacts of social and structural inequities in society. COVID-19 is having a disproportionate impact on people who are already disadvantaged by virtue of their race and ethnicity, age, health status, residence, occupation, socioeconomic condi- tion, and/or other contributing factors. At a moment when racial inequality and discrimination are at the center of national conversations in the United States, and a well-established source of poor health outcomes as well as the legacy of medical experimentation, these considerations must be a critical component of COVID-19 vaccine allocation. The committee weighed these realities not only because of their moral and ethical implications, but also because, in our highly interconnected world, the challenges experienced by particular subpopulations have an effect on us all. If we have learned anything from this pandemic, it is that we are inevitably all in this together. Current evidence has shown how COVID-19 disproportionately affects particular racial and ethnic minority groups, including Black, Hispanic or Latinx, American Indian and Alaska Native, and Native Hawaiian and Pacific Islander communities. Many of these groups disproportionately face social and structural factors and comorbid conditions that put them at higher risk of severe morbidity and mortality from COVID-19. Furthermore, historically, non-Hispanic Whites have had higher coverage for routine

SUMMARY 3 immunizations compared to racial and ethnic minority groups. CDC has compiled data by race and ethnicity on the rates of COVID-19 cases, age- adjusted hospitalizations, and death. Compared to non-Hispanic Whites, American Indian and Alaska Native persons had a case rate that was 2.8 times higher, a hospitalization rate that was 4.6 times higher, and a death rate that was 1.4 times higher. Hispanic or Latinx persons had a case rate that was 2.8 times higher, a hospitalization rate that was 4.7 times higher, and a death rate that was 1.1 times higher. Black and African American persons had a case rate that was 2.6 times higher, a hospitalization rate that was 4.7 times higher, and a death rate that was 2.1 times higher. COVID-19 has also disproportionately affected members of other groups (see Table S-1). In particular, older adults are extremely vulnerable to severe outcomes and death due to COVID-19; people aged 65 and older represent 8 out of every 10 reported deaths due to COVID-19 in the United States. TABLE S-1 Key Data on the Impact of COVID-19 on Certain Populations Population Key Impact Data Black • Compared to non-Hispanic White populations, this group has a case rate that is 2.6 times higher, a hospitalization rate that is 4.7 times higher, and a death rate that is 2.1 times higher (United States). Hispanic/Latinx • Compared to non-Hispanic White populations, this group has a case rate that is 2.8 times higher, a hospitalization rate that is 4.7 times higher, and a death rate that is 1.1 times higher (United States). American Indian and • Compared to non-Hispanic White populations, this group has Alaska Native a case rate that is 2.8 times higher, a hospitalization rate that is 4.6 times higher, and a death rate that is 1.4 times higher (United States). Native Hawaiian and • Group has experienced mortality from COVID-19 at a rate Pacific Islander up to five times its proportion of the population compared to the general population (United States). Older adults • Group accounts for approximately 80 percent of reported (≥65 years) deaths related to COVID-19 (United States). • Population-level COVID-19 mortality risk is estimated to be 16- to 52-fold higher (United States) and 30- to 100-fold higher (worldwide) for this group than for younger people. Older adults • Group is experiencing a mortality rate 5-fold greater than (>80 years) average (United States). • Group is experiencing an “overwhelming percentage” of severe outcomes due to COVID-19 (worldwide). continued

4 FRAMEWORK FOR EQUITABLE ALLOCATION OF COVID-19 VACCINE TABLE S-1 Continued Population Key Impact Data People with underlying • Group is 6-fold more likely to be hospitalized and 12- or comorbid conditions fold more likely to die from COVID-19 as people without underlying conditions (United States). • Group is at a greater risk of SARS-CoV-2 infection. People who live and/ • Older adults living in senior living facilities are at high risk of or work in congregate severe COVID-19. settings • Long-term care facility residents accounted for half of >10,000 COVID-19 deaths reported by April 2020 (United States). Sex • Men with COVID-19 are more at risk for worse outcomes and death than women, independent of age (China). Children • Children and adolescents account for 10 percent of COVID-19 cases and less than 0.3 percent of deaths (United States). • Among children with COVID-19, 1.8 percent of cases resulted in hospitalization (United States). • 78 percent of deaths among adolescents (under 21) reported to the Centers for Disease Control and Prevention between mid-February and the end of July 2020 were people from Black, Hispanic and Latinx, or American Indian and Native Alaskan communities. People who are • Group may be at an increased risk of developing severe pregnant or COVID-19 disease that requires intensive care unit admission breastfeeding and mechanical ventilation. • Black and Hispanic women who are pregnant appear to be disproportionately at risk of severe disease and hospitalization (United States). • Babies born to women infected with SARS-CoV-2 during pregnancy appear to be more likely to be born preterm or require neonatal intensive care. NOTES: This table is included in Chapter 1 with references. The following groups are omitted from the table due to a lack of COVID-specific epidemiological data: people who are undocu- mented, people with mental and physical disabilities, and people experiencing homelessness. LESSONS LEARNED FROM OTHER ALLOCATION EFFORTS This is not the first time the nation, or the world, has faced the issue of allocating what is likely to be an early scarcity of resources in the midst of a public health emergency. Plans drawing on those experiences are beginning to emerge for ensuring equitable allocation of vaccines and therapeutics for COVID-19. The committee began its work by reviewing lessons learned from previous mass vaccination efforts in the United States and globally, including from the 2009 H1N1 influenza vaccination campaign and the 2013–2016 vaccination efforts during the Ebola outbreak in West Africa. These lessons are described in Box S-1.

SUMMARY 5 BOX S-1 Key Lessons Learned from Prior Mass Vaccination Efforts • Leverage relationships with professional medical societies and other key downstream stakeholders from the outset. • When cost, insurance, and other policies create barriers, consider the issue of rationing at the state, local, and practice levels. • Develop effective systems for tracking distribution. • Ensure that ancillary supply distribution is timely and appropriate. • “Under promise and over deliver” in planning and communication efforts. • Ensure up-to-date information on vaccine production, inventory, and projec- tions via stronger and more formal partnerships between federal entities and vaccine producers. • Plan for a range of vaccine supply scenarios. • Continue to use the Vaccines for Children program infrastructure as a basis for emergency vaccination distribution programs; consider something similar for adults. • Deploy limited vaccine supplies equitably and transparently using pre- established, evidence-based criteria to prioritize allocation. • Promote global regulatory harmonization and standardization in vaccine de- velopment to improve speed, flexibility, and efficiency. • Use consistent, respectful, accurate communication to earn, secure, and maintain trust. The committee also reviewed and synthesized relevant elements of principles, goals, and prioritization strategies proposed in other frameworks recently developed for allocating scarce resources during the COVID-19 pandemic. Some of these frameworks are vaccine specific (including an in- terim framework developed by a group at Johns Hopkins University, forth- coming efforts from CDC, and a values framework developed by WHO), some focused on inpatient treatments (like remdesivir), and others address the overall allocation of scarce medical resources. These frameworks are discussed in detail in Chapter 2. A FRAMEWORK FOR EQUITABLE ALLOCATION OF COVID-19 VACCINE Foundational Principles, Goal, and Allocation Criteria The committee based its framework for equitable allocation of COVID-19 vaccine on current evidence, recognizing its uncertainties and the need for flexibility as evidence emerges and medical realities change. The framework’s foundational principles guide its goal, allocation criteria, and allocation phases (see Figure S-1).

6 FRAMEWORK FOR EQUITABLE ALLOCATION OF COVID-19 VACCINE Allocation Framework Goal Allocation Criteria Reduce CVVCVC severe Risk of (1) acquiring morbidity and infection, (2) severe Four Allocation mortality and morbidity and Phases negative societal mortality, (3) negative impact due to the societal impact, and transmission of CVVCVC (4) 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 S-1 Major elements of the framework for equitable allocation of COVID-19 vaccine. To ensure that the allocation framework is equitable and can be seen as equitable, the committee designed its framework so that it (1) can be easily and equally understood by diverse audiences, (2) reflects widely accepted social and ethical principles, (3) can be reliably translated into operational terms, (4) distinguishes scientific and ethical judgments in its application, and (5) does not perpetuate discrimination and inequities. The foundational principles consist of ethical and procedural principles that reflect this line of thinking: • Ethical Principles Maximum benefit encompasses the obligation to protect and °  promote the public’s health and its socioeconomic well-being in the short and long term. Equal concern requires that every person be considered and °  treated as having equal dignity, worth, and value. Mitigation of health inequities includes the obligation to ex- °  plicitly address the higher burden of COVID-19 experienced by the populations affected most heavily, given their exposure and compounding health inequities. • Procedural Principles Fairness requires engagement with the public, particularly °  those most affected by the pandemic, and impartial decision making about and even-handed application of allocation cri- teria and priority categories.

SUMMARY 7 Transparency includes the obligation to communicate with the °  public openly, clearly, accurately, and straightforwardly about the allocation framework as it is being developed, deployed, and modified. Evidence-based expresses the requirement to base the allocation °  framework, including its goal, criteria, and phases, on the best available and constantly updated scientific information and data. Guided by these foundational principles, the goal of the committee’s framework for equitable allocation of COVID-19 vaccine is to: Reduce severe morbidity and mortality and negative societal impact due to the transmission of SARS-CoV-2. The framework pursues that goal while mitigating health inequities, showing equal concern for all, being fair and transparent, and building on the best available evidence. Given the current state of the pandemic, the early phases of the committee’s proposed framework emphasize prevention of severe morbidity and mortality, particularly with regard to maintaining essential health and emergency services. The focus shifts toward reducing transmission in later phases. There are multiple reasons for this approach: •  Death is an irreversible outcome. There are legitimate claims for many groups (e.g., schoolchildren, “non-essential” workers) to be in earlier phases as negative societal impact could occur if these groups are not prioritized. For example, there might be a substan- tial impact on the economy if a primarily transmission-focused strategy is not employed from the outset. However, the non-trivial effects of an economic downturn or an online semester can at least be partially reversed. •  Preventing severe morbidity and mortality protects the health care system from being overwhelmed, contributing to the prevention of excess morbidity and mortality from other causes as well, with ripple effects on society and the economy. • For vaccination to materially reduce transmission requires vac- cinating a critical mass of individuals, much greater than will be possible in the early phases of vaccine deployment. • The ongoing COVID-19 vaccine trials are not designed to estimate the impact of the vaccine candidates on transmission and evidence of the vaccines’ actual impact on transmission might not be available for some time after U.S. Food and Drug Administration approval. • While data on all aspects of COVID-19 are emerging, data on trans- mission risk groups (e.g., age, profession) are particularly limited.

8 FRAMEWORK FOR EQUITABLE ALLOCATION OF COVID-19 VACCINE To operationalize its foundational principles, the committee developed four risk-based criteria that were then used to set general priorities among population groups. • Risk of acquiring infection: Individuals have higher priority to the extent that they have a greater probability of being in settings where SARS-CoV-2 is circulating and of being exposed to a suf- ficient dose of the virus. •  Risk of severe morbidity and mortality: Individuals have higher priority to the extent that they have a greater probability of severe disease or death if they acquire infection. • Risk of negative societal impact: Individuals have higher priority to the extent that societal function and other individuals’ lives and liveli- hood depend on them directly and would be imperiled if they fell ill. •  Risk of transmitting infection to others: Individuals have higher priority to the extent that there is a higher probability of their transmitting the infection to others. The committee recognizes that decisions about COVID-19 vaccine al- location 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 previ- ously infected with COVID-19), the effectiveness of vaccines in tandem with existing preventive measures, public confidence in the vaccine, the possibility of ultra-cold storage requirements for the vaccine, the phar- macovigilance evidence, and many other unknowns. Chapter 4 describes how the allocation process can adapt to plausible scenarios involving these factors. Allocation Phases In light of the foundational principles, goal, and allocation criteria, the committee recommends a four-phased approach to equitable COVID-19 vaccine allocation (see Figure S-2 and described in detail in Chapter 3). The committee uses the term “phases,” suggesting successive deployments, rather than the hierarchical term “tiers.” Within each phase, all groups have equal priority. This approach applies the best available current evidence to implementing the framework’s foundational principles. It cannot be emphasized enough that the dynamic nature of the COVID-19 pandemic means that features of the pandemic will change over time, as will collective understanding of its effects. For each population group, the committee recommends prioritizing for areas identified as vulnerable through CDC’s Social Vulnerability Index

SUMMARY 9 (SVI) or another more specific index such as the COVID-19 Community Vulnerability Index (CCVI). The evidence clearly shows that people of color—specifically Black, Hispanic or Latinx, American Indian and Alaska Native, and Native Hawaiian and Pacific Islander—have been dispropor- tionately impacted by COVID-19, with higher rates of severe morbidity, mortality, and transmission. This disproportionate burden largely reflects the impacts of systemic racism and socioeconomic factors that are associ- ated with increased likelihood of acquiring the infection (e.g., frontline jobs that do not allow social distancing, crowded living conditions, lack of access to personal protective equipment, inability to work from home) and of having more severe disease when infected (as a result of a higher prevalence of comorbid conditions or other factors). Use of a vulnerability index, like SVI or CCVI, represents an attempt to incorporate the variables that the committee believes are most linked to the disproportionate impact of COVID-19 on people of color. A vulnerability index allows the efficient focus of resources on these needs instead of on discrete racial and ethnic categories. The committee does not propose an approach in which, within each phase, all vaccine is first given to people in high-SVI areas. Rather the committee proposes that state, tribal, local, and territorial (STLT) authori- ties ensure that special efforts are made to deliver vaccine to residents of high-vulnerability areas (defined as 25 percent highest in the state). Summary of the Population Groups Within Each Allocation Phase As summarized here and described more fully in Chapter 3, the com- mittee based its specific proposals on broad estimates of the number of individuals covered across each phase of the allocation framework, a practice also used by WHO. Importantly, the committee acknowledges that the population groups included in each allocation phase overlap to a certain extent, and there are assuredly individuals who fit into mul- tiple categorizations. When individuals within a group fall into multiple phases, the higher phase should take precedent. It also recognizes the heterogeneity within each group, with some members facing less risk and having greater ability to protect themselves and others. The framework provides guidance to the STLT authorities administering the program in adapting its risk-based criteria to these realities in ways consistent with its foundational principles. Phase 1 Phase 1 of the allocation framework has two subsections: a “Jump- start” Phase 1a that covers approximately 5 percent of the U.S. population, and a Phase 1b covering an additional 10 percent.

10 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 S-2 A phased approach to vaccine allocation for COVID-19.

SUMMARY 11 Phase 1a includes high-risk health workers (e.g., in hospitals or nursing homes, or providing home care). These health professionals are involved in direct patient care. Also included are workers who provide transportation, environmental services, and other health care facility services and who risk exposure to bodily fluids or aerosols. This group is included in Phase 1a for multiple reasons: their critical role in maintaining health care system functionality, their high risk of exposure to patients exhibiting symptoms of COVID-19, and their risk of then transmitting the virus to others, including family members. This is of particular concern for those workers who are members of communities that have been disproportionately impacted by COVID-19. First responders whose jobs put them at high risk of exposure to COVID-19 are also included in Phase 1a (although depending on the jurisdiction and outbreak context, this may not include all first responders). Like frontline health workers, first responders play vital roles in both the response to COVID-19 and society’s overall functioning. Phase 1b focuses attention on two groups that are particularly vulner- able to severe morbidity and mortality due to COVID-19: (1) people of all ages with comorbid and underlying conditions that put them at significantly higher risk and (2) older adults living in congregate or overcrowded settings. CDC currently lists the following comorbid conditions as associated with increased risk of severe COVID-19 disease: cancer, chronic kidney disease, chronic obstructive pulmonary disease, immunocompromised state from solid organ transplant, obesity (body mass index ≥30), serious heart condi- tions (e.g., heart failure, coronary artery disease, cardiomyopathies), sickle cell disease, and type 2 diabetes mellitus. Recognizing the limited initial vaccine supply, Phase 1b proposes setting a priority on individuals with two or more of these conditions, recognizing that these priorities can be refined as better evidence emerges. Based on data from the COVID-19 Associated Hospitalization Surveillance Network (COVID-NET), adults with two or more comorbid conditions make up the large majority of those hospitalized for COVID-19 in the United States. Phase 1b also includes older adults living in congregate or overcrowded settings—including nursing homes, long-term care facilities, homeless shel- ters, group homes, prisons, or jails. As a group, they face the joint risk fac- tors of severe disease and reduced resilience associated with advanced age and of acquisition and transmission due to their living settings. A significant proportion of COVID-19 deaths in the United States have occurred among individuals living in nursing homes and long-term care facilities, highlight- ing the critical need to protect individuals in this group. Phase 2 Moving to Phase 2 and beyond, it is important to note the overlap is- sue discussed earlier. Individuals who fall within population groups in this

12 FRAMEWORK FOR EQUITABLE ALLOCATION OF COVID-19 VACCINE phase may also be high-risk health workers or first responders, have comor- bid and underlying conditions that put them at significantly higher risk, or be older and living in congregate or overcrowded settings, and therefore should be vaccinated in Phase 1. Phase 2 of the allocation framework would cover approximately 30–35 percent of the U.S. population, bringing the total coverage across Phases 1 and 2 to an estimated 45–50 percent of the total population. K–12 teachers, school staff, and child care workers are included in Phase 2. This category includes administrators, environmental services staff, maintenance work- ers, and school bus drivers, all of whom are essential to education and face disease exposure. Vaccinating these individuals supports their vital societal role in providing children’s education and development, while reducing their role in transmission between schools and the community and protect- ing their own health risks from exposure in these settings. Phase 2 also includes critical workers in high-risk settings—a group of individuals whose occupations are in essential industries and who cannot avoid a high risk of exposure to COVID-19. They include workers in the food supply system, public transit, and other vital services. It would be useful for public health agencies, including CDC, the Occupational Safety and Health Administra- tion, the Mine Safety and Health Administration, and state and local public health agencies, to provide additional guidance in the designation of jobs or tasks involved as well as occupational codes or job titles in this group. Phase 2 includes people of all ages with comorbid and underlying conditions that put them at moderately higher risk, which the committee defined as having one of the previously mentioned conditions and poten- tially some rare diseases as well. Phase 2 also includes people in homeless shelters or group homes, and staff who work in those settings. Group home populations include people with disabilities—such as serious mental illness, developmental and intel- lectual disabilities, and physical disabilities—as well as those in recovery. Many of these individuals have chronic health care needs and challenging living settings that increase potential exposure. Phase 2 includes people in prisons, jails, detention centers, and similar facilities, and staff who work in those settings, with the expectation that they have limited opportunity to follow public health measures such as maintaining physical distance, putting them at significant risk of acquiring and transmitting COVID-19. All older adults not included in Phase 1b are included in Phase 2, because advanced age is in itself a risk factor for severe disease and death due to COVID-19. Phase 3 Phase 3, which assumes wider availability of COVID-19 vaccine, fo- cuses on preventing transmission of COVID-19 and restoring social and

SUMMARY 13 economic activity. This phase would cover an estimated 40–45 percent of the U.S. population, bringing the total to 85–95 percent vaccination cover- age across Phases 1–3. Phase 3 includes young adults, children, and workers in industries that are both important to the functioning of society and pose moderately high risk of exposure. Young adults between the ages of 18 and 30 typically have broader social networks than older adults, increasing their risks of infection and transmission, but are less likely to become severely ill or die due to COVID-19, making them targets for transmission preven- tion. Children, too, are much less likely than adults to experience severe outcomes due to COVID-19, but can play a role in transmission. How- ever, it is important to note that clinical trials of COVID-19 vaccine have not started in children in the United States. Workers in this category are important to the functioning of society and are at moderately high risk of exposure. Representative industries may include universities, entertainment, and goods-producing industries, whose occupational risk of transmission is lower than those in Phase 2 because they work in settings where protective measures are likely to be implemented without great difficulty. Phase 4 Finally, Phase 4 includes everyone residing in the United States who did not have access to the vaccine in prior phases. While the committee’s phased allocation approach is limited by imper- fect data, information unknowns, and potential unintended consequences, it is intended to be adapted by STLT partners based on their needs, and should rely on mid-course corrections and real-time updates based on the science about effectiveness of different vaccines in different populations. RECOMMENDATION 1. Adopt the committee’s framework for equi- table allocation of COVID-19 vaccine. The U.S. Department of Health and Human Services and state, tribal, local, and territorial (STLT) 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. Important considerations include the following: •  This framework can also inform the decisions of other groups, such as the Advisory Committee on Immunization Practices and those in the global health community. •  STLT authorities will have to make final decisions on refining and applying the framework and should plan for situations when pri-

14 FRAMEWORK FOR EQUITABLE ALLOCATION OF COVID-19 VACCINE oritization has to be adapted midway through the process. In doing so, they should refer to the principles and allocation criteria that guided the formulation of the phases. IMPLEMENTATION CONSIDERATIONS In Chapters 5 and 6, the report also discusses the administration, moni- toring, data collection, communication, community engagement, health promotion, and evaluation activities needed to implement an effective, equitable national COVID-19 vaccination program, including the roles of federal and STLT authorities and their partners. CDC traditionally holds a leadership role in vaccination program coordination, working with fed- eral partners such as the Office of the Assistant Secretary for Preparedness and Response, the U.S. Food and Drug Administration, NIH, the Health Resources and Services Administration, and the Centers for Medicare & Medicaid Services. Secure vaccine storage, transport, and safe, efficient, and equitable vaccine distribution are critical to a successful national CO- VID-19 vaccination program, especially given the potential vaccine ultra- cold chain requirements and a multi-dose vaccine regimen. Successfully establishing a coordinated approach to COVID-19 vaccination will require leveraging existing systems, along with strong and real-time rapid moni- toring and evaluation procedures, including assessment of the program’s penetrance among key populations. RECOMMENDATION 2. Leverage and expand the use of existing systems, structures, and partnerships across all levels of government and provide the necessary resources to ensure equitable allocation, distribution, and administration of COVID-19 vaccine. The U.S. Department of Health and Human Services should com- mit to leveraging and expanding the use of existing systems, struc- tures, and partnerships across all levels of government and provide the resources necessary to ensure equitable allocation, distribution, and administration of COVID-19 vaccine. Equitable allocation must be supported by equitable distribution and administration. Specific action steps to implement this recommendation are as follows: •  Provide resources (including resources for staff) to state, tribal, lo- cal, and territorial authorities and their implementation partners and adequately fund indirect assets (e.g., needles, syringes, personal protective equipment for vaccinators, resources for ultra-cold chain management, and so forth) necessary for effective vaccine alloca- tion, distribution, and administration. •  ensure identification and delivery of COVID-19 vaccine to prior- To ity population groups, develop the capacity and systems to collect

SUMMARY 15 and integrate the necessary data (digital and other) from public health and private providers of care to facilitate the identification and monitoring of people with pre-existing conditions and other high-risk characteristics. • Establish a robust and comprehensive surveillance system to moni- tor, detect, and respond to identified problems, gaps, inequities, and barriers. Monitoring should encompass equitable vaccine allocation and distribution, vaccine delivery, adverse events following immuni- zation, promotion and communication, and uptake and coverage. • Ensure that a rigorous COVID-19 vaccine safety monitoring pro- gram, built on existing systems, is in place, with an emphasis on rapid reporting and timely and transparent assessment of adverse events to determine whether events are associated with receipt of vaccine or occurring by chance. Several COVID-19 vaccines under development have received consider- able taxpayer support. Therefore, it is essential that COVID-19 vaccines be delivered through a central mechanism that ensures availability of vaccines to all individuals, regardless of their social and economic resources or their employment, immigration, or insurance status. This can best be achieved if this federal mechanism makes vaccines available at no cost to the public health and health care sectors. To ensure equity and to decrease vaccine hesitancy, there should be no out-of-pocket costs for those being vaccinated and this includes covering fees for administration of the vaccine. RECOMMENDATION 3. Provide and administer COVID-19 vaccine with no out-of-pocket costs for those being vaccinated. The U.S. Department of Health and Human Services should co- ordinate across agencies so that (1) COVID-19 vaccine is available at no cost to the public health and health care sectors and thus free to the individual; (2) providers are assured that they have the ability to submit for reimbursement of allowable and reasonable administration fees to a third party but with no costs shared by the individual being vaccinated; and (3) public health mass vaccination clinics are federally supported and funded to provide vaccinations at no cost to individuals being vaccinated, which is particularly important for reaching popula- tions that do not have insurance. Specific action steps to implement this recommendation are as follows: •  Apply Patient Protection and Affordable Care Act regulations re- garding no cost sharing for preventive services for COVID-19 vac- cinations for insured individuals, while addressing instances where these regulations fail to protect the beneficiary from out-of-pocket costs. Require health insurance providers and self-insured employ-

16 FRAMEWORK FOR EQUITABLE ALLOCATION OF COVID-19 VACCINE ers to waive co-pays and deductibles for vaccine administration based on a reasonable nationally determined administrative rate set by the Centers for Medicare & Medicaid Services for all providers, irrespective of site of care or network participation status. •  reach uninsured individuals, provide federal support and funding To for mass vaccination clinics and for reimbursement for providers serving uninsured individuals directly. In all cases, a billing code of some kind will be needed to monitor uptake, for pharmacovigi- lance, and to monitor disparities. • Keep barriers to provider participation in administration of the vac- cine as low as possible, especially for those providers who are in communities that are disproportionately impacted by COVID-19 by ensuring vaccines are available at no cost and that administration of the vaccine is adequately reimbursed even if there is no cost sharing for the patient. Engaging with communities will be a critical task for STLT authorities to ensure equity and develop effective, localized COVID-19 vaccination plans (further discussed in Chapters 5 and 6). Community-based organiza- tions and other partner organizations—including hospitals, pharmacies, faith-based organizations, community centers, and schools and universi- ties—can support community outreach and foster accountability. Employ- ers and unions could support improved access by providing work-site clinics and by covering costs for employees. As part of community engagement, the ethical principles, implementa- tion processes, expected outcomes, and how well the program has achieved equitable allocation of safe and effective COVID-19 vaccine actual per- formance must be transparently communicated. Communication must be accessible and available for a diverse audience, and should pay attention to disease processes that can be misunderstood unless properly explained, equity in the vaccination program’s procedures and performance, empirical testing, and appropriate tailoring. Effective communication requires cultural competence, establishment of a trusted authority, special consideration for unfamiliar material, and approaches to address different users’ needs, includ- ing engagement with a variety of partners. The communication workforce must reflect the diversity of the communities being vaccinated, and must rely on the scientific foundations of risk communication and community engage- ment, as well as collect the evidence needed to serve the public effectively. RECOMMENDATION 4. Create and appropriately fund a COVID-19 vaccine risk communication and community engagement program. The U.S. Department of Health and Human Services should cre- ate and appropriately fund a COVID-19 vaccination risk communi-

SUMMARY 17 cation and community engagement program to support state, tribal, local, and territorial (STLT) authorities as an integral part of an ef- fective and equitable national COVID-19 vaccination program. The program should: •  Ensure public understanding of the foundational principles, proce- dures, expected outcomes, and performance of vaccination efforts, including changes in response to research, experience, and public input. •  informed by the concerns and beliefs, as revealed by surveys, Be news media, public discourse, and social media channels, with spe- cial attention to information gaps and misinformation. •  Support STLT authorities in their engagement and partnership with community-based organizations, local stakeholders, and others to provide two-way communication with their constituencies and most effectively reach diverse populations. •  grounded on scientific foundations, incorporating the expertise Be of individuals with the cultural competency to hear and speak to diverse communities that have a stake in successful vaccination efforts. •  Rely on transparent, trustworthy assessments of vaccine safety and efficacy, as reviewed by the federal government and independent external scientists. •  Begin immediately and sustain proactive two-way communication. Achieving Acceptance of COVID-19 Vaccine Recent polling data suggest that approximately one-third of U.S. resi- dents would not accept a COVID-19 vaccine if offered today, with skepti- cism even higher among certain populations, including Black and Hispanic communities. Histories of medical research exploitation, such as during the Tuskegee syphilis study, fuel skepticism in minority communities. Beyond this understandable distrust, vaccine hesitancy is increasingly common in the United States, and influential anti-vaccine groups have been particularly ef- fective in spreading their views online. Concerns about the development and approval of COVID-19 vaccines, including the unprecedented speed of test- ing for safety and efficacy in clinical trials, and significant concerns of politi- cal considerations affecting evaluation of the data from those trials, create a more challenging environment for vaccine hesitancy and reduced acceptance. WHO’s Measuring Behavioral and Social Drivers of Vaccination (BeSD) Increasing Vaccination Model offers one tool for investigating people’s mo- tivations toward becoming vaccinated. It considers people’s thoughts and feelings, as well as the social processes that affect their motivation. Multiple reviews of the evidence have found that there is not a “one-size-fits-all” so-

18 FRAMEWORK FOR EQUITABLE ALLOCATION OF COVID-19 VACCINE lution to vaccine hesitancy. Rather, addressing this issue requires a combina- tion of interventions, including the engagement of community leaders, mass media campaigns, and health care professional training. People-centered and dialogue-based solutions, including those based on social marketing tactics, will be key to promoting acceptance of COVID-19 vaccine. Those guiding and implementing these programs must represent the communities they are trying to reach. In Chapter 7, the committee reviews the complex and dynamic landscape of vaccine hesitancy and discusses its specific ap- plication and relevance to COVID-19 vaccination. RECOMMENDATION 5. Develop and launch a COVID-19 vaccine promotion campaign. The Centers for Disease Control and Prevention should rapidly develop and launch a national, branded, multi-dimensional COVID-19 vaccine promotion campaign, using rigorous, evidence-informed risk and health communication, social marketing, and behavioral science techniques. The COVID-19 vaccine promotion campaign should: •  consistent in its messaging but also flexible and modular to allow Be state, tribal, local, and territorial authorities to tailor it to specific communities and audiences, similar to the truth campaign against tobacco use. •  Partner with diverse stakeholders (e.g., health care providers, His- torically Black Colleges and Universities research centers, Hispanic Association of Colleges and Universities, Tribal Colleges and Univer- sities research centers, social marketing firms and other groups with specific expertise reaching underserved communities) and prioritize promoting the vaccine to Black, Hispanic or Latinx, American In- dian and Alaska Native, Hawaiian Native and Pacific Islander, and other communities in which vaccine hesitancy and skepticism have been documented.  •  Engage thought and opinion leaders, such as celebrities, to help promote COVID-19 vaccination acceptance and uptake. •  Incorporate messaging (in a variety of languages) and graphical elements that increase motivation, counter misinformation, and overcome perceived or actual practical barriers to vaccination. •  Include print, radio, television, and social media formats; incor- porate toolkits, educational materials, and guidebooks to support community discussion about the COVID-19 vaccine; and make materials available in multiple languages. •  incorporated into broader messaging that provides consistent Be information on COVID-19 public health strategies that include non- pharmaceutical interventions, such as mask usage, physical distanc- ing, hand washing, and so forth; expanded and accessible diagnostic

SUMMARY 19 testing linked to contact tracing, isolation, and quarantine strategies aimed at containing transmission, suppressing outbreaks, and inter- rupting super-spreading events; and the deployment of therapeutic measures that mitigate morbidity and mortality. RECOMMENDATION 6. Build an evidence base for effective strate- gies for COVID-19 vaccine promotion and acceptance. The Centers for Disease Control and Prevention (CDC) and the Na- tional Institutes of Health should invest in rapidly building an evidence base for effective strategies for COVID-19 vaccine promotion and ac- ceptance, acknowledging the unique circumstances around COVID-19 vaccination and the knowledge gaps related to understanding commu- nity needs and perceptions and effective promotion and delivery strate- gies. Specific action steps to implement this recommendation include: •  Support innovation in vaccine promotion at the state, tribal, local, and territorial levels and among community-based organizations through existing and expanded program grant mechanisms, with an emphasis on supporting existing entities, programs, and infrastruc- ture with community knowledge and expertise; and on expanding CDC’s existing Vaccinate with Confidence programs. •  Support a new rapid response research grant mechanism to advance the science of COVID-19 vaccine acceptance through grants that: °  and community-basedresearch entities, public health agen- Foster partnership among cies, organizations; Evaluate existing or novel theory-driven strategies and inter- ° ventions to decrease COVID-19 vaccine hesitancy, increase COVID-19 vaccine uptake, and eliminate social, cultural, logis- tic, and legal barriers to COVID-19 vaccination in focal popula- tions; and Support research grounded in diverse theoretical and method- ° ological approaches, with an emphasis on novel approaches and data sources. ENSURING EQUITY IN COVID-19 VACCINE ALLOCATION GLOBALLY Entities outside of the United States are also working to ensure COVID-19 vaccine access and equitable allocation worldwide. The Ac- cess to COVID-19 Tools Accelerator was established by a diverse range of development partners and its vaccine pillar—referred to as COVAX—is convened by the Coalition for Epidemic Preparedness Innovations and Gavi, the Vaccine Alliance. Gavi, the Vaccine Alliance’s financing approach for COVAX is designed to provide all countries with the opportunity to

20 FRAMEWORK FOR EQUITABLE ALLOCATION OF COVID-19 VACCINE participate in securing an initial supply of vaccine for 20 percent of their population. The COVAX Facility provides a pooling mechanism for pro- curement. A total of 156 economies, representing more than two-thirds of the global population, are now either committed to or eligible for the COVAX Facility—with more to expected to follow. Although the United States is not currently among those countries, the report discusses the rea- sons favoring its participation, including COVAX serving as an insurance policy to OWS, should the vaccine that it is supporting prove less effective or less available than hoped; the recognition that infectious disease threats do not respect international boundaries; the need for domestic preparedness and national security; and the moral duty to support it. RECOMMENDATION 7. Support equitable allocation of COVID-19 vaccine globally. The U.S. government should commit to a leadership role in the equitable allocation of COVID-19 vaccine globally, including •  Opt in to the COVAX Facility at Gavi, the Vaccine Alliance. The U.S. government can pledge its support while still pursuing its bilat- eral national efforts through Operation Warp Speed and executing its own robust vaccine manufacturing and distribution plans. •  Deploy a proportion (e.g., 10 percent) of the U.S. vaccine supply for global allocation, both as a means to help contain the COVID-19 pandemic and as an effort to build global solidarity in addressing this pandemic—and the next. This deployment should be imple- mented through the COVAX Facility led by Gavi, the Vaccine Alli- ance, which is developing a fair and equitable allocation for global distribution in concert with the member states of the World Health Assembly.  •  Engage with and support the World Health Organization and its member states to optimize the fair and equitable allocation of COVID-19 vaccines both between and within all nations, regard- less of their income level. CONCLUDING REMARKS SARS-CoV-2 will continue to spread around the world until a vaccine is developed and widely distributed and administered. Ultimately, in these uncertain and challenging times, the integrity of the COVID-19 vaccine de- velopment, allocation, and distribution processes will be critical to ensuring widespread access to vaccines that are safe and effective, and convincingly so for the public. The committee hopes that the evidence-based delibera- tions and policy recommendations set forth in this report and summarized in Box S-2 contribute to society’s ability to respond to and recover from the COVID-19 pandemic.

SUMMARY 21 BOX S-2 Summary of Recommendations The following points collectively summarize the necessary actions recom- mended by the committee to achieve equitable allocation of COVID-19 vaccine: • Adopt the committee’s framework for equitable allocation of COVID-19 vaccine. • Leverage and expand the use of existing systems, structures, and partner- ships across all levels of government and provide the necessary resources to ensure equitable allocation, distribution, and administration of COVID-19 vaccine. • Provide and administer COVID-19 vaccine with no out-of-pocket costs for those being vaccinated. • Create and appropriately fund a COVID-19 vaccine risk communication and community engagement program. • Develop and launch a COVID-19 vaccine promotion campaign. • Build an evidence base for effective strategies for COVID-19 vaccine pro- motion and acceptance. • Support equitable allocation of COVID-19 vaccine globally.

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Framework for Equitable Allocation of COVID-19 Vaccine Get This Book
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In response to the coronavirus disease 2019 (COVID-19) pandemic and the societal disruption it has brought, national governments and the international community have invested billions of dollars and immense amounts of human resources to develop a safe and effective vaccine in an unprecedented time frame. Vaccination against this novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), offers the possibility of significantly reducing severe morbidity and mortality and transmission when deployed alongside other public health strategies and improved therapies.

Health equity is intertwined with the impact of COVID-19 and there are certain populations that are at increased risk of severe illness or death from COVID-19. In the United States and worldwide, the pandemic is having a disproportionate impact on people who are already disadvantaged by virtue of their race and ethnicity, age, health status, residence, occupation, socioeconomic condition, or other contributing factors.

Framework for Equitable Allocation of COVID-19 Vaccine offers an overarching framework for vaccine allocation to assist policy makers in the domestic and global health communities. Built on widely accepted foundational principles and recognizing the distinctive characteristics of COVID-19, this report's recommendations address the commitments needed to implement equitable allocation policies for COVID-19 vaccine.

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