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Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine (2020)

Chapter: A Framework for Equitable Allocation of COVID-19 Vaccine

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Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
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Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
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Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
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Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
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Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
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Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
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Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
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Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
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Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
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Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
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Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
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Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
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Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
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Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
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Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
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Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
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Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 47
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 48
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 49
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 50
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 51
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 52
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 53
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 54
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 55
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 56
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 57
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 58
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 59
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 60
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 61
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 62
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
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Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
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Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 65
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
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Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 67
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 68
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
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Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 70
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 71
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 72
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
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Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
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Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 75
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 76
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 77
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 78
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 79
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 80
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 81
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 82
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 83
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 84
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 85
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
Page 86
Suggested Citation:"A Framework for Equitable Allocation of COVID-19 Vaccine." National Academies of Sciences, Engineering, and Medicine. 2020. Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. doi: 10.17226/25914.
×
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Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

617 A Framework for Equitable Allocation of COVID-19 Vaccine 618 In this chapter—drawing from the lessons learned from other allocation frameworks 619 outlined in the prior chapter—the committee lays out the foundational principles that inform its 620 recommended COVID-19 vaccine allocation framework, and describes the primary goal of its 621 framework, the risk-based allocation criteria used to apply the principles, and the resulting 622 allocation phases (see Figure 1). The chapter concludes with an in-depth description and 623 discussion of the phases, including the rationale behind the inclusion of groups listed in each 624 phase. 625 626 627 DRAFT FIGURE 1 Major elements of the framework for equitable allocation of COVID-19 628 vaccine DISCUSSION DRAFT FOR PUBLIC COMMENT 31

629 630 Numerous uncertainties about COVID-19 vaccine still exist that must eventually be 631 addressed, and allocation and prioritization will likely depend on certain key vaccine 632 characteristics. These uncertainties include the safety and efficacy of the vaccines in certain 633 populations (such as children, pregnant women, older adults, and individuals previously infected 634 with COVID-19); the effective use of vaccines in tandem with existing preventive measures; 635 public confidence in the vaccine; the ability to adapt plans based on pharmacovigilance; and 636 others. 637 Such uncertainties require the framework to be adaptable to a variety of circumstances, 638 including the state of the pandemic when a vaccine becomes available. Designing the framework 639 to be adaptable to a range of possible circumstances means that the committee must consider 640 how the framework would operate ethically and effectively in a range of plausible scenarios. 641 Planning is crucial, but a rigid framework is unlikely to match the specific circumstances that 642 actually emerge, and will likely change depending on the goal of the vaccination program, the 643 state of the pandemic, the state of the science, and the extent to which people are engaging in 644 social distancing and other preventive measures. The following chapter describes several such 645 scenarios and their implications for the framework. Likewise, the framework must be 646 implementable. To be able to guide policy makers in planning for vaccine allocation, it must be 647 feasible to put the framework into operation. For example, for individuals or groups prioritized to 648 receive the vaccine, it must be possible to identify them accurately and quickly. 649 One-third or more of the U.S. population may decline a free and U.S. Food and Drug 650 Administration (FDA-approved) vaccine for the novel coronavirus (Mullen O’Keefe, 2020). 651 Concerns about inclusion and diversity in COVID-19 vaccine trials (Jaklevic, 2020) and 652 uncertainties like those previously noted compound the already significant doubts that some 653 members of the public have about the vaccine. The committee’s framework for vaccine 654 allocation cannot address the general lack of confidence in vaccination. A mass vaccination 655 program for public health will fail if there is widespread public mistrust. The committee believes 656 that the equitable allocation framework that it recommends, if properly implemented and 657 communicated, can secure public trust by being based on foundational principles that are simple, 658 clear, coherent, and consistent in their application. The hope is that an equitable allocation DISCUSSION DRAFT FOR PUBLIC COMMENT 32

659 framework will gain public trust, by providing benefit to individuals and communities, thereby 660 mitigating the damage caused by the pandemic and aggravated by existing health inequities. 661 FOUNDATIONAL PRINCIPLES OF THE FRAMEWORK 662 The committee was charged with developing an overarching framework for the equitable 663 allocation of COVID-19 vaccine. This framework is intended to assist and guide policy makers 664 in planning for vaccine allocation under conditions of scarcity that will necessitate vaccinating 665 persons in phases over time. In presenting the sponsor’s charge at the committee’s first meeting 666 on July 24, 2020, the director of the National Institutes of Health (NIH), Dr. Francis Collins, 667 stressed that the overarching framework should include “foundational principles.” Such 668 principles, which are summarized and explicated below, informed the committee’s deliberations 669 about allocation criteria. 670 The committee recognizes that its proposed framework must not only be equitable but 671 also be perceived as equitable by audiences who are socioeconomically, culturally and 672 educationally diverse, and who have distinct historical experiences with the health system. As a 673 result, the framework’s public face must do justice to its scientific and ethical foundations. 674 Therefore, the committee has designed the framework so that it: 675 676 • Can be easily and equally well understood by the diverse audiences whose concerns 677 the vaccine allocation scheme must address; 678 • Reflects widely accepted social and ethical principles; 679 • Can be reliably translated into operational terms; 680 • Distinguishes scientific and ethical judgments in their application; and 681 • Does not perpetuate discrimination and inequities. 682 Foundational Principles 683 The foundational principles for the equitable allocation framework for COVID-19 684 vaccine include ethical and other principles embedded in U.S. social institutions and culture (see 685 Box 3). The committee recognized that the principles required for its deliberations had to be DISCUSSION DRAFT FOR PUBLIC COMMENT 33

686 solid and broad enough to urgently address a pandemic of a magnitude not seen in a century with 687 disastrous effects not only on the public’s health for persons with COVID-19 and other health 688 problems and their communities but also on the economy, education, and other central aspects of 689 society. 690 The committee immediately invoked a principle of maximization of benefits that sets an 691 primary goal of maximizing societal benefit through the reduction of morbidity and mortality 692 caused by the transmission of the novel coronavirus. While spread throughout the society, the 693 pandemic’s damage has more significantly harmed some populations more than others, 694 particularly causing higher rates of infection, serious illness, hospitalization, and death among 695 people of color. This reality led the committee to formulate a principle of mitigation of health 696 inequities to address the higher risks faced by such persons in certain work environments and 697 living arrangements which correspond to higher risk of transmitting and acquiring infection and 698 with having a higher prevalence of certain health problems that make it more likely that they will 699 suffer severe outcomes and even die from COVID-19. In tragic choices about vaccine allocation, 700 the principle of equal regard directs attention to the equal worth and value of every person, 701 protecting each one from discrimination, while the principle of fairness requires impartiality and 702 the engagement and participation of affected populations in setting allocation criteria and 703 determining priority groups. Furthermore, the principle of transparency ensures the disclosure of 704 the principles, criteria, and priority groups that will determine people’s chances of getting a 705 vaccine sooner rather than later. Finally, none of these principles can accomplish its goals 706 without the principle that all decisions must be evidence-based. 707 Not unexpectedly, these principles overlap substantially with those in other frameworks 708 for the allocation of scarce medical and public health goods, including vaccines for pandemic 709 influenza (Williams and Dawson, 2020). Virtually every such framework has a principle like the 710 committee’s on the maximization of benefits. Most frameworks also include principles like the 711 committee’s relating to equality and to equity, fairness, and justice (Emanuel et al., 2020; 712 Nuffield Council on Bioethics, 2020; Persad et al., 2009; Toner et al., 2020; Williams and 713 Dawson, 2020). These frameworks vary in how clusters of ethical considerations are combined 714 into primary principles and the weight assigned to those principles. DISCUSSION DRAFT FOR PUBLIC COMMENT 34

715 In seeking a set of foundational principles to guide its deliberations, the committee 716 identified the following principles as both necessary and sufficient for formulating vaccine 717 allocation criteria and their implementation in phases of vaccine allocation. These principles, 718 which are unranked, do not reflect any specific ethical theory, but are consonant with many and 719 grounded in U.S. social values and cultural discourse. 720 BOX 3 Foundational Principles for Equitable Allocation • Maximization of benefits • Equal Regard • Mitigation of health inequities • Fairness • Evidence-based • Transparency 721 Maximization of Benefits 722 This principle encompasses the obligation to protect and promote the public’s health and 723 its socioeconomic well-being in the short- and long-run. In this pandemic, it entails the 724 obligation, as previously noted, to maximize societal benefit by reducing morbidity and mortality 725 caused by transmission of the novel coronavirus. Meeting this obligation constitutes the 726 overarching goal of the committee’s proposed allocation framework. Societal benefit is broadly 727 understood in this context (public’s health and socioeconomic well-being). While it includes 728 individuals’ health and well-being, the committee recognizes that conflicts may emerge between 729 the society’s and the individuals’ needs and risks and require resolution. The framework the 730 committee proposes seeks to combine them to the extent possible. 731 The vaccine allocation framework thus seeks to reduce the risks of severe morbidity and 732 mortality caused by transmission due to the novel coronavirus for those (a) most at risk of 733 infection and serious outcomes, (b) in roles considered to be essential for societal functioning, 734 and (c) most at risk of transmitting the coronavirus to others. Individuals in these roles include: DISCUSSION DRAFT FOR PUBLIC COMMENT 35

735 736 • Those whose work puts them at additional risk of infection; and 737 • Those whose absence from their societal roles or work puts others and the society at 738 risk of loss of needed goods and services if they become infected (e.g., physicians, 739 nurses, other health care providers, first responders, workers employed in the food 740 supply system, transportation workers, teachers, etc.). 741 742 The interconnection between protecting and promoting the public’s health and 743 socioeconomic quality of life is generally understood and appreciated. However, it can be 744 difficult scientifically to determine the best way to achieve both aims through vaccine allocation 745 and other measures. Given present scientific knowledge, it is also difficult to determine the most 746 effective combination of focusing vaccine allocation on reducing morbidity and mortality versus 747 reducing transmission of COVID-19. Making those determinations wisely will require accurate, 748 evidence-based assessments of the state of the pandemic and the available vaccine. 749 Equal Regard 750 The government’s obligation to express equal regard to residents should both guide and 751 constrain its allocation and distribution of goods, such as vaccines, and burdens, such as delays 752 in the provision of vaccines. This fundamental obligation requires that everyone be considered 753 and treated as having equal dignity, worth, and value. It presupposes that no one person is 754 intrinsically more valuable or worthy of regard than another. It entails treatment as an equal 755 rather than, automatically, an equal share (several versions of an egalitarian principle appear in 756 Emanuel et al., 2020; Persad et al., 2009; and Nuffield Council on Bioethics, 2020). 757 The principle of equal regard retains its force even when it is necessary and ethically 758 justifiable to ration vaccines and other health related goods under conditions of scarcity. It 759 requires allocation and distribution by criteria that are non-discriminatory in design and impact. 760 It excludes rationing based on criteria such as religion, race, ethnicity, national origin, etc. The 761 moral right to equal regard and concern requires that allocation of vaccine proceed impartially 762 according to fair criteria as will be further specified below. Moreover, the requirement of equal 763 regard does not preclude consideration of people’s social roles in such allocations. Some social DISCUSSION DRAFT FOR PUBLIC COMMENT 36

764 roles are essential in this pandemic to ensure the provision of necessary goods and services to the 765 community and to individuals, including but not limited to medical care. This means that the 766 people filling those roles may legitimately gain priority (e.g., clinicians, emergency responders, 767 food processors) in those circumstances. 768 If the supply of vaccine is too limited to provide it to everyone in a particular priority 769 population group at the same time, the principle of equal regard supports random selection (e.g., 770 lottery) within that population group. It can also support a weighted lottery18 for vaccine 771 allocation as it has for the allocation of COVID-19 therapies such as remdesivir (White et al., 772 2020). 773 Mitigation of Health Inequities 774 The obligation to mitigate health inequities and their effects has become particularly 775 salient in this pandemic. COVID-19 infections and deaths are strongly associated with race, 776 ethnicity, occupation, and socioeconomic status. A significantly higher burden is experienced by 777 Black, Hispanic or Latinx, and American Indian and Alaska Native populations. Currently there 778 is no evidence that this is biologically mediated, but rather the impact of systemic racism leading 779 to higher rates of comorbidities that increase the severity of COVID-19 infection and the 780 socioeconomic factors that increase likelihood of acquiring the infection (front line jobs, 781 crowded living conditions, lack of access to personal protective equipment (PPE), inability to 782 work from home, etc.). A significantly higher burden is also experience by individuals who hold 783 jobs with high transmission risk that cannot be done from home and often are poorly paid. These 784 groups also experience disproportionately large burdens of other adverse health conditions. 785 Many factors contribute to these health inequities, defined as “systematic differences in the 786 health status of different population groups” (WHO, 2017) (see Box 4). Fundamental health 787 inequities in COVID-19 and in other health conditions are rooted in structural inequalities, 788 racism, and residential segregation. Any vaccine allocation scheme designed to reduce COVID- 789 19 risk must explicitly address the higher burden of COVID-19 experienced by the populations 790 affected most heavily, given their exposure and compounding health inequities. Mitigating those 18 A weighted lottery system could be used to fairly allocate the scarce supply of vaccine with certain groups receiving heightened priority. DISCUSSION DRAFT FOR PUBLIC COMMENT 37

791 health inequities is, therefore, a moral imperative of an equitable vaccine allocation system. In 792 addition, any vaccine allocation plan implemented at the federal and state levels must respect the 793 tribal sovereignty of American Indian and Alaska Native nations. 794 795 BOX 4 796 Health Inequities 797 798 The World Health Organization defines health inequities as “systematic differences in the health 799 status of different population groups […] which have significant social and economic costs both 800 to individuals and societies” (WHO, 2017). Health inequities arise from social, economic, 801 environmental, and structural disparities that contribute to intergroup differences in health 802 outcomes both within and between societies. A 2017 report of the National Academies of 803 Sciences Engineering and Medicine identified two root causes of health inequities: 804 805 • Structural inequities, or the “systemic disadvantage of one social group compared to other 806 groups with whom they coexist, and which encompasses policy, law, governance, and 807 culture and refers to race, ethnicity, gender or gender identity, class, sexual orientation, and 808 other domains” (NASEM, 2017). 809 • Social determinants of health, or the “ conditions in the environments in which people live, 810 learn, work, play, worship, and age that affect a wide range of health, functioning, and quality 811 of-life outcomes and risks” (NASEM, 2017). 812 813 The interplay between these two root causes can lead to systematic differences in the 814 opportunities certain communities have to achieve optimal health, leading to unfair and 815 avoidable differences in health outcomes (Braveman, 2006; WHO, 2017) 816 817 Thus, the vaccine allocation criteria should mitigate the negative effects of existing health 818 inequities on the transmission of and harms from the novel coronavirus. The committee’s 819 allocation criteria do so in part by taking into account to the “vulnerability” of 820 DISCUSSION DRAFT FOR PUBLIC COMMENT 38

821 • People at increased risk of infection because of social conditions, such as working 822 conditions and living in multigenerational homes19; and 823 • People at increased risk of severe outcomes because of comorbid conditions that often 824 result from or are worsened by social determinants, limited access to health care, etc. 825 826 These allocation criteria identify people who are considered to be the most disadvantaged 827 or the “worst off” because of conditions of ill health or social deprivation or both that could 828 make them more susceptible to infection or severe outcomes. Such criteria are often called 829 “prioritarian” because of the primary place assigned to the “worst off” (Emanuel et al., 2020; 830 Toner et al., 2020). A further way to mitigate the effects of health inequities is to incorporate 831 some metric of social disadvantage, such as the Centers for Disease Control and Preventions 832 (CDC’s) Social Vulnerability Index20, into the prioritization of vaccine recipients by making it an 833 additional consideration within the phases. 834 Ultimately, the mitigation of health inequities includes development and deployment of 835 distribution systems that ensure that people who are allocated a vaccine actually receive it (e.g., 836 by taking it to where they are) and can afford it, even if they are hard to reach. 837 Fairness 838 The principle of fairness includes the obligation to develop allocation criteria based only 839 on relevant non-discriminatory characteristics, already noted under the principle of equal regard, 840 to apply these criteria impartially, and to employ fair procedures in allocation and distribution. 841 The principle of fairness here entails formulating criteria focused on individual, community, and 842 social needs and risks, and vigilantly avoiding the sometimes conventional practices that create 843 and sustain discrimination. 844 Questions often arise about fair rationing when age is involved. This committee has been 845 clear that it does not use age as a criterion of allocation, but only as a predictor of heightened (1) 846 risk of acquiring infection, (2) risk of severe outcomes of infection, or (3) risk of transmission to 19 Multigenerational homes consist of more than two generations living under the same roof. 20 CDC’s Social Vulnerability Index was developed for local preparedness for public health emergencies such as natural disasters and disease outbreaks, identifies geographic areas of vulnerability based on 15 census variables. These variables capture many recognized social determinants of health, indicators of access, infection transmission, increased risk of adverse COVID-19 outcomes (ATSDR, 2018). DISCUSSION DRAFT FOR PUBLIC COMMENT 39

847 others. Given the currently available evidence about the pandemic’s behavior, priority for older 848 adults in certain phases, if warranted, would probably be based mainly on risk of severe 849 outcomes of infection, whereas priority for young adults, if warranted, would probably be based 850 mainly on risk of transmission to others.. The conflict is not so direct between these two 851 populations in the current pandemic because children who are infected with the novel 852 coronavirus and can transmit it tend not to have such severe outcomes as older adults. If such a 853 direct conflict existed because of widespread severe outcomes among children, there would be 854 strong arguments for prioritizing children over older adults on the basis of severe outcomes. 855 Children would be “worse off” because of the years of life they would lose, older adults have had 856 their “fair innings,” and so forth (Daniels, 2008; Emanuel and Wertheimer, 2006; Emanuel et al., 857 2020; Kamm, 1993; Williams, 1997). In the current context, the more difficult conflict to resolve 858 is between reducing transmission among children in order to make it more likely that they can 859 attend school in person and to reduce transmission to others in the community, on the one hand, 860 and reducing severe illness and death among older adults, on the other hand. 861 A related debate about age concerns the loss of life years versus the loss of life. Older 862 adults in their eighties, for instance, generally lose fewer life years if they die than children or 863 young adults who die. However, given the large numbers of older adults who die from COVID- 864 19, those numbers multiplied by fewer life years can still end up being quite substantial. 865 Resolving these conflicts depends on evidence about the relative effectiveness of different 866 vaccine strategies at particular stages in the pandemic give available supplies of vaccine, as will 867 be examined later in this chapter. 868 Fairness should guide not only the formulation of allocation criteria, but also their 869 application, which should be impartial and evenhanded, and avoid arbitrary exceptions and 870 gaming. Implementation should be as uniform as possible across the country, consistent with 871 allowing discretion to state, local, tribal, and territorial (SLTT) authorities to address specific 872 patterns of COVID-19 transmission, extent of spread, and severity of outcomes. Unless clearly 873 communicated and justified, extreme variation in applying the criteria can evoke charges of 874 unfairness. 875 Procedural fairness is also crucial. This means that decisions about allocation, 876 distribution, and access to vaccine should incorporate input from affected groups, especially DISCUSSION DRAFT FOR PUBLIC COMMENT 40

877 those disproportionately affected. Decisions about whether a group has heightened risk and 878 which individuals fall in that particular group should be data-driven and made by impartial 879 decision makers, such as public health officials. Ideally, affected individuals and communities 880 should be able to appeal decisions, and in doing so, the committee believes that the transparency 881 of its principles will help adjudicate those subsequent debates. 882 Reciprocity, defined as rewarding people for their past contributions, is sometimes 883 presented as an additional ethical principle, in part to account for common intuitions about 884 certain situations, particularly giving priority to vaccine clinical trial participants who received a 885 placebo or an ineffective vaccine. The committee agrees with the common practice of post-trial 886 access for research participants but believes that this is covered by the principle of fairness. 887 Evidence-Based 888 Vaccination phases—who receives the vaccine when—should be based on the best 889 available evidence and models for identifying the populations most likely to become seriously ill 890 or die without vaccination, for determining when slowing the pandemic is best accomplished 891 with a focus on those most likely to spread the infection, and for estimating the added effect of 892 vaccination on transmission in public and crowded settings. The framework must be adaptive, 893 capable of being changed as the understanding of the disease and its risk factors deepens, and as 894 vaccines become available, especially if some are more useful for particular populations than 895 others. Models and their inputs will be revised as the pandemic and available information 896 evolves. The criteria used to identify categories of individuals or groups for each phase will 897 evolve accordingly but will at all times be stated clearly and applied in a neutral fashion. 898 Transparency 899 The principle of transparency includes the obligation to communicate with the public 900 openly, clearly, accurately, and straightforwardly about the vaccine allocation criteria and 901 framework, as they are being developed and deployed. Central to this process is clear articulation 902 and explanation of the allocation criteria. Those explanations must include the principles 903 underlying these criteria, as grounded in widely accepted societal institutions and culture, as well 904 as the procedures for ensuring their faithful implementation. DISCUSSION DRAFT FOR PUBLIC COMMENT 41

905 Sometimes governments present vaccine allocation criteria without explicitly or 906 adequately explaining their grounding in principles. This is a mistake in at least two ways. First, 907 the public has a legitimate reason to expect such a justification when criteria affect when they 908 can receive a vaccination, especially when their government funds the vaccine program. Second, 909 such communication is essential to generating and sustaining public trust in the vaccine 910 allocation criteria and program. 911 Transparency should also extend to other aspects of procedural fairness. Individuals (or 912 their trusted surrogates) must be able to observe, understand, and monitor how the program’s 913 procedures are formulated and applied. That will require simple, clearly defined, and 914 comprehensibly communicated rules. It will also require accessible documentation of how the 915 allocation system performs and how it responds to the unanticipated consequences inevitable 916 with such a complex human enterprise. 917 Without transparency regarding the allocation criteria, their ethical rationale, the 918 deliberative process used to formulate them, and fair procedures, it will be difficult to generate 919 and maintain the trust that is indispensable for the public’s cooperation with a mass vaccination 920 program. 921 To achieve transparency, it is necessary to ensure that the program’s principles and 922 operations are accessible and comprehensible to all those affected by it. This cannot be done 923 without empirically testing proposed communications in two essential ways: Can people find a 924 program’s procedures and guiding principles easily, following their normal search patterns? Can 925 they interpret them in ways that inform their evaluations regarding the legitimacy of the program 926 and their own vaccination choices? 927 Using the Principles 928 Each pandemic has what Yale historian Frank Snowden calls its distinctive “personality” 929 (Snowden, 2019), that is, its distinctive characteristics of disease and rates of infection, its modes 930 of transmission, the groups and individuals most susceptible to infection, ages most affected, 931 varying rates of severity and mortality, etc. Determining the specific criteria for vaccine 932 allocation will require attention to up-to-date scientific information about the pandemic, on the 933 one hand, and to foundational principles, on the other. These principles need to be specified and 934 applied in the process of developing vaccine allocation criteria and phases to match the features DISCUSSION DRAFT FOR PUBLIC COMMENT 42

935 of the pandemic, along with the characteristics, supply, safety, and efficacy of any available 936 vaccines. 937 This is evident, to take just one example, in applications of the principle of maximization 938 of benefits and the primary goal it sets for vaccine allocation. Determining how best to protect 939 and promote the public’s health and socioeconomic well-being, both immediate and long-term, 940 while the vaccine is being phased in before becoming available to everyone in the society 941 requires solid scientific evidence (principle of evidence-based) in the several ways previously 942 noted. Similar points apply to the principles of mitigation of health inequities, equal regard, and 943 fairness as well as to transparency. In the final analysis, each proposed allocation criterion and 944 its proposed weight or strength must pass scrutiny in light of all of these principles. To be sure, 945 conflicts may appear and require resolution, even necessitating trade-offs. Possible conflicts 946 notwithstanding, these principles provide the foundation for the allocation criteria and the phases 947 in vaccine allocation derived from them. The overall allocation framework reflects the 948 committee’s best judgment about how to balance sometimes conflicting aims as the pandemic 949 evolves and vaccine becomes incrementally available over time. 950 COVID-19 VACCINE ALLOCATION FRAMEWORK 951 Primary Goal of the Framework 952 Previous proposals for allocation of scarce resources in pandemics and other settings 953 articulate various overarching goals to guide allocation that are focused on aspects of reducing 954 morbidity and mortality, reducing disease transmission, minimizing societal disruptions, 955 maintaining national security, and mitigating health inequities. For example, the 2018 CDC 956 guidance document, Allocating and Targeting Pandemic Influenza Vaccine During an Influenza 957 Pandemic states that its overarching goals are to reduce the impact of the pandemic on health and 958 minimize the disruption to society and the economy. 959 Emanuel and colleagues (2020) recommended that in the context of a pandemic, such as 960 COVID-19, the principle of maximization of benefits is most important and reflects the 961 importance of responsible stewardship of scarce, valuable resources. Therefore, the primary goal 962 of the committee’s framework on equitable allocation of COVID-19 vaccine derives from the 963 ethical principle of maximization of benefits, which is: DISCUSSION DRAFT FOR PUBLIC COMMENT 43

964 965 “Maximize societal benefit by reducing morbidity and mortality caused by 966 transmission of the novel coronavirus.” 967 968 The primary goal of the committee’s allocation framework has a dual focus: 969 maximization of benefit through prevention of morbidity and mortality and through reduction in 970 transmission. Moreover, the framework attempts to mitigate health inequities and is informed by 971 the current evidence. In the early phases, prevention of morbidity and mortality, and maintenance 972 of health and emergency services to aid prevention of morbidity and mortality is emphasized 973 more than the reduction in transmission;21 with an increased focus on transmission in later 974 phases. 975 There are multiple reasons for this approach. 976 977 • Morbidity and mortality are clearly identified and provide a logical and 978 understandable start to selecting the first vaccine recipients. 979 • Any substantive impact of vaccination on reducing transmission would require a 980 critical mass of individuals to be vaccinated. Even if this critical mass is lower than 981 the nominal herd immunity threshold, in the early phases of vaccine deployment, 982 there will not be sufficient courses of the vaccine available for an effective 983 transmission-focused strategy. 984 • The ongoing COVID-19 vaccine trials are not designed to estimate the impact of the 985 vaccine candidates on transmission and evidence of the vaccines’ impact on 986 transmission might not be available for some time after approval or authorization. 987 • While data on all aspects of COVID-19 are emerging, data on transmission risk 988 groups (e.g., by age, profession etc.) is particularly limited. 989 • There are legitimate claims for many groups (such as school children, “non-essential” 990 workers important for the economy) to be in earlier phases as damage could occur if 991 these groups are not prioritized. For example, there might be a substantial impact on 21 For clarification, the committee considered transmission in terms of transmitting infection to others and not acquiring infection. DISCUSSION DRAFT FOR PUBLIC COMMENT 44

992 the economy if a primarily transmission focused strategy is not employed from the 993 outset. However, while the non-trivial effects of an economic downturn or an online 994 semester can at least be partially reversed, death is the most irreversible outcome. 995 • Preventing severe morbidity and mortality indirectly protects the health care system 996 (i.e., an overwhelmed health care may have an impact on excess morbidity and 997 mortality). 998 999 A focus on preventing mortality and severe morbidity in the initial phases does not mean 1000 vaccinating only groups at a direct risk of these outcomes. Prevention of transmission to groups 1001 at a high risk of morbidity and mortality should also be a part of the early phases of the vaccine 1002 program. For example, vaccinating nursing home workers would protect the high-risk residents 1003 of these facilities—particularly if the vaccine efficacy is lower among the elderly compared to 1004 younger individuals. Moreover, as more courses of vaccines become available, an increasing 1005 focus on reducing transmission, starting with high transmission settings and moving to the 1006 general population, would ensure sustainable long-term control of COVID-19. Focusing on 1007 health care and emergency workers in the initial phases will help mitigate the pandemic’s impact 1008 on morbidity and mortality due to disruptions in the health care system. 1009 Ultimately, the U.S. COVID-19 vaccination program should aim to vaccinate all who 1010 choose to be vaccinated and are without medical contraindications to the vaccine. 1011 Allocation Criteria 1012 The ethical principle of transparency, as well as the practical requirement of efficient, 1013 consistent administration of the framework have led the committee to develop risk-based criteria 1014 for operationalizing the foundational principles to achieve its primary goal (see Box 5). After 1015 presenting these criteria briefly, this section discusses their compatibility with the foundational 1016 principles, practical aspects of implementation, and their likely implications for allocation as 1017 vaccines becomes increasingly available. The committee notes that the fidelity of the allocation 1018 process to these foundational principles and criteria depends on the availability of data, as well as 1019 the resolution of the uncertainties discussed earlier. Achieving this goal requires comprehensive, 1020 consistent data collection that includes the needed variables of race/ethnicity, age, gender, and DISCUSSION DRAFT FOR PUBLIC COMMENT 45

1021 social status. The section below on the allocation framework provides operational definitions of 1022 these criteria, suiting to current and emerging evidence regarding the disease, the vaccine, and 1023 their impact on society. 1024 BOX 5 Risk-Based Criteria • Risk of acquiring infection: Individuals have higher priority to the extent that they have a greater probability of being in settings where COVID-19 is circulating and exposure to a sufficient 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 livelihood depend on them directly and would be imperiled if they fell ill. • Risk of transmitting disease to others: Individuals have higher priority to the extent that there is a higher probability of their transmitting the disease to others. 1025 Risk of Acquiring Infection 1026 Individuals have higher priority to the extent that they have a greater probability of being 1027 in settings where COVID-19 is circulating and exposure to a sufficient dose of the virus to 1028 become infected. 1029 Risk of Severe Morbidity and Mortality 1030 Individuals have higher priority to the extent that they have a greater probability of severe 1031 disease or death should they acquire infection. 1032 Risk of Negative Societal Impact 1033 Individuals have higher priority to the extent that societal function and other individuals’ 1034 lives and livelihood depend on them directly and would be imperiled if they fell ill. This risk is 1035 interpreted through the number of other people potentially affected. It does not consider their DISCUSSION DRAFT FOR PUBLIC COMMENT 46

1036 wealth, income, or other factors. It does not consider how readily an individual could be replaced 1037 in a work setting, given labor market conditions. 1038 Risk of Transmitting Infection to Others 1039 Individuals have higher priority to the extent that there is a higher probability of their 1040 transmitting the infection to others. This risk reflects individuals’ interactions with others, given 1041 their normal course of life and their material, physical, and social resources. It is important to 1042 note that there is limited data on differential transmissibility. 1043 Compatibility of Allocation Criteria with Foundational Principles 1044 Maximization of Benefits 1045 Each of the four types of risk reflects a threat to the public’s health and socioeconomic 1046 well-being. Reducing each risk would bring such benefits in the short and long run. These risk- 1047 based criteria expressed the foundational principles in terms that are further specified in the 1048 allocation phases that follow. 1049 Equal Regard 1050 These criteria treat all people equally. They make no reference to who people are, just to 1051 their circumstances, what social roles they fill and what personal challenges they face (e.g., 1052 health). If more vaccine goes to members of one population group than another, it will not reflect 1053 who they are, but what they do, and what has happened in their lives. 1054 Mitigation of Health Inequities 1055 Although the criteria do not directly address health inequities, the first criterion addresses 1056 them indirectly insofar as those inequities have increased individuals’ risk of disease (e.g., social 1057 disadvantage is linked to having more disease and more severe disease). The second criterion 1058 addresses them indirectly insofar as workers who have been subject to health inequities play 1059 essential roles in jobs with greater exposure. The third criterion addresses them indirectly insofar 1060 as those individuals are more likely to live in dense settings. A measure such as CDC’s Social 1061 Vulnerability Index could identify people in geographic areas who have suffered health 1062 inequities that put them at greater risk. DISCUSSION DRAFT FOR PUBLIC COMMENT 47

1063 Fairness 1064 These criteria focus solely on four forms of risk, with no explicit recognition of any other 1065 individual characteristics. The committee anticipates that the criteria will, in practice, tend to 1066 give higher priority to lower-income individuals (because it is they who more frequently live in 1067 high-density settings, work in jobs that cannot be done without having personal contact with 1068 others, and have multiple comorbidities due to their circumstances and their relative lack of 1069 access to health care) and Black, Hispanic or Latinx, and American Indian and Native Alaskan 1070 communities given the ways in which these risks disproportionately affect people in these 1071 groups. 1072 Evidence-Based 1073 These three risk-based criteria apply well-understood analytical procedures to the best 1074 available scientific evidence (NRC, 1983, 1994, 2009). They can readily incorporate new 1075 evidence as it becomes available and characterize uncertainties in ways that can guide future data 1076 collection. Their application in the allocation phases reflects the committee’s assessment of the 1077 evidence regarding how vaccines can best maximize benefits to individuals and communities and 1078 the health inequities that must be mitigated in that process (NRC, 2009). 1079 Transparency 1080 There are explicit, auditable procedures for defining risk and applying those definitions. 1081 The guidance provided by various reports of the National Academies of Sciences, Engineering, 1082 and Medicine can achieve transparency, including the procedural fairness that it requires (NRC, 1083 1996). 1084 The committee notes that it chose not to consider three issues: 1085 1086 • Political context: The committee appreciates that decisions about the public’s health 1087 are made in the context of existing political realities and those are not static. 1088 However, the committee believes that regardless of the political context, officials at 1089 all levels will administer these principles faithfully, considering the wellbeing of all 1090 members of the communities that they are elected or appointed to serve. The DISCUSSION DRAFT FOR PUBLIC COMMENT 48

1091 committee also acknowledges, as stated earlier, that other groups are working to 1092 inform allocation strategies as well. 1093 • Regulatory and public health changes: The committee recognizes that there are 1094 settings where risks could be changed by regulatory or public health requirements 1095 (e.g., mask mandates, greater spacing of workers in food processing facilities). 1096 Recommending such changes is beyond the committee’s statement of task. However, 1097 should they occur, they will affect some individuals’ risks of getting sick or 1098 transmitting infection if they do. As a result, they will affect the operation of the 1099 allocation procedure, and require adaptive implementation, which the proposed 1100 framework is designed to make possible. However, it is crucial that these other 1101 protective measures not be prematurely abandoned. 1102 • Advances in medical treatment and therapeutic agents: The committee recognizes 1103 the vast, creative efforts made to improve medical treatment and develop therapeutic 1104 agents. As they succeed, they should reduce the risk of disease severity and may 1105 reduce the risk of transmission of infection. Here, too, the adaptability of the 1106 allocation procedure can accommodate changes in risk. 1107 Allocation Phases 1108 Major efforts are being made by the federal government through Operation Warp Speed 1109 (OWS) to have enough COVID-19 vaccine available for everyone in the United States as soon as 1110 possible. However, even with this commitment, the length of time to develop enough vaccine is 1111 unknown, and the committee has been tasked with considering the difficult choices that will need 1112 to be made for allocating the tightly constrained initial supply of vaccine (e.g., 10–15 million 1113 courses, enough to vaccinate approximately 3–5 percent of the U.S. population). The supply of 1114 vaccine, as it increases, will be incrementally phased in so that some persons or groups of 1115 persons will receive it earlier than others. The committee here uses the term “phases,” suggesting 1116 successive deployments, rather than the hierarchical, and static term “tiers.” As vaccine supplies 1117 are phased in, it will be necessary to have in place an equitable framework to determine who will 1118 receive a vaccine first, second, and so forth. In this committee’s judgment, an equitable—that is, 1119 just and reasonable—framework for these phases should follow the proposed foundational 1120 principles. DISCUSSION DRAFT FOR PUBLIC COMMENT 49

1121 It should be noted that the guidance offered through the committee’s allocation 1122 framework is intended to inform the work of the Advisory Committee on Immunization 1123 Practices (ACIP) and that of SLTT authorities in their COVID-19 vaccine allocation 1124 planning. There are certain communities (such as the U.S. military) that may handle vaccine 1125 allocation separate from this proposed framework.. If the federal government were to provide 1126 states with an allotment of COVID-19 vaccine, in the interest of speed and workability, federal 1127 allocation to states could be conducted based on these jurisdictions’ population size.22 While 1128 there is obviously variation among SLTT communities in disease burden and demography, these 1129 differences are not large enough to justify the delay and deliberation that would be required to 1130 decide on customized allocations to each location. Speed is essential because many difficult 1131 choices need to be made at the state and local levels. 1132 One exception to a straightforward population-based approach would be to withhold a 1133 percentage (e.g., 10 percent) of available vaccine supply at the federal level as a reserve for 1134 deployment by CDC for use in areas of special need or epidemiological “hot spots.”23 If by the 1135 time COVID-19 vaccines become available, the United States. has achieved the success seen in 1136 other countries in stopping widespread community transmission with non-pharmaceutical 1137 interventions and test, trace, isolate, quarantine approaches, a more focused outbreak response 1138 will be feasible. 1139 Specific to tribal nations, it is important to acknowledge that the federal government 1140 would allocate vaccine to tribal, urban Indian, and Indian Health Service (IHS) facilities directly 1141 through the existing IHS system. Federal trust responsibility for health care to Native people 1142 mandates that. To do so successfully, IHS allocation will require additional funding and external 1143 oversight. While separate from state allocation, it may also be in states’ best interest to 1144 supplement IHS allocation with a portion of their own supply in order to protect the public’s 1145 health. Even in this scenario, states would not oversee how tribal governments allocate vaccine 1146 in order to ensure tribal sovereignty. 22 There remains uncertainty as to whether private entities, such as healthcare systems or businesses, will be able to access allotments of COVID-19 vaccines outside of a federal-to-state allotment system. 23 Planning for whether an epidemiological “hot spot” reserve would be valuable and make a difference also depends on the characteristics of the vaccine (e.g., how long it takes for immunity to develop, etc.). DISCUSSION DRAFT FOR PUBLIC COMMENT 50

1147 Operationalizing the Criteria to Determine Allocation Phases 1148 Data will not be available to characterize each individual in terms of these criteria. Even 1149 were those data available, an allocation system based on individual priority scores would be 1150 technically impractical for delivering millions of courses of vaccine to geographically distributed 1151 individuals. To determine the population groups that comprise each allocation phase, the 1152 committee operationalized the above criteria by characterizing certain population groups in terms 1153 of the risks faced by their typical members and the ability of a vaccine to reduce those risks (see 1154 Table 2). The committee also considered the role mitigating factors such as access to PPE and 1155 the ability to social distance / isolate or telework when applying the risk-based criteria and 1156 determining the priority population groups. 1157 DISCUSSION DRAFT FOR PUBLIC COMMENT 51

1158 DRAFT TABLE 2 Applying the Allocation Criteria to Specific Population Groups Criterion 2: Criterion 3: Criterion 4: Criterion 1: Risk of Risk of Risk of Risk of Severe Negative Transmitting Acquiring Morbidity Societal Infection to Phases Population Group Infection and Mortality Impact Others Mitigating Factors for Consideration High risk of acquiring infection due to no High risk workers in choice in setting but may have access to 1a H M H H health care facilities personal protective equipment. Essential to protecting the health care system. High risk of acquiring infection due to no choice in setting but may have access to 1a First responders H M H H personal protective equipment. Essential to protecting the health care system. People with High risk of severe morbidity and mortality, 1b significant comorbid M H M L but may be able to social distance and conditions isolate. Older adults in High risk of acquiring infection due to lack 1b congregate or H H L L of choice in setting. overcrowded settings High risk of acquiring infection due to no Critical risk workers 2 H M H M choice in setting, but may have access to (part 1) personal protective equipment. High risk of loss to an essential service, but Teachers and school there are alternative choices such as online 2 H M H H staff schooling (lower grades should be given priority). Moderate risk of severe morbidity and People with moderate 2 M M M L mortality, but may be able to social distance comorbid conditions and isolate. High risk of severe morbidity and mortality, 2 All older adults M H L L but may be able to social distance and isolate. DISCUSSION DRAFT FOR PUBLIC COMMENT 52

People in homeless High risk of acquiring infection due to lack 2 shelters or group H H L H of choice in setting. homes Incarcerated/detained High risk of acquiring infection due to lack 2 H M L M people and staff of choice in setting. Low risk of severe morbidity and mortality, 3 Young adults H L M H high risk of transmission, but may be able to social distance/isolate/close bars, etc. 3 Children M L M H Low risk of severe morbidity and mortality Critical risk workers Moderate risk of acquiring infection due to 3 M L M L (part 2) lack of choice in setting. 1159 NOTES: Cell entries are for a typical member of each group. H = high risk, M = medium risk, L = low risk. M can indicate either a heterogeneous 1160 group or one whose typical member bear medium risk. All cell entries are relative to risks in the overall population, not measures of absolute risk, 1161 and are based on the committee’s expert judgment of the evidence and the uncertainties at the time of this writing. Lastly, the committee has 1162 elected not to use the designation “essential worker.” Instead, the committee refers to these workers as critical risk workers as they are both 1163 working in industries vital to the functioning of society and in occupations where they cannot avoid exposure risk by, for example, teleworking. 1164 This is described further later in this chapter. DISCUSSION DRAFT FOR PUBLIC COMMENT 53

1165 The framework recognizes current uncertainty regarding the disease, its spread, and 1166 treatments and the possibility that new evidence may change the risks and, with them, the 1167 priorities. Achieving all of these goals requires evidence, regarding the disease, the program, 1168 treatments, and their impacts. That evidence is required by both those managing the COVID-19 1169 vaccination program and those who depend on it. The COVID-19 vaccination program must 1170 immediately begin developing and implementing procedures that continuously collect data. 1171 Discussion of the Allocation Phases 1172 The committee recommends a four-phased approach to COVID-19 vaccine allocation. 1173 Within the population groups included in each of these four phases, the committee recommends 1174 that vaccine access should be prioritized for geographic areas identified as vulnerable through 1175 CDC’s Social Vulnerability Index. This issue is discussed further in the ensuring equity section 1176 later in this chapter. 1177 Included in the first phase would be “frontline” health workers—health professionals 1178 who are involved in direct patient care, as well as those in transport, environmental services staff, 1179 or other health care facility services, who risk exposure to bodily fluids or aerosols. Under 1180 conditions of such scarcity, access should not be defined by professional title, but rather by the 1181 individual’s actual risk of exposure to COVID-19. The rationale for including “frontline” health 1182 workers in the first phase is manifold: their contact with patients exhibiting COVID-related 1183 symptoms puts them at obvious risk of exposure (despite the use of PPE, which is also often 1184 inadequate in supply); the fact that they work in an essential industry, but may be precluded from 1185 performing their professional duties if not adequately protected; and the reality that many are 1186 potentially important nodes in onward transmission networks given that many live in 1187 multigenerational homes and belong to communities whose opportunities for well-being have 1188 been forestalled by systemic racism and discrimination. The latter is especially true for many of 1189 those who work in nursing homes and as home health aides. In addition to frontline health care 1190 workers, first responders are included as well. 1191 Another group to include in the first phase would be those older adults living in 1192 congregate settings—such as nursing homes or skilled nursing facilities—and other similar 1193 settings. Last, individuals with select high-risk comorbid and underlying conditions are included 1194 in Phase 1. DISCUSSION DRAFT FOR PUBLIC COMMENT 54

1195 In Phase 2, expansion of vaccine supply would allow for the immunization of another 1196 cohort of individuals with comorbid and underlying conditions that put them at increased risk, as 1197 well as all older adults not already included in Phase 1. Health care providers and public health 1198 authorities will need to assess the risk of increased age (while morbidity and mortality begins to 1199 rise substantially with age starting around age 50, it is most prevalent above age 70), as well as 1200 the presence of comorbid conditions. Current knowledge of the relative risks stemming from 1201 specific underlying risk factors is evolving quickly and will be better known by the time vaccines 1202 actually become available. This may allow decision makers to target those at greatest risk of 1203 serious morbidity and mortality more effectively than is possible today. This could also allow the 1204 identification of younger people who are at high risk of infection or serious morbidity/mortality 1205 so that they can also be prioritized. The development of life-saving therapeutics may also alter 1206 the prioritization if early detection and treatment provide a means for averting much of the 1207 serious morbidity and mortality seen with COVID-19 today. 1208 Recognizing the importance of education and child development, teachers and school 1209 staff are included in Phase 2. It is important to include this group relatively early to facilitate the 1210 reopening of schools, and to protect the most high-risk adults present when this occurs given 1211 current knowledge about morbidity and mortality due to COVID-19. 1212 People who are incarcerated or detained and people who live in group homes and 1213 homeless shelters—congregate settings—are also included in Phase 2 along with the staff who 1214 work in such settings. With respect to these groups, the committee stressed the importance of 1215 recognizing their reduced autonomy and the recognized difficulty of preventing spread in such 1216 settings should COVID-19 be introduced. Last, the first cohort of workers who are both in 1217 industries essential to the functioning of society and at high risk of exposure are included in 1218 Phase 2. 1219 In Phase 3, vaccine supply will become more widely available and allow the broader 1220 immunization of workers essential to restoring full economic activity. In this phase many 1221 workers will still be able to safely work from home and thus would be prioritized for later access 1222 to the vaccine. In this phase the broad immunization of children and young adults is included, 1223 given emerging evidence of the role they may play in asymptomatic transmission, especially in 1224 intrafamilial situations. An important caveat here is that broad immunization of children will DISCUSSION DRAFT FOR PUBLIC COMMENT 55

1225 depend on whether new COVID-19 vaccines have been adequately tested for safety and efficacy 1226 in childhood age groups. Most initial trials are testing vaccines among older age groups who are 1227 known to suffer more serious morbidity and mortality. 1228 Finally, once vaccine supply becomes more broadly available (Phase 4), vaccines would 1229 be made available to healthy adult individuals who would be interested in receiving the vaccine 1230 for personal protection. Ideally, these individuals would be willing to participate in an egalitarian 1231 process (such as a lottery) if there are persistent local or regional shortages in this phase. It is 1232 important to acknowledge that uncertainties about the COVID-19 vaccine and the nature of the 1233 pandemic itself persist, but the committee approached its framework under the best available 1234 evidence today. Under the context described, the committee’s allocation approach is shown in 1235 Figure 2 and described in greater detail below—first as a description of the various phases, 1236 following by discussion of ensuring equity across all phases. 1237 The proposed approach assumes a poorly-controlled outbreak in which the relative 1238 distribution of burden of morbidity and mortality is similar to what exists today. Given the 1239 epidemiology of COVID-19 so far, it is reasonable to assume these underlying conditions will 1240 hold around the anticipated start of the U.S. COVID-19 vaccination program. However, it is 1241 possible that the United States is able to substantially control the outbreak similar to situations in 1242 countries such as New Zealand. In that case, a prioritization approach that initially emphasizes 1243 transmission over direct protection from morbidity and mortality could be considered. DISCUSSION DRAFT FOR PUBLIC COMMENT 56

A F T 1244 D R 1245 DRAFT FIGURE 2 A phased approach to vaccine allocation for COVID-19 DISCUSSION DRAFT FOR PUBLIC COMMENT 57

1246 A Phased Approach to Vaccine Allocation 1247 Phase 1 1248 Phase 1 includes the following groups: 1249 1250 • High-risk workers in health care facilities; 1251 • First responders; 1252 • People of all ages with comorbid and underlying conditions that put them at 1253 significantly higher risk; and 1254 • Older adults living in congregate or overcrowded settings. 1255 1256 According to estimates provided by OWS (Slaoui, 2020), there should be sufficient 1257 courses available relatively soon after commencement of vaccine production to cover an 1258 estimated 10–15 million people. In that limited supply scenario, high-risk and high-exposure 1259 workers in health care facilities and first responders should constitute an initial “Jumpstart” 1260 Phase 1a. This would be followed by Phase 1b comprised of people with comorbid and 1261 underlying conditions that put them at significantly higher risk and older adults living in 1262 congregate or overcrowded settings. 1263 Phase 1a would cover approximately 5 percent of the U.S. population, and in its entirety, 1264 Phase 1 would cover an estimated 15 percent. Such a structure could help kick off initial vaccine 1265 administration, while SLTT authorities prepare distribution procedures for the next phases. 1266 Phase 1a 1267 Population: High-Risk Workers in Health care Facilities 1268 This group includes front line health care workers (in hospitals, nursing homes, or 1269 providing home care) who either: (1) work in situations where risk of SARS-CoV-2 transmission 1270 is high, or (2) are at an elevated risk of transmitting the infection to patients at high risk of 1271 mortality and severe morbidity. These individuals—who are themselves unable to avoid 1272 exposure to the virus—play a critical role in ensuring that the health system can care for COVID- 1273 19 patients. DISCUSSION DRAFT FOR PUBLIC COMMENT 58

1274 These groups include not only clinicians (e.g., nurses, physicians, respiratory technicians, 1275 dentists and hygienists) but also other workers in health care settings who meet the Phase 1a risk 1276 criteria (e.g., nursing assistants, environmental services staff, assisted living home staff, long- 1277 term care facility staff, group home staff, and home caregivers). Situations with high risk of 1278 transmission include caring for COVID-19 patients, cleaning areas where COVID-19 patients are 1279 admitted and treated, and performing procedures with high risk of aerosolization such as 1280 endotracheal intubation, bronchoscopy, suctioning, turning the patient to the prone position, 1281 disconnecting the patient from the ventilator, invasive dental procedures and exams, invasive 1282 specimen collection, and cardiopulmonary resuscitation. The committee also includes morticians 1283 and funeral home workers involved in handling bodies as part of this high-risk group. 1284 Rationale 1285 Front line health care workers are particularly important in stemming the pandemic and 1286 preventing death and severe illness. From the beginning of the pandemic, many frontline workers 1287 have worked in environments where they have been exposed to the virus, often without adequate 1288 PPE. These individuals are critical to providing essential care, especially to older adults who are 1289 at greatest risk of COVID-19 disease or death. Vaccinating these individuals not only enables 1290 them to provide these services, but also reduces the risk that they will spread the infection as they 1291 work in hospitals, nursing homes, assisted living facilities, home care, and group homes, or 1292 return to their own homes. 1293 Frontline health care workers are at significantly higher risk of becoming infected with 1294 SARS-CoV-2 compared to members of the general public. A recently cohort study using data 1295 from the United States and the United Kingdom found that frontline health care workers had 1296 nearly 12 times the risk of the general population of testing positive for COVID-19 (Nguyen et 1297 al., 2020). Protecting these workers will have a great impact on protecting older individuals, who 1298 receive a large share of health services and have borne a large share of the disease burden from 1299 COVID-19. 1300 Nearly 80 percent of all COVID-19 deaths in the United States have occurred in people 1301 over the age of 65 (CDC, 2020e). Nursing home residents and staff have been at the center of the 1302 pandemic since the first reported cases. As of August 2, 2020, there were 286,382 confirmed or 1303 suspected COVID-19 cases and 45,958 deaths among nursing home residents, according to the DISCUSSION DRAFT FOR PUBLIC COMMENT 59

1304 Centers for Medicare and Medicaid Services (CMS) (CMS, 2020a), and these numbers are likely 1305 to be underreported (Ouslander and Grabowski, 2020). Nursing home workers are at increased 1306 risk themselves—CMS also reports that nearly 800 nursing home staff in the United States have 1307 died from COVID-19—and play a role in infection spread within and between institutions (CMS, 1308 2020b). Asymptomatic spread by nursing home workers is a well-established route (Lee et al., 1309 2020), and vaccinating this group could have a significant impact on the incidence of infection in 1310 this setting. Nursing home and home care employment is low-paying, with many workers 1311 holding jobs at more than one nursing home or home care setting. Many of these workers take 1312 public transportation and live in multi-generational housing, increasing the likelihood of 1313 exposure and exposing others. 1314 In addition to their occupational and community exposures, these workers are statistically 1315 at higher risk of COVID-19 disease and severe health effects because they come from 1316 populations with higher rates of comorbid conditions. A relatively high proportion of nursing 1317 home workers are Black (27.8 percent) as are home care workers likely to be Black (29.7 1318 percent) or Latinx (17.5 percent) (McCormack et al., 2020). A sizable proportion of such 1319 workers are over 65 as well (Black: 9.1 percent Latinx: 11.3 percent). In the first months of the 1320 pandemic, some hospitals were unprepared for the large number of COVID-19 cases. Exposure 1321 of hospital workers was often poorly controlled, and many workers received inadequate PPE. 1322 Tens of thousands of hospital workers have been infected, and many hundreds have died, 1323 although there are no accurate data on these cases. While there is still a severe national PPE 1324 shortage, it appears that many hospitals are now better able to protect members of their 1325 workforce who directly work with COVID-19 patients. However, this is not true uniformly 1326 across the country, and, even better equipped hospitals still leave some workers exposed. 1327 Nursing homes have struggled with having adequate PPE since the beginning of the pandemic 1328 and some continue to do so (Clark, 2020). Individuals who provide home care or work in 1329 hospitals, nursing homes, and assisted and living (or similar) facilities—who are also at high risk 1330 for severe illness and death because of comorbid conditions and age—should be among the first 1331 receiving the vaccine. 1332 Vaccination is not a substitute for non-medical or (non-therapeutic) preventive policies 1333 and equipment. All exposed workers should be, for example, provided an adequate supply of 1334 appropriate PPE. It is vitally important that the prospect of vaccination not supplant efforts to DISCUSSION DRAFT FOR PUBLIC COMMENT 60

1335 assure adequate supply of protective equipment or continuing the use mitigation strategies after 1336 vaccination. 1337 Estimated Group Size24 1338 According to the best currently available estimates for the United States, among health 1339 care practitioners and technical staff, 6,728,000 are exposed to COVID-19 more than once per 1340 week; among health care support staff, 3,160,000 are exposed to COVID-19 more than once per 1341 week. There are also approximately 1,500,000 full-time nursing home employees, 432,000 health 1342 care practitioners who work in skilled nursing facilities, and 3,162,000 home health care workers 1343 (Baker et al., 2020; BLS, 2019b). The number of morticians, undertakers, and funeral directors in 1344 the United States is estimated to be approximately 25,000 people (Statista, 2020). 1345 Population: First Responders 1346 This group includes emergency medical services (EMS) personnel, police, and 1347 firefighters (including volunteer firefighters). Like health care workers, many first responders 1348 have been working in situations in which exposure to infected individuals is sometimes 1349 unavoidable. Given their public serving role, first responders who become ill can transmit 1350 infection to their families and to the broader community. While data on exposure risk for first 1351 responders are limited, initial estimates indicate high infection rates among first responders in 1352 high COVID-19 transmission settings. For example, in early April, approximately 20 percent of 1353 New York Police Department (NYPD) officers were out sick (DeStefano, 2020) and, as of May, 1354 43 NYPD officers had died of COVID-19 (Eyewitness News, 2020). 1355 Rationale 1356 First responders are central to society’s overall functioning, to its response to the virus, 1357 and to ensuring that others with medical emergencies receive necessary immediate care. When 1358 emergency medical personnel and fire fighters are unable to work, because of illness or when 1359 isolating because of exposure to the virus, their ability to provide badly needed, medical, rescue 1360 and fire-fighting services, is impaired. First responders who are at high risk of exposure who are 24 Estimated group sizes across phases are not intended to be entirely cumulative, and the committee acknowledges there is overlap between the group estimates provided. Please see the discussion of limitations at the end of this chapter for additional discussion of data. DISCUSSION DRAFT FOR PUBLIC COMMENT 61

1361 also at high risk for severe illness and death because of comorbid conditions and age should be 1362 among the first in this group receiving the vaccine. 1363 Many of the reasons for protecting health care workers also apply to first responders. 1364 These include the social value of maintaining emergency services, reciprocity for assumption of 1365 additional risk by these groups, and—in some cases—high risk of acquisition and, potentially, 1366 transmission. Similarly, until substantial and sustained suppression of the COVID-19 outbreak is 1367 achieved, first responders are likely to need PPE for performing their responsibilities. 1368 Estimated Group Size 1369 An estimated 2.1 million first responders are covered by this population group 1370 comprising 262,000 EMS personnel, 701,000 police, and 1,100,000 firefighters (approximately 1371 300,000 of whom are paid with the rest serving in a volunteer capacity, and a subset of whom 1372 provide emergency medical services) (BLS, 2019; BLS, 2020a; Evarts, 2020). 1373 Phase 1b 1374 Population: People of All Ages with Comorbid and Underlying Conditions That Put Them at 1375 Significantly Higher Risk 1376 It remains unclear precisely which comorbid and underlying conditions put individuals at 1377 a significantly higher risk of severe COVID-19 disease or death. CDC continues to gather 1378 evidence on this topic, and lists the following as factors associated with an increased risk of 1379 severe COVID-19 disease: Cancer, chronic kidney disease, chronic obstructive pulmonary 1380 disease (COPD), immunocompromised state from solid organ transplant, obesity (body mass 1381 index [BMI] ≥30), serious heart conditions (e.g., heart failure, coronary artery disease, 1382 cardiomyopathies), sickle cell disease, and type 2 diabetes mellitus (CDC, 2020d). Vaccinating 1383 all individuals with the above comorbid conditions in Phase 1b would prove unmanageable, as 1384 the group includes hundreds of millions of people in the United States. In a highly constrained 1385 vaccine scenario, the initial group of recipients with comorbid and underlying conditions could 1386 focus specifically on individuals with two or more of these designated conditions. 1387 It should be noted that as the relationship between severe COVID-19 disease and certain 1388 comorbid conditions becomes clearer, this list is subject to evolve. ACIP and CDC will play a 1389 key role in assessing relevant evidence on this topic, and in the process of prioritization, it will DISCUSSION DRAFT FOR PUBLIC COMMENT 62

1390 be critical to recognize that not all comorbid conditions are equal when it comes to their 1391 placement in an allocation framework. 1392 Rationale 1393 According to data recently published through the Coronavirus Disease 2019 (COVID-19) 1394 Associated Hospitalization Surveillance Network (COVID-NET) from March 1 through August 1395 15, 2020, approximately 75 percent of adults hospitalized for COVID-19 in the United States had 1396 at least two comorbid conditions. More than 60 percent of hospitalized adults had three or more 1397 underlying conditions (McClung, 2020).25 1398 Multiple studies have explored a range of comorbid and underlying conditions as 1399 potential risk factors for severe COVID-19 disease. According to CDC’s surveillance data for 1400 March 2020, people with COVID-19 who had underlying health conditions—most commonly 1401 hypertension, obesity, cardiovascular disease, diabetes mellitus, and chronic lung disease—were 1402 6 times as likely to be hospitalized and 12 times as likely to die from the disease as those without 1403 underlying health conditions. A study from a large health care system in New York found that 1404 individuals below age 60 with a BMI of 30 or higher were more likely to be admitted to acute 1405 and critical care than patients in the same age categories with a BMI below 30 (Lighter et al., 1406 2020). Another recent study suggests that, in particular, those with chronic heart failure, kidney 1407 disease, and a BMI of 40 or higher are particularly high-risk groups (Petrilli et al., 2020). 1408 Ultimately, given the high risk of adverse outcomes in individuals with select comorbid 1409 conditions and the evolving evidence on this topic, it will be critical to monitor how the nature 1410 and number of comorbid conditions affect morbidity and mortality at the individual level. 1411 Estimated Group Size 1412 There is currently no clear data to accurately estimate the size of this population group 1413 with multiple select comorbid conditions, which the committee acknowledges as a key 1414 limitation. A recent modeling study by Clark et al. (2020) may help to provide some insight on a 1415 general range for this population group. In the study, the authors highlighted a “high risk” group 25 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. DISCUSSION DRAFT FOR PUBLIC COMMENT 63

1416 defined as individuals who would require hospitalization if infected with COVID-19, calculated 1417 using age-specific infection-hospitalization ratios for COVID-19. The study estimated that 19–20 1418 million people in the United States fall into this category. Given that approximately 75 percent of 1419 those hospitalized for COVID-19 based on the COVID-NET data had multiple comorbid 1420 conditions, the committee estimates that the value of 19–20 million may approximate the number 1421 of individuals with multiple comorbid conditions (from the CDC list above). 1422 Population: Older Adults Living in Congregate or Overcrowded Settings 1423 This group includes older individuals living in situations that increase their risk of SARS- 1424 CoV-2 infection and resultant morbidity and mortality. The scientific community’s 1425 understanding of age-specific COVID-19 mortality is still emerging, and there are concerns, 1426 based on the lower efficacy of other vaccines (such as influenza vaccine) among the elderly, that 1427 COVID-19 vaccines will have a lower efficacy among older adults. For these reasons, the 1428 committee recommends that ACIP determine age guidelines as health and vaccine efficacy data 1429 become more available. 1430 Rationale 1431 According to CDC, the case fatality proportion for COVID-19 is substantially higher 1432 among older adults in the United States. As a result, as of August 1, 2020, approximately 80 1433 percent of all deaths occurred in adults 65 and older (Freed, 2020). Similarly, the risk of 1434 hospitalization from COVID-19 increases with age, with rates per 100,000 significantly higher 1435 for adults 65 and older (~199 per 100,000 for 65–74 year old individuals, ~329 per 100,000 for 1436 75–84 individuals, and ~513 per 100,000 for individuals 85 and older) (CDC, 2020b). A 1437 significant proportion of COVID-19 deaths occurred in individuals living in long-term care 1438 facilities (CMS, 2020a). Data from Canada and other countries, as well as investigative 1439 reporting in the United States, suggests that the percentage of COVID-19 deaths in long-term 1440 care facilities may be higher than indicated by CDC’s database (CIHI, 2020; NYT, 2020a). 1441 Whatever the precise numbers, it is clear that directly protecting older adults—particularly those 1442 living in congregate or overcrowded settings—will have substantial impact on COVID-19- 1443 related severe outcomes. Although there is some uncertainty regarding how well the vaccine will 1444 work in older individuals, models find that prioritizing older adults will have a substantial impact DISCUSSION DRAFT FOR PUBLIC COMMENT 64

1445 on mortality, even if the vaccine is up to 50 percent less effective among people 60 or older 1446 compared people younger than 60 (Lipsitch, 2020). In addition, adjuvanted vaccines such as the 1447 recombinant zoster vaccine (RZV; Shingrix) have been demonstrated to provide efficacy to older 1448 adults across the age spectrum (Bastidas et al., 2019; Dagnew et al., 2020). 1449 The committee also suspects that many older adults living in overcrowded settings may 1450 live in multigenerational households. Historically, in virtually every society, people lived 1451 together in households comprised of three and even four generations (Miller and Nebeker- 1452 Adams, 2017). Although such households are less common overall in the United States today, 1453 they are still often found in lower income communities. Such households typically have 1454 relatively few bedrooms and bathrooms, with crowded sleeping arrangements and reduced 1455 opportunity to practice social distancing. Because many individuals living in multigenerational 1456 households in the United States also work in jobs that put them at elevated risk of exposure to 1457 COVID-19, it is important to vaccinate the members of those households who are most 1458 vulnerable to protect them from acquiring COVID-19 infection. 1459 The combination of risk of severe disease due to advanced age and high risk of COVID- 1460 19 acquisition and transmission among older adults included in this population group make it 1461 among the highest priority groups for receiving the COVID-19 vaccine. 1462 Estimated Group Size 1463 There are approximately 1,347,000 nursing home residents in the United States and 1464 811,000 individuals living in residential care facilities. In addition, 4,700,000 adults over the age 1465 of 65 live below the poverty line, meaning the individuals included in this group total more than 1466 6.8 million people (CDC, 2020a,f; Cubanski, 2018). 1467 Phase 2 1468 Phase 2 includes the following groups: 1469 1470 • Critical risk workers—workers who are both in industries essential to the functioning 1471 of society and at substantially high risk of exposure; 1472 • Teachers and school staff; DISCUSSION DRAFT FOR PUBLIC COMMENT 65

1473 • People of all ages with comorbid and underlying conditions that put them at 1474 moderately higher risk; 1475 • All older adults not included in Phase 1 1476 • People in homeless shelters or group homes for individuals with physical or mental 1477 disabilities or in recovery; and 1478 • People in prisons, jails, detention centers, and similar facilities, and staff who work in 1479 such settings. 1480 1481 Phase 2 would cover an estimated 30–35 percent of the U.S. population; combined with 1482 Phase 1, the groups included across both phases would total approximately 45–50 percent of the 1483 population. 1484 Population: Critical Risk Workers—Workers in Both Industries Essential to the Functioning of 1485 Society and at Substantially High Risk of Exposure 1486 Another group included in Phase 2 are people whose work is vital to the functioning of 1487 society and the economy, and whose work causes them to have a high level of exposure to 1488 persons with SARS-CoV-2 infection. The U.S. Department of Homeland Security (DHS) has 1489 identified categories of “Essential Critical Infrastructure Workers” whose functioning “is 1490 imperative during the response to the COVID-19 emergency for both public health and safety as 1491 well as community well-being” (Krebs, 2020). The list of categories of workers designated by 1492 DHS includes many groups of workers who are at high risk of exposure. Others designated by 1493 DHS, however, are either able to telework or are otherwise isolated and not at high risk of 1494 exposure. Recent work has found that 37 percent of jobs in the U.S. economy are 1495 “teleworkable.” Many of these jobs are in occupations in essential industries, but they also 1496 represent “white collar” positions in industries that are generally considered “blue collar” 1497 (Dingel and Neiman, 2020). Thus, while performing “essential work,” they are able to avoid the 1498 exposure risk while doing vital work. For this reason, the committee has elected not to use the 1499 designation “essential worker” in the allocation framework. Instead, the committee refers to these 1500 workers as critical risk workers as they are both working in industries vital to the functioning of 1501 society and in occupations where they cannot avoid exposure risk. 1502 The industries in which these critical risk workers are employed are essential to keep 1503 society and the economy functioning. Since the beginning of the pandemic, millions of people DISCUSSION DRAFT FOR PUBLIC COMMENT 66

1504 have been going to work and risking exposure to the virus to ensure there is food in markets; 1505 pharmaceutical products in drug stores; public safety and order maintained; mail and packages 1506 delivered; and buses, trains, and planes operated. This group also includes other health care 1507 workers who are not already accounted for in Phase 1a. Importantly, only those occupations in 1508 these essential industries where there is unavoidable high risk of exposure qualify as the critical 1509 risk workers in this group. 1510 Rationale 1511 Large numbers of these workers whose work is vital to the function of society and the 1512 economy have been infected with COVID-19 while on the job, although precise counts are not 1513 available (The Lancet, 2020). It is the committee’s belief that those members of these sectors 1514 who are at higher risk for exposure and infection should be given priority. Many of them work 1515 without adequate protection while in close proximity with coworkers and members of the public. 1516 Groups of workers in essential industries and who are at high risk of exposure (CDC, 2020g) 1517 include workers in the U.S. food supply system who plant, harvest and package crops; slaughter 1518 and process meat; deliver food to stores and stock shelves and staff checkout lines. In many food 1519 system workplaces, inadequate protections have been provided. There are many reasons that 1520 food supply workers are at increased risk of infection and disease, including prolonged close 1521 workplace contact with coworkers, frequent community contact with fellow workers, mobility of 1522 the work force (i.e., migrant workers), shared transportation to and from the workplace, lack of 1523 paid sick leave, congregate housing (including living in employer-furnished housing and shared 1524 living quarters, and living in crowded and multigenerational homes) (Oliver, 2020). These low- 1525 paid workers may be less likely to attempt to use the health care system for care for economic or 1526 legal reasons. Workers in other sectors are at increased risk as well, including workers employed 1527 in public transportation, (such as buses, trains, car services or planes), especially in localities or 1528 situations where passengers are not required to wear masks. Also, in this population group are 1529 postal workers and workers in warehouses and fulfillment centers. Not all workers in these 1530 essential industries are U.S. citizens or green card holders; some may have come to the United 1531 States as refugees or may be undocumented. All workers in this population group need to be 1532 provided the vaccine, and special efforts must be made to reach these workers in ways that 1533 encourage them to be vaccinated. DISCUSSION DRAFT FOR PUBLIC COMMENT 67

1534 Echoing what was stated in Phase 1, it is important to note that while community 1535 transmission of SARS-CoV-2 continues, vaccination is not a substitute for providing other 1536 interventions to mitigate exposure risk, such as engineering and administrative controls and 1537 providing adequate personal protective equipment (OSHA, 2020). 1538 Estimated Group Size 1539 Workers from numerous essential industries are included in this group, such as workers 1540 in food and beverage production (1,700,000), cashiers/food store workers (865,000), pharmacists 1541 and pharmacy staff (621,000), and public transit workers (179,000). There are more than 15 1542 million health care workers in the United States, though a large percentage of them are already 1543 covered in Phase 1a above (BLS, 2019c, 2020b,c; USDA, 2020). Ideally, workers included in 1544 this group would cover the initial 20 percent of those from industries deemed to be essential. 1545 Population: Teachers and School Staff 1546 This group includes school staff, including teachers, child-care workers, administrators, 1547 environmental services staff, and maintenance workers, and school bus drivers. 1548 Rationale 1549 Across the nation, states and localities are placing a high priority on re-opening schools 1550 and expanding childcare programs to promote children’s educational and social development and 1551 facilitate parents’ employment. Exposure is very difficult to control in these institutions, 1552 especially those providing care or education to young children. All workers in these facilities are 1553 among those who need to be protected from the virus during Phase 2. Due to the nature of their 1554 work, teachers and school staff who return to work in schools are at higher risk of COVID-19 1555 infection and serve an important societal role in ensuring that students’ educational needs are 1556 met. One could also argue that vaccinating teachers and school staff could help to reduce viral 1557 transmission, with these teachers and staff serving as connections between schools and broader 1558 society. 1559 Furthermore, the importance of re-opening schools, especially for elementary-aged 1560 children, cannot be understated. Reestablishing a sense of normalcy for students and their 1561 families through in-person education will help to achieve long-term health benefits for children 1562 and facilitate important social development for them as well. DISCUSSION DRAFT FOR PUBLIC COMMENT 68

1563 As some states and localities choose to begin reopening schools, it is also important to 1564 consider the direct impact of COVID-19 disease on teachers and staff. A recent study found that 1565 39.8 percent of teachers had “definite” and 50.6 percent had “definite or possible” risk factors for 1566 severe COVID-19 disease (with similar results for other school staff), emphasizing the vaccine’s 1567 potential importance in protecting teachers and promoting in-person education safely (Gaffney et 1568 al., 2020). Therefore, it is likely that teachers at highest risk would be vaccinated in Phase 1b. 1569 Estimated Group Size 1570 Across the United States, there are 8,605,000 teachers and staff at elementary and 1571 secondary schools; there are also approximately 463,000 people who provide child care services 1572 (BLS, 2019). 1573 Population: People of All Ages with Comorbid and Underlying Conditions That Put Them at 1574 Moderately Higher Risk 1575 Drawing on CDC’s list of comorbid conditions discussed in Phase 1b, this population 1576 group would include anyone with one of the previously mentioned conditions (Phase 1b includes 1577 individuals with multiple comorbid conditions from among those listed). 1578 Other comorbid conditions may be considered for this phase as evidence emerges. In 1579 addition to CDC’s list of comorbid conditions that put individuals at increased risk, CDC has 1580 also compiled a list of comorbid conditions that might put individuals at increased risk. This list 1581 includes asthma (moderate-to-severe); cerebrovascular disease; cystic fibrosis; hypertension; 1582 immunocompromised state from blood or bone marrow transplant, immune deficiencies, 1583 HIV/AIDS, use of corticosteroids, or use of other immunosuppressive medicines; neurologic 1584 conditions; liver disease; pregnancy; pulmonary fibrosis; smoking; thalassemia; and type 1 1585 diabetes mellitus (CDC, 2020c). 1586 Rationale 1587 Similar to the discussion in Phase 1b, the rationale for prioritizing persons with such 1588 conditions is that the vaccine may have a greater impact among those with increased likelihood 1589 of severe illness (hospitalizations, intensive care unit admissions, and deaths) than in persons 1590 without these conditions, resulting in a decreased burden on the health care system and more 1591 lives being saved from all conditions. Based on the aforementioned COVID-NET data, DISCUSSION DRAFT FOR PUBLIC COMMENT 69

1592 approximately 12 percent of adults hospitalized for COVID-19 in the United States. between 1593 March 1 and August 15, 2020 had one select comorbid or underlying condition.26 1594 Estimated Group Size 1595 Without accounting for those with multiple comorbid conditions in Phase 1b, the 1596 committee is not currently in a position to accurately estimate the number of individuals in this 1597 population group. Furthermore, it remains possible that additional comorbid conditions are 1598 included in this category as evidence emerges, but this population group would likely include 1599 tens of millions of people. 1600 Population: All Other Older Adults 1601 Beyond the older adult group already discussed in Phase 1b (those older adults living in 1602 congregate or overcrowded settings), this group includes all older adults residing in the United 1603 States. As discussed earlier, the committee defers to ACIP to determine specific age guidelines 1604 as health and vaccine efficacy data become more available. 1605 Rationale 1606 As discussed in the rational for a subset of older adults in Phase 1b, the case fatality 1607 proportion for COVID-19 is substantially higher among older adults in the United States, and the 1608 rate of hospitalization for COVID-19 increases with age. Ultimately, one could argue that age is 1609 itself an underlying condition for COVID-19 given the high risk of severe disease and death due 1610 to COVID-19 among older adults. 1611 Estimated Group Size 1612 There are estimated to be more than 49.2 million older adults (people 65 and older) living 1613 in the United States (Survey, 2018). Accounting for some overlap with the groups above, it is 1614 estimated that there are 13.2 million older adults in the United States without comorbid or 1615 underlying conditions. 26 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. DISCUSSION DRAFT FOR PUBLIC COMMENT 70

1616 Population: People in Homeless Shelters or Group Homes 1617 This group includes people who live in homeless shelters or group homes for individuals 1618 with physical or mental disabilities or in recovery, as well as staff of these facilities. 1619 Rationale 1620 Many of these people are at risk because of their underlying diseases and because of their 1621 living setting (Landes et al., 2020). Individuals living in congregate settings face increased risk 1622 of exposure to COVID-19 if they have limited or shared bathroom facilities and limited ability to 1623 practice social distancing. In addition, staff at these facilities are at increased risk of exposure 1624 and are more likely to transmit COVID-19 if infected. 1625 Among people who experience homelessness, many are at high risk of acquiring and 1626 transmitting infection given their frequent time spent in public places or in congregate settings 1627 such as shelters. In addition, many people who experience homelessness may suffer from one or 1628 more underlying health conditions that may put them at higher risk. Among group home 1629 residents, they may also have comorbid conditions that increase their risk of severe COVID-19 1630 outcomes, and their autonomy is reduced by living in a group home setting, putting them at risk 1631 of COVID-19 acquisition and transmission. 1632 Estimated Group Size 1633 469,000 people live in group homes, and 575,000 people experience homelessness across 1634 the United States (Culhane, 2020; Williams, 2013). 1635 Population: People in Prisons, Jails, Detention Centers, and Similar Facilities, and Staff Who 1636 Work in Such Settings 1637 Another group to be included in Phase 2 are staff members and persons in prisons, jails, 1638 and detention centers, including immigration detention facilities. A prisoner is defined as anyone 1639 who is deprived of personal liberty against his or her will following conviction of a crime. 1640 Although not afforded all the rights of a free person, a prisoner is assured certain rights by the 1641 U.S. Constitution and the moral standards of the community. Detainees are individuals who are 1642 kept in jail or some other holding facility even though they have not been convicted of a crime. 1643 A majority of detainees in jails are individuals who cannot obtain sufficient funds to post bail 1644 and are not released from jail pending a trial on the criminal charges. DISCUSSION DRAFT FOR PUBLIC COMMENT 71

1645 Rationale 1646 Data show that persons in state and federal prisons are at a 5.5-fold greater risk of 1647 COVID-19 compared to the general U.S. population (Saloner et al., 2020). These people, as well 1648 as those in jails, have reduced autonomy and cannot physically distance from others in their 1649 congregate living setting and thus need additional protection (Page et al., 2020). As such, their 1650 risk of both acquiring and transmitting COVID-19 infection to others is high. 1651 Others may be in detention centers after entering the country without documentation and 1652 are now awaiting resolution of their asylum or other claims in immigration detention facilities. 1653 Vaccination for this population in Phase 2 is important because other controls, such as 1654 maintaining 6-foot distancing, are difficult or impossible to achieve. Most of these people are 1655 housed in one of the more than 250 public and private facilities under contract with the federal 1656 government, but with varying levels of care as they are not always subject to federal standards. 1657 Outbreaks of seasonal influenza demonstrate the porous nature of the medical system in these 1658 facilities (Page et al., 2020). Furthermore, as has been described in literature on seasonal 1659 influenza vaccine, vaccinating individuals held in immigration detention facilities can help to 1660 prevent outbreaks of infectious disease both within these facilities and between facilities and the 1661 rest of society (Omer, 2019; Sunderji et al., 2020). This is an especially important consideration 1662 for staff in these facilities, as they serve as the conduit between the two. 1663 Estimated Group Size 1664 There are currently an estimated 2.3 million incarcerated or detained individuals in the 1665 United States, in addition to 423,000 correctional officers, jailers, and support staff, totaling 1666 more than 2.7 million people in this group (BLS, 2019). 1667 Phase 3 1668 Phase 3 includes the following groups: 1669 1670 • Young adults; 1671 • Children; and 1672 • Workers in industries essential to the functioning of society and at increased risk of 1673 exposure not included in Phases 1 or 2. DISCUSSION DRAFT FOR PUBLIC COMMENT 72

1674 1675 Phase 3 would cover approximately 40–45 percent of the U.S. population. Cumulatively, 1676 Phases 1–3 would then cover 85–95 percent of the U.S. population. 1677 Population: Young Adults 1678 This group includes all young adults aged 18–30 residing in the United States. 1679 Rationale 1680 In Phase 3, vaccine supply will become more widely available and allow for broader 1681 immunization of the U.S. population, which is essential to stem transmission and restore full 1682 social and economic activity. While both the case fatality rate and hospitalization rate for 1683 COVID-19 are substantially lower in young adults aged 18–30, there is increasing evidence that 1684 this group may be disproportionately fueling asymptomatic and/or pre-symptomatic transmission 1685 (CIDRAP, 2020; Moghadas et al., 2020). Studies have shown that adults under the age of 30 1686 report significantly higher levels of social contacts, and broader social networks, than adults in 1687 any other age group (Bruine de Bruin et al., 2020), thus potentially putting them at heightened 1688 risk of both COVID-19 exposure and transmission. 1689 In addition, this group includes college-aged individuals who are more likely to be living 1690 in congregate settings—such as college dormitories, house shares and other communal living 1691 facilities—and thus face increased risk of contracting SARS-CoV-2 infections. Numerous 1692 outbreaks of COVID-19 are already occurring in such settings in the United States (NYT, 1693 2020b). Furthermore, SARS-CoV-2 infections in college-aged adults can threaten the health of 1694 professors and other university staff, many of whom are older or have underlying illnesses that 1695 put them at risk of severe COVID-19. Similarly, 2019 U.S. Census data show that approximately 1696 one in two young adults currently live in parental homes, thus are at higher risk of transmitting 1697 the infection to their family members, who may also be at increased risk of severe disease and 1698 death due to age or other comorbidity (U.S. Census, 2019). 1699 Given the emerging evidence of the role of pre-symptomatic and asymptomatic 1700 transmission in intrafamilial situations and/or congregate settings, the committee deemed it 1701 critical to include this group in Phase 3. DISCUSSION DRAFT FOR PUBLIC COMMENT 73

1702 Estimated Group Size 1703 According the 2019 U.S. Census Bureau data, there are approximately 58 million young 1704 adults between the ages of 18 and 30 (U.S. Census, 2019). Accounting for the potential overlap 1705 with other groups across other phases, the committee estimates that approximately 46.5 million 1706 young adults would be included in this phase. 1707 Population: Children 1708 This group includes all children—including schoolchildren who attend preschool, 1709 elementary school, middle school, and high school. 1710 Rationale 1711 While the proportion of children who become infected with SARS-CoV-2 who become 1712 severely ill is much smaller than that in adults, severe cases of COVID-19 do occur in children, 1713 and the long-term effects of such illnesses are not yet understood. Children also can play a role in 1714 COVID-19 disease transmission (Gaffney et al., 2020). Furthermore, when SARS-CoV-2 1715 infections are documented in children, they can cause major disruptions of educational activities 1716 (e.g., school closings, quarantine and isolation) for children, staff, and families. They can 1717 threaten the health of teachers and staff, many of whom are older or have underlying illnesses 1718 that put them at risk of severe COVID-19, as well as members of their extended families. These 1719 disruptions can also reduce their parents’ or guardians’ ability to work. Vaccination, any needed 1720 booster, and resultant transient or immunity to SARS-CoV-2 infection among children will allow 1721 schools of all types and sizes to safely re-open and remain open, which will, in turn, allow 1722 parents and guardians to return to the workforce. At the same time, the other important benefits 1723 to children being back in school (e.g., provision of nutritious meals, emotional well-being, 1724 detection of and response to possible child abuse or neglect, etc.) can be realized. It will also be 1725 critical to conduct additional trials to gain better understanding of safety and efficacy of COVID- 1726 19 vaccine among children before they receive the vaccine. 1727 Estimated Group Size 1728 There are well over 80 million children (infant – 19 years of age) in the United States. DISCUSSION DRAFT FOR PUBLIC COMMENT 74

1729 Population: Workers in Both Industries Essential to the Functioning of Society and at 1730 Moderately High Risk of Exposure 1731 Examples of such occupational groups include workers in restaurants, hotels, and the 1732 entertainment industry; in banks and libraries; and in hair and nail salons, barber shops, and 1733 exercise facilities, or in factories or other goods producing facilities. Many of these workers are 1734 among the DHS designated categories of “Essential Critical Infrastructure Workers” and include 1735 workers whose job is of economic importance, and who have continued to work from outside 1736 their homes since the beginning of the pandemic. However, their risk of exposure or severe 1737 illness is lower than that of members of Phase 2. The jobs of some of these workers are primarily 1738 in settings where distancing and other protective measures can be implemented without great 1739 difficulty, but who may still be at increased risk. There are others in this population group, like 1740 those employed in entertainment, who cannot easily social distance or use PPE, but whose 1741 industry was not considered as essential to societal functioning and was therefore suspended at 1742 the beginning of the pandemic. 1743 Rationale 1744 These workers play important roles in society; are central to the return of commerce; and 1745 are often exposed to large numbers of individuals in the performance of their jobs. Their safe 1746 return to work is important as society re-opens and, comparing this cohort of workers to those 1747 discussed in Phase 2, their inclusion in Phase 3 focuses more on prevention of transmission of 1748 COVID-19. In comparison to workers called out in Phase 2, workers in Phase 3 are likely to 1749 have lower exposure risk to COVID-19 through their occupation, hold a role that is considered 1750 less central to economic and social recovery, or both. Nonetheless, including this group in Phase 1751 3 will support social and economic recovery and restoration as access to the vaccine becomes 1752 more widespread. 1753 Estimated Group Size 1754 The workers included here cover a wide variety of industries that are important to societal 1755 function and reopening. Among those listed included restaurant wait staff (nearly 2.6 million), 1756 hotel cleaning and management staff (nearly 1.2 million), bank tellers (442,000), librarians 1757 (136,000), barbers, hair stylists and cosmetologists (406,000), and exercise instructors (326,000) DISCUSSION DRAFT FOR PUBLIC COMMENT 75

1758 (BLS, 2019a). Ideally, these workers included in this group would cover 80 percent of those 1759 from industries deemed to be essential. 1760 Phase 4 1761 Phase 4 includes everyone residing in the United States. who did not receive the vaccine 1762 in previous phases (and for whom the vaccine is not medically contraindicated, though none are 1763 known at this time). In a pandemic caused by a new pathogen, most—if not all—individuals are 1764 at risk of being infected by the pathogen. Estimates in the percent of the population with 1765 immunity vary for COVID-19 and the efficacy of COVID-19 vaccines is yet to be determined 1766 (Britton et al., 2020). Therefore, precise estimates of target vaccination coverage are not 1767 available. Nevertheless, resumption of social functions will require high vaccination coverage in 1768 the general population. Moreover, individuals have the right to protect themselves against SARS- 1769 CoV-2 and thus the right to have equitable access to vaccines against this virus in a timely 1770 manner. Therefore, the Unites States should ensure that all U.S.-based individuals who did not 1771 receive the vaccine in previous phases (and for whom the vaccine is not medically 1772 contraindicated) receive the vaccine within the first 12-18 months after the commencement of 1773 the vaccine roll out. 1774 Ensuring Equity 1775 As discussed earlier in this chapter, the principles and allocation criteria underlying these 1776 phases explicitly avoid perpetuating health inequities, while implicitly valuing the essential 1777 social roles played by individuals in groups that have faced discrimination, as well as their 1778 greater risk due to health conditions reflecting inequities (Karaca-Mandic et al., 2020). In 1779 defining each priority group, the committee has considered their equity implications. For 1780 example, it has included all health care staff at the risk of infection exposure, and not those who 1781 are better paid (e.g., physicians, nurses). Each phase gives equal priority to all individuals in a 1782 group, facing similar exposure and with similar vulnerability. Nonetheless, when applying these 1783 criteria, vaccine distribution systems must actively ensure equity. 1784 Social Vulnerability Index 1785 The data clearly demonstrate that people of color—specifically Black, Hispanic or 1786 Latinx, and American Indian and Alaska Native—have been disproportionately impacted by DISCUSSION DRAFT FOR PUBLIC COMMENT 76

1787 COVID-19 with higher rates of morbidity, mortality, and transmission. As previously mentioned, 1788 there is currently no evidence that this is biologically mediated, but rather reflects the impact of 1789 systemic racism leading to higher rates of comorbidities that increase the severity of COVID-19 1790 infection and the socioeconomic factors that increase likelihood of acquiring the infection. 1791 The committee’s allocation framework focuses on these underlying causes through the 1792 application of CDC’s Social Vulnerability Index within its framework instead of focusing on 1793 discrete racial and ethnic categories. Vaccine should be allocated in adequate quantities to areas 1794 of high social vulnerability and delivered, in a timely manner, at locations accessible to the 1795 populations living in those areas. CDC’s Social Vulnerability Index, developed for local 1796 preparedness for public health emergencies such as natural disasters and disease outbreaks, 1797 identifies geographic areas of vulnerability based on 15 census variables (ATSDR, 2018). These 1798 variables capture many recognized social determinants of health (e.g., income or race/ethnicity), 1799 indicators of access (e.g., transportation), infection transmission (e.g., crowding), increased risk 1800 of adverse COVID-19 outcomes (e.g., proportion 65 or older). This index can be calculated at 1801 the census tract level—enabling immunization programs to better identify areas of vulnerability. 1802 Using CDC’s Social Vulnerability Index in the committee’s framework represents an attempt to 1803 incorporate the variables that the committee believes are most linked to the disproportionate 1804 impact of people of color. While other equity considerations such as disability status and age are 1805 partially addressed in the criteria underlying the phases, there are additional concerns that need 1806 to be addressed. For example, the ability of frail or disabled individuals to access vaccination 1807 location must be taken into account while operationalizing vaccine access and delivery. 1808 Costs Associated with Vaccination 1809 Several vaccines under development have received considerable taxpayer support. 1810 Therefore, it is essential that COVID-19 vaccines are delivered through a central mechanism that 1811 ensures vaccines to all individuals whatever their social and economic resources, employment, 1812 immigration or insurance status. This is especially a concern when vaccine courses are 1813 administered through private health providers, who may otherwise demand fees for the service. 1814 In the national interest, Medicare and Medicaid should require free vaccine administration; 1815 providers should not charge private plans or consumers; and private insurers and employers 1816 should not charge co-pays or deductibles for vaccine administration. DISCUSSION DRAFT FOR PUBLIC COMMENT 77

1817 The 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act requires health 1818 insurance plans (group and individual) to offer vaccination without patient cost sharing (Section 1819 3203) (KFF, 2020). The Patient Protection and Affordable Care Act (ACA) required all private 1820 insurance coverage to cover—without cost-sharing—immunizations that have a favorable ACIP 1821 rating, but the CARES Act requires the coverage to begin within 15 days of the ACIP 1822 recommendation, rather than the ordinarily much longer lag time. 1823 For those on Medicare, Part B will cover co-pay or administrative charges (Section 1824 3713). Those on Medicare Advantage plans are similarly covered. The U.S. Department of 1825 Veterans Affairs covers immunizations but service members and their families may have to pay 1826 for the cost of an office visit. 1827 For Medicaid, coverage depends on the several factors. Most state Medicaid agencies 1828 cover at least some adult immunizations but not all offer vaccines at the ACIP standards. 1829 Generally, Medicaid covers ACIP-recommended vaccines for all beneficiaries up to age 21 1830 under the program’s Early and Periodic Screening, Diagnostics, and Treatment (EPSDT) 1831 program. For children under 19, the Vaccines for Children Program guarantees free vaccination 1832 to uninsured, underinsured, and American Indian and Native Alaskan children. Adults in a 1833 Medicaid expansion plan or an Alternative Benefit Plan also receive ACIP-recommended 1834 vaccines with no cost sharing. But for other adults, who are not in states with Medicaid 1835 expansion and who are on traditional Medicaid coverage, it is up to each state to determine 1836 whether to cover vaccines. There is an incentive to do so, as states that cover ACIP- 1837 recommended vaccines and all the services recommended by the U.S. Preventive Services Task 1838 Force may be eligible for increased federal payments. However, a survey of states prior to the 1839 pandemic showed that only 22 were offering the full list of ACIP-recommended adult 1840 vaccinations under their program (Granade et al., 2020; Shen and Orenstein, 2020). 1841 Additional resources are available to cover eventual COVID-19 vaccines for the 1842 uninsured, including funds made available in the CARES Act through the Public Health and 1843 Social Service Emergency Fund. The federal government has also used authorities under Section 1844 317 of the Public Health Service Act to make vaccines available to uninsured adults. As of 1845 October 1, 2012, Section 317-funded vaccines can be used to vaccinate uninsured or 1846 underinsured adults, and for fully insured individuals seeking vaccines during public health DISCUSSION DRAFT FOR PUBLIC COMMENT 78

1847 response activities including outbreak response, mass vaccination campaigns or exercises for 1848 public health preparedness and individuals in correctional facilities and jails. 1849 Legal Status 1850 All individuals in the United States and its territories should receive the vaccine in the 1851 appropriate phase irrespective of their legal status, and individuals whose legal status is uncertain 1852 should be reassured that their coming forward to receive the vaccine will not lead to deportation 1853 or be used against them in immigration proceedings. In addition to considerations of equity and 1854 fairness, including all individuals in the immunization program is appropriate from a disease 1855 control perspective. If there are pockets of susceptibility among those who do not receive the 1856 vaccine, the risk of outbreaks is likely to increase for everyone—including those who are legally 1857 present in the United States—as no vaccine is 100 percent effective. 1858 Considerations for Pregnant Women 1859 While data on the risk of adverse outcomes associated with COVID-19 in pregnancy are 1860 uncertain, current evidence suggests that pregnant women are more likely to be hospitalized with 1861 COVID-19 than non-pregnant women (CDC, 2020h). Therefore, it is concerning that most, if not 1862 all, of the current Phase II/III trials exclude pregnant women; thus, putting them at a 1863 disadvantage for protecting themselves against SARS-CoV-2. OWS, NIH, and CDC should 1864 include assessment of vaccine efficacy, effectiveness, and safety among pregnant women in their 1865 clinical development and post-marketing surveillance plans. These data, and characteristics of 1866 the approved vaccine(s), will enable ACIP to develop recommendations for vaccinating pregnant 1867 women against SAS-CoV-2. 1868 Vaccine Allocation for the Military 1869 The U.S. military, which is tasked with protecting the United States from foreign threats, 1870 currently comprises approximately 1.2 million active duty troops, 781,000 reservists, and 1871 728,000 civilian employees working for the U.S. Department of Defense (DoD, 2020). The U.S. 1872 military has its own health care system, which serves active duty troops and their dependents; 1873 they live in diverse settings inside and outside the United States, ranging from onboard ships to 1874 military bases to civilian communities. Among active duty troops and their dependents are 1875 individuals at varying levels of risk of infection and life-threatening complications of COVID- DISCUSSION DRAFT FOR PUBLIC COMMENT 79

1876 19, including frontline health care providers; those living in congregate settings or in tightly 1877 confined spaces (e.g., outbreaks have occurred on U.S. naval ships): and those with underlying 1878 comorbid conditions associated with an increased risk of severe COVID-19, among others. 1879 While the U.S. military has separate advisory groups (e.g. the Armed Forces Epidemiology 1880 Board) and decision-making processes with regard to health care, disease prevention, and public 1881 health, in the absence of a separate allotment of COVID-19 vaccine to the U.S. military, the 1882 committee recommends that priority setting for the use of COVID-19 vaccine among active duty 1883 troops and their dependents, as well as reservists, follow the principles and criteria set forth for 1884 use in the civilian population. Civilian employees working for DoD should be considered for 1885 COVID-19 vaccination, as appropriate, through programs established to provide vaccine to other 1886 civilian populations. 1887 Vaccine Allocation for Volunteer Participants in Vaccine Trials 1888 There is a long tradition in biomedical research of offering research volunteers priority 1889 access to interventions following trials (Cook, 2015; Emanuel et al., 2020; Resnik, 2018). . 1890 Given this precedent, the committee assumes that volunteer participants in vaccine trials will be 1891 vaccinated early regardless of the committee’s phased prioritization scheme because doing so is 1892 a typical standard of vaccine trial protocol. 1893 The ethical principle underlying this allocation priority is the principle of fairness, which 1894 includes what is often called reciprocity. This prioritization acknowledges the service that 1895 volunteers have provided and the additional risk they have assumed in participating in the trial, 1896 irrespective of any financial compensation for research subjects. A further justification for 1897 including COVID-19 Phase III vaccine trial volunteers as an early priority group is the possible 1898 effect on motivation to volunteer for trials, which may in turn increase the pace of recruitment 1899 into trials and decrease the time needed to complete the target enrollment. 1900 The anticipated total in this group is approximately 150,000 individuals. OWS expects to 1901 support up to seven Phase III trials of promising vaccine candidates, of which two are underway 1902 in the United States as of mid-August 2020. Each Phase III trial plans to enroll approximately 1903 30,000 participants. The total calculated here assumes that 1904 DISCUSSION DRAFT FOR PUBLIC COMMENT 80

1905 • Four of the trials will fail, and all subjects in those trials are offered access to an 1906 approved vaccine (4 × 30,000 = 120,000) 1907 • Three of the trials will succeed, and, under a 1:1 ratio between members of the 1908 treatment group compared to the placebo group, 15,000 participants from each of 1909 those trials who were assigned to the placebo condition are offered an approved 1910 vaccine (3 x 15,000 = 45,000) (HHS, 2020; NIH, 2020a,b). 1911 Limitations and Additional Considerations on the Framework 1912 The committee notes the following limitations and considerations as SLTT authorities 1913 adapt it to their local conditions. First, the phases identify population groups of similar priority. 1914 Within phases, authorities have the flexibility to adapt to their conditions. For example, some 1915 counties have no tertiary hospitals and are served by neighboring counties, and others may have 1916 chicken and pork production facilities. Some areas may have no evidence of virus spread and be 1917 given a lower geographic priority as compared to other areas of a state. SLTT authorities will 1918 have to make final decisions on refining and applying the suggested priorities listed here. In so 1919 doing they can refer to the principles and allocation criteria that guided the formulation of the 1920 phases. 1921 Second, the committee acknowledges the risk of potential unintended consequences of 1922 the allocation framework and the need to assess prioritization based on operational and supply 1923 realities. For example, immunizing older adults early on, and the resulting perception of their 1924 security, could “neutralize” one of the key reasons used to encourage younger people to follow 1925 guidance on preventive measures currently being encouraged to prevent the spread of COVID- 1926 19. This argument could apply to everyone who receives the vaccine and chooses not to be 1927 careful in regards to following key preventive measures. As such, the committee acknowledges 1928 that SLTT authorities and other decision makers need to remain vigilant of these realities and 1929 other public health interventions being implemented in tandem with the vaccine allocation and 1930 distribution. 1931 Third, the committee recognizes that properly classifying individuals in specific 1932 categories described above may be difficult to do in practice given the need to sort people based 1933 on individual level information, some of which may be difficult to collect or ascertain. 1934 Furthermore, as noted earlier, the dynamic nature of the COVID-19 pandemic means that DISCUSSION DRAFT FOR PUBLIC COMMENT 81

1935 features of the pandemic will change over time and collective understanding of its effects will, 1936 too (e.g., the list of comorbid conditions that put individuals at higher risk of severe disease or 1937 death due to COVID-19 infection). 1938 Last, it is critical to acknowledge the limitations around the use of demographic data 1939 across phases in this chapter. The task of accurately describing the total number of individuals 1940 included in each priority group and phase was challenging because of the near-certain—and as of 1941 yet uncaptured—overlap between individuals counted across phases. For example, there is likely 1942 significant overlap between those counted above in the nursing home population and the 1943 population of older adults living in overcrowded settings, and significant overlap between 1944 members of multigenerational families and other categories listed in earlier phases, such as 1945 occupational groups. As such, the committee acknowledges that the population estimates 1946 provided serve as a guidepost for the general size of key priority groups discussed, but do not 1947 reflect a wholly accurate and nuanced analysis of phase population size in relation to one 1948 another. 1949 CONCLUDING REMARKS 1950 This iterative vaccination allocation framework will be dynamic and hopefully ever- 1951 improving. While current population data values are large, values for each group will be 1952 improved as the program is underway. Populations in each phase, especially in Phases 1a and 1b, 1953 may well exceed the vaccine available. In such a case, SLTT authorities should make best efforts 1954 to complete each phase before proceeding to the next phase. Additional adjustments in response 1955 to new evidence and data will be made as necessary. For example, the committee will consider 1956 new information on important vaccine characteristics emerging from vaccine trials and other 1957 sources such as the number of vaccine courses to be made available, considerations for special 1958 populations (e.g., pregnant women or individuals previously infected with COVID-19), 1959 anticipated vaccine efficacy, and anticipated vaccine safety and pharmacovigilance planning as it 1960 becomes available. Making mid-course corrections will be the rule rather than the exception and 1961 will be dependent on real-time surveillance of all aspects of the program. DISCUSSION DRAFT FOR PUBLIC COMMENT 82

1962 REFERENCES 1963 ATSDR (Agency for Toxic Substances and Disease Registry). 2018. CDC’s Social Vulnerability Index. 1964 https://svi.cdc.gov (accessed August 28, 2020). 1965 Baker, M. G., T. K. Peckham, and N. S. Seixas. 2020. Estimating the burden of United States workers 1966 exposed to infection or disease: A key factor in containing risk of COVID-19 infection. PLOS 1967 ONE 15(4):e0232452. 1968 Bastidas, A., G. Catteau, S. Volpe, T. Mrkvan, A. Enemuo, J. Smetana, T. Schwarz, L. Rombo, K. 1969 Pauksens, E. Berengier, C. Hervé, L. Oostvogels, and A. Schuind. 2019. Long-term 1970 immunological persistence of the adjuvanted recombinant zoster vaccine: Clinical data and 1971 mathematical modeling. Open Forum Infectious Diseases 6(Suppl_2):S84–S85. 1972 BJS (Bureau of Justice Statistics). 2019. Local police departments, 2016: Personnel. 1973 https://www.bjs.gov/content/pub/pdf/lpd16p_sum.pdf (accessed August 28, 2020). 1974 BLS (Bureau of Labor Statistics). 2019a. Occupational employment statistics: May 2019 occupational 1975 profiles. https://www.bls.gov/oes/current/oes_stru.htm (accessed August 28, 2020). 1976 BLS. 2019b. Occupational employment and wages, May 2019-29-0000 healthcare practitioners and 1977 technical occupations (major group). https://www.bls.gov/oes/current/oes290000.htm#nat 1978 (accessed August 28, 2020). 1979 BLS. 2019c. Occupational employment statistics: May 2018 national industry-specific occupational 1980 employment and wage estimates-naics 446110-pharmacies and drug stores. 1981 BLS. 2020a. EMTs and paramedics. https://www.bls.gov/ooh/healthcare/emts-and-paramedics.htm 1982 (accessed August 28, 2020). 1983 BLS. 2020b. Occupational employment statistics-May 2019 national industry-specific occupational 1984 employment and wage estimates-naics 611100-elementary and secondary schools. 1985 BLS. 2020c. Occupational employment statistics-occupational employment and wages, May 2019-53- 1986 3052 bus drivers, transit and intercity. 1987 Britton, T., F. Ball, and P. Trapman. 2020. A mathematical model reveals the influence of population 1988 heterogeneity on herd immunity to SARS-CoV-2. Science 369(6505):846–849. 1989 Bruine de Bruin, W., A. M. Parker, and J. Strough. 2020. Age differences in reported social networks and 1990 well-being. Psychology and Aging 35(2):159–168. 1991 CDC (Centers for Disease Control and Prevention). 2019. Current cigarette smoking among adults in the 1992 United States. 1993 https://www.cdc.gov/tobacco/data_statistics/fact_sheets/adult_data/cig_smoking/index.htm#:~:te 1994 xt=In%202018%2C%20nearly%2014%20of,with%20a%20smoking%2Drelated%20disease 1995 (accessed August 28, 2020). 1996 CDC. 2020a. Nursing home care. https://www.cdc.gov/nchs/fastats/nursing-home-care.htm (accessed 1997 August 28, 2020). 1998 CDC. 2020b. Older adults and COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/need-extra- 1999 precautions/older-adults.html (accessed August 28, 2020). 2000 CDC. 2020c. People with certain medical conditions. https://www.cdc.gov/coronavirus/2019-ncov/need- 2001 extra-precautions/people-with-medical- 2002 conditions.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019- 2003 ncov%2Fneed-extra-precautions%2Fgroups-at-higher-risk.html (accessed August 28, 2020). 2004 CDC. 2020d. People with certain medical conditions. 2005 CDC. 2020e. Provisional covid-19 death counts by sex, age, and state. 2006 CDC. 2020f. Residential care communities. https://www.cdc.gov/nchs/fastats/residential-care- 2007 communities.htm (accessed August 28, 2020). 2008 CDC. 2020g. Update: Covid-19 among workers in meat and poultry processing facilities—United States, 2009 April–May 2020. Morbiditiy and Mortality Weeekly Report 69:887–892. DISCUSSION DRAFT FOR PUBLIC COMMENT 83

2010 CDC. 2020h. Data on COVID-19 during pregnancy. https://www.cdc.gov/coronavirus/2019- 2011 ncov/cases-updates/special-populations/pregnancy-data-on-covid-19.html (accessed 2012 August 28, 2020). 2013 CIDRAP. 2020. COVID-19 cases among US young adults spike. 2014 CIHI. 2020. Pandemic experience in the long-term care sector: How does Canada compare with other 2015 countries? Ottowa, Canada. 2016 Clark, C. A. 2020. AHCA/ NCAL: COVID-19 testing positivity rates and PPE supply shortage for nursing 2017 homes across nation. https://ladailypost.com/ahca-ncal-covid-19-testing-positivity-rates-ppe- 2018 supply-shortages-for-nursing-homes (accessed August 28, 2020). 2019 CMS (Centers for Medicare & Medicaid Services). 2020a. COVID-19 nursing home data. 2020 CMS. 2020b. COVID-19 nursing home dataset-archived data-week ending 7/12/20. 2021 Cohn, D. a. J. S. P. 2018. A record 64 million americans live in multigenerenational household. 2022 Cook, K., J. Synder, and J. Calvert. 2015. Attitude toward post-trail access to medical interventions: A 2023 review of academic literature, legislations, and international guidelines. Developing World 2024 Bioethics 16(2):70–79. 2025 Cubanski, J., W. Koma, A. Damico, and T. Neuman. 2018. How many seniors live in poverty. Kaiser 2026 Family Foundation. 2027 Culhane, D., D. Treglia, and K. Steif. 2020. Estimated emergency and observational/quarantine capacity 2028 need for the us homeless population related to COVID-19 exposure by county; projected 2029 hospitalizations, intensive care units and mortality. 2030 Dagnew, A. F., N. P. Klein, C. Hervé, G. Kalema, E. Di Paolo, J. Peterson, B. Salaun, and A. Schuind. 2031 2020. The adjuvanted recombinant zoster vaccine in adults aged ≥65 years previously vaccinated 2032 with a live-attenuated herpes zoster vaccine. The Journal of Infectious Diseases. 2033 Daniels, N. 2007. Just health: Meeting health needs fairly. Cambridge University Press. 2034 DeStefano, A. M. 2020. NYPD: Covid-19's wrath on cops appears to have passed. Newsday, 2035 https://www.newsday.com/news/health/coronavirus/nypd-covid-19-1.44453275 (accessed August 2036 28, 2020). 2037 Dingel, J., and B. Neiman. 2020. How many jobs can be done at home? Becker Friedman Institute for 2038 Economics at the University of Chicago. 2039 DoD (U.S. Department of Defense). 2020. DoD Personnel, Workforce Reports & Publications. 2040 https://www.dmdc.osd.mil/appj/dwp/dwp_reports.jsp (accessed August 28, 2020). 2041 Emanuel, E. J., and A. Wertheimer. 2006. Public health. Who should get influenza vaccine when not all 2042 can? Science 312(5775):854–855. 2043 Emanuel, E. J., G. Persad, R. Upshur, B. Thome, M. Parker, A. Glickman, C. Zhang, C. Boyle, M. Smith, 2044 and J. P. Phillips. 2020. Fair allocation of scarce medical resources in the time of COVID-19. 2045 New England Journal of Medicine 382(21):2049–2055. 2046 Evarts, B. a. G. P. S. 2020. U.S. Fire department profile 2018. NFPA Research. 2047 Eyewitness News. 2020. Coronavirus news: NYPD announces 43rd covid-19 death in department. 2048 Eyewitness News, https://abc7ny.com/nypd-death-doris-kirkland-covid-deaths-coronavirus-in- 2049 the/6208730 (accessed August 28, 2020). 2050 Freed, M., J. Cubanski, T. Neuman, J. Kates, and J. Michaud 2020. What share of people who have died 2051 of COVID-19 are 65 and older-and how does it vary by state? https://www.kff.org/coronavirus- 2052 covid-19/issue-brief/what-share-of-people-who-have-died-of-covid-19-are-65-and-older-and- 2053 how-does-it-vary-by-state/?utm_campaign=KFF-2020- 2054 Coronavirus&utm_medium=email&_hsmi=2&_hsenc=p2ANqtz- 2055 9Dz7Qdw6f7NaR2NZ_5AHs0VfBE2ez27c8Etj0gfVDxdozH-Tcb-d_aYxnpLx67oQzcdXoQ- 2056 0DwGneVGoBqdu8uAGiRAw&utm_content=2&utm_source=hs_email (accessed August 28, 2057 2020). 2058 Gaffney, A. W., D. Himmelstein, and S. Woolhandler. 2020. Risk for severe COVID-19 illness among 2059 teachers and adults living with school-aged children. Annals of Internal Medicine. DISCUSSION DRAFT FOR PUBLIC COMMENT 84

2060 Granade, C. J., R. F. McCord, A. A. Bhatti, and M. C. Lindley. 2020. State policies on access to 2061 vaccination services for low-income adults. JAMA Network Open 3(4):e203316. 2062 HHS (U.S. Department of Health and Human Services). 2020. Fact sheet: Explaining operation warp 2063 speed. https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html (accessed 2064 August 28, 2020). 2065 HIV.gov. 2020. U.S. Statistics. https://www.hiv.gov/hiv-basics/overview/data-and- 2066 trends/statistics#:~:text=Fast%20Facts,and%20gay%20and%20bisexual%20men (accessed 2067 August 28, 2020). 2068 Jaklevic, M. C. 2020. Researchers strive to recruit hard-hit minorities into COVID-19 vaccine trials. 2069 JAMA. 2070 Kamm, F. M. 1998. Morality, mortality volume I: Death and whom to save from it. Oxford University 2071 Press. https://oxford.universitypressscholarship.com/view/10.1093/0195119118.001.0001/acprof- 2072 9780195119114 (accessed August 27, 2020). 2073 Karaca-Mandic, P., A. Georgiou, and S. Sen. 2020. Assessment of COVID-19 hospitalizations by 2074 race/ethnicity in 12 states. JAMA Internal Medicine. 2075 KFF (Kaiser Family Foundation). 2020. The Coronavirus Aid, Relief, and Economic Security Act: 2076 Summary of key health provisions. https://www.kff.org/coronavirus-covid-19/issue-brief/the- 2077 coronavirus-aid-relief-and-economic-security-act-summary-of-key-health-provisions (accessed 2078 August 28, 2020). 2079 Kolata, G. 2020. Who gets the COVID-19 vaccine first? Here’s one idea. The New York Times, 2080 https://www.nytimes.com/2020/07/23/health/coronavirus-vaccine-allocation.html (accessed 2081 August 28, 2020). 2082 Krebs, C., C. 2020. Advisory memorandum on identifications of essential critical infrastructure workers 2083 during COVID-19 response. 2084 https://www.cisa.gov/sites/default/files/publications/Version_3.1_CISA_Guidance_on_Essential_ 2085 Critical_Infrastructure_Workers_0.pdf (accessed August 28, 2020). 2086 The Lancet. 2020. The plight of essential workers during the COVID-19 pandemic. Lancet (London, 2087 England) 395(10237):1587. 2088 Landes, S. D., M. A. Turk, M. K. Formica, K. E. McDonald, and J. D. Stevens. 2020. COVID-19 2089 outcomes among people with intellectual and developmental disability living in residential group 2090 homes in new york state. Disability and Health Journal 100969. 2091 Lee, S., P. Meyler, M. Mozel, T. Tauh, and R. Merchant. 2020. Asymptomatic carriage and transmission 2092 of SARS-CoV-2: What do we know? Canadian Journal of Anaesthesia 1–7. 2093 Lighter, J., M. Phillips, S. Hochman, S. Sterling, D. Johnson, F. Francois, and A. Stachel. 2020. Obesity 2094 in patients younger than 60 years is a risk factor for covid-19 hospital admission. Clinical 2095 Infectious Diseases 71(15):896–897. 2096 Lipsitch, M. 2020. Using models of SARS-CoV-2 dynamics to inform vaccine prioritization. Paper read 2097 at Committee on Equitable Allocation of Vaccine for the Novel Coronavirus: Public Workshop. 2098 McClung, N. 2020. Epidemiology of Individuals at Increased Risk of COVID-19 Disease. Presented at 2099 the August 26, 2020 Meeting of the Advisory Committee on Immunization Practices. 2100 McCormack, G., C. Avery, A. K.-L. Spitzer, and A. Chandra. 2020. Economic vulnerability of 2101 households with essential workers. JAMA 324(4):388–390. 2102 Miller, R. B., and C. A. Nebeker-Adams. 2017. Multigenerational households. In Encyclopedia of couple 2103 and family therapy, edited by J. Lebow, A. Chambers, and D. C. Breunlin. Cham, Switzerland: 2104 Springer International Publishing. Pp. 1–3. 2105 Moghadas, S. M., M. C. Fitzpatrick, P. Sah, A. Pandey, A. Shoukat, B. H. Singer, and A. P. Galvani. 2106 2020. The implications of silent transmission for the control of COVID-19 outbreaks. 2107 Proceedings of the National Academy of Sciences 117(30):17513–17515. 2108 Mullen O’Keefe, S. 2020. One in three Americans would not get COVID-19 vaccine. 2109 NCHS (National Center for Health Statistics). 2020. Fast Stats. 2110 https://www.cdc.gov/nchs/fastats/default.htm (accessed August 28, 2020). DISCUSSION DRAFT FOR PUBLIC COMMENT 85

2111 Nguyen, L. H., D. A. Drew, M. S. Graham, A. D. Joshi, C.-G. Guo, W. Ma, R. S. Mehta, E. T. Warner, D. 2112 R. Sikavi, C.-H. Lo, S. Kwon, M. Song, L. A. Mucci, M. J. Stampfer, W. C. Willett, A. H. 2113 Eliassen, J. E. Hart, J. E. Chavarro, J. W. Rich-Edwards, R. Davies, J. Capdevila, K. A. Lee, M. 2114 N. Lochlainn, T. Varsavsky, C. H. Sudre, M. J. Cardoso, J. Wolf, T. D. Spector, S. Ourselin, C. J. 2115 Steves, A. T. Chan, C. M. Albert, G. Andreotti, B. Bala, B. A. Balasubramanian, L. E. Beane- 2116 Freeman, J. S. Brownstein, F. J. Bruinsma, J. Coresh, R. Costa, A. N. Cowan, A. Deka, S. L. 2117 Deming-Halverson, M. Elena Martinez, M. E. Ernst, J. C. Figueiredo, P. Fortuna, P. W. Franks, 2118 L. B. Freeman, C. D. Gardner, I. M. Ghobrial, C. A. Haiman, J. E. Hall, J. H. Kang, B. Kirpach, 2119 K. C. Koenen, L. D. Kubzansky, Lacey, J. V. Jr, L. Le Marchand, X. Lin, P. Lutsey, C. R. 2120 Marinac, M. E. Martinez, R. L. Milne, A. M. Murray, D. Nash, J. R. Palmer, A. V. Patel, E. 2121 Pierce, M. M. Robertson, L. Rosenberg, D. P. Sandler, S. H. Schurman, K. Sewalk, S. V. Sharma, 2122 C. J. Sidey-Gibbons, L. Slevin, J. W. Smoller, C. J. Steves, M. I. Tiirikainen, S. T. Weiss, L. R. 2123 Wilkens, and F. Zhang. 2020. Risk of COVID-19 among front-line health-care workers and the 2124 general community: A prospective cohort study. The Lancet Public Health. 2125 NIAID (National Institute of Allergy and Infectious Diseases). 2016. Primary immune deficiency diseases 2126 (PIDDs). https://www.niaid.nih.gov/diseases-conditions/primary-immune-deficiency-diseases- 2127 pidds (accessed August 28, 2020). 2128 NIH (National Institutes of Health). 2020a. Study to describe the safety, tolerability, immunogencitiy, and 2129 efficacy of RNA vaccine candidates against COVID-19 healthy adults. 2130 NIH. 2020b. A study to evalutate efficacy, safety, and immunogenicity of mrna-1273 vaccine in adult 2131 aged 18 years and older to prevent COVID-19. 2132 https://clinicaltrials.gov/ct2/show/NCT04470427?term=Moderna&cond=Covid19&draw=2&rank 2133 =1 (accessed August 28, 2020). 2134 NRC (National Research Council). 1983. Risk assessment in the federal government: Managing the 2135 process. Washington, DC: National Academy Press. 2136 NRC. 1994. Science and judgment in risk assessment. Washington, DC: National Academy Press. 2137 NRC. 1996. Understanding risk: Informing decisions in a democratic society. Washington, DC: National 2138 Academy Press. 2139 NRC. 2009. Science and decisions: Advancing risk assessment. Washington, DC: The National 2140 Academies Press. 2141 Nuffield Council on Bioethics. 2020. Fair and equitable access to COVID-19 treatments 2142 and vaccines. 2143 NYT (The New York Times). 2020a. More than 40% of U.S. coronavirus deaths are linked to nursing 2144 homes. https://www.nytimes.com/interactive/2020/us/coronavirus-nursing- 2145 homes.html#:~:text=More%20Than%2040%25%20of%20U.S.%20Coronavirus%20Deaths%20 2146 Are%20Linked%20to%20Nursing%20Homes,- 2147 By%20The%20New&text=At%20least%2068%2C000%20residents%20and,a%20New%20York 2148 %20Times%20database (accessed August 28, 2020). 2149 NYT. 2020b. COVID College Case Tracker. 2150 Oliver, S. 2020. Epidemiology of COVID-19 in essential workers, including healthcare personnel. Paper 2151 read at ACIP July 2020 Meeting. 2152 Omer, S. 2019. Withholding flu vaccine from migrants isn’t just cruel. It’s dangerous. The Washington 2153 Post. 2154 OSHA (Occupational Safety and Health Administration). 2020. Guidance on preparing workplaces for 2155 COVID-19. https://www.osha.gov/Publications/OSHA3990.pdf (accessed August 28, 2020). 2156 Ouslander, J. G., and D. C. Grabowski. 2020. COVID-19 in nursing homes: Calming the perfect storm. 2157 Journal of the American Geriatrics Society. 2158 Page, K. R., M. Venkataramani, C. Beyrer, and S. Polk. 2020. Undocumented U.S. immigrants and 2159 COVID-19. New England Journal of Medicine 382(21):e62. DISCUSSION DRAFT FOR PUBLIC COMMENT 86

2160 Pennsylvania Department of Health. 2020. Ethical allocation framework for emerging treatment of 2161 COVID-19. https://www.health.pa.gov/topics/disease/coronavirus/Pages/Guidance/Ethical- 2162 Allocation-Framework.aspx (accessed August 28, 2020). 2163 Persad, G., A. Wertheimer, and E. J. Emanuel. 2009. Principles for allocation of scarce medical 2164 interventions. Lancet (London, England) 373(9661):423–431. 2165 Petrilli, C. M., S. A. Jones, J. Yang, H. Rajagopalan, L. O’Donnell, Y. Chernyak, K. A. Tobin, R. J. 2166 Cerfolio, F. Francois, and L. I. Horwitz. 2020. Factors associated with hospital admission and 2167 critical illness among 5279 people with coronavirus disease 2019 in New York City: Prospective 2168 cohort study. BMJ 369:m1966. 2169 Resnik, D. B. 2018. The ethnics of research with human subjects. 1st ed. Vol. 74, International Library of 2170 Ethics, Law, and the New Medicine. Springer International Publishing. 2171 Saloner, B., K. Parish, J. A. Ward, G. DiLaura, and S. Dolovich. 2020. COVID-19 cases and deaths in 2172 federal and state prisons. JAMA 324(6):602–603. 2173 Shen, A. K., and W. Orenstein. 2020. Continued challenges with medicaid coverage of adult vaccines and 2174 vaccination services. JAMA Network Open 3(4):e203887. 2175 Slaoui, M. 2020. Operation warp speed. Paper read at Committee on Equitable Allocation of Vaccine for 2176 the Novel Coronavirus: Public Workshop. 2177 Snowden, F. M. 2019. Epidemics and society: From the black dealth to the present. Yale University 2178 Press. 2179 Statista. 2020. Number of morticians, undertakers, and funeral directors in the United States from 2012 to 2180 2019. 2181 Sunderji, A., K. N. Mena, J. Winickoff, J. Melinek, and J. Sharfstein. 2020. Influenza vaccination and 2182 migration at the us southern border. American Journal of Public Health 110(4):466–467. 2183 Survey, A. C. 2018. Population 65 years and older in the United States: 2016. 2184 Toner E., A. Barnill, C. Krubiner, et al. 2020. Interim framework for COVID-19 vaccine 2185 allocation and distribution in the United States. Baltimore, MD: Johns Hopkins Center 2186 for Health Security. 2187 U.S. Census. 2019a. National population by characteristics: 2010–2019. 2188 U.S. Census. 2019b. Historical living arrangements of adults. 2189 USDA (U.S. Department of Agriculture). 2020. Ag and food sectors and the economy. 2190 https://www.ers.usda.gov/data-products/ag-and-food-statistics-charting-the-essentials/ag-and- 2191 food-sectors-and-the- 2192 economy/#:~:text=In%202018%2C%20the%20U.S.%20food,of%20all%20U.S.%20nonfarm%20 2193 employment (accessed August 28, 2020). 2194 White, D. B., M. Schmidhofer, E. McCreary, R. Bariola, G. M. Snyder, R. Sackrowitz, N. N. Jonassaint, 2195 J. Daley, D. M. Yealy, T. Sonmez, M. U. Unver, P. Pathak, G. Persad, and R. Truog. 2020. Model 2196 hospital policy for fair allocation of scarce medications to treat COVID-19. University of 2197 Pittsburgh. 2198 WHO (World Health Organization). 2017. 10 facts on health inequities and their causes. 2199 https://www.who.int/features/factfiles/health_inequities/en (accessed August 28, 2020). 2200 Williams, A. 1997. Intergenerational equity: An exploration of the “fair innings” argument. Health 2201 Economics 6(2):117–132. 2202 Williams, J. H., and A. Dawson. 2020. Prioritising access to pandemic influenza vaccine: A review of the 2203 ethics literature. BMC Medical Ethics 21(1):40. 2204 Williams, J., D. De Vos, and D. Russell 2013. 2010 census group quarters enumeration assessment report. 2205 2206 DISCUSSION DRAFT FOR PUBLIC COMMENT 87

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On September 1, 2020, the National Academies of Sciences, Engineering, and Medicine invited public comment on the Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine, commissioned by the Centers for Disease Control and the National Institutes of Health. Input from the public, especially communities disproportionately affected by the COVID-19 pandemic, is essential to produce a final report that is objective, balanced, and inclusive. The public comment period was open for 4 days, from 12:00 p.m. ET on Tuesday, September 1, until 11:59 p.m. ET on Friday, September 4.

In addition, the study committee hosted a listening session on Wednesday, September 2, from 12:00 to 5:00 p.m. ET to hear comments from the public. For more information, please visit the study webpage. If you have any questions, please email COVIDVaccineFramework@nas.edu.

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