2

Lessons Learned from Other Allocation Efforts

This is not the first time the United States, or the world, has faced the issue of allocating scarce resources in the midst of a public health emergency. In developing a framework for equitable allocation of coronavirus disease 2019 (COVID-19) vaccine, the committee’s deliberations were informed by practical lessons from previous efforts to allocate vaccines for 2009 H1N1 pandemic influenza and Ebola virus disease, as well as by the goals, ethical principles, and prioritization strategies set forth in other allocation frameworks—including several that have recently been developed to distribute scarce inpatient medications for COVID-19. The committee also reflected on the guiding principles and prioritization criteria established by concurrent efforts being led by the World Health Organization (WHO), the Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP), and others to develop frameworks for allocating COVID-19 vaccine.

LESSONS FROM MASS VACCINATION CAMPAIGNS FOR PRIOR INFECTIOUS DISEASE OUTBREAKS

A mass vaccination campaign for an infectious disease outbreak is a complex enterprise that requires balancing different strategies for allocation, distribution, administration, access, monitoring, and other considerations. Each infectious disease outbreak differs in terms of its clinical characteristics, epidemiology, and impact across various populations; thus, each outbreak requires a tailored mass vaccination approach. Although the committee was tasked with developing a framework specifically for alloca-

tion, it is instructive to look back at some of the broader successes and challenges of previous mass vaccination campaigns from both operational and ethical perspectives. The committee identified several key lessons learned from prior mass vaccination campaigns that relate to or have an impact on vaccine allocation; these are outlined in Box 2-1.

H1N1 Influenza Vaccination Campaign (2009)

The development of the U.S. plan for vaccine allocation in response to the 2009 H1N1 influenza A pandemic illustrated some of the fundamental challenges involved in implementing a mass national vaccination campaign at the local level, where many jurisdictions have limited resources and capacity (Rambhia et al., 2010). CDC’s ACIP began planning an ambitious vaccination program shortly after the first H1N1 cases were detected in the United States in June 2009 and vaccine development was under way (IOM, 2010). Based on epidemiological data from the first wave in the United States, ACIP recommended that vaccination efforts should target five groups: (1) pregnant women, (2) people who lived with or cared for infants <6 months old, (3) health care and emergency medical service personnel, (4) people aged >6 months to 24 years, and (5) adults aged 25–64 years

with chronic health conditions or compromised immune systems. At that time, the number of vaccine doses that would be required was unknown.

In September 2009, the U.S. Food and Drug Administration (FDA) approved four monovalent H1N1 influenza vaccines, including one intranasal and three injectable forms.¹ CDC created a centralized distribution system for shipping vaccines to states for the national vaccine campaign that began the next month (IOM, 2010). However, major challenges began to emerge in the early months of the rollout. The vaccine supply schedule that was projected by manufacturers and accepted by the U.S. government was much faster than could be achieved, which severely limited the supply when demand was high. The initial supply was insufficient even to cover ACIP’s target populations, which undermined the government’s credibility when the promised number of vaccine doses could not be delivered (GAO, 2011). By the time the supply was more ample, it was clear that the virus rarely caused severe illness and demand crashed; thus, there was far too little vaccine until there was far too much.

Potential Impact of Allocation Decisions on Vaccine Uptake and Risk Communications

During the 2009 H1N1 vaccine campaign, decisions about how to prioritize groups for allocation impacted the rates of vaccine uptake and posed specific challenges to risk communication (IOM, 2010). ACIP’s priority groups for this campaign were different than the priority groups established during prior pandemic preparedness efforts. For instance, the priority groups included pregnant women and younger people aged >6 months to 24 years, but did not include adults aged >65 years, first responders, or critical infrastructure personnel. At the local level, it was challenging to communicate the rationale for establishing these target groups; this was compounded by the availability of multiple vaccine formulations that had varying contraindications for use among those priority groups. Older adults were excluded because the 2009 H1N1 influenza virus was found to predominantly affect younger people. However, older adults are a group targeted for receipt of the seasonal influenza vaccines and some felt alienated by their exclusion from the priority groups for H1N1 vaccination (IOM, 2010). In certain tribal areas, the exclusion of tribal elders—who are well-respected community leaders—is believed to have contributed to reducing the overall H1N1 vaccination rates among American Indians who were included in ACIP’s priority groups (IOM, 2010). This highlights the need to consider the impact of excluding older adults when making

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¹ A fifth injectable monovalent vaccine was later approved by FDA in November 2009. More information about the H1N1 influenza vaccines is available at https://www.fda.gov/vaccines-blood-biologics/vaccines/influenza-h1n1-2009-monovalent (accessed August 18, 2020).

allocation decisions and developing communications strategies. Although pregnant women were a priority group due to their high risk of complications, severe disease, and mortality related to 2009 H1N1, vaccine uptake among this group was relatively low nationwide (IOM, 2010). Many pregnant women and their health care providers reported having concerns about the safety of receiving the vaccine during pregnancy, further underscoring the need for clear risk communication with priority groups and health care providers.

Potential Impact of Distribution Strategies on Allocation

Although distribution is not the focus of the committee’s framework, prior vaccination campaigns can illustrate how distribution systems can make different allocation schemes more or less feasible and how the choice of distribution system can support or impede choices regarding allocation. For example, to facilitate centralized distribution of the forthcoming H1N1 vaccine in 2009, the national vaccine distribution plan leveraged the existing federal Vaccines for Children program, through which state and local health departments supplied providers with recommended pediatric vaccines. Vaccines funded by the federal government were allocated to states based on their population size, regardless of disease burden or the number of people who fell into ACIP’s priority categories. State and local health departments were left to develop and implement their own distribution plans, with some states choosing to closely follow ACIP’s recommendations for priority groups and others choosing to adapt them (Rambhia et al., 2010).

The H1N1 vaccine program benefited from prior planning and funding to support vaccine production, as well as from the use of a central distribution mechanism. Although it provided state and local jurisdictions with flexibility and autonomy in developing their own distribution methods (e.g., health care providers, local health departments, pharmacies), this led to confusion and communication challenges. Health authorities struggled with dilemmas, such as deciding whether to turn away patients who were not part of the initial priority groups, determining when to allow broader immunization to occur, and coordinating across jurisdictions about their decisions. Some jurisdictions allotted the vaccine on a first-come, first-served basis while others attempted to adhere to CDC guidance, resulting in shortages of vaccine in some locales. Furthermore, the 100-dose minimum vaccine order required for shipment was a barrier for localities that did not need that many doses (GAO, 2011). Ancillary supplies, such as syringes, were distributed separately, but in some cases they were inappropriate for their intended use and some were of varying quality.

Conflicts also emerged regarding certain priority groups—including children—that were established without a clear system to track high-priority individuals. Consequently, vaccinators had to develop ad hoc relationships with local providers and other stakeholders to try to reach individuals designated as having priority (Rambhia et al., 2010). The distribution of vaccines was not fully tracked from manufacturers to individuals, undercutting the ability to efficiently administer the vaccine to those most in need and to monitor supplies (IOM, 2010).

CDC’s Roadmap to Implementing Pandemic Influenza Vaccination of Critical Workforce

As part of the U.S. Department of Health and Human Services’ (HHS’s) 2017 Pandemic Influenza Plan, CDC built on lessons learned in vaccine allocation during the 2009 H1N1 pandemic to develop a Roadmap to Implementing Pandemic Influenza Vaccination of Critical Workforce. This framework provides guidance for state and local efforts to target and allocate pandemic influenza vaccine in scenarios in which vaccine demand exceeds supply (CDC, 2018). For an influenza pandemic of high or very high severity, the roadmap identifies five tiers of population groups, stratified by priority for vaccination:

• Tier 1 includes the highest priority target groups who serve important societal needs (e.g., health care providers, emergency services personnel, pandemic vaccine and antiviral drug manufacturers) and vulnerable populations,² such as pregnant women and infants;
• Tier 2 includes groups critical to national security (e.g., the National Guard, intelligence services), critical community support personnel (e.g., pharmacists), other critical infrastructure (e.g., just-in-time utility services), high-risk children aged 3–18 years old, and household contacts of infants <6 months old;
• Tier 3 includes other critical infrastructure groups (e.g., those who maintain transportation, financial infrastructure), other health care and critical government personnel, and children aged 3–18 years without a high-risk condition;
• Tier 4 includes adults aged 19–64 years with high-risk conditions and adults aged >65 years; and
• Tier 5 includes healthy adults aged 19–64 years not included in the other groups (CDC, 2018).

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² These populations also have substantially greater morbidity and mortality associated with influenza than do other population groups.

Vaccination Campaign During the Ebola Epidemic in West Africa (2013–2016)

WHO developed an operational plan for the allocation of Ebola vaccines in response to the Ebola epidemic in West Africa (2013–2016) (Costa, n.d.). The goal was to make the best possible use of limited vaccine supplies in accordance with guiding principles of equity and transparency. The vaccine would be deployed using clear, pre-established criteria for allocation based on appropriate scientific and ethical foundations, with information shared equitably and decision making by consensus. The plan proposed that vaccines be deployed first to a qualified subset of health care workers, given that this population comprised the highest number of cases and had the greatest risk of infection; they could also be feasibly vaccinated and would likely be most amenable to data collection efforts (Gostin, 2014). After all health care workers in designated countries were vaccinated, a public vaccination strategy would be implemented in the most affected districts in Guinea, Liberia, and Sierra Leone (Costa, n.d.). Phases II and III trial results were available to inform the strategy, including data on vaccine efficacy, impacts of vaccination, feasibility of vaccination, and vaccination policies for various age groups and sexes. Proposed vaccination strategies included both mass vaccination in each affected nation and a ring vaccination approach.³ Important data and legal considerations included ownership, WHO donations, countries’ requests for vaccines, legal liability, informed consent, authorization by national regulatory authorities for vaccine use, and data collection and sharing.

In the early months of the Ebola outbreak in West Africa, lack of effective community engagement was among the barriers that delayed a rapid and effective response; it also contributed to fear and stigma around the disease and potential vaccine among community members. The design and implementation of the Ebola vaccine trials in Sierra Leone during and after the outbreak sought to address this through engagement strategies that included local community liaison teams. A qualitative study looked at these strategies for engaging communities and building trust to encourage vaccine trial participation (Dada et al., 2019). The study found that four principles were critical for building trust with community members: (1) ensuring reciprocal communication, (2) communicating using relatable examples, (3) fostering interpersonal relationships, and (4) respecting community members and their culture.

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³ A ring vaccination strategy focuses on vaccinating the social networks of people with laboratory-confirmed disease, including household contacts, and contacts of contacts (e.g., neighbors, friends, workplace contacts, extended family). A vaccination ring typically includes an average of 150 individuals. See https://www.who.int/emergencies/diseases/ebola/frequently-asked-questions/ebola-vaccine (accessed August 24, 2020).

Consequences of Vaccine Allocation Decisions for Pregnant and Breastfeeding Women

The Ebola vaccine campaign also illustrates the stark consequences of allocation decisions to exclude certain groups—in this case, pregnant and breastfeeding women—from potentially life-saving vaccination. It highlights the critical importance of considering in advance how to represent fairness principles in the absence of group-specific data on safety and efficacy. During the Ebola vaccine campaign, the proposed criteria for deployment according to vaccine availability considered including pregnant women (Costa, n.d.), but WHO ultimately recommended against vaccinating pregnant and breastfeeding women against Ebola, even if they were registered as contacts of known cases (Soucheray, 2019).⁴ This decision was contentious from both ethical and public health perspectives (Faden et al., 2018). Limited evidence of the safety of the live vaccine in pregnant and lactating women was a rationale, but this group was largely excluded from the clinical trials to establish the vaccine’s safety profile and potential fetal risk (Gomes et al., 2017). Evidence soon emerged that pregnancy is associated with increased risks of infection, high risk of maternal death (>90 percent), and even greater risk of neonatal death related to Ebola virus disease (Bebell et al., 2017; Black et al., 2015). Women of childbearing age are also more likely to be caregivers for relatives who are sick (Faden et al., 2018). Despite this mounting evidence suggesting that the benefit of vaccination outweighed the risk for pregnant and lactating women, WHO did not reverse the decision until February 2019, during a subsequent outbreak in the Democratic Republic of the Congo (UN News, 2019). The magnitude of these repercussions on pregnant and lactating women underscores the need to ensure that allocation decisions are fair, even if they are ethically complex or otherwise challenging due to the absence of group-specific data, for example.

Frameworks for Allocating Pandemic Influenza Vaccines

Many countries have developed national plans and frameworks to prepare for the allocation of limited vaccine supply during an outbreak of pandemic influenza, which are distinct from vaccination campaigns conducted outside of outbreak or pandemic scenarios in terms of goals and operationalization. These national plans are tailored to countries’ own systems and resources and each influenza outbreak, as outbreaks differ in terms of specific clinical and epidemiology characteristics and the differential burden of disease across populations (Williams and Dawson, 2020). However, a re-

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⁴ Children were also excluded from the vaccination deployment at the early stages, although they were included in the Ebola vaccine trials conducted in East Africa.

view of pandemic vaccination prioritization strategies in 31 countries⁵ found some commonalities. For instance, more than 80 percent had at least one vaccination priority group (Straetemans et al., 2007). All of those countries prioritized health care workers and almost all prioritized essential service providers and other people at high risk. The authors noted that most of the public plans did not feature clear criteria for prioritization, which are critical for garnering public acceptance of a prioritization framework.

A more recent review looked at ethical arguments used to justify the prioritization of vaccination during an influenza pandemic based on literature published between 2005 and 2015,⁶ much of which was informed implicitly or explicitly by interest in the ethics of vaccination allocation spurred by the severe acute respiratory syndrome (SARS) (2003–2004) and H1N1 (2009) pandemics (Williams and Dawson, 2020). In this literature, the most commonly proposed group for priority was health care workers, followed by vaccine manufacturers, emergency service workers, and basic infrastructure workers (e.g., those in utility, transportation, food, and law enforcement jobs). Some literature prioritized certain age groups, people who are medically vulnerable or otherwise at “high risk,” or socially vulnerable groups—noting that the concept of vulnerability is employed frequently, but it is rarely defined or explained sufficiently. The most commonly cited goal of vaccination was to prevent illness or save lives, which was framed variously as benefiting the most individuals, maximizing quality-adjusted life-years or minimizing years of life lost, or saving particular groups, including people who are vulnerable and stigmatized, people who are most likely to recover, younger people, or people most likely to contribute to minimizing the pandemic’s impact or to contribute to society more broadly. A much less common approach was to prioritize the vaccination of those most likely to be significant transmitters of infection. The ethics arguments used in the literature were largely focused on outcomes, in terms of maximizing a good or minimizing a harm. Many appealed to justice—which is sometimes framed as fairness or equity—and reciprocity. For instance, arguments based on distributive justice often called for giving priority to vulnerable groups, whereas appeals to reciprocity were used to justify priority given to health care workers.

LESSONS FROM PAST CRISIS STANDARDS OF CARE GUIDANCE

During the 2009 influenza pandemic, HHS asked the Institute of Medicine (IOM) to convene a committee of experts to develop guidance for health officials toward establishing and implementing a system of standards of care during disasters, or crisis standards of care (CSC). The committee defined

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⁵ The 27 European Union (EU) member states and the 4 non-EU countries of the Global Health Security Action Group.

⁶ One of the 40 articles was published in 2017.

CSC as “a substantial change in usual health care operations and the level of care it is possible to deliver, which is made necessary by a pervasive (e.g., pandemic influenza) or catastrophic (e.g., earthquake, hurricane) disaster” (IOM, 2009, p. 3). The committee identified five key elements to uphold in order to equitably allocate scarce resources under disaster conditions:

• A strong ethical grounding. In order to be recognized as fair by all those affected by them, CSC must uphold a set of core ethical principles, including fairness; duty to care; duty to steward scarce resources; transparency in design and decision making; consistency in application across all populations; proportionality in the public and individual requirements in a way that is commensurate with the scale of the emergency and degree of scarce resources; and accountability of individuals and governments deciding and implementing CSC (IOM, 2009).
• Integrated and ongoing community and provider engagement, education, and communication. CSC planning must proactively involve both providers and the public, including vulnerable populations and those with special medical needs, in order to ensure transparency, accountability, inclusivity and the legitimacy of the process, and to warrant the public’s trust (IOM, 2009).
• Assurances regarding legal authority and environment. Under disaster and emergency circumstances, health care workers may have to make difficult decisions while implementing CSC, and thus must have adequate guidance and legal protections to do so. It is therefore crucial to have a legal environment that, under certain conditions, empowers necessary and appropriate actions and interventions through statutory or regulatory provisions that can be altered as needed in real time. Clarity is crucial regarding the division of legal authority between the federal government and the states and among executive, judicial, and legislative branches (in both federal and state governments), and regarding the relative authority in each state among its statewide, countywide, and municipal governments (IOM, 2009).
• Clear indicators, triggers, and lines of responsibility. Key indicators need to be pre-defined and shared among all institutions. When observed, those indicators must trigger detailed plans to shift to CSC levels of care, with clearly defined lines of authority and accountability (IOM, 2009).
• Evidence-based clinical processes and operations. Under CSC, decisions made at the bedside should follow clear and evidence-based predictive scoring systems for patient outcomes. Updated evidence-based care guidelines may evolve over the course of the crisis, as the further data are gathered (IOM, 2009).

More recently, at the beginning of the COVID-19 pandemic, the National Academies Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats drafted a rapid expert consultation to provide a rationale for the implementation of CSC in response to the outbreak. The expert committee reiterated key elements of CSC planning and implementation outlined in the 2009 and 2012 IOM reports. Although the committee did not outline details of actual choices and preferences, it provided the rationales and ethical principles upon which such decisions could be made. Importantly, the committee reemphasized that any health care decision made under crisis conditions must be transparent, inclusive, and communicated to the public, and must justify the legalities of such decisions. Failure to do so would “diminish public trust in health care providers and systems, as well as in government leadership” (NASEM, 2020, p. 6).

LESSONS FROM GUIDANCE AND FRAMEWORKS FOR ALLOCATING SCARCE MEDICAL RESOURCES DURING THE COVID-19 PANDEMIC

In addition to lessons learned from prior mass vaccination campaigns, the committee’s deliberations were informed by the principles, goals, and prioritization strategies set forth in guidance and frameworks recently developed for allocating scarce resources during the COVID-19 pandemic. This section provides an overview of the frameworks that address the overall allocation of scarce medical resources and specifically inpatient treatments. The last section of this chapter focuses on those frameworks that are vaccine specific. At the end of this section, Box 2-2 summarizes key guiding principles gleaned by the committee from these efforts, and Table 2-1 provides an overview of the ethical values, principles for allocation, and prioritization strategies set forth by the frameworks presented in this section.

Ethical Frameworks for Broadly Allocating Scarce Medical Resources

Fair Allocation of Scarce Medical Resources in the Time of COVID-19

In May 2020, an article in The New England Journal of Medicine proposed a set of ethical values to underpin recommendations for allocating scarce medical resources during the COVID-19 pandemic (Emanuel et al., 2020).⁷ Drawing on previous proposals about how to allocate

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⁷ This publication builds on the “complete lives system” for allocation of scarce medical interventions that was proposed by a subset of the authors in a 2009 publication. The system “prioritizes younger people who have not yet lived a complete life, and also incorporates prognosis, save the most lives, lottery, and instrumental value principles” (Persad et al., 2009).

resources during scenarios of absolute scarcity, such as pandemics, the authors identify four fundamental ethical values: (1) maximize benefit, (2) treat people equally, (3) promote and reward instrumental value (i.e., providing benefit to others), and (4) give priority to the worst off. Importantly, the authors maintain that none of these values should be used in isolation to determine the allocation of resources; instead, fair allocation requires a multi-value framework that can be tailored to specific settings and resources. Each of these values could be operationalized in different ways in the context of the COVID-19 pandemic. In a pandemic, the most important ethical value is maximizing the benefits of scarce resources, which could aim to save the greatest number of lives or to save the most life-years (e.g., by prioritizing people with the best prognosis). The authors recommend that both of these factors should receive the highest priority. They suggest that treating people equally would be best operationalized by random selection among people with similar prognoses, because a first-come, first-served system is inappropriate for a pandemic. Instrumental value can be promoted retrospectively by giving priority to people who have saved others’ lives—for example, research participants and health care workers—or prospectively by giving priority to people who are likely to save others in the future, such as health care workers. Giving priority to the worst off could either be operationalized by priority to the sickest patients or to younger patients who stand to lose the most life-years. The authors use these four values

TABLE 2-1 Overview of Principles and Prioritization Strategies Used in Frameworks for Allocating Scarce Medical Resources During the COVID-19 Pandemic

^a The Model Hospital Policy for Fair Allocation of Medications to Treat COVID-19 is available at https://ccm.pitt.edu/sites/default/files/2020-0528b%20Model%20hospital%20policy%20for%20allocating%20scarce%20COVID%20meds.pdf (accessed August 17, 2020).

to generate six recommendations for fair allocation of resources during the COVID-19 pandemic:

• To maximize the benefit of limited resources, prioritization should balance two aims: saving the greatest number of lives and maximizing improvements in people’s length of life after treatment.
• By virtue of their instrumental value in the pandemic response, health care workers and others who maintain critical infrastructure should be prioritized.
• For patients with similar prognoses, equality should be operationalized by random allocation.
• Criteria for prioritization should be tailored to the specific resource that is scarce and responsive to changing evidence.
• Research participants should be recognized by receiving some priority, but only as a tiebreaker among those with similar prognoses.
• The same criteria for allocation should apply to people with and without COVID-19.

Ethics of Creating a Resource Allocation Strategy During the COVID-19 Pandemic

In a July 2020 article in Pediatrics, a group of bioethicists reviewed the fundamental ethical principles that frequently underpin scarce resource allocation frameworks and interpreted those principles in the context of the COVID-19 pandemic (Laventhal et al., 2020). They found broad agreement that such frameworks should seek to provide “the greatest benefit to the greatest number of individuals while the fewest resources are used” (Laventhal et al., 2020). Systems for allocation should be fair, transparent, consistently applied, and mindful of socially vulnerable populations without making allocation decisions based solely on sociodemographic factors. Furthermore, allocation frameworks should integrate criteria from across multiple moral dimensions. The authors categorize five principles of allocation drawn from different frameworks with specific relevance to COVID-19:

• Allocation frameworks should optimize the likelihood of benefit by allocating resources to those most likely to survive.
• For people with similar likelihood of benefit, resources should be allocated to those with the greatest urgent or acute need.
• Consider the absolute number of people who can be helped by available resources and maximize opportunities to help more people.
• People who perform vital functions (e.g., health care workers, first responders) are prioritized for resource allocation as a tiebreaker in decisions between people with similar likelihood of survival.

• When all other factors are equal, randomization should be used to prioritize the allocation of resources rather than a first-come, first-served process that can compound inequities.

When creating new resource allocation guidance in a COVID-19 context, the authors suggest the following guiding principles: (1) short-term survival (i.e., survival to discharge) is a reasonable criterion for prioritization; (2) first-come, first-served systems should not be used to determine who receives scarce resources; and (3) to make decisions between people of equal priority with respect to other factors, people who perform vital functions should be prioritized to receive resources.

WHO Policy Brief on Ethics and COVID-19: Resource Allocation and Priority Setting

A policy brief by WHO’s Working Group on Ethics and COVID-19 was developed to provide guidance on scarce resource allocation and priority setting, with the caveat that the allocation of different types of resources will likely be ethically justified by different principles or values (WHO Working Group on Ethics and COVID-19, 2020). This brief is distinct from WHO’s guidance on the allocation of a vaccine, described in the next section.

Broadly, the brief suggests that a fair process for allocating scarce resources should promote certain ethical values, including transparency of allocation decisions and prioritization criteria, inclusiveness of affected groups in the decision-making process, consistent treatment of all persons in the same categories, and accountability of decision makers. In making decisions about prioritization, they highlight four key ethical considerations. The principle of equality can be used in allocating scarce resources to individuals or populations expected to derive the same benefit (e.g., to justify a lottery system). The principle of best outcomes (i.e., utility) can guide the allocation of scarce resources according to their potential to maximize good or minimize harm. Maximizing utility should be balanced with the principle of prioritizing the worst off; the latter can be used to justify the allocation to treat those in greatest medical need or protect those at greatest risk. Finally, the principle of prioritizing those “tasked with helping others” (WHO Working Group on Ethics and COVID-19, 2020, p. 3) can apply to allocating resources to health care workers, for example. In the context of COVID-19 vaccine allocation specifically, the brief recommends prioritizing three categories of individuals or populations, with greater priority for those who are included in multiple categories: (1) people at greatest risk of becoming infected and seriously ill, (2) people who would prevent the greatest spread of the virus if vaccinated, and (3) people who have volunteered to participate in research to develop the vaccine. The first two categories are prioritized to maximize the benefit of the vaccine.

The rationale for the third category is “reciprocal obligation to those who were voluntarily put at risk to aid in this effort” (WHO Working Group on Ethics and COVID-19, 2020, p. 3), although this group should not be prioritized over those at greatest risk.

Nuffield Council on Bioethics Policy Brief on Fair and Equitable Access to COVID-19 Treatments and Vaccines

The Nuffield Council on Bioethics has developed a policy brief that identifies key factors that determine fair and equitable access to COVID-19 treatments and vaccines (Nuffield Council on Bioethics, 2020). These factors include how research is prioritized and funded; how the burdens and benefits of that research are distributed between low- and high-income countries; structural and health inequalities that pose barriers to access; and public engagement and trust in the development and deployment of treatments and vaccines. In making difficult decisions about the allocation of resources that affect access, the authors suggest hewing to an ethical compass of three broadly shared values: (1) ensuring equal respect, dignity, and human rights; (2) helping to reduce suffering of those who are sick or otherwise in need; and (3) maintaining fairness through both nondiscriminatory treatment of others and equitable distribution of benefits and burdens.

Ethical Frameworks for Specifically Allocating Scarce Inpatient Treatments for COVID-19

After FDA issued an Emergency Use Authorization for the use of the antiviral remdesivir for patients with severe COVID-19 in May 2020, decisions about how to allocate remdesivir have been largely delegated to state health departments. However, many hospitals are operating without clear guidance about how to ethically allocate limited supplies of the medication to eligible patients (White and Angus, 2020). This issue will likely be compounded as more treatments for COVID-19 become available, but demand exceeds supply. In some states, such as New Jersey, advisory committees have recommended that remdesivir should be allocated to eligible patients on a first-come, first-served basis. However, other states and research groups are developing various types of ethical frameworks and policies to guide the fair allocation of scarce medications to treat COVID-19. Many of these allocation plans provide for some type of independent decision maker. Controversy has already emerged around some of these plans—particularly regarding the allocation of ventilators—with regard to their disparate impact based on patients’ race or disability status (Schmidt, 2020; Truog et al., 2020). Some plans have subsequently been revised to address these types of critiques.

Minnesota’s Ethical Framework for Distributing Remdesivir

In June 2020, the state of Minnesota developed an ethical framework for distributing remdesivir to facilities statewide and for prioritizing specific patients within each facility who are at greatest risk of mortality and serious morbidity, as well as those who would benefit from access to the drug (Lim et al., 2020).⁸ The framework’s guiding ethical principles are to (1) responsibly allocate the scarce resource to reduce risk while providing benefit; (2) save the most lives possible while respecting rights and fairness; (3) promote the common good through transparency, accountability, and trustworthiness; and (4) use the best available evidence while addressing uncertainty. To ensure that the framework protects the rights and interests of all, the approach rejected allocation based on race, ethnicity, gender or gender identity, citizenship or immigration status, socioeconomic status, or ability to pay for treatment. Age, disability status, and comorbid conditions are disallowed as criteria unless relevant to clinical prognosis and likelihood of survival. To protect those at greatest risk while also maximizing remdesivir’s benefit, it is allocated to patients based both on need and on likelihood of survival to hospital discharge. The framework focuses on short-term rather than longer-term prognosis to avoid disadvantaging people based on age, comorbid conditions, disabilities, or systemic health inequities. The framework highlights the importance of obtaining patient consent, because remdesivir was not FDA approved when the framework was developed and the drug has the potential to cause serious adverse events. It is important to note that this framework is a living document that will likely be updated as better data are available to guide the use of remdesivir.

Pennsylvania’s Weighted Lottery System for Allocating Scarce Medications for COVID-19

The Commonwealth of Pennsylvania has endorsed a weighted lottery system for ethically allocating medications for COVID-19 to eligible patients in cases of shortage. This lottery system is part of a model hospital policy,⁹ developed by a multidisciplinary team at the University of Pittsburgh, which is guided by the ethical duties to steward scarce resources in the interest of public health and to mitigate the impact of social inequities on COVID-19 outcomes in disadvantaged communities. This model policy recommends that hospitals create an allocation team to unburden treating clinicians of

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⁸ The ethical framework to allocate remdesivir in the COVID-19 pandemic (updated August 2020) is available at https://www.health.state.mn.us/diseases/coronavirus/hcp/remdesivir.pdf (accessed August 17, 2020).

⁹ The model hospital policy for fair allocation of medications to treat COVID-19 is available at https://ccm.pitt.edu/sites/default/files/2020-05-28b%20Model%20hospital%20policy%20for%20allocating%20scarce%20COVID%20meds.pdf (accessed August 17, 2020).

the responsibility and potential moral distress of making decisions about the allocation of scarce medications to their patients. The weighted lottery system is designed to fairly allocate the supply of a medication for treating COVID-19 if it is insufficient for the number of eligible patients, with certain groups receiving heightened priority: (1) individuals who reside in disadvantaged areas, as defined by an address with an Area Deprivation Index score of 8–10; and (2) individuals who are essential workers, as defined by the state’s list of businesses required to continue physical operations during the pandemic. The latter group includes health care workers, but also lower-paid workers who tend to be socially and economically vulnerable (e.g., people employed in grocery stores, public transportation, agriculture, and custodial work). Individuals who are expected to die within 1 year from an end-stage condition are not excluded from the lottery but receive lower priority than individuals without such conditions. Others have argued that lottery systems to allocate scarce medications for COVID-19 should be centralized and run by state health departments—rather than by individual hospitals—in order to expedite distribution and to allow for the collection of larger volumes of pooled clinical data about the effectiveness of remdesivir or other scarce medications (White and Angus, 2020).

Ethical Framework for Allocating Therapies to Hospitalized Patients with COVID-19

Another ethical framework for allocating scarce inpatient medications for COVID-19 was developed by a group at the University of California, San Francisco, in May 2020. This framework was developed as a practical guide for clinicians and health care facilities faced with decisions about how to ethically allocate therapies to hospitalized patients with COVID-19, including existing therapies such as remdesivir, as well as novel treatments under development (e.g., monoclonal antibodies) (DeJong et al., 2020). The aims of this framework are to maximize benefit to patients, mitigate disparities, adhere to ethical principles, and revise allocation policies as more evidence becomes available. The guiding ethical principles of this framework are that reducing mortality provides benefit to the community as a whole and benefit should be assessed using the best available evidence. The framework holds that during a shortage, medications should be prioritized for indications with demonstrated efficacy and safety, ideally from randomized controlled trials. Patient preferences should be respected to the extent that the drug supply allows, and scarce medications should be allocated in a way that is fair, avoids discrimination, and mitigates health disparities. Allocation policies should be made transparent, accountable, responsive to the concerns of the affected population, and proportionate to the epidemiological situation and the drug supply relative to need. Prioritization in this framework does not exclude people based on age, disability, religion, race

or ethnicity, national origin, gender, sexual orientation, or perceived quality of life or comorbid conditions. Random allocation (e.g., lottery) is deemed the fairest way to allocate scarce supplies among eligible patients—although workers in essential jobs may be assigned some priority—because a “first-come, first-served” system is not random and puts people who face barriers to care at a disadvantage. An additional advantage of a random lottery system is the potential for knowledge generation, because a randomized sample could potentially be used to causally evaluate the effect of being vaccinated on relevant outcomes. The authors also outline five goals that can be derived from the ethical framework for allocating scarce therapies for COVID-19: (1) to save the most lives in the short and near term, with additional goals of preventing new cases and reducing the durations of hospitalization and mechanical ventilation; (2) to decrease disparities in COVID-19 case-fatality proportions that disproportionately affect racial and ethnic minority communities; (3) to strengthen the community’s pandemic response ability; (4) to preserve a supply of existing medications for non-COVID-19 indications that patients with chronic conditions may depend on; and (5) to reserve enough of the therapy to conduct randomized controlled trials and develop a stronger evidence base for effective therapies.

SPECIFIC FRAMEWORKS FOR COVID-19 VACCINE ALLOCATION WITHIN AND AMONG COUNTRIES

This section outlines ethical frameworks developed specifically for COVID-19 vaccine allocation within and among countries, including an interim framework developed by a group at Johns Hopkins University, forthcoming efforts from CDC, and a values framework developed by WHO. It is important to note that these frameworks were and are being developed in the context of rapidly changing goals for vaccination (e.g., as schools began to re-open in August 2020) and evolving data about SARS-CoV-2 and vaccine candidates. Table 2-2 at the end of this chapter summarizes the goals, ethical principles, and prioritization approaches of these COVID-19 vaccine-specific allocation frameworks.

Johns Hopkins Interim Framework for COVID-19 Vaccine Allocation and Distribution in the United States

In August 2020, Johns Hopkins University’s Center for Health Security released an interim framework for COVID-19 vaccine allocation and distribution in the United States (Toner et al., 2020) that is framed by three broad ethical values: (1) promoting the common good, (2) treating people fairly and equally, and (3) promoting legitimacy, trust, and a sense of ownership in a pluralistic society. In this framework, the ethical value of promoting the common good includes the more specific ethical principles

of promoting public health (e.g., preventing illness and death and protecting health systems) as well as promoting economic and social well-being, which includes the protection of essential services, supporting economic activity, and enabling children to return to school and child care. Ethical principles falling under the broader value of treating people fairly and equitably include addressing background and emerging inequities experienced by disadvantaged and marginalized groups, giving priority to the worst-off people at greatest risk of severe illness and death, and ensuring reciprocity to protect those who provide essential services and advance the development of treatments and vaccines. The third ethical value calls for respecting the diversity of views in a pluralistic society and engaging with communities to strengthen vaccine campaigns. Based on this ethical foundation, the framework suggests that the following groups should be candidates for high-priority access to a scarce vaccine, including provisional examples of the groups in each tier.

Tier 1 priority groups include the following:

• Those most essential in sustaining the ongoing COVID-19 response (e.g., frontline health workers, emergency services personnel, and public health workers; pandemic vaccine manufacturing and supply chain personnel; COVID-19 diagnostic and immunization teams).
• Those at greatest risk of severe illness and death, and their caregivers (e.g., adults aged ≥65 years; others at elevated risk of serious COVID-19 and complications; frontline long-term care providers and health care workers providing direct care to patients with high-risk conditions).
• Those most essential to maintaining core societal functions (e.g., workers in frontline public transport, food supply, and schools).

Tier 2 priority groups include the following:

• Those involved in broader health provision (e.g., health workers and staff with direct but non-COVID-19-specific patient contact; pharmacy staff).
• Those who face greater barriers to access care if they become seriously ill (e.g., people living in remote locations with substandard infrastructure and health care access).
• Those contributing to the maintenance of core societal functions (e.g., frontline infrastructure workers who cannot work remotely; warehouse and delivery workers; deployed military involved in operations; police and fire personnel with frequent public contact; Transportation Security Administration and border security personnel with direct public contact).

• Those whose living or working conditions give them an elevated risk of infection, even if they have a lesser or unknown risk of severe illness and death (e.g., people who are unable to maintain safe physical distances in their home or work environments, including people living in shelters, people who are incarcerated, and people who work in prisons).

CDC’s Ongoing Vaccine Allocation Efforts

CDC’s ACIP is currently developing a plan for the allocation of COVID-19 vaccine in the United States. As a CDC federal advisory committee, ACIP provides recommendations on the use of vaccines in the U.S. civilian population and provides guidance to CDC and the Secretary of HHS on the optimal use of vaccines, but ACIP does not traditionally play a role in implementation (Lee et al., 2020). An ACIP COVID-19 Vaccine Workgroup was established in April 2020 to provide overarching guidance and vaccine-specific recommendations to CDC. The workgroup will evaluate available evidence and make recommendations; evaluate the likelihood that vaccines will reduce COVID-19 transmission, morbidity, and mortality and minimize disruption to society; and explore approaches to ensure equity in allocation. The ACIP workgroup has established three guiding principles to inform decision making: (1) safety, (2) diversity in clinical trials, which is necessary for diversity in vaccine allocation, and (3) efficient and equitable vaccine distribution. The focus of ACIP is on vaccine recommendations, rather than implementation; the latter will depend on partnerships with state and local public health entities. During ACIP’s initial deliberations, proposed groups for prioritized allocation included health care workers, essential workers, adults aged ≥65 years, long-term care facility residents, and persons with high-risk medical conditions (Splete, 2020). At its September 22, 2020, meeting, ACIP presented its proposed ethics/equity framework for COVID-19 vaccine (Oliver, 2020) with the goals of minimizing death and serious disease; preserving functioning of society; reducing disproportionate burden on those with existing disparities; and increasing equity of opportunity to enjoy health and well-being. The proposed ethical principles are:

• Maximize benefits and minimize harms: minimize death and serious disease; address the obligation to promote public health and promote the common good, balanced with the obligation to respect and care for persons; and is based on best available science.
• Equity: vaccine allocation reduces rather than increases health disparities and ensures that everyone has a fair and just opportunity to be as healthy as possible.

• Justice: commitment to remove unfair, unjust, and avoidable barriers to good health and well-being that disproportionately affect the most disadvantaged populations; interventions must intentionally ensure that groups, populations, and communities affected by a policy are being treated fairly.
• Fairness: commitment to fair stewardship in the distribution of a scarce resource.
• Transparency: supporting principles and process for allocation decisions are clear, understandable, and open for review; to the degree possible, given the urgency of the response, public participation in the creation and review of processes should be recognized and honored; essential to build and maintain public trust during planning and implementation; and all recommendations are evidence based, with information used to make recommendations made publicly available.

WHO SAGE Values Framework for the Allocation and Prioritization of COVID-19 Vaccination

WHO has several related global planning efforts under way for global COVID-19 vaccine allocation. WHO leads the efforts pertaining to global vaccine allocation guidance, which informs the COVAX Facility’s (the vaccines pillar of the Access to COVID Tools Accelerator) procurement schemes.¹⁰ These global efforts are discussed further in Chapter 8. WHO has been working with its member states and the Strategic Advisory Group of Experts (SAGE)—which is the vaccine advisory body within WHO—to finalize the allocation framework of vaccines from the COVAX Facility among countries. Within-country allocation decisions remain under the authority of each individual Member State.

The WHO SAGE Values Framework for the Allocation and Prioritization of COVID-19 Vaccination, published in September 2020, provides guidance both on allocating COVID-19 vaccines among countries and on prioritizing groups for vaccination within countries while the supply is limited (WHO, 2020). The overarching goal of the framework is to ensure that

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¹⁰ Access to COVID Tools Accelerator is a global initiative bringing together governments, health organizations, scientists, businesses, civil society, and philanthropists to accelerate the development and deployment of the key countermeasures needed to respond to the COVID-19 pandemic, including COVID-19 tests, therapeutics, and vaccines. More information about the Access to COVID Tools Accelerator is available at https://www.who.int/publications/m/item/access-to-covid-19-tools-(act)-accelerator (accessed August 25, 2020). The COVAX pillar’s primary goal is to accelerate the development and manufacture of vaccines and ensure equitable access worldwide. More information about COVAX is available at https://www.who.int/initiatives/act-accelerator/covax (accessed August 25, 2020).

COVID-19 vaccines are a global public good that contributes significantly to equitably protecting and promoting human well-being for all people worldwide. The framework is guided by six ethical values:

• Human well-being: Protect and promote human well-being including health, social and economic security, human rights and civil liberties, and child development.
• Equal respect: Recognize and treat all human beings as having equal moral status and their interests as deserving of equal moral consideration.
• Global equity: Ensure equity in vaccine access and benefit globally among people living in all countries, particularly those living in low- and middle-income countries.
• National equity: Ensure equity in vaccine access and benefit within countries for groups experiencing greater burdens from the COVID-19 pandemic.
• Reciprocity: Honor obligations of reciprocity to those individuals and groups within countries who bear significant additional risks and burdens of COVID-19 response for the benefit of society.
• Legitimacy: Make global decisions about vaccine allocation and national decisions about vaccine prioritization through transparent processes that are based on shared values, best available scientific evidence, and appropriate representation and input by affected parties.

This framework also describes how those ethical values can be operationalized into specific objectives and unranked priority groups for vaccination. For the principle of human well-being, the objective of reducing COVID-19-related deaths and disease burden could translate to prioritizing populations with significantly elevated risks of severe disease or death (e.g., older adults, people with certain comorbid conditions or health states, sociodemographic groups at disproportionately higher risks) and populations with significantly elevated risks of infection (e.g., health workers, employment categories and social groups of people who are unable to physically distance, people living in dense neighborhoods and multigenerational households).

The objective of reducing societal and economic disruption could warrant prioritizing groups such as those at high risk of transmitting SARSCoV-2, school-aged children, and workers in non-essential but economically critical sectors. To protect the continuity of essential services, priority could be assigned to health workers, non-health-sector essential workers, and other essential personnel (e.g., government leaders and those involved in producing vaccines, therapeutics, and diagnostics). The principle of equal

respect requires that no one who is eligible for inclusion in a priority group is excluded for unjustifiable reasons.

The principle of global equity holds that (1) the priority groups identified by the WHO SAGE values framework should inform global-level allocation decisions and (2) countries with greater financial resources should not undermine vaccine access for low- and middle-income countries. According to the principle of national equity, within-country vaccine prioritization should take into account the risks and needs of vulnerable groups at risk of disproportionate burdens from the COVID-19 pandemic, including people living in poverty, people experiencing homelessness, migrants, refugees, other hard-to-reach groups, and groups that are disadvantaged or persecuted based on ethnicity, race, gender, religion, sexual orientation, or disability status. The principle of reciprocity calls for protecting people who “bear significant additional risks and burdens of COVID-19 to safeguard the welfare of others” (WHO, 2020, p. 2), including health workers, other essential workers, and COVID-19 vaccine clinical trial participants who did not receive an effective vaccine. The objectives of the legitimacy principle are to ensure transparency, trust, and lack of bias in the process of making evidence-based allocation decisions.

Table 2-2 starts on next page.

TABLE 2-2 Overview of Ongoing COVID-19 Vaccine Allocation Efforts

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