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

Chapter: Lessons Learned from Other Allocation Efforts

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Suggested Citation:"Lessons Learned from Other Allocation Efforts." 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:"Lessons Learned from Other Allocation Efforts." 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:"Lessons Learned from Other Allocation Efforts." 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:"Lessons Learned from Other Allocation Efforts." 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:"Lessons Learned from Other Allocation Efforts." 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:"Lessons Learned from Other Allocation Efforts." 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 10
Suggested Citation:"Lessons Learned from Other Allocation Efforts." 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:"Lessons Learned from Other Allocation Efforts." 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 12
Suggested Citation:"Lessons Learned from Other Allocation Efforts." 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:"Lessons Learned from Other Allocation Efforts." 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:"Lessons Learned from Other Allocation Efforts." 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:"Lessons Learned from Other Allocation Efforts." 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:"Lessons Learned from Other Allocation Efforts." 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:"Lessons Learned from Other Allocation Efforts." 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:"Lessons Learned from Other Allocation Efforts." 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:"Lessons Learned from Other Allocation Efforts." 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 20
Suggested Citation:"Lessons Learned from Other Allocation Efforts." 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:"Lessons Learned from Other Allocation Efforts." 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 22
Suggested Citation:"Lessons Learned from Other Allocation Efforts." 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 23
Suggested Citation:"Lessons Learned from Other Allocation Efforts." 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 24
Suggested Citation:"Lessons Learned from Other Allocation Efforts." 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 25
Suggested Citation:"Lessons Learned from Other Allocation Efforts." 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 26
Suggested Citation:"Lessons Learned from Other Allocation Efforts." 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 27
Suggested Citation:"Lessons Learned from Other Allocation Efforts." 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 28
Suggested Citation:"Lessons Learned from Other Allocation Efforts." 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 29
Suggested Citation:"Lessons Learned from Other Allocation Efforts." 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 30

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1 Lessons Learned from Other Allocation Efforts 2 In response to the COVID-19 pandemic and the societal disruption it has brought, 3 national governments and the international community have invested vast sums in the 4 development of a safe and effective vaccine. Although subject to myriad uncertainties, mass 5 vaccination against this novel coronavirus offers the possibility to significantly reduce 6 transmission and severe morbidity and mortality beyond what might be accomplished through 7 non-pharmaceutical interventions, better diagnostic tests, and improved therapies. The goal of 8 protecting the public’s health is intertwined with the goal of protecting society’s socioeconomic 9 well-being, which in turn has an impact on the public’s overall health. Even if one or more safe 10 and effective COVID-19 vaccines under development are tested and quickly approved for use, 11 they are unlikely to be available immediately in amounts sufficient to vaccinate the whole 12 population, despite plans to begin large-scale production of promising vaccines even before trials 13 are completed. As a result, at the outset and in the months to follow, vaccines will almost 14 certainly be available only in limited supplies. In this context, a scarce vaccine or vaccines will 15 need to be allocated in ways that reduce virus transmission and/or reduce morbidity and 16 mortality in order to protect the public’s health and its socioeconomic well-being. 17 This is not the first time the nation, nor the world, has been faced with the issue of 18 allocating scarce resources in the midst of a public health emergency. In developing a framework 19 for equitable COVID-19 vaccine allocation, the committee’s deliberations were informed by 20 practical lessons from previous efforts to allocate vaccines for pandemic influenza and Ebola 21 virus disease, as well as by the goals, ethical principles, and prioritization strategies set forth in 22 other allocation frameworks—including several that have recently been developed to distribute 23 scarce inpatient medications for COVID-19. The committee also reflected on the guiding DISCUSSION DRAFT FOR PUBLIC COMMENT 5

24 principles and prioritization criteria established by concurrent efforts being led by the World 25 Health Organization (WHO), the Centers for Disease Control and Prevention’s (CDC’s) 26 Advisory Committee on Immunization Practices (ACIP), and others to develop frameworks for 27 allocating COVID-19 vaccines. 28 LESSONS FROM MASS VACCINATION CAMPAIGNS FOR PRIOR INFECTIOUS 29 DISEASE OUTBREAKS 30 A mass vaccination campaign for an infectious disease outbreak is a complex enterprise 31 that requires balancing different strategies for allocation, distribution, administration, access, and 32 other considerations. Each infectious disease outbreak differs in terms of its clinical 33 characteristics and impact across various populations, thus each outbreak requires a tailored mass 34 vaccination approach. Although the committee was tasked with developing a framework 35 specifically for allocation, looking back at some of the broader successes and challenges of 36 previous mass vaccination campaigns is instructive from both operational and ethical 37 perspectives. For instance, prior campaigns can illustrate how distribution systems can make 38 different allocation schemes more or less feasible and how the choice of distribution system can 39 support or impede choices regarding allocation. The committee identified several key lessons 40 learned from prior mass vaccination campaigns that relate to or impact on vaccine allocation, 41 which are outlined in Box 1 later in this section. 42 H1N1 Influenza Vaccination Campaign (2009) 43 The development of the U.S. plan for vaccine allocation and distribution in response to 44 the 2009 H1N1 influenza A pandemic illustrated some of the fundamental challenges involved in 45 implementing a mass national vaccination campaign at the local level, where many jurisdictions 46 have limited resources and capacity (Rambhia et al., 2010). CDC’s ACIP began planning an 47 ambitious vaccination program shortly after the first cases were detected in the United States in 48 June 2009 and vaccine development was under way (IOM, 2010). Based on epidemiological data 49 from the first wave in the United States, ACIP recommended that vaccination efforts should 50 target five groups: (1) pregnant women, (2) people who lived with or cared for infants <6 months 51 old, (3) health care and emergency medical service personnel, (4) people aged >6 months to 24 DISCUSSION DRAFT FOR PUBLIC COMMENT 6

52 years, and (5) adults aged 25–64 years with chronic health disorders or compromised immune 53 systems. At that time, the number of vaccine doses that would be required was unknown. To 54 facilitate centralized distribution of the forthcoming H1N1 vaccine, the national vaccine 55 distribution plan leveraged the existing federal Vaccines for Children program, through which 56 state and local health departments supplied providers with recommended pediatric vaccines. 57 Vaccines funded by the federal government were allocated to states based on their population 58 size, regardless of disease burden or number of people who fell into ACIP’s priority categories. 59 In September 2009, the U.S. Food and Drug Administration (FDA) approved four monovalent 60 H1N1 influenza vaccines, including one intranasal and three injectable forms.1 CDC created a 61 centralized distribution system for shipping vaccines to states for the national vaccine campaign 62 that began the next month (IOM, 2010). State and local health departments were left to develop 63 and implement their own distribution plans, with some states choosing to closely follow ACIP’s 64 recommendations for priority groups and others choosing to adapt them (Rambhia et al., 2010). 65 The H1N1 vaccine program benefited from prior planning and funding to support vaccine 66 production, as well as the use of a central distribution mechanism. It also provided state and local 67 jurisdictions with flexibility and autonomy in developing their own distribution plans. However, 68 major challenges began to emerge in the early months of the rollout. The vaccine supply 69 schedule that was projected by manufacturers and accepted by the U.S. government was much 70 faster than could actually be achieved, which severely limited the supply when demand was high. 71 The initial supply was insufficient even to cover ACIP’s target populations, which undermined 72 the government’s credibility when the promised number of vaccine doses could not be delivered 73 (GAO, 2011). By the time supply was more ample, it was clear that the virus rarely caused 74 severe illness and demand crashed; thus, there was far too little vaccine until there was far too 75 much. Furthermore, the ability of state and local authorities to choose their own distribution 76 methods (e.g., health care providers, local health departments, pharmacies) led to confusion and 77 communication challenges. Health authorities struggled with dilemmas, such as deciding 78 whether to turn away patients who were not part of initial priority groups, determining when to 79 allow broader immunization to occur, and coordinating across jurisdictions about their decisions. 80 Furthermore, the 100-dose minimum vaccine order required for shipment was a barrier for 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). DISCUSSION DRAFT FOR PUBLIC COMMENT 7

81 localities that did not need that many doses (GAO, 2011). Conflicts also emerged regarding 82 certain priority groups—including children—that were established without a clear system to 83 track high-priority individuals. Consequently, vaccinators had to develop ad hoc relationships 84 with local providers and other stakeholders to ensure that they reached individuals designated as 85 having priority (Rambhia et al., 2010). The distribution of vaccines was not fully tracked from 86 manufacturers to individuals, undercutting the ability to efficiently administer the vaccine to 87 those most in need and to monitor supplies (IOM, 2010). Ancillary supplies, such as syringes, 88 were distributed separately, but in some cases they were inappropriate for their intended use and 89 some were of varying quality. Although the shortage of vaccine was hugely problematic at the 90 outset, the demand had decreased by January 2010 and many vaccine doses were left unused. Of 91 note is that the demand for influenza vaccine generally drops around that time of year, even as 92 seasonal influenza peaks. 93 The Texas Department of State Health Services (DSHS) conducted an after-action 94 assessment of its response to the H1N1 pandemic, which identified successes and challenges 95 with respect to vaccine distribution (Litaker et al., 2010). A major success was the use of a 96 public-private partnership, led by the DSHS, to allocate and distribute the vaccine to local 97 jurisdictions, supported by the rapid implementation of a vaccine management system. 98 Availability of the vaccine was identified as a major challenge. Due to the timing of when the 99 vaccine became available, the H1N1 strain could not be included in the seasonal influenza 100 vaccine, so two separate vaccines had to be produced. 101 CDC’s Roadmap to Implementing Pandemic Influenza Vaccination of Critical Workforce 102 As part of the U.S. Department of Health and Human Services’ (HHS’s) 2017 Pandemic 103 Influenza Plan, CDC built on lessons learned in vaccine allocation during the 2009 H1N1 104 pandemic to develop a Roadmap to Implementing Pandemic Influenza Vaccination of Critical 105 Workforce. This framework provides guidance for state and local level efforts to target and 106 allocate pandemic influenza vaccine in scenarios in which vaccine demand exceeds supply 107 (CDC, 2019). For an influenza pandemic of high or very high severity, the roadmap identifies 108 five tiers of population groups, stratified by priority for vaccination: 109 DISCUSSION DRAFT FOR PUBLIC COMMENT 8

110 • Tier 1: the highest priority target groups who serve important societal needs (e.g., 111 health care providers, emergency services personnel, pandemic vaccine and antiviral 112 drug manufacturers) and vulnerable populations,2 such as pregnant women and 113 infants; 114 • Tier 2: groups critical to national security (e.g., National Guard, intelligence 115 services), critical community support personnel (e.g., pharmacists), other critical 116 infrastructure (e.g., just-in-time utility services), high-risk children aged 3–18 years 117 old, and household contacts of infants <6 months old; 118 • Tier 3: other critical infrastructure groups (e.g., those that maintain transportation, 119 financial infrastructure), other health care, critical government personnel, and 120 children aged 3–18 years without a high-risk condition; 121 • Tier 4: adults aged 19–64 years with high-risk conditions and adults aged >65 years; 122 and 123 • Tier 5: healthy adults aged 19–64 years not included in other groups. 124 Vaccination Campaign During Ebola Epidemic in West Africa (2013–2016) 125 WHO developed an operational plan for the allocation and distribution of Ebola vaccines 126 in response to the Ebola epidemic in West Africa (2013–2016) (Costa, n.d.). The goal was to 127 make the best possible use of limited vaccine supplies in accordance with guiding principles of 128 equity and transparency. The vaccine would be deployed using clear, pre-established criteria for 129 allocation based on appropriate scientific and ethical foundations, with information shared 130 equitably and decision making by consensus. The plan proposed that vaccines be deployed first 131 to a qualified subset of health care workers, given that this population comprised the highest 132 number of cases and had the greatest risk of infection; they could also be feasibly vaccinated and 133 would likely be most amenable to data collection efforts (Gostin, 2014). After all health care 134 workers in designated countries were vaccinated, a public vaccination strategy would be 135 implemented in the most affected districts in Sierra Leone, Guinea, and Liberia (Costa, n.d.). 136 Phase 2 and 3 trial results were available to inform the strategy, including data on vaccine 137 efficacy, impacts of vaccination, feasibility of vaccination, and vaccination policies for various 2 These populations also have substantially greater morbidity and mortality associated with influenza than other population groups. DISCUSSION DRAFT FOR PUBLIC COMMENT 9

138 age groups, sexes, and pregnant women. Proposed vaccination strategies included both mass 139 vaccination in each affected nation and a ring vaccination approach.3 Important data and legal 140 considerations included ownership, WHO donations, countries’ requests for vaccines, legal 141 liability, informed consent, authorization by national regulatory authorities for vaccine use, and 142 data collection and sharing. 143 In the early months of the Ebola outbreak in West Africa, lack of effective community 144 engagement was among the barriers that delayed a rapid and effective response; it also 145 contributed to fear and stigma around the disease and potential vaccine among community 146 members. The design and delivery of the Ebola vaccine trials in Sierra Leone during and after 147 the outbreak sought to address this through engagement strategies that included local community 148 liaison teams. A qualitative study looked at these strategies for engaging communities and 149 building trust to encourage vaccine trial participation (Dada et al., 2019). The study found that 150 four principles were critical for building trust with community members: (1) ensuring reciprocal 151 communication; (2) communicating using relatable examples; (3) fostering interpersonal 152 relationships; and (4) respecting community members and their culture. 153 The Ebola vaccine campaign also illustrates the stark consequences of allocation 154 decisions to exclude certain groups from potentially life-saving vaccination. Although the 155 proposed criteria for deployment according to vaccine availability considered including pregnant 156 women (Costa, n.d.), WHO ultimately recommended against vaccinating pregnant and 157 breastfeeding women against Ebola, even if they were registered as contacts of known cases 158 (Soucheray, 2019).4 This decision was contentious from both ethical and public health 159 perspectives (Faden et al., 2018). Limited evidence of the safety of the live vaccine in pregnant 160 and lactating women was a rationale, but this group was largely excluded from the clinical trials 161 to establish the vaccine’s safety profile and potential fetal risk (Gomes et al., 2017). Evidence 162 soon emerged that pregnancy is associated with increased risks of infection, high risk of maternal 163 death (>90 percent), and even greater risk of neonatal death related to Ebola virus disease (Bebell 3 A ring vaccination strategy focuses on vaccinating the social networks of people with laboratory-confirmed disease, including household contacts, contacts of contacts (e.g., neighbors, friends, workplace contacts, extended family). A vaccination ring typically includes an average of 150 individuals. Source: https://www.who.int/emergencies/diseases/ebola/frequently-asked-questions/ebola-vaccine (accessed August 24, 2020). 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. DISCUSSION DRAFT FOR PUBLIC COMMENT 10

164 et al., 2017; Black et al., 2015). Women of childbearing age are also more likely to be caregivers 165 for relatives who are sick (Faden et al., 2018). Despite this mounting evidence suggesting that 166 the benefit of vaccination outweighed the risk for pregnant and lactating women, WHO did not 167 reverse the decision until February 2019, during a subsequent outbreak in the Democratic 168 Republic of the Congo (UN News, 2019). 169 BOX 1 Key Lessons Learned from Prior Mass Vaccination Efforts • Leverage relationships with professional medical societies and other key downstream stakeholders from the outset. • When cost, insurance and other policies create barriers, consider the issue of rationing at the state, local, and practice levels. • Develop effective systems for tracking distribution. • Ensure that ancillary supply distribution is timely and appropriate. • “Under-promise and over-deliver” in planning and communication efforts. • Ensure up-to-date information on vaccine production, inventory, and projections via stronger and more formal partnerships between federal entities and vaccine producers. • Plan for a range of vaccine supply scenarios. • Continue to use the Vaccines for Children program infrastructure as a basis for emergency vaccination distribution programs; consider something similar for adults. • Deploy limited vaccine supplies equitably and transparently using pre-established, evidence-based criteria to prioritize allocation. • Promote global regulatory harmonization and standardization in vaccine development to improve speed, flexibility, and efficiency. • Consistent, respectful, accurate communication to earn, secure, and maintain trust. 170 Frameworks for Allocating Pandemic Influenza Vaccines 171 Many countries have developed national plans and frameworks to prepare for the 172 allocation of limited vaccine supply during an outbreak of pandemic influenza, which are distinct 173 from vaccination campaigns conducted outside of outbreak or pandemic scenarios in terms of DISCUSSION DRAFT FOR PUBLIC COMMENT 11

174 goals and operationalization. These national plans are tailored to countries’ own systems and 175 resources and each influenza outbreak will differ in terms of specific clinical characteristics and 176 distribution of the burden of disease across populations (Williams and Dawson, 2020). However, 177 a review of pandemic vaccine prioritization strategies in 31 countries5 found some 178 commonalities. For instance, more than 80 percent had at least one vaccine priority group 179 (Straetemans et al., 2007). All of those countries prioritized health care workers and almost all 180 prioritized essential service providers and people at high risk. The authors noted that most of the 181 public plans did not feature clear criteria for prioritization, which are critical for garnering public 182 acceptance of a prioritization framework. 183 A more recent review looked at ethical arguments used to justify the prioritization of 184 vaccine during an influenza pandemic based on literature published between 2005–2015,6 much 185 of which was informed implicitly or explicitly by interest in the ethics of vaccine allocation 186 spurred by the severe acute respiratory syndrome (SARS) (2003–2004) and H1N1 (2009) 187 pandemics (Williams and Dawson, 2020). In this literature, the most commonly proposed group 188 for priority was health care workers, followed by vaccine manufacturers, emergency service 189 workers, and basic infrastructure workers (e.g., utility, transportation, food, law enforcement). 190 Some literature prioritized certain age groups, people who are medically vulnerable or otherwise 191 at “high risk,” or socially vulnerable groups—noting that the concept of vulnerability is 192 employed frequently, but it is rarely defined or explained sufficiently. The most commonly cited 193 goal of vaccination was to prevent illness or save lives, which was framed variously as benefiting 194 the most individuals, maximizing quality-adjusted life years or minimizing years of life lost, or 195 saving particular groups, including people who are vulnerable and stigmatized, people who are 196 most likely to recover, younger people, or people most likely to contribute to minimizing the 197 pandemic’s impact or to contribute to society more broadly. A much less common approach was 198 to prioritize vaccination of those most likely to be significant transmitters of infection. The ethics 199 arguments used in the literature were largely focused on outcomes, in terms of maximizing a 200 good or minimizing a harm. Many appealed to justice—which is sometimes framed as fairness or 201 equity—and reciprocity. For instance, arguments based on distributive justice often called for 5 The 27 European Union (EU) member states and the four non-EU countries of the Global Health Security Action Group. 6 One of the 40 articles was published in 2017. DISCUSSION DRAFT FOR PUBLIC COMMENT 12

202 giving priority to vulnerable groups, while appeals to reciprocity were used to justify priority 203 given to health care workers. 204 LESSONS FROM GUIDANCE AND FRAMEWORKS FOR ALLOCATING SCARCE 205 RESOURCES DURING THE COVID-19 PANDEMIC 206 In addition to lessons learned from prior mass vaccination campaigns, the committee’s 207 deliberations were informed by the goals, principles, and prioritization strategies set forth in 208 guidance and frameworks recently developed for the allocation of scarce resources during the 209 COVID-19 pandemic. Some of these frameworks are vaccine-specific, some are focused on in- 210 patient treatments, and others address the allocation of scarce medical resources more broadly. 211 This section provides an overview of these frameworks’ guiding ethical principles and (when 212 available) the criteria for prioritizing allocation of the vaccine to specific groups. Box 2 213 summarizes key guiding principles gleaned by the committee from these efforts. 214 Ethical Frameworks for Allocating Scarce Medical Resources 215 Fair Allocation of Scarce Medical Resources in the Time of COVID-19 216 In May 2020, a publication in the New England Journal of Medicine proposed a set of 217 ethical values to underpin recommendations for allocating scarce medical resources during the 218 COVID-19 pandemic (Emanuel et al., 2020).7 Drawing on previous proposals about how to 219 allocate resources during scenarios of absolute scarcity, such as pandemics, the authors identify 220 four fundamental ethical values: (1) maximize benefit, (2) treat people equally, (3) promote and 221 reward instrumental value (i.e., providing benefit to others), and (4) give priority to the worst off. 222 Importantly, the authors maintain that none of these values should be used in isolation to 223 determine the allocation of resources; instead, fair allocation requires a multi-value framework 224 that can be tailored to specific settings and resources. Each of these values could be 225 operationalized in different ways in the context of the COVID-19 pandemic. In a pandemic, the 226 most important ethical value is maximizing benefits of scarce resources, which could aim to save 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). DISCUSSION DRAFT FOR PUBLIC COMMENT 13

227 the greatest number of lives or to save the most life-years (e.g., by prioritizing people with the 228 best prognosis). The authors recommend that both of these factors should receive the highest 229 priority. They suggest that treating people equally would be best operationalized by random 230 selection among people with similar prognoses, because a first-come, first-served system is 231 inappropriate for a pandemic. Instrumental value can be promoted retrospectively by giving 232 priority to people who have saved other’s lives—for example, research participants and health 233 care workers—or prospectively by giving priority to people who are likely to save others in the 234 future, such as health care workers. Giving priority to the worst off could either be 235 operationalized by priority to the sickest patients or to younger patients who stand to lose the 236 most life-years. The authors use these four values to generate six recommendations for fair 237 allocation of resources during the COVID-19 pandemic: 238 239 • To maximize the benefit of limited resources, prioritization should balance two aims: 240 saving the greatest number of lives and maximizing improvements in people’s length of 241 life after treatment. 242 • By virtue of their instrumental value in the pandemic response, health care workers and 243 others who maintain critical infrastructure should be prioritized. 244 • For patients with similar prognoses, equality should be operationalized by random 245 allocation. 246 • Criteria for prioritization should be tailored to the specific resource that is scarce and 247 responsive to changing evidence. 248 • Research participants should be recognized by receiving some priority, but only as a 249 tiebreaker among those with similar prognoses. 250 • The same criteria for allocation should apply to people with and without COVID-19. 251 Ethics of Creating a Resource Allocation Strategy During the COVID-19 Pandemic 252 In a July 2020 article for Pediatrics, a group of bioethicists reviewed the fundamental 253 ethical principles that frequently underpin scarce resource allocation frameworks and interpreted 254 those principles in the context of the COVID-19 pandemic (Laventhal et al., 2020). They found 255 broad agreement that such frameworks should seek to provide “the greatest benefit to the greatest 256 number of individuals while the fewest resources are used” (Laventhal et al., 2020). Systems for DISCUSSION DRAFT FOR PUBLIC COMMENT 14

257 allocation should be fair, transparent, consistently applied, and mindful of socially vulnerable 258 populations without making allocation decisions based solely on sociodemographic factors. 259 Furthermore, allocation frameworks should integrate criteria from across multiple moral 260 dimensions. The authors categorize five principles of allocation drawn from different 261 frameworks with specific relevance to COVID-19: 262 263 1. Allocation frameworks should optimize the likelihood of benefit by allocating 264 resources to those most likely to survive. 265 2. For people with similar likelihood of benefit, resources should be allocated to those 266 with the greatest urgent or acute need. 267 3. Consider the absolute number of people who can be helped by available resources 268 and maximize opportunities to help more people. 269 4. People who perform vital functions (e.g., health care workers, first responders) are 270 prioritized for resource allocation as a tiebreaker in decisions between people with 271 similar likelihood of survival. 272 5. When all other factors are equal, randomization should be used to prioritize the 273 allocation of resources rather than a first-come, first-served process that can 274 compound inequities. 275 276 When creating new resource allocation guidance during the COVID-19 context, the 277 authors suggest the following guiding principles: (1) short-term survival (i.e., survival to 278 discharge) is a reasonable criterion for prioritization; (2) first-come, first-serve systems should 279 not be used to determine who receives scarce resources, and (3) to make decisions between 280 people of equal priority with respect to other factors, people who perform vital functions should 281 be prioritized to receive resources. 282 WHO Policy Brief on Ethics and COVID-19: Resource Allocation and Priority Setting 283 A policy brief by WHO’s Working Group on Ethics and COVID-19 was developed to 284 provide guidance on scarce resource allocation and priority setting, with the caveat that the 285 allocation of different types of resources will likely be ethically justified by different principles 286 or values (WHO Working Group on Ethics and COVID-19, 2020). This brief is distinct from the DISCUSSION DRAFT FOR PUBLIC COMMENT 15

287 WHO’s forthcoming guidance on the allocation of vaccine described in the next section. 288 Broadly, the brief suggests that a fair process for allocating scarce resources should promote 289 certain ethical values, including transparency of allocation decisions and prioritization criteria, 290 inclusiveness of affected groups in the decision making process, consistent treatment of all 291 persons in the same categories, and accountability of decision makers. In making decisions about 292 prioritization, they highlight four key ethical considerations. The principle of equality can be 293 used in allocating scarce resources to individuals or populations expected to derive the same 294 benefit (e.g., to justify a lottery system). The principle of best outcomes (i.e., utility) can guide 295 the allocation of scarce resources according to their potential to maximize good or minimize 296 harm. Maximizing utility should be balanced with the principle of prioritizing the worst off; the 297 latter can be used to justify the allocation to treat those in greatest medical need or protect those 298 at greatest risk. Finally, the principle of prioritizing those “tasked with helping others” can apply 299 to allocating resources to health care workers, for example. In the context of COVID-19 vaccine 300 allocation specifically, the brief recommends prioritizing three categories of individuals or 301 populations, with greater priority for those who are included in multiple categories: (1) people at 302 greatest risk of becoming infected and seriously ill, (2) people who would prevent the greatest 303 spread of the virus if vaccinated, and (3) people who have volunteered to participate in research 304 to develop the vaccine. The first two categories are prioritized to maximize the benefit of the 305 vaccine. The rationale for the third category is “reciprocal obligation to those who were 306 voluntarily put at risk to aid in this effort,” although this group should not be prioritized over 307 those at greatest risk. 308 Nuffield Council on Bioethics Policy Brief on Fair and Equitable Access to COVID-19 309 Treatments and Vaccines 310 The Nuffield Council on Bioethics has developed a policy brief that identifies key factors 311 that determine fair and equitable access to COVID-19 treatments and vaccines (Nuffield Council 312 on Bioethics, 2020). These factors include how research is prioritized and funded; how the 313 burdens and benefits of that research is distributed between low- and high-income countries; 314 structural and health inequalities that pose barriers to access, and public engagement and trust in 315 the development and deployment of treatments and vaccines. In making difficult decisions about 316 the allocation of resources that affect access, the authors suggest hewing to an ethical compass of DISCUSSION DRAFT FOR PUBLIC COMMENT 16

317 three broadly shared values: (1) ensuring equal respect, dignity, and human rights, (2) helping to 318 reduce suffering of those who are sick or otherwise in need, and (3) maintaining fairness through 319 both non-discriminatory treatment of others and equitable distribution of benefits and burdens. 320 Ethical Frameworks for Allocating Scarce In-Patient Treatments for COVID-19 321 After FDA issued an Emergency Use Authorization for the use of the antiviral remdesivir 322 for patients with severe COVID-19 in May 2020, decisions about how to allocate remdesivir 323 have been largely delegated to state health departments. However, many hospitals are operating 324 without clear guidance about how to ethically allocate limited supplies of the medication to 325 eligible patients (White and Angus, 2020). This issue will likely be compounded as more 326 treatments for COVID-19 become available, but demand exceeds supply. In some states, such as 327 New Jersey, advisory committees have recommended that remdesivir should be allocated to 328 eligible patients on a first-come, first-served basis. However, other states and research groups are 329 developing various types of ethical frameworks and policies to guide the fair allocation of scarce 330 medications to treat COVID-19. Many of these allocation plans provide for some type of 331 independent decision maker. Controversy has already emerged around some of these plans— 332 particularly regarding the allocation of ventilators—with regard to their disparate impact based 333 on patients’ race or disability status (Schmidt, 2020; Truog et al., 2020). Some plans have 334 subsequently been revised to address these types of critiques. 335 Minnesota’s Ethical Framework for Distributing Remdesivir 336 In June 2020, the state of Minnesota developed an ethical framework for distributing 337 remdesivir to facilities statewide and for prioritizing specific patients within each facility who 338 are at greatest risk of mortality and serious morbidity, as well as those who would benefit from 339 access to the drug (Lim et al., 2020).8 The framework’s guiding ethical principles are to (1) 340 responsibly allocate the scarce resource to reduce risk while providing benefit, (2) save the most 341 lives possible while respecting rights and fairness, (3) promote the common good through 342 transparency, accountability, and trustworthiness, and (4) use the best available evidence while 343 addressing uncertainty. To ensure that the framework protects the rights and interests of all, the 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). DISCUSSION DRAFT FOR PUBLIC COMMENT 17

344 approach rejected allocation based on race, ethnicity, gender or gender identity, citizenship or 345 immigration status, socioeconomic status, or ability to pay for treatment. Age, disability status, 346 and comorbid conditions are disallowed as criteria unless relevant to clinical prognosis and 347 likelihood of survival. To protect those at greatest risk while also maximizing remdesivir’s 348 benefit, it is allocated to patients based both on need and on likelihood of survival to hospital 349 discharge. The framework focuses on short-term rather than longer-term prognosis to avoid 350 disadvantaging people based on age, comorbid conditions, disabilities, or systemic health 351 inequities. The framework highlights the importance of obtaining patient consent, because 352 remdesivir was not FDA approved when the framework was developed and the drug has the 353 potential to cause serious adverse events. It is important to note that this framework is a living 354 document that will likely be updated as better data are available to guide the use of remdesivir. 355 Pennsylvania’s Weighted Lottery System for Allocating Scarce Medications for COVID-19 356 The Commonwealth of Pennsylvania has endorsed a weighted lottery system for ethically 357 allocating medications for COVID-19 to eligible patients in cases of shortage. This lottery 358 system is part of a model hospital policy,9 developed by a multidisciplinary team at the 359 University of Pittsburgh, which is guided by the ethical duties to steward scarce resources in the 360 interest of public health and to mitigate the impact of social inequities on COVID-19 outcomes 361 in disadvantaged communities. This model policy recommends that hospitals create an allocation 362 team to unburden treating clinicians of the responsibility and potential moral distress of making 363 decisions about the allocation of scarce medications to their patients. The weighted lottery 364 system is designed to fairly allocate the supply of a medication for treating COVID-19 if it is 365 insufficient for the number of eligible patients, with certain groups receiving heightened priority: 366 (1) individuals who reside in disadvantaged areas, as defined by an address with an Area 367 Deprivation Index score of 8–10; and (2) individuals who are essential workers, as defined by the 368 state’s list of businesses required to continue physical operations during the pandemic. The latter 369 group includes health care workers, but also lower-paid workers who tend to be socially and 370 economically vulnerable (e.g., people employed in grocery stores, public transportation, 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). DISCUSSION DRAFT FOR PUBLIC COMMENT 18

371 agriculture, and custodial work). Individuals who are expected to die within a year from an end- 372 stage condition are not excluded from the lottery but receive lower priority than individuals 373 without such conditions. Others have argued that lottery systems to allocate scarce medications 374 for COVID-19 should be centralized and run by state health departments—rather than by 375 individual hospitals—in order to expedite distribution and allow for the collection of larger 376 volumes of pooled clinical data about the effectiveness of remdesivir or other scarce medications 377 (White and Angus, 2020). 378 Ethical Framework for Allocating Therapies to Hospitalized Patients with COVID-19 379 Another ethical framework for allocating scarce inpatient medications for COVID-19 was 380 developed by a group at the University of California, San Francisco, in May 2020. This 381 framework was developed as a practical guide for clinicians and health care facilities faced with 382 decisions about how to ethically allocate therapies to hospitalized patients with COVID-19, 383 including existing therapies such as remdesivir, as well as novel treatments under development 384 (e.g., monoclonal antibodies) (DeJong et al., 2020). The aims of this framework are to maximize 385 benefit to patients, mitigate disparities, adhere to ethical principles, and revise allocation policies 386 as more evidence becomes available. The guiding ethical principles of this framework are that 387 reducing mortality provides benefit to the community as a whole and benefit should be assessed 388 using the best available evidence. The framework holds that during a shortage, medications 389 should be prioritized for indications with demonstrated efficacy and safety, ideally from 390 randomized controlled trials. Patient preferences should be respected to the extent that the drug 391 supply allows, and scarce medications should be allocated in a way that is fair, avoids 392 discrimination, and mitigates health disparities. Allocation policies should be made transparent, 393 accountable, responsive to the concerns of the affected population, and proportionate to the 394 epidemiological situation and the drug supply relative to need. Prioritization in this framework 395 does not exclude people based on age, disability, religion, race or ethnicity, national origin, 396 gender, sexual orientation, or perceived quality of life or comorbid conditions. Random 397 allocation (e.g., lottery) is deemed the fairest way to allocate scarce supplies among eligible 398 patients—although workers in essential jobs may be assigned some priority—because a “first- 399 come, first-serve” system is not random and puts people who face barriers to care at a 400 disadvantage. An additional advantage of random lottery system is the potential for knowledge DISCUSSION DRAFT FOR PUBLIC COMMENT 19

401 generation, because a randomized sample could potentially be used to causally evaluate the 402 effect of being vaccinated on relevant outcomes. The authors also outline five goals that can be 403 derived from the ethical framework for allocating scarce therapies for COVID-19: (1) to save the 404 most lives in the short/near term, with additional goals of preventing new cases and reducing the 405 durations of hospitalization and mechanical ventilation; (2) to decrease disparities in COVID-19 406 case-fatality proportions that disproportionately affect racial and ethnic minority communities; 407 (3) to strengthen the community’s pandemic response ability; (4) to preserve a supply of existing 408 medications for non-COVID-19 indications that patients with chronic conditions may depend on; 409 and (5) to reserve enough of the therapy to conduct RCTs and develop a stronger evidence base 410 for effective therapies. 411 BOX 2 Guiding Principles from Allocation Frameworks Developed for the COVID-19 Pandemic • Ensure that allocation maximizes benefit to patients, mitigates inequities and disparities, and adheres to ethical principles. • Promote the common good through fairness, transparency, accountability, and trustworthiness. • Save the greatest number of lives possible—while respecting rights and fairness—to maximize benefit to the community as a whole. • Use the best available evidence to assess benefit to communities and address uncertainty. • Allocate scarce resources responsibly to reduce risk while providing benefit. • Provide clear and transparent criteria for prioritization strategies. • Ensure that allocation policies are flexible, responsive to the concerns of the affected population, and proportionate to the epidemiological situation and the vaccine supply relative to need. 412 Allocation Frameworks Developed for Vaccine Allocation During the COVID-19 Pandemic 413 This section outlines ethical frameworks developed specifically for vaccine allocation 414 during the COVID-19 pandemic, including an interim framework developed by a group at Johns DISCUSSION DRAFT FOR PUBLIC COMMENT 20

415 Hopkins University and forthcoming efforts from WHO and CDC. Table 1 summarizes the 416 goals, ethical principles, and prioritization approaches of these vaccine-specific allocation 417 frameworks. It is important to note that these frameworks were developed in the context of 418 rapidly changing goals for vaccination (e.g., as schools began to reopen in August 2020) and 419 evolving data about the SARS coronavirus 2 (SARS-CoV-2) virus and vaccine candidates. 420 Interim Framework for COVID-19 Vaccine Allocation and Distribution in the United States 421 In August 2020, Johns Hopkins University’s Center for Health Security released an 422 interim framework for COVID-19 vaccine allocation and distribution in the United States that is 423 framed by three broad ethical values: (1) promoting the common good, (2) treating people fairly 424 and equally, and (3) promoting legitimacy, trust, and sense of ownership in a pluralistic society. 425 In this framework, the ethical value of promoting the common good includes the more specific 426 ethical principles of promoting public health (e.g., preventing illness and death and protecting 427 health systems) as well as promoting economic and social well-being, which includes protection 428 of essential services, supporting economic activity, and enabling children to return to school and 429 childcare. Ethical principles falling under the broader value of treating people fairly and 430 equitably include addressing background and emerging inequities experienced by disadvantaged 431 and marginalized groups, giving priority to the worst off people at greatest risk of severe illness 432 and death, and ensuring reciprocity to protect those who provide essential services and advance 433 the development of treatments and vaccines. The third ethical value calls for respecting the 434 diversity of views in a pluralistic society and engaging with communities to strengthen vaccine 435 campaigns. Based on this ethical foundation, the framework suggests that the following groups 436 should be candidates for high priority access to scarce vaccine, including provisional examples 437 of the groups in each tier. 438 Tier 1 priority groups include: 439 440 • Those most essential in sustaining the ongoing COVID-19 response (e.g., frontline 441 health workers, emergency services personnel, and public health workers; pandemic 442 vaccine manufacturing and supply chain personnel; COVID-19 diagnostic and 443 immunization teams) DISCUSSION DRAFT FOR PUBLIC COMMENT 21

444 • Those at greatest risk of severe illness and death, and their caregivers (e.g., adults 445 aged ≥65 years; others at elevated risk of serious COVID-19 and complications; 446 frontline long-term care providers and health care workers providing direct care to 447 patients with high-risk conditions) 448 • Those most essential to maintaining core societal functions (e.g., workers in frontline 449 public transport, food supply, and schools) 450 451 Tier 2 priority groups include: 452 453 • Those involved in broader health provision (e.g., health workers and staff with direct 454 but non-COVID-19-specific patient contact; pharmacy staff) 455 • Those who face greater barriers to access care if they become seriously ill (e.g., 456 people living in remote locations with substandard infrastructure and health care 457 access) 458 • Those contributing to maintenance of core societal functions (e.g., frontline 459 infrastructure workers who cannot work remotely; warehouse and delivery workers; 460 deployed military involved in operations; police and fire personnel with frequent 461 public contact; Transportation Security Administration and border security personnel 462 with direct public contact) 463 • Those whose living or working conditions give them elevated risk of infection, even 464 if they have lesser or unknown risk of severe illness and death (e.g., people who are 465 unable to maintain safe physical distance in their home or work environments, 466 including people living in shelters, people who are incarcerated, and people who work 467 in prisons) 468 Multi-Value Ethical Framework for Fair Global Allocation of a COVID-19 Vaccine 469 A group of authors from Vanderbilt University have developed a multi-value ethical 470 framework for fair global allocation of a COVID-19 vaccine to different countries by analyzing DISCUSSION DRAFT FOR PUBLIC COMMENT 22

471 four types of allocation paradigms10 and synthesizing their ethical principles into a model for the 472 COVID-19 pandemic (Liu et al., 2020). To promote fair vaccine allocation across countries of 473 different resource levels, the authors propose stratifying countries into groups for prioritization 474 based on three guiding ethical principles: (1) ability to provide care, (2) ability to implement, and 475 (3) reciprocity. The rationale for the first principle is that vaccines are the only effective 476 intervention in low-income countries lacking in capacity to treat people with severe COVID-19, 477 so those countries should receive priority. The rationale for the second principle is that vaccines 478 should not be allocated if they cannot be used, so low-income countries’ capacities for 479 distribution and implementation should be supported. The third principle, reciprocity, prioritizes 480 countries based on their level of contribution and participation in developing and testing 481 vaccines. 482 WHO’s Ongoing COVID-19 Vaccine Allocation Efforts 483 WHO has several related global planning efforts under way for vaccine allocation, 484 including COVAX, guiding principles for immunization activities during the COVID-19 485 pandemic, and a global framework to ensure equitable and fair allocation of COVID-19 486 products, including vaccines (see Table 1). COVAX11 is the vaccines pillar of the Access to 487 COVID Tools Accelerator,12 a global initiative bringing together governments, health 488 organizations, scientists, businesses, civil society, and philanthropists to accelerate the 489 development and deployment of the key countermeasures needed to respond to the COVID-19 490 pandemic, including COVID-19 tests, therapeutics, and vaccines. The COVAX pillar’s primary 491 goal is to accelerate the development and manufacture of vaccines and ensure equitable access 492 worldwide. COVAX is co-led by the Global Alliance for Vaccines and Immunizations (GAVI), 493 the Coalition for Epidemic Preparedness Innovations (CEPI), and WHO. As of August 19, 2020, 494 GAVI, CEPI, and WHO were seeking representatives from civil society and community 10 The allocation paradigms considered include a country’s ability to develop or purchase vaccine, reciprocity in prioritizing countries that contribute samples or have participants in research trials, countries’ ability to deploy vaccine to its population, and distributive justice for developing countries. 11 More information about COVAX is available at https://www.who.int/initiatives/act-accelerator/covax (accessed August 25, 2020). 12 More information about the Access to COVID Tools Accelerator is available at https://www.who.int/initiatives/act- accelerator#:~:text=The%20Access%20to%20COVID%2D19%20Tools%20(ACT)%20Accelerator%2C,tests%2C %20treatments%2C%20and%20vaccines (accessed August 25, 2020). DISCUSSION DRAFT FOR PUBLIC COMMENT 23

495 organizations (CSOs) to participate in COVAX and help to foster the necessary support at both 496 political and community-engagement levels to ensure equitable access and delivery of future 497 COVID-19 vaccines.13 The plan is for these CSOs to advocate for civil society and community 498 perspectives and help build public trust and capacity across health care systems for COVID-19 499 vaccination programs. 500 Within the COVAX pillar,14 CEPI is leading the development and manufacturing of a 501 portfolio of vaccine development partnerships. GAVI is leading the work on global procurement 502 and financing through the COVAX Facility, which is designed to provide all countries with an 503 opportunity to participate in securing initial access to vaccine supply sufficient to cover 20 504 percent of their populations (per WHO’s allocation guidance). WHO leads the efforts pertaining 505 to policy and vaccine allocation guidance, which informs the COVAX Facility’s procurement 506 schemes. As of August 2020, WHO was working with its member states and the Strategic 507 Advisory Group of Experts—which is the apical vaccine advisory body within WHO—to 508 finalize the allocation framework for distribution of vaccines from COVAX between countries. 509 The Strategic Advisory Group of Experts (SAGE) on Immunization, was established to serve as 510 WHO’s principal advisory group on global policies and strategies for immunization and its link 511 to other health interventions for all vaccine-preventable diseases. Their preliminary estimate is 512 that distribution of enough vaccines for 20 percent of the population should be sufficient for each 513 member state to immunize frontline health care workers, other essential workers, older adults, 514 and those with significant comorbidities that increase the risk of serious COVID-19 illness in 515 most countries. The current plan is to initially distribute enough vaccine for countries to cover 3 516 percent of their respective populations, followed by vaccine to cover the additional 17 percent of 517 the populations later. Within-country allocation decisions remain under the authority of each 518 individual Member State. However, WHO/SAGE is developing an interim guidance on guiding 519 principles for immunization activities during the COVID-19 pandemic, which is a values 13 See https://www.who.int/news-room/articles-detail/covax-seeks-civil-society-representatives-to-contribute-to- ensuring-equitable-global-access-to-covid-19-vaccines (accessed August 25, 2020). 14 Background information on the COVAX pillar is available at https://www.gavi.org/sites/default/files/covid/COVAX-Pillar-background.pdf (accessed August 13, 2020). DISCUSSION DRAFT FOR PUBLIC COMMENT 24

520 framework for within-country prioritization and other country-level decision making related to 521 the provision of COVID-19 immunization.15 522 WHO’s global framework to ensure equitable and fair allocation of COVID-19 products 523 aims to reduce mortality due to COVID-19, protect health systems, improve the well-being of 524 populations, and reduce the impact of the pandemic on societies and economies.16 The 525 framework has prioritized three populations: (1) health care system workers, who represent about 526 1 percent of the global population (50 million people) and would require about 115 million 527 doses;17 (2) adults aged ≥65 years, who represent roughly 8 percent of the population (650 528 million people) and would requires about 1,500 million doses; and (3) other high-risk adults, 529 who represent about 15 percent of the population (around 1.15 billion people) and would require 530 about 2.65 billion doses. Additional prioritized groups would be based on risk assessment of the 531 country’s vulnerability and an estimated burden or threat of COVID-19. The guiding principles 532 of the WHO allocation framework include transparency, ethical values, public health needs, 533 collaboration with stakeholders, flexible and robust regulatory approaches, good governance and 534 the “open scientific collaboration, transparency, and sharing of data and biological samples” that 535 will be critical to the success of global vaccination efforts (Bollyky et al., 2020). Although WHO 536 has shared the forthcoming framework’s overarching principles for allocating COVID-19 537 products, its detailed ethical justification for the vaccine allocation guidance had not yet been 538 shared as of August 2020. 539 CDC’s Ongoing COVID-19 Vaccine Allocation Efforts CDC’s ACIP is currently 540 developing a plan for the allocation of COVID-19 vaccine in the United States. As a CDC 541 federal advisory committee, ACIP provides recommendations on the use of vaccines in the 542 United States civilian population and provides guidance on the optimal use of vaccines for the 543 CDC and the Secretary of HHS. ACIP does not traditionally play a role in implementation (Lee 15 WHO’s interim guidance on guiding principles for immunization activities during the COVID-19 pandemic (updated March 26, 2020) is available at https://www.who.int/publications/i/item/guiding-principles-for- immunization-activities-during-the-covid-19-pandemic-interim-guidance (accessed August 13, 2020). 16 The WHO Member States Briefing on a global framework to ensure equitable and fair allocation of COVID-19 products and potential implications for COVID-19 vaccines (June 18, 2020) is available at https://apps.who.int/gb/COVID- 19/pdf_files/18_06/Global%20Allocation%20Framework.pdf?utm_source=POLITICO.EU&utm_campaign=18fd11 8248-EMAIL_CAMPAIGN_2020_06_22_04_52_COPY_01&utm_medium=email&utm_term=0_10959edeb5- 18fd118248-189787901 (accessed August 13, 2020). 17 The estimates of doses needed to vaccinate in this framework assume two doses per person and a 15 percent wastage rate. DISCUSSION DRAFT FOR PUBLIC COMMENT 25

544 et al., 2020). An ACIP COVID-19 Vaccine Workgroup was established in April 2020 to provide 545 overarching guidance and vaccine-specific recommendations to CDC. The workgroup will 546 evaluate available evidence and make recommendations, evaluate the likelihood that vaccines 547 will reduce COVID-19 transmission, morbidity and mortality, and minimize disruption to 548 society, and explore approaches to ensure equity in allocation. The ACIP workgroup has 549 established three guiding principles to inform decision making: (1) safety, (2) diversity in clinical 550 trials, which is necessary for diversity in vaccine allocation, and (3) efficient and equitable 551 vaccine distribution. ACIP focuses on vaccine recommendations, rather than implementation; the 552 latter will depend on partnerships with state and local public health entities. During their initial 553 deliberations, proposed groups for prioritized allocation included health care workers, essential 554 workers, adults aged ≥65 years, long-term care facility residents, and persons with high-risk 555 medical conditions (Splete, 2020). More information about ACIP’s efforts is provided in Table 1 556 below. DISCUSSION DRAFT FOR PUBLIC COMMENT 26

557 DRAFT TABLE 1 Overview of Ongoing COVID-19 Vaccine Allocation Efforts (To be updated as more information becomes 558 available.) Effort Leaders Goals Guiding Principles Prioritized Groups COVAX WHO • Provide a process mechanism for • Mitigate economic damage. Groups likely to be CEPI between-country coordination • Accelerate availability of vaccine. prioritized in first round of GAVI and allocation. • Ensure globally fair allocation and access for vaccination: • Offer advance purchase Low- and Middle- Income Countries. 1. Health care system agreements to vaccine candidates workers meeting technical threshold 2. Adults aged ≥65 years criteria. 3. Other high-risk adults with underlying conditions (e.g., hypertension, diabetes) Guiding WHO • Provide a values framework for • Ensure continuity of routine immunization principles for SAGE within-country prioritization and services during the COVID-19 pandemic immunization decision making about (where feasible) to prevent outbreaks of activities during immunization services. vaccine-preventable diseases. the COVID-19 pandemic Global WHO • Ensure equitable and fair • Reduce COVID-19 mortality and protect health 1. Health care workers Allocation allocation of COVID-19 systems to improve population well-being and 2. Adults aged≥65 years Framework for products. reduce societal and economic impact. 3. Other high-risk adults COVID-19 • Issue policy recommendations to • Ensure flexibility to adapt to each new product, Products inform optimal use of scarce evolving epidemiology, and risk. resources as more product- • Use transparent criteria for allocating doses as specific information becomes they become available. available. ACIP COVID- ACIP • Develop plan for allocation of • Monitor effectiveness and safety in real time to 19 Vaccine vaccine in the United States revise recommendations based on the Workgroup risk/benefit balance in different populations. • Ensure diversity in vaccine clinical trials to ensure that recommendations are based on safety and efficacy data across all populations who may benefit. DISCUSSION DRAFT FOR PUBLIC COMMENT 27

• Distribute vaccines efficiently and equitably; avoid compounding inequities and disparities. Interim Johns • Provide an interim framework for • Promote the common good Tier 1: Framework for Hopkins COVID-19 vaccine allocation • Treat people fairly and equally • Those most essential in COVID-19 Center and distribution in the United • Promote legitimacy, trust, and sense of sustaining the ongoing Vaccine for States ownership in a pluralistic society COVID-19 response Allocation in the Health • Those at greatest risk of United States: Security severe illness and death, Assisting Policy and their caregivers Maker, • Those most essential to Stakeholder and maintaining core societal Public functions Deliberation Tier 2: • Those involved in broader health provision • Those who face greater barriers to access care if they become seriously ill • Those contributing to maintenance of core societal functions • Those whose living or working conditions give them elevated risk of infection, even if they have lesser or unknown risk of severe illness and death 559 DISCUSSION DRAFT FOR PUBLIC COMMENT 28

560 REFERENCES 561 562 Bollyky, T. J., L. O. Gostin, and M. A. Hamburg. 2020. The equitable distribution of COVID-19 563 therapeutics and vaccines. JAMA 323(24):2462-2463. 564 CDC (Centers for Disease Control and Prevention). 2019. Roadmap to implementing pandemic influenza 565 vaccination of critical workforce. 566 Costa, A. n.d. Development of an operational plan for distribution of ebola vaccines. 567 Dada, S., G. McKay, A. Mateus, and S. Lees. 2019. Lessons learned from engaging communities for 568 Ebola vaccine trials in Sierra Leone: Reciprocity, relatability, relationships and respect (the four 569 R’s). BMC Public Health 19(1):1665. 570 DeJong, C., A. H. Chen, and B. Lo. 2020. An ethical framework for allocating scarce inpatient 571 medications for COVID-19 in the US. JAMA 323(23):2367-2368. 572 Emanuel, E.J., et al. 2020. Fair allocation of scarce medical resources in the time of COVID-19. New 573 England Journal of Medicine 382:2049-2055. 574 Essien, U. R., N. D. Eneanya, and D. C. Crews. 2020. Prioritizing equity in a time of scarcity: The 575 COVID-19 pandemic. Journal of General Internal Medicine 1-3. 576 GAO (U.S. Government Accountability Office). 2011. Lessons from the H1N1 pandemic should be 577 incorporated into future planning. Report to Congressional Requesters. 578 Gostin, L. O. 2014. Ethical allocation of drugs and vaccines in the West African Ebola epidemic. The 579 Milbank Quarterly 92(4):662-666. 580 IOM (Institute of Medicine). 2010. The 2009 H1N1 influenza vaccination campaign: Summary of a 581 workshop series. Washington, DC: The National Academies Press. 582 Laventhal, N., et al. 2020. The ethics of creating a resource allocation strategy during the COVID-19 583 Pandemic. Pediatrics 146(1):e20201243. 584 Lee, G. M., B. P. Bell, and J. R. Romero. 2020. The advisory committee on immunization practices and 585 its role in the pandemic vaccine response. JAMA 324(6):546-547. 586 Lim, S., D. DeBruin, J. Leider, N. Sederstrom, R. Lynfield, J. Baker, S. Kline, S. Kesler, S. Rizza, J. Wu, 587 R. Sharp, and S. Wolf. 2020. Developing an ethics framework for allocating remdesivir in the 588 COVID-19 pandemic. Mayo Clinic Proceedings. 589 Litaker, J., D. Stabeno, M. McGlothlin, J. Chou, and M. Ramon. 2010. Response to the novel H1N1 590 pandemic influenza (2009 and 2010): Final report to the Texas Department of State Health 591 Services. 592 Nuffield Council on Bioethics. 2020. Rapid policy brief: Fair andequitable access to COVID-19 593 treatments and vaccines. https://www.nuffieldbioethics.org/assets/pdfs/Ethical-considerations-in- 594 responding-to-the-COVID-19-pandemic.pdf (accessed August 25, 2020). 595 Persad, G., A. Wertheimer, and E. J. Emanuel. 2009. Principles for allocation of scarce medical 596 interventions. Lancet 373(9661):423-431. doi: 10.1016/S0140-6736(09)60137-9. 597 Rambhia, K. J., M. Watson, T. K. Sell, R. Waldhorn, and E. Toner. 2010. Mass vaccination for the 2009 598 h1n1 pandemic: Approaches, challenges, and recommendations. Biosecurity and Bioterrorism: 599 Biodefense Strategy, Practice, and Science 8(4):321-330. 600 Schmidt, H. 2020. The way we ration ventilators is biased. The New York Times, April 15. 601 Straetemans, M., U. Buchholz, S. Reiter, W. Haas, and G. Krause. 2007. Prioritization strategies for 602 pandemic influenza vaccine in 27 countries of the European Union and the Global Health 603 Security Action Group: A review. BMC Public Health 7:236-236. 604 Truog, R. et al. 2020. The toughest triage—allocating ventilators in a pandemic. New England Journal of 605 Medicine 382:1973-1975. 606 White, D. B., and D. C. Angus. 2020. A proposed lottery system to allocate scarce COVID-19 607 medications: Promoting fairness and generating knowledge. JAMA 324(4):329-330. DISCUSSION DRAFT FOR PUBLIC COMMENT 29

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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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