Allocating pandemic influenza vaccines in Minnesota: Recommendations of the Pandemic Influenza Ethics Work Group

Vaccine 25 (2007) 6522–6536

Allocating pandemic influenza vaccines in Minnesota: Recommendations of the Pandemic Influenza Ethics Work Group Dorothy E. Vawter 1 , Karen G. Gervais 2 , J. Eline Garrett ∗ Minnesota Center for Health Care Ethics, 601 25th Avenue S, Minneapolis, MN 55454, United States Received 9 March 2007; received in revised form 21 May 2007; accepted 24 May 2007 Available online 14 June 2007

Abstract A public–private, multidisciplinary work group developed recommendations for rationing vaccines in Minnesota during a worst-case influenza pandemic. The recommendations encompass an ethical framework of principles, goals, and strategies. The primary goal is to maximize Minnesotans’ chances of surviving both the pandemic and the years immediately thereafter and to limit two major causes of death: (a) influenza and complications of influenza, and (b) disruption of basic health care, public health, and public safety infrastructures. The work group also developed a sample rationing plan, but stressed that any final plan must reflect the best available evidence during an actual pandemic. © 2007 Elsevier Ltd. All rights reserved. Keywords: Pandemic influenza; Vaccines; Rationing; Ethics

1. Introduction The looming threat of pandemic influenza (a worldwide outbreak of a highly contagious lethal respiratory virus) has led to the development of many plans for pandemic preparedness and response—international, national, state, and local. While health experts warn that influenza pandemics are inevitable, the actual severity of the next pandemic is not known, nor can we know when it will occur. What we do know is that pandemics happen. Deciding not to prepare is not a viable option. The last century saw three influenza pandemics—in 1918–1919, 1957, and 1968. The moderate pandemics of 1957 and 1968 resembled exaggerated versions of typical, annual influenza epidemics [1]. The pandemic of 1918–1919 was dramatically different from the other two because of its significant mortality rate, which triggered massive social and ∗

Corresponding author. Tel.: +1 651 690 7719; fax: +1 651 690 7774. E-mail addresses: [email protected] (D.E. Vawter), [email protected] (K.G. Gervais), [email protected] (J.E. Garrett). 1 Tel.: +1 651 690 7897; fax: +1 651 690 7774. 2 Tel.: +1 651 690 7896; fax: +1 651 690 7774. 0264-410X/$ – see front matter © 2007 Elsevier Ltd. All rights reserved. doi:10.1016/j.vaccine.2007.05.057

economic change and degradation [2]. Twice as many people died of influenza than on World War I’s battlefields [3,4]. In New York City alone, 21,000 children were left orphaned [5]. Most notably, the disease struck those who were hardiest: healthy young adults whose immune systems fatally overresponded [6,7]. Normal business operations were crippled. Distribution of essential goods and services were interrupted or completely halted at times [3]. Both moderate and worst-case pandemic influenza preparedness plans promote particular balances of the interests of individuals and society and are thoroughly value-laden. If we envision the next pandemic as a modern version of a worst-case, 1918-type pandemic—which some predict—what ethical principles should guide our preparations? How shall we distribute scarce health care and public health resources among us? Should some individuals and some groups have prioritized access to resources? If so, why? Though there is no single ethical framework for responding to large-scale public health disasters [8–10], can Minnesotans agree on an ethical framework for rationing vaccines in a worst-case pandemic? Remarkably, few plans focus on worst-case pandemics (see [1,11–13]) or provide much in the way of ethical

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rationale to support their recommendations. If decisionmakers are to have a stable guide for weighty decisions during pandemic, frameworks for ethically informed decisionmaking must be agreed upon in advance. Such frameworks need to be developed with informed public input. Public involvement is a prerequisite for the public to trust the framework and its associated plan, and to have a worthy basis for complying.

2. Process In December 2005 the Minnesota Center for Health Care Ethics convened the Pandemic Influenza Ethics Work Group, a multidisciplinary group of approximately 35 people interested in providing ethical guidance for Minnesota’s statewide pandemic planning efforts. Together, work group members had extensive expertise and experience in • • • • • • • • •

health care ethics and public health ethics; public health; infectious disease; health system, health plan, and academic administration; spiritual health and faith-health collaborations; health journalism; health care economics; health law; community service.

Invitations to participate in the work group went out to a community-wide spectrum of health system and community stakeholders, who then self-selected based on their willingness to process the value choices inherent in the public health crisis of an influenza pandemic. Participants were not asked to represent or bind their respective organizations. Pandemic response requires clarity on how to allocate different kinds of scarce resources [14]. The work group chose to focus on allocating vaccines in Minnesota during a worstcase, 1918-type of influenza pandemic because: • vaccines are the public health gold standard for preventing and containing disease; • demand for vaccines is expected to vastly outstrip supply; • the ethical issues about allocating scarce vaccines are in the sharpest relief in a worst-case pandemic; • allocating scarce vaccines in a worst-case influenza pandemic has been under analyzed in publicly available pandemic plans and scholarly articles; • the federal plan calls for states to develop vaccine allocation plans [1]; and • the sensitive issue of rationing, i.e., deciding which groups of Minnesotans will and will not have access to vaccines when there are insufficient vaccines for all who could benefit, requires broad stakeholder input, which the work group could initiate. The work group agreed to develop an ethical framework comprising principles, goals, and strategies to guide

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the allocation of vaccines for the period when vaccines are anticipated to be first available, i.e., beginning in month six of phase six of the pandemic. (The World Health Organization defines the sixth phase as “increased and sustained transmission in the general population [15].”) The work group’s reflections were enhanced by extensive mutual education. The members learned from one another about a wide range of topics, including influenza, the 1918–1919 pandemic, vaccines, high-risk populations, infrastructure and operational issues, and individual and community values. Proposals to the work group also were informed by our review of the literature (on public health disasters, previous pandemics, the SARS outbreak, rationing, triage, and public health ethics) and vaccine allocation plans for moderate influenza pandemics, among them: • the World Health Organization’s Global Influenza Preparedness Plan [15]; • the Canadian Pandemic Influenza Plan [16]; • the US Department of Health and Human Services’ Pandemic Influenza Plan [1]; and • the draft California Pandemic Influenza Preparedness and Response Plan [12]. Using audience response technology—computerized keypads to enable voting—work group members ranked the following list of potential goals for a vaccine allocation plan: • prevent geographic spread of influenza through strategic use of vaccine; • minimize serious, chronic influenza-related morbidity and number of deaths from influenza; • minimize severe social disruption immediately and minimize long-term social impact; • minimize severe economic hardship; • maximize number of life-years saved; • minimize the number of persons who contract influenza; • grant everyone lacking immunity an equal chance to be vaccinated; and • incent essential workers to report to work. While ranking the goals, participants were instructed to adopt an ethics perspective, to think of the goals as guiding a vaccination allocation strategy under conditions of extreme scarcity, to consider the goals relative to the pursuit of the common good for Minnesota, and to think realistically. Little could be concluded from this initial exercise except that minimizing severe economic hardship was ranked lowest of the goals. We then drafted several extreme model frameworks for rationing vaccine. Each model framework centered on a different ethical commitment and outlined the principles, goals, and strategies that follow. The model frameworks focused on medical need, minimizing mortality, social and economic stability, equal access, and a blend of multiple ethical commitments. They provided common ground for the work group’s discussions. The concrete thinkers could work from the more concrete implications and strategies to the ethical princi-

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ples. The more conceptual thinkers could work from the ethical principles to strategies and implications. Group reflection on the model frameworks’ strengths and weaknesses led to the recommended ethical framework that is reported below. The work group met five times over the course of 3 months, and the smaller ethics subgroup (formed from work group members for in-depth processing of the work group’s ideas) met regularly between meetings of the larger group. The initial product is this report, comprising (1) a recommended ethical framework to guide a vaccine rationing plan for Minnesota in a worst-case influenza pandemic, as well as (2) a sample vaccine rationing plan.

3.

4.

3. Work group’s assumptions about pandemic influenza and vaccines Pandemic vaccine allocation plans vary in their underlying assumptions about: (1) whether the pandemic will be mild, moderate, or severe, and which demographic groups will have the greatest risk of influenza-related mortality; (2) what the supply and availability of pandemic vaccines will be, for which groups influenza vaccines will be most effective, and whether vaccines can be used to contain the pandemic; and (3) what information will be available about who is at risk, who can benefit from vaccine, and other operational matters. The work group concluded that there is no one-size-fits-all ethical framework for vaccine allocation plans for mild, moderate, and worst-case pandemics. Such plans and the ethical frameworks supporting them must be context specific. So, articulating the underlying assumptions is crucial. We explicitly state our assumptions about the pandemic, vaccines, and operational matters so that in the event that they fail to fit our next influenza pandemic, those in charge of deciding how to allocate vaccines can adjust the strategies. In each of the sections below, we number the list of assumptions for the reader’s convenience. The numbers do not imply priority. For example, assumption 1 is not more important than assumption 2 or 3 in any of these lists.

5.

6.

7. 8.

ate pandemics. (The case-fatality rate is the number of persons contracting the disease who die.) Over the two-year course of the pandemic, the number of persons who will become ill, need various health care services, and die from influenza and its complications will be as shown in Table 1. Deaths will be concentrated in an unusually young and healthy group, that is, in persons 15–40 years old [7,17,18]. The disease poses very high mortality risks for those with the most robust immune systems. Essentially, their healthy immune systems often overrespond to the disease, with fatal results [7,19]. As with routine influenza outbreaks, the disease will also strike hard the very young and very old, often inducing severe pneumonia. Thus, the disease will present a W-shaped, age-specific mortality curve with peaks of mortality among very young children, young adults, and the elderly [18] (see Fig. 1). The case-fatality rate for pregnant women will range from 23 to 71% (averaging 50%), with mortality risk increasing during the course of the pregnancy [20]. One-third of Minnesotans will become infected; the percentage of health care workers and first responders that will become infected could be much higher. Nevertheless, in accord with assumption 2 above, more than 97% of people with clinically reported influenza will survive [21]. Patients will vary in their response to the disease, with some becoming ill and never fully recovering. Most patients, however, will be ill for approximately 2 weeks, experiencing a 3–5-day fever followed by complete recovery [22]. Those who contract the disease and survive will develop natural immunity [23]. Persons who become ill may shed virus and transmit infection for up to one day before the onset of symptoms. Viral shedding and the risk of transmission will be

3.1. Assumptions about the influenza pandemic The work group decided that its ethical framework would be most useful if it was based on a worst-case scenario, i.e., a pandemic like the one in 1918–1919. 1. A pandemic virus equivalent in pathogenicity to the virus of 1918–1919 will kill more than 100 million people worldwide [7]. 2. The disease will be exceptionally virulent. In the US an aggregate, case-fatality rate of 2.0–2.5% will occur, compared to less than 0.1–0.2% in moderate influenza pandemics like those occurring in 1957 and 1968 [17,18]. Thus, the case-fatality rate of a worst-case pandemic will be as much as 25 times the rate suffered during moder-

Fig. 1. 1918 Pandemic influenza and pneumonia mortality rates. “U-” and “W-” shaped combined influenza and pneumonia mortality, by age at death, per 100,000 persons in each age group, United States, 1911–1918. Influenzaand pneumonia-specific death rates are plotted for the interpandemic years 1911–1917 (dashed line) and for the pandemic year 1918 (solid line) [18].

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Table 1 Number of persons who will become ill, need various health care services, and die from influenza and its complications during a worst-case pandemica

Total population (2004 estimates) Illness Outpatient medical care Hospitalization ICU care Mechanical ventilation Deaths Case-fatality rate

US

Minnesota

293,655,404 90 million (30% of population) 45 million (50% of those with flu) 9.9 million 1.48 million 742,500 1.9 million 2.1%

5,145,106 1,544,000 (30% of population) 772,000 (50% of those with flu) 172,000 25,700 12,900 32,900 2.1%

a Minnesota Department of Health. Pandemic Influenza Plan: All-Hazards Response and Recovery Supplement Draft Version 2.5. April 2006. (Accessed February 27, 2007, at http://www.health.state.mn.us/divs/idepc/diseases/flu/pandemic/plan/mdhpanfluplan.pdf.).

greatest during the first two days of symptoms, although the transmission risk remains for five days following first symptoms. Children usually shed the greatest amount of virus and therefore pose significant risk for transmission. On average, infected persons will transmit infection to approximately two other people [1]. 9. The pandemic will last approximately two years, with three waves of disease during the pandemic’s course, each wave lasting 2–3 months [24]. 10. Worst-case pandemics—which have W-shaped, rather than U-shaped, age-specific mortality curves (see assumption 4 above and Fig. 1)—cause significant social and economic disruptions and have the potential to cripple essential health care, public health, and public safety infrastructures. The nature, duration, and magnitude of the disruptions distinguish worst-case pandemic influenza from other public health emergencies. The US gross domestic product will drop about 4.5–5.5% in a year [25,26]. Supply chains and trade will be disrupted in the face of voluntary and mandated travel restrictions [25–27]. Demand for medical services, drugs, and other products will surge, leading to dramatic shortages [17,25,26]. Morgue and mortuary services will be overwhelmed [1]. Breakdowns in public order should be expected [28]. 3.2. Assumptions about vaccines The work group decided that the ethical framework would be most useful if it assumed that vaccines were in short supply. Thus, the vaccine assumptions are not worst-case. (If they were worst-case, there would be no vaccines available and no rationing decisions to make.) 1. When the influenza pandemic first reaches the stage of increased and sustained transmission in the general population (WHO pandemic phase six) [15], there will be no vaccines against the specific strain of influenza. Vaccines will not become available in any significant amount for at least 6 months into WHO phase six [1,7]. The work group developed its recommendations for when supplies of the pandemic vaccines begin regularly to arrive in Minnesota.

2. Initially we anticipate that two million doses of vaccine will be available weekly in the US.3 Minnesota’s population is 1.75% of the total US population, so Minnesota will receive approximately 35,000 doses weekly, for a total of 420,000 doses rolling in over 12 weeks. About 8% of Minnesotans will have access to vaccines during this period. 3. Herd immunity within the general population and ring immunity around smaller areas will not be achievable 6 months into WHO pandemic phase six, because of the scarcity of vaccines and the highly contagious nature of worst-case influenza. Controlling spread of the illness by this point in the pandemic will not be possible. 4. The safety of pandemic influenza vaccines will be comparable to current influenza vaccines. Vaccines will be relatively safe for all populations, except for those in whom the vaccines are contraindicated, e.g., those allergic to eggs if the vaccines are egg-based. (We note, though, that this assumption may be optimistic. It is likely that vaccine development during a pandemic will be fast-tracked, and FDA approval of new vaccines may be based on less evidence than it would require in a nonpandemic situation [1,29].) 5. Vaccine response will vary depending on demographic factors. • Vaccines will, in general, be most effective in healthy older teenagers and young adults, given their robust immune systems [30]. • Vaccines will be ineffective or inadequate among the elderly, children less than 6 months of age, and severely immunocompromised persons [30–32]. Indirect immunization (i.e., immunizing persons who come into contact with these populations) will protect them better than direct immunization [33].

3 Actual vaccine production capacity is unknown. Vaccines for avian influenza strain H5N1 (which may or may not be the strain that develops into pandemic) are still being developed, as are new manufacturing techniques. The work group members decided that assuming a weekly supply of two million doses nationally would be reasonable and further that one dose per person would be sufficient. The federal plan assumes three to five million doses will be available weekly, but that two doses will be needed per person [1].

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6. Pandemic influenza vaccines are a public health good and how they are allocated has a significant effect on Minnesota’s public health [34]. Influenza vaccines benefit the direct recipients, assuming that they have sufficient vaccine response, but can also have a multiplier effect. They can benefit those who would otherwise be exposed to influenza by the recipient and those who would otherwise fail to receive needed goods or services because the recipient was absent from work due to influenza or influenza-related death.

7. The federal government will be making vaccine distribution decisions to protect national security. Minnesota will not have a role in decisions about the amount or prioritization of groups relative to those goals, though the supply of vaccine to Minnesota may be affected by federal distribution decisions.

3.3. Operational assumptions

The work group offers (a) an ethical framework consisting of principles, goals, and strategies to guide Minnesota’s selection of a vaccine rationing plan in a worst-case influenza pandemic (Table 2), and (b) a sample vaccine rationing plan consistent with the recommended framework (Table 3). The framework expresses the aspirations and constraints that should shape Minnesota’s allocation of vaccines during the pandemic.

The work group incorporated several assumptions about what information will be available to support implementation of a vaccine rationing plan. We note, however, that there are many operational matters that lie beyond the scope of this report. 1. Six months into WHO pandemic phase six, useful information will exist about the disease profile, including relative mortality rates among some populations and vaccine efficacy and safety [1,35]. The first wave of illness will have passed, if not in Minnesota then elsewhere, and that wave of illness will have provided information about the disease. 2. Employers, health care providers, and local and state government agencies will have data to help identify persons prioritized to receive vaccine in the early weeks of vaccine availability (e.g., being under age 40, healthy, and serving an essential function) [13,36]. 3. A large proportion of essential workers and the general public will develop natural immunity in the months prior to vaccine being available. To the extent that it is possible rapidly to identify individuals who are naturally immune, vaccines will be redirected to those who lack immunity. 4. Employers will be directed to selectively deploy essential workers, as much as possible, to minimize their need for vaccines. For example, those who are naturally immune will be deployed first in essential service roles. 5. The ethical framework and plan will be adjusted to respond to the best available evidence. 6. In a worst-case pandemic, significant public education and cooperation will be needed to distribute the limited vaccine supply efficiently and to promote our public health goals effectively. The success of any vaccine rationing plan requires that all health care providers and public health officials are consistent when explaining who should be coming in and when for vaccinations, and who should be waiting and why. In Minnesota we have the luxury of a relatively cohesive, collaborative health care and public health community that is accustomed to working together in times of crisis. Accordingly, we assume that such consistency is possible and that the public health, public safety, and health care sectors will cooperate in communicating to the public.

4. Recommended ethical framework and a vaccine rationing plan

4.1. Ethical principles The ethical principles include core commitments to protect Minnesota’s public health against serious avoidable harm, wisely steward scarce resources, respect the moral equality of all Minnesotans, and treat them fairly. Four of the six ethical principles are explicitly devoted to different aspects of fairness. They respect the moral equality of all, require similar treatment of those similarly eligible for vaccine, set criteria for substantive fairness (e.g., levels of mortality risk and vaccine response), limit significant disparities in influenza-related mortality, and attend to a balanced range of mortality risks. The work group concluded that a vaccine rationing plan for a worst-case pandemic can balance these multiple ethical principles in such a way that all are honored in significant measure. 4.2. Goals The primary goal is to maximize Minnesotans’ chances of surviving two major threats to their lives during the pandemic and the years immediately following. A secondary goal of the work group’s recommended framework is to foster social cohesiveness and collaboration [37]. Social cohesiveness and collaboration are of value in themselves, but they also can support implementation of a vaccine rationing plan. If two vaccine rationing plans would similarly maximize Minnesotans’ chances of surviving, but one did so in a way that better promoted social cohesiveness and collaboration, then that plan would be preferred. Similarly, if data suggest that an entire generation may be lost to the ravages of influenza, and if the allocation (direct or indirect) of vaccine could help protect against this loss, Minnesotans should use a portion of the vaccine sup-

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Table 2 Recommended ethical framework for rationing vaccines in Minnesota during a worst-case influenza pandemic Ethical principles • Contain and limit serious harm to Minnesota’s public health • Respect the moral equality of all Minnesotans • Reduce significant differences in influenza-related mortality • Steward scarce pandemic vaccines efficiently and effectively • Treat equally those who are similarly situated with respect to their priority to receive vaccine • Use fair procedures to implement the vaccine rationing plan Goals Primary: • Maximize Minnesotans’ chances of surviving: ◦ influenza and influenza-related complications; and ◦ significant disruption of the basic health care, public health and public safety infrastructures during the pandemic and in the years immediately following Secondary: • Promote social cohesiveness and collaboration among Minnesotans • Protect against the loss of any single generation when reasonable measures to do so are available Strategies Given our assumptions, ethical principles, and our primary goal: • Any of these characteristics render groups ineligible for vaccines: ◦ confirmation of natural immunity, i.e., have contracted and survived influenza; ◦ low risk of influenza-related mortality; ◦ low vaccine response; or ◦ availability of satisfactory alternative protections • Various combinations of these characteristics warrant prioritizing some groups to receive scarce vaccines before others: ◦ high risk of influenza-related mortality; ◦ high vaccine response; ◦ perform basic health care, public health, or public safety functions; ◦ high risk of transmitting influenza to groups served that are at high risk of influenza-related mortality; and ◦ lack of satisfactory alternative protections • Determine which combinations of characteristics warrant prioritizing access to vaccines • Use a fair procedure for distributing limited vaccines within a prioritized group when not all group members can receive vaccine at the same time • Make reasonable efforts to remove barriers to fair access, e.g., vaccines should be available without cost to recipients • When appropriate and feasible, attend to the secondary goals • Secure informed public input and trust; commit to transparency in the development and implementation of the vaccine rationing plan; and educate the public about the plan and its rationale

ply to limit such a loss when it is possible to do so without significantly compromising the primary goal. This objective reflects commitments to reduce significant differences in influenza-related mortality and to respect the moral equality of all Minnesotans, without committing to pure generational equity. Each generation contributes to a community’s capacity to flourish. The work group recommends that reasonable steps be taken to preserve against the loss of any generation when doing so does not directly threaten the primary public health objectives. 4.3. Strategies The work group assumes that sufficient information will be available 6 months into the pandemic to justify prioritizing some groups to receive scarce vaccines over others, consistent with the recommended ethical principles and goals. We agreed on the characteristics that are relevant to deciding which groups receive vaccines first, which later, and which not at all. Each characteristic is consistent with our assumptions (see above), ethical principles, and goals.

4.3.1. Characteristics We agreed that fairness and wise stewardship call on us to exclude groups based on any of the following characteristics: • confirmation of natural immunity, i.e., have contracted and survived influenza; • low risk of influenza-related mortality; • low vaccine response; or • availability of satisfactory alternative protections. These exclusions avoid wasting the limited supply of vaccines and allow Minnesota to maximize the life-saving potential of vaccines. Groups that are naturally immune do not need vaccines; groups at low risk or with low vaccine response neither need nor will benefit from vaccines as much as other groups with higher mortality risk and higher vaccine response; and groups with satisfactory alternative protections free up vaccines for others without such alternative protections. The work group judged the five characteristics below to be relevant to prioritizing some groups to receive scarce vaccines

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Table 3 Sample vaccine rationing plan for Minnesotaa Track A—limit mortality due to flu and infrastructure breakdown

Track B—limit mortality due to flu and limit significant disparities in flu-related mortality

Tier One

Key government leaders as well as Vaccinators, including people who deliver vaccines, staff vaccination clinics, and provide security

None

Tier Twob

Groups of essential workersc : • at high risk of flu-related mortality • with high vaccine response, and • without satisfactory alternative protections

Groups, if any: • at disproportionately high risk of flu-related mortality • with high vaccine response, and • without satisfactory alternative protections

Tier Three

None

Groups of essential workersc : • at high risk of transmitting flu to vulnerable people best protected indirectly (i.e., people at high risk of flu-related mortality but without adequate vaccine response or satisfactory alternative protections), and • with acceptable vaccine response as well as Groups: • at high risk of flu-related mortality • with high vaccine response, and • without satisfactory alternative protections

Tier Four

None

Groups: • at high risk of flu-related mortality • with acceptable vaccine response, and • without satisfactory alternative protections

Tier Five

None

Groups: • at moderate risk of flu-related mortality • with acceptable vaccine response, and • without satisfactory alternative protections

Tier Six

None

General population: • with acceptable vaccine response, and • without satisfactory alternative protectionsd

a This sample plan is based on specific background assumptions about a worst-case pandemic, the supply and efficacy of vaccines and other operational matters. It will need to be modified in light of the best available scientific evidence about the actual pandemic and available vaccine(s). b In Tier Two 100% of vaccines are allocated to Track A unless a group is discovered to have a disproportionately high risk of influenza-related mortality coupled with a high vaccine response. For instance, if pregnant women in the third trimester are determined to be at disproportionately high risk, Minnesota might allocate vaccine to both tracks. A range of empirical and value considerations will inform the apportioning of the vaccine supply to the two tracks. c “Essential workers” refers to those whose functions are critical to limiting flu-related deaths and deaths due to degradation of the health care, public health, and public safety infrastructures. d Note: If there is a risk of losing an entire generation that has not already been prioritized for vaccination, this group should be protected—either with direct or indirect vaccination—before the general population.

before others. While each of the following characteristics is relevant, none is sufficient on its own to justify prioritized access to vaccines. 4.3.1.1. High risk (including disproportionately high risk) of influenza-related mortality. In a worst-case influenza pandemic, our commitment to protect the public’s health points to the ethical relevance of medical need when deciding how to allocate scarce vaccines [38]. When life itself is at stake, fairness (not to mention compassion) compels attention to significant disparities in chances of survival. In common annual influenza outbreaks as well as moderate pandemics, the very young, the very old and those with immune problems are the groups at highest risk of influenza-related mortality. In a worst-case pandemic, these groups are joined by the

group of healthy persons between the ages of 15 and 40.4 In 1918–1919 pregnant women suffered the highest mortality risk of all, with a case fatality rate as high as 70% in the late stages of pregnancy.5 4.3.1.2. Vaccine response. Age and health status cause some individuals to respond better to influenza vaccines than others (see Section 3.2 above). Some have a high vaccine response 4 The work group had insufficient information about whether groups at high risk of exposure to influenza are placed at increased risk of influenzarelated mortality. The high risk of exposure to influenza was not included in the work group’s recommended ethical framework or sample vaccine allocation plan. This issue deserves further study and consideration. 5 Though it may be easy to agree in cases when the difference in magnitude is large, it may be harder to agree when the difference in magnitude is small.

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(e.g., healthy persons from 15 to 40 years of age), whereas others have little or no response (e.g., very young infants, elderly persons, and those with severe immunological problems). Our commitment to wise stewardship and fairness justify considering different levels of vaccine efficacy. 4.3.1.3. Essential workers. Essential workers are those whose job functions are critical to sustaining basic health care, public health, or public safety infrastructures both during and in the aftermath of the pandemic. In order to limit deaths due to the degradation of these infrastructures, essential workers must be protected.6 4.3.1.4. High risk of transmission. Some essential workers serve groups that are vulnerable in that they are at high risk of influenza-related mortality and are unlikely to respond well to the vaccine (e.g., frail, institutionalized elderly; immunocompromised asthmatics; and infants). These essential workers present a high risk of transmitting influenza to these vulnerable groups. 4.3.1.5. Without satisfactory alternative protections. It is unclear what protections will be available when the pandemic occurs. Wise stewardship requires us, nevertheless, to inquire about and consider them when developing the final vaccine rationing plan. Non-vaccine forms of protection could include social isolation and various types of medical supplies. 4.3.2. Combinations of characteristics The work group concluded that the following combinations of the characteristics reviewed above warrant prioritization to receive pandemic vaccines. 4.3.2.1. Groups with all of the following characteristics:. • • • •

high risk of influenza-related mortality; high vaccine response; lack of satisfactory alternative protections; and essential work role in basic health care, public health, or public safety.

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its aftermath.7 This prioritization uses vaccine efficiently to protect against the two threats of mortality simultaneously. 4.3.2.2. Essential workers who have an adequate vaccine response and are at high risk of transmitting influenza to groups that both are prone to high rates of influenza-related mortality and lack acceptable vaccine responses. The protection of those in need can sometimes be accomplished directly and at other times only indirectly. Groups at high risk of influenza-related mortality, but that have little chance of responding to vaccines, are not best served by being vaccinated when vaccines are in short supply. The strategic vaccination of those who serve these vulnerable groups, so long as the workers also have an acceptable vaccine response, provides these groups with better protection than direct vaccination. Vaccinating workers (e.g., healthy, older nursing home workers or pulmonologists who are not at high risk of mortality themselves) is ethically justified when it offers indirect protection to vulnerable groups in their care. Unfortunately, vaccine supplies will be insufficient to vaccinate all who come in contact with such vulnerable persons. For instance, while household members are likely to transmit influenza to one another including young children, they transmit disease to fewer people than those essential workers whose jobs entail regular direct contact with larger numbers of vulnerable persons. To reduce mortality, vaccines should be given to those essential workers at high risk of transmitting influenza to groups that are at increased risk of influenza-related mortality and that also lack an adequate vaccine response. 4.3.2.3. Groups, if any and without regard to employment, that:. • are at disproportionately high risk of influenza-related mortality; • have a high vaccine response; and • lack satisfactory alternative protections.

Among groups that have a high risk of mortality coupled with a high likelihood of significant benefit from vaccination, it is reasonable to vaccinate first those who also have an essential role in the basic health and public safety infrastructures. Rationing a significant portion of the first available vaccines to these groups limits permanent loss of essential workers due to death among those at high risk and protects the health and public safety infrastructures, on which we all depend, against severe degradation during the pandemic and

If a group emerges that is demonstrated to be at disproportionately high risk of influenza-related mortality, we recommend prioritizing such a group only if members also have a high vaccine response and lack satisfactory alternative protections. Seeking to reduce large disparities in influenzarelated mortality is a requirement of fairness that honors Minnesotans’ equal moral status. Prioritizing such a group also fulfills the principle of stewardship since the group has a high likelihood of significant benefit and the number of lives saved per vaccination is expected to be substantial. It efficiently promotes our primary goal of maximizing Minnesotans’ chances of surviving the pandemic.

6 Deciding how essential a particular job function is and how well to staff the function requires particularized knowledge of each of the employers, industries, and agencies comprising the public health, health care, and public safety infrastructures. We leave these assessments to others better suited to make them.

7 We expect that significant social pressure will be exerted to encourage workers, vaccinated as a result of their essential roles, to work. The framework does not suggest criminal or civil penalties for failure to work. It leaves open the question of whether employers may or should require vaccination of some workers as a condition of their employment.

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4.3.2.4. Groups, without regard to employment, that:. • are at high risk of influenza-related mortality; • have a high vaccine response; and • lack satisfactory alternative protections. Prioritizing the vaccination of groups at high risk of mortality, with a high vaccine response, and that lack satisfactory alternative protections serves the common good, attends to reducing significant differences in influenza-related mortality, and constitutes a wise and efficient use of scarce vaccines. It promises to maximize Minnesotans’ chances of surviving influenza and influenza-related complications. Various other combinations of characteristics might be thought to warrant high prioritization for vaccines. However, in the context of a worst-case pandemic, extreme vaccine scarcity, and the agreed upon goal of addressing the dual threats of mortality, the work group concluded that the above combinations of characteristics warrant first attention when vaccines become available. 4.4. Sample vaccine rationing plan The final vaccine rationing plan (as opposed to a sample plan) must be made in real time in light of the actual pandemic and the best available scientific evidence about such things as mortality rates, vaccine response, vaccine supply, and capacity to contain the pandemic. An advisory group with broad expertise and representation should be convened for the purpose of applying the ethical framework and adjusting the strategies in response to relevant new information. Consistent with our recommended ethical framework and background assumptions about a pandemic with a W-shaped age-specific mortality curve, the work group offers a sample for consideration consisting of two tracks and six tiers (see Table 3). Both tracks of the sample plan are dedicated to limiting influenza-related mortality. Additionally, Track A aims to prevent mortality due to the collapse of health and public safety infrastructures, while Track B seeks to reduce significant disparities in influenza-related mortality. The two tracks signal the importance and feasibility of pursuing multiple ethical objectives and principles in a single plan. Determining the exact proportion of vaccines that should be allocated between these two tracks will be informed by the epidemiological data emerging during the pandemic itself, as well as by information about the viability of infrastructures. The scope of services that merits protection during a worstcase pandemic is a matter of debate, and likely to be affected by the evolution of the particular pandemic. Some will prefer to define health care, public health, and public safety services very broadly, e.g., including such things as food production and communication systems; others will prefer to draw the boundaries more narrowly. How broadly or narrowly Minnesota defines the basic services of these core infrastructures should depend on the services’ role in protecting against the threats to Minnesotans’ lives.

The percentages of the vaccine supply distributed to the two tracks shift when Tier Two of the plan is accomplished. Early on, Track A receives the bulk of vaccine to both limit mortality in high-risk groups and to preserve the basic health care, public health, and public safety infrastructures protective of Minnesotans’ chances of survival. When sufficient vaccination levels have been achieved among selected highrisk groups that also serve core functions, the focus shifts fully to Track B. Here, the goal is to protect groups (without regard for employment status) at high risk of influenza-related mortality—both those groups that can best be protected indirectly by reducing the chances of essential workers transmitting influenza to them and groups with a high vaccine response that are best protected directly. The higher the tier, the more important it is to reach as many members of the tier as possible. However, with the possible exception of Tier One, it is impractical to assume that 100% of all eligible members of a tier could be reached, especially under circumstances as urgent and dire as a worstcase pandemic. Indeed, to try to do so could slow down vaccine distribution unnecessarily. Accordingly, the tiers are offered to guide distribution efforts, but with the caution that forward momentum in distributing vaccine must be maintained. 4.4.1. Tier One In its first tier, the recommended plan rations vaccines only to preserve core public health decision-making capacity and to ensure the viability of the vaccine production and distribution infrastructure. During a worst-case influenza pandemic, those most critical to protecting the lives of all Minnesotans are (a) a few key government leaders who direct the pandemic response and make decisions concerning the adequate functioning of essential services, and (b) those responsible for delivering, providing, and securing vaccines. These two core sets of essential roles are performed by those elected or appointed to office or by persons with very specific skills, knowledge, and experience. Their roles are so crucial to the preservation of the public’s health that their individual risks of mortality, vaccine response, and risks of transmission are irrelevant. They should be vaccinated unless it is confirmed that they possess natural immunity. Vaccinating Tier One is anticipated to be easily and quickly accomplished, as it involves a limited number of readily identifiable individuals. The number of people in Tier One can be reduced if the supply of vaccinators and other support personnel is ample in relation to demand (such as when a vaccine first becomes available and supplies trickle in). Substantive fairness and wise stewardship require that the number of persons vaccinated in Tier One be the smallest number possible, given the lack of other constraints on groups in this tier (e.g., lack of requirements concerning vaccine response and adequacy of alternative protections). By first deploying those who are naturally immune, more vaccine will be available earlier for groups prioritized to receive vaccine in Tier Two.

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Table 4 Examples illustrating individuals’ likely priority for vaccination Examples

Priority

Rationale

55-year-old truck driver who delivers vaccines to clinics 35-year-old respiratory therapist

Tier 1, Track A Tier 2, Track A

35-year-old communications worker with structural heart disease 25-year-old water supply worker

Tier 2, Track A

15-year-old pregnant woman in 3rd trimester

Tier 2, Track B

45-year-old police officer responsible for crowd control

Tier 3, Track B

35-year-old institutionalized, non-essential worker, paralyzed with pulmonary difficulties but otherwise healthy immune system 10-year-old with severe asthma

Tier 3, Track B

Core essential role; risk of mortality and vaccine response irrelevant High risk of flu-related mortality, high vaccine response, and essential role High risk of flu-related mortality, high vaccine response, and essential role High risk of flu-related mortality, high vaccine response, and essential role Disproportionately high risk of flu-related mortality and high vaccine response High risk of transmission to vulnerable groups, acceptable vaccine response, and essential role High risk of flu-related mortality and high vaccine response

45-year-old hospital janitor working around low-risk patients

Tier 5, Track B

50-year-old dermatologist working with low-risk patients

Tier 5, Track B

Frail 85-year-old long term care resident

Not prioritized

Healthy 75-year-old living independently

Not prioritized

Tier 2, Track A

Tier 4, Track B

4.4.2. Tier Two Tier Two, Track A of the plan rations early allotments of vaccines to those at high risk and with high vaccine response (i.e., healthy persons 40 years old or younger) who perform an essential health care, public health, or public safety function. Tier Two allows for a parallel Track B to prioritize any group—regardless of employment status—that is at disproportionately high risk of influenza-related mortality, so long as the group has a high vaccine response and lacks satisfactory alternative protections (e.g., pregnant women in the third trimester). 4.4.3. Tiers Three and later Starting with Tier Three, all vaccines are directed to Track B to limit disparities in influenza-related mortality. Tier Three prioritizes the next neediest group—those with high (as opposed to disproportionately high) risk of influenza-related mortality (e.g., healthy 15–40-year olds). Each subsequent tier of the plan expands eligibility for vaccination by relaxing the degree of mortality risk and vaccine response requirements. In accord with Tier Six, if it becomes evident that a generation is at risk of being lost and if vaccine can be used effectively as a tool to ameliorate that loss (either by vaccinating members of that generation or vaccinating those around them), then the strategies for allocating vaccine may be adjusted. As we developed the dual-track, multi-tiered rationing plan, we considered examples of individuals and their vaccination priority. We reflected on the plan’s effect on individuals

High risk of flu-related mortality and acceptable vaccine response (can benefit from indirect protection offered by vaccination of health care workers in Track A and Tier 3, Track B) Moderate risk of flu-related mortality and acceptable vaccine response Moderate risk of flu-related mortality and acceptable vaccine response Low vaccine response (can benefit from indirect protection offered by vaccination of health care workers in Track A and Tier 3, Track B) Low vaccine response

as a way to test and confirm whether the relative priority of different groups seemed appropriate given our public health goal. Table 4 displays our conclusions.

5. Discussion How best to ration pandemic vaccines when demand will vastly outstrip supply is a major health policy question with serious public health, social justice, and individual health implications. The federal government has clarified that it is up to states to develop plans to allocate the limited vaccines expected to become available [1]. The HHS Pandemic Influenza Plan provides some assistance to states. It includes a recommended plan (developed by the National Vaccine Advisory Committee and the Advisory Committee on Immunization Practices) for allocating vaccine in a moderate influenza pandemic [1]. Our work group did not assess the appropriateness of the vaccine recommendations for a moderate pandemic with a U-shaped, age-specific mortality curve. It did, however, conclude that the HHS vaccine plan would not be optimal given our assumptions about a worst-case pandemic. Failure to attend to vaccine efficacy for all groups, including essential workers, is inconsistent with the ethical principles and goals of our proposed ethical framework. Before settling on our recommended ethical framework, we considered several potential frameworks (available upon request), including one that would ration vaccine to stave off serious long-term economic and social disruption. We concluded that the causes of pandemic-related social and

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economic disruption for decades to come are so many and so complex that it is difficult to anticipate the mitigating effects alternative vaccine rationing plans might have on such long-term disruptions.8 Nor would such an approach address specifically enough the proximate risks of shorter-term mortality posed by pandemic influenza. This led us to adopt a Minnesota-wide perspective and to focus on some (but not all) mortality risks during a defined (but not too limited) period of time. We also considered and rejected a purely egalitarian ethical framework. Its strongest defense is that since everyone who lacks immunity to the pandemic virus is at risk of the same catastrophic harm, namely premature death, we all are equal and should have an equal chance of receiving the vaccine. Equal access to vaccine, supporters insist, protects against unjustified and unfair decisions about who should have access to the scarce vaccines. Supporters might also maintain that 6 months into the pandemic we will likely be operating under considerable uncertainty (e.g., uncertainty about different susceptibilities to contracting influenza and risks of mortality from the disease; variable responses to vaccine in terms of both safety and efficacy, etc.). In turn, the argument continues, there will be serious disagreement about why some groups should be prioritized to receive vaccine. The commitment to moral equality, coupled with such uncertainty and lack of consensus, suggest that it would be fairest to offer everyone without proven immunity equal access to influenza vaccine. The work group, however, rejected this purely egalitarian framework, because we believe that information necessary to ethically justify vaccine rationing decisions will be available, and that public agreement (by an informed public) is achievable. Instead of relying exclusively on commitments to equality, we embrace a commitment to the moral equality of all Minnesotans as one of several ethical principles comprising our recommended ethical framework. Though the work group found elements of several model ethical frameworks compelling, we judged none fully adequate to guide and constrain the rationing of scarce vaccine during a worst-case pandemic. We crafted a framework that recommends blending several ethical commitments in a manner that honors each. 5.1. Public health perspective The work group’s first decision, and one easily reached, was that a worst-case influenza pandemic requires a collective rather than an individual strategy for allocating vaccines. For the good of us all in the case of a virulent, highly contagious disease, access to extremely scarce, preventive vaccines is best determined from a statewide, public health perspective. Allocating vaccines based on the status quo, that 8 The federal plan identifies “minimizing societal and economic impacts” as a secondary pandemic response goal [1]. Minimizing social disruption and minimizing economic loss are two of three primary goals for California’s draft vaccine intervention plan [12].

is, on customary market principles and urgency of individual medical need alone, would be indefensibly harmful to the public’s health. To allow individual personal interests to control whether, when, and how Minnesotans access scarce vaccines would result in significant numbers of preventable premature deaths to achieve only the illusion of individual autonomy and personal security. The public health perspective we advocate requires policymakers and citizens alike to adopt a statewide approach to protecting the common good. Thus, Minnesota’s vaccine rationing plan should: • fit the types and magnitude of risks the pandemic poses to the health status of Minnesotans collectively; • contain rather than exacerbate, the public health disaster in Minnesota; and • provide both direct and indirect protections against risks of mortality. 5.2. Public health goals Which pandemic-related harms should a Minnesota-wide vaccine rationing plan seek to contain or ameliorate?9 The answer depends on what Minnesotans take to be the most serious threats as well as the most important public health benefits that an ethically defensible vaccine rationing plan should attend to. We concluded that Minnesota’s primary public health goal in a worst-case pandemic should be to maximize Minnesotans’ chances of surviving the pandemic and the years immediately following. Focusing on the years immediately following the pandemic as well as the pandemic itself avoids the problem of concentrating on a too narrow set of pandemic effects or too broadly on significant social and economic harms for generations to come. We did not explicitly focus on limiting morbidity because we anticipate considerable overlap between groups at high risk of mortality and groups at high risk of morbidity. By addressing mortality risks, we assume that groups at high risk of morbidity will also receive protection. We recommended against confining the focus solely to reducing deaths from influenza and complications of influenza. Hurricane Katrina showed the deadly impacts of infrastructure collapse. Seeking only to vaccinate those at high risk of influenza-related mortality leaves them and every other Minnesotan unprotected from death due to breakdowns in basic health care, public health, and public safety infrastructures. Severe infrastructure failure is anticipated, resulting in massive loss of life. Everyone’s risks will increase regardless of health status or usual access to health care, public health, or public safety services. Minnesotans’ interests in surviving a pandemic and the years immediately following can be optimized by exploiting the role of vaccination in 9 A statewide perspective can be expected to differ from the perspective of a single health care organization or a single group of Minnesotans.

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protecting vital health and public safety services as well as limiting influenza-related mortality. It is not just the number of persons vaccinated but their strategic vaccination that can best address the dual threats to Minnesota’s health status. 5.3. Ethical principles, strategies, and sample plan The framework provides six principles, four of which are concerned with fairness: • Common good: minimize serious harm to Minnesota’s public health; • Fairness: ◦ respect the moral equality of all Minnesotans; ◦ limit disparities in influenza-related mortality; ◦ treat similarly situated persons similarly; ◦ fairly implement the plan; and • Stewardship of scarce resources: allocate vaccines wisely and efficiently. The work group noted that determining the right balance of public and individual interests, fairness, and stewardship is a common problem in public health. When resolving such quandaries policymakers often allow one ethical principle to trump others. For example, prioritizing the medically neediest can require expending resources on one generation (e.g., the elderly) at the expense of other generations. Arguments in favor of generational equity, on the other hand, often sacrifice medical need in favor of expending resources on generations that have not yet had an opportunity to live a normal lifespan.10 Under our assumptions about a worstcase influenza pandemic in which healthy young people are among those at greatest risk, these ethical principles, rather than being in regrettable, irresolvable tension, converge and can be aligned [8,39]. A vaccine rationing plan for a global public health disaster will be unable to address all the inequities that plague our health care system. Nevertheless, our sample vaccine rationing plan makes a significant commitment to substantive and procedural fairness, including a commitment to the moral equality of all Minnesotans. It sets criteria for substantive fairness (e.g., levels of mortality risk and vaccine response), limits significant disparities in influenza-related mortality, attends to a balanced range of mortality risks, and requires similar treatment of those similarly eligible for vaccine. The sample vaccine rationing plan is expected, in effect, to prioritize healthy adolescents and young adults—especially young adults employed in essential service roles—over elderly persons, infants, and persons with comorbidities. It is healthy adolescents and young adults who are among those at 10 The assumptions we adopted about which demographic groups are at highest risk and most likely to benefit from access to vaccines, namely, young healthy 15–40-year-olds, enabled us to avoid considering whether to prioritize the young over the old. More attention to this controversial topic could be necessary in a pandemic with different distributions of mortality risk and vaccine response.

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greatest risk of influenza-related mortality and who have the best chance of responding to the vaccines. Rationing a portion of the first available vaccines to young healthy essential workers leverages vaccine’s capacity both to limit influenzarelated mortality and to protect Minnesota’s health and public safety infrastructures against severe degradation, protections that are necessary for us all. Seeking to reduce significant differences in influenzarelated mortality among Minnesotans, the sample plan also prioritizes those essential workers who have an acceptable (as opposed to a high) vaccine response and are at high risk of transmitting influenza to vulnerable groups they serve, that is, groups at high risk of influenza-related mortality but that lack an adequate vaccine response and satisfactory alternative protections. Though our sample plan does not prioritize all essential workers, it does prioritize healthy workers 40 years old or less and other workers at high risk of transmitting influenza to groups that both are at high risk of influenza-related mortality and lack an adequate vaccine response. This strategy is expected to offer vaccines to substantial numbers of essential workers, without offering them to all. Our sample plan may be controversial for two opposing reasons. Some people may be disappointed that the work group’s recommendations allow some groups of essential workers to have prioritized access to vaccine, while others may bemoan our failure to prioritize all essential workers. The first objection arises from the belief that it is unfair to prioritize groups that have been privileged with education, employment, wealth and good health over other groups, including those that are systematically disadvantaged. In response, we maintain that our recommended strategy values the lives of all Minnesotans, not just the privileged. We prioritize groups without regard for social value and attend to a wide array of health and public safety reasons for increased mortality during a pandemic and its aftermath. In light of the large number of healthy adolescents and young adults—from all walks of life—who are best protected by direct vaccination against the high risk of influenza-related mortality, the work group rejected plans that would prioritize all essential workers or even all health care workers as unfair and inefficient. Our plan does not presume that the lives of persons in essential service roles are more valuable than the lives of other persons. The second line of objection, held by some in our own work group, stems from views common in other influenza vaccine allocation plans. Vaccine plans often prioritize the vaccination of all health care workers in order to: • prevent transmission of the disease to those they serve; • minimize medically preventable loss of life during the outbreak; • increase workers’ willingness to work and to reciprocate for asking them to accept high risks of exposure to influenza in the service of others [40]; • and to preserve the health care system as we know it.

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These plans are designed for diseases with less virulence and greater vaccine supplies than the worst-case pandemic on which our assumptions are based. The view of the authors and of most in our work group is that prioritizing all health care workers is not appropriate for pandemics with a W-shaped mortality curve. In moderate pandemics the groups at highest risk of influenza-related mortality are groups that are best protected indirectly (i.e., the very young, the very old, and people who are immunocompromised). This justifies the diversion of vaccines to workers who care for them. In a worst-case pandemic healthy adolescents and young adults are also at great risk. Most in the work group maintain that it is ethically preferable to redirect a portion of the vaccine supply away from essential workers who have lesser vaccine responses and mortality risks to the large cohort of healthy adolescents and young adults who are at higher risk of mortality and are best protected by direct vaccination. Devoting the entire supply of vaccines to essential workers regardless of their mortality risk and vaccine response would leave healthy adolescents and young adults unprotected. Thus, it would unfairly allocate vaccines based on social role. We believe that the sample plan offers Minnesotans—the sick and the well, the young and the old, the employed and the unemployed, the rich and the poor, the able-bodied and the disabled—the maximum chances of surviving both the pandemic and the years immediately thereafter. 5.4. Public acceptance: the confluence of public health and informed self-interest perspectives A vaccine shortage in a worst-case pandemic challenges each of us to accept the likelihood that we will not be vaccinated as early as we would like—and perhaps not at all. It is important, therefore, to consider whether the public will accept the proposed framework and vaccine rationing plan. While some Minnesotans may be persuaded by the public health arguments offered in this report—which include significant commitments to fairness and wise stewardship of scarce resources—others may not. Because it is human nature to be concerned about our own survival and the survival of those we care about, it is reasonable to ask, “Would we, as individuals, be persuaded to support and abide by the recommended ethical framework and rationing plan?” Though allocating pandemic vaccines from an individual health perspective is contraindicated, the work group maintains that its recommended framework and sample vaccine rationing plan is consistent with the ethical perspective of informed self-interest. The argument could be articulated as follows: Initially, some of us might think that our best shot at surviving the pandemic is to fend for ourselves and find ways to obtain the few doses of vaccine available. Upon reflection, however, many of us may conclude that in a worst-case pandemic, our usual feelings of independence

and self-sufficiency are misplaced. As we come to appreciate the scope, scale, and duration of the risks associated with a worst-case pandemic, it becomes clear that our survival is not something that any of us can ensure on our own. Second, we realize that it is short-sighted to assume that our primary challenge is to obtain vaccine when the risks to our lives and to the lives of those we care about and depend on are far more complicated, both during and after the pandemic. Regardless of my wealth, power, or health status, I depend for my life on others, whether, for instance, I am a diabetic and rely on a supply of insulin or I need a fire department and reliable water pressure to douse my burning home. Finally, even if I believe I have ways to assure obtaining vaccine out of turn, my (and others’) personal gaming of a rationing plan is counterproductive if it contributes to a worse outcome for me and those I care about and depend on. Failure to comply with (and to enforce) a sound, statewide vaccine rationing plan will result in more cases of influenza, more deaths, and significant damage, immediate and long-term, to Minnesota’s basic health care, public health, and public safety infrastructures. With adequate appreciation of worst-case pandemics, many of us will see the personal benefits of joining with others to prevent the extreme social chaos that would follow if each of us seeks vaccines by whatever means available to us (e.g., wealth, use of force). The worse the contagious pandemic, the greater the threats to me and those I depend on [41]. The worse the contagious pandemic, the greater my need for a collective approach to rationing vaccines and my obligation to support it. Overall, it is in my best interest to comply with a strategic, enforced vaccine rationing plan that offers me, my family, and those individuals (known and unknown) on whom I depend, the best chances of survival, not simply my best chances of being vaccinated. A public health perspective that includes strong commitments to fairness and wise stewardship of scarce resources is consistent with an informed, self-interest perspective. This confluence offers reason to believe that Minnesotans may find the recommendations persuasive. That there is more than one set of compelling reasons for Minnesotans to agree contributes to our optimism that a statewide, fair, and effective vaccine rationing plan can be fashioned. Agreement that a plan is fair and reasonable, however, is insufficient to ensure compliance. The public also needs to trust that the state can and will enforce the agreed-upon plan. 6. Next steps Public trust—so necessary for implementing any vaccine allocation plan—depends on Minnesotans having the opportunity for reflection prior to the pandemic’s onslaught [42]. Though this report reflects the hard work of many stakeholders—expert and lay—who were willing to learn about influenza pandemics and to tackle the tough ethical

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questions about rationing pandemic vaccines, the recommendations must be refined in light of informed public input in order to reflect the values of a broader cross-section of Minnesotans. Even with such transparency, public acceptance of vaccine rationing will be fragile. In addition to educating the public, soliciting input, and marshaling support for the plan, the state must streamline the plan’s implementation and control the supply and distribution of vaccines to protect against subversion and ensure compliance. Essential, too, is the need to develop the capacity to adjust the plan in response to an actual pandemic and vaccine supply.

7. Conclusion The prospect of a worst-case influenza pandemic, such as was suffered in 1918–1919, is horrendous. As terrible as such a pandemic is to imagine in modern times, it is worse to contemplate one for which we have not adequately prepared. Some horrors we cannot predict with certainty, but if the pandemic were to occur soon, we know that vaccines would be very scarce. Failing to think through in advance the challenges of how best to ration scarce vaccines would itself be an ethical failure. The work group concluded that there is no one-size-fitsall ethical framework for vaccine allocation plans for mild, moderate, and severe pandemics. Such plans and the ethical frameworks supporting them must be context specific. The work group offers for public consideration a framework of ethical principles, goals, and strategies to guide the rationing of vaccines in a worst-case pandemic as well as a sample vaccine rationing plan consistent with this framework. Remarkably, the perspectives of public health, fairness, and informed self-interest mutually support the recommended approach, the primary goal of which is to maximize Minnesotans’ chances of surviving a worst-case pandemic and the years immediately following.

Acknowledgments The authors gratefully acknowledge the many individuals and organizations who contributed to this report. We worked with a remarkable and committed group of people. We give special thanks to two colleagues from the Minnesota Center for Health Care Ethics, Timothy McIndoo, MA, and Angela Witt Prehn, PhD, both of whom participated in the work group and its ethics subgroup, as well as provided significant input between meetings and to this report. We also thank the seven other work group members who participated in the ethics subgroup, energetically and thoughtfully guiding the philosophical underpinnings of this work: Debra DeBruin, PhD; Allan Kind, MD; Loie Lenarz, MD; Sarah Marchand; Ruth Mickelsen, JD, MPH; Michael Olesen, CIC; and Carol Tauer, PhD. Finally—and most of all—we thank the members of the Pandemic Influenza Ethics Work Group, each of whom gen-

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erously contributed time, energy, intellect and even humor to this work. They listened respectfully, thought creatively, and spoke candidly. It is with immense respect that we bring their work forward in this report. Their affiliations are listed in order to show the breadth of participation, but participants were not asked to represent or bind their respective organizations: Barry Baines, MD, UCare Minnesota; Donald Brunnquell, PhD, Children’s Hospitals & Clinics of Minnesota; Medhi Dastrange, St. Olaf College (student); Debra DeBruin, PhD, University of Minnesota Center for Bioethics; Dave Draz, Big Brothers Big Sisters of the Greater Twin Cities; Kristen Ehresmann, Minnesota Department of Health; David Emery, PhD, St. Olaf College; J. Eline Garrett, JD, Minnesota Center for Health Care Ethics; Karen G. Gervais, PhD, Minnesota Center for Health Care Ethics; Kerry Gervais (intern); Katherine Grimm, MPH, HealthEast Care System; Alan Hagstrom, DMin, St. Croix Valley Health and Faith Coalition; John Hick, MD, Hennepin County Medical Center; Harry Hull, MD, Minnesota Department of Health; Helen Jackson, Stairstep Foundation; Danny Kehler, St. Olaf College (student); Allan Kind, MD, Park Nicollet Institute; Loie Lenarz, MD, Fairview Health Services; Stephanie Malone, RN, CCM, CMCN, Medica; Sarah Marchand; Elizabeth McClure, MD, University of Minnesota Center for Infectious Disease Research and Policy; Timothy Q. McIndoo, MA, Minnesota Center for Health Care Ethics; Molly McKay, Fairview Health Services (student); LuAnne McNichols, Minnesota Department of Health; Ruth Mickelsen, JD, MPH, Allina Hospitals & Clinics; MaiKia Moua, Hmong Health Care Professionals Coalition; Paul S. Mueller, MD, MPH, Mayo Clinic; James Nordin, MD, MPH, HealthPartners Research Foundation; Michael Olesen, CIC, Abbott Northwestern Hospital; Alison Page, MSN, MHA, Fairview Health Services; Angela Witt Prehn, PhD, Minnesota Center for Health Care Ethics; Michele Schermann, Hmong Health Care Professionals Coalition; Gary Schwitzer, University of Minnesota School of Journalism; Alan Sickbert, PhD, Hamline University; Patsy Stinchfield, RN, MS, CPNP, Children’s Hospitals & Clinics of Minnesota; Christopher Tate, St. Olaf College (student); Carol Tauer, PhD, University of Minnesota Center for Bioethics; Pat Tommet, PhD, Minnesota Department of Health; Dorothy E. Vawter, PhD, Minnesota Center for Health Care Ethics; Howard Vogel, JD, Hamline University; Mary Wellik, MPH, Olmsted County Health Department.

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