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The Veterans Health Administration (VHA) COVID-19 vaccine allocation plan showcases several lessons for government and health care leaders in planning for future pandemics.1 Many state governments—underresourced and overwhelmed with other COVID-19 demands—have struggled to get COVID-19 vaccines into the arms of their residents.2 In contrast, the VHA was able to mobilize early to identify vaccine allocation guidelines and proactively prepare facilities to vaccinate VHA staff and veterans as soon as vaccines were approved under Emergency Use Authorization by the US Food and Drug Administration.3,4

In August 2020, VHA formed a COVID-19 Vaccine Integrated Project Team, composed of 6 subgroups: communications, distribution, education, measurement, policy, prioritization, and vaccine safety. The National Center for Ethics in Health Care weighed in on the ethical justification for the developed vaccination risk stratification framework, which was informed by, but not identical to, that recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.5

Prioritizing who gets early access to a potentially life-saving vaccine weighs heavily on those leaders charged with making such decisions. The ethics of scarce resource allocation and triage protocols that may be necessary in a pandemic are often in tension with the patient-centered clinical ethics that health care practitioners (HCPs) encounter. HCPs require assistance in appreciating the ethical rationale for this shift in focus from the preference of the individual to the common good. The same is true for the risk stratification criteria required when there is not sufficient vaccine for all those who could benefit from immunization. Decisions must be transparent to ensure widespread acceptance and trust in the vaccination process. The ethical reasoning and values that are the basis for allocation criteria must be clearly, compassionately, and consistently communicated to the public, as outlined below. Ethical questions or concerns involve a conflict between core values: one of the central tasks of ethical analysis is to identify the available ethical options to resolve value conflicts. Several ethical frameworks for vaccine allocation are available—each balances and weighs the primary values of equity, dignity, beneficence, and utility slightly differently.6

For example, utilitarian ethics looks to produce the most good and avoid the most harm for the greatest number of people. Within this framework, there can be different notions of “good,” for example, saving the most lives, the most life years, the most quality life years, or the lives of those who have more life “innings” ahead. The approach of the US Department of Veterans Affairs (VA) focuses on saving the most lives in combination with avoiding suffering from serious illness, minimizing contagion, and preserving the essential workforce. Frameworks that give primacy to 1 notion of the good (ie, saving the most lives) may deprioritize other beneficial outcomes, such as allowing earlier return to work, school, and leisure activities that many find integral to human flourishing. Other ethical theories and principles may be used to support various allocation frameworks. For example, a pragmatic ethics approach might emphasize the importance of adapting the approach based on the evolving science and innovation surrounding COVID-19. Having more than 1 ethically defensible approach is common; the goal in ethics work is to be open to diversity of thought and reflect on the strength of one’s reasoning in resolving a core values conflict. We identify 2 central tenets of pandemic ethics that inform vaccine allocation.

 

 

1. Pandemic Ethics Requires Proactive Planning and Reevaluation of Continually Evolving Facts

There is an oft quoted saying among bioethicists: “Good ethics begins with good facts.” One obvious challenge during the COVID-19 pandemic has been the difficulty accessing up-to-date facts to inform decision making. If a main goal of a vaccination plan is to minimize the incidence of serious or fatal COVID-19 disease and contagion, myriad data points are needed to identify the best way to do this. For example, if 2 doses of the same vaccine are needed, this impacts the logistics of identifying, inviting, and scheduling eligible individuals and staffing vaccine clinics as well as ensuring that sufficient personal protective equipment and rescue equipment/medication are available to treat allergic reactions. If the adverse effects of vaccines lead to staff absenteeism or vaccine hesitancy, this needs to be factored into logistics.7 Tailored messaging is important to reduce appointment no-shows and vaccine nonadopters.8 Transportation to vaccination sites is a relevant factor: how a vaccine is stored, thawed, and reconstituted and its shelf life impacts whether it can be transported after thawing and what must be provided on site.

Consideration of the multifaceted factors influencing a successful vaccination campaign requires proactive planning and the readiness to pivot when new information is revealed. For example, vaccine appointment no-shows should be anticipated along with a fair process for allocating unused vaccine that would otherwise be wasted. This is an example of responsible stewardship of a scarce and life-saving resource. A higher than anticipated no-show rate would require revisiting a facility’s approach to ensuring that waste is avoided while the process is perceived to be fair and transparent. Ethical theories and principles cannot do all the work here; mindful attention to detail and proactive, informed planning are critical. Fortunately, the VA is well resourced in this domain, whereas many state health departments floundered in their response, causing unnecessary vaccination delays.9

2. Utility: Necessary But Insufficient

Most ethical approaches recognize to some extent that seeking good and minimizing harm is of value. However, a strictly utilitarian approach is insufficient to address the core values in conflict surrounding how best to allocate limited doses of COVID-19 vaccine. For example, some may argue that prioritizing the elderly or those in long-term care facilities like VA’s community living centers because they have the highest COVID-19 mortality rate produces less net benefit than prioritizing younger veterans with comorbidities or certain higher risk essential workers. There are 2 important points to make here.

First, the VHA vaccination plan balances utility with other ethical principles, namely, treating people with equal concern, and addressing health inequities, including a focus on justice and valuing the worth and dignity of each person. Rather than giving everyone an equal chance via lottery, the prioritization plan recognizes that some people have greater need or would stand to better mitigate viral contagion and preserve the essential workforce if they were vaccinated earlier. However, the principle of justice requires that efforts are made to treat like cases the same to avoid perceptions of bias, and to demonstrate respect for the dignity of each individual by way of promoting a fair vaccination process.

This requires transparency, consistency, and delivery of respectful and accurate communication. For example, the VA recognizes that lifetime exposure to social injustice produces health inequities that make Black, Hispanic, and Native American persons more susceptible to contracting COVID-19 and suffering serious or fatal illness. The approach to addressing this inequity is by giving priority to those with higher risk factors. Again, this is an example of blending and balancing ethical principles of utility and justice—that is, recognizing and remedying social injustice is of value both because it will help achieve better outcomes for persons of color and because it is inherently worthwhile to oppose injustice.

However, contrary to some news reports, the VHA approach does not allocate by race/ethnicity alone, as it does by age.10,11 Doing so would present logistical challenges—for example, race/ethnicity is not an objective classification as is age, and reconciling individuals’ self-reports could create confusion or chaos that is antithetical to a fair, streamlined vaccination program. Putting veterans of color at the front of the vaccination line could backfire by amplifying worries that they are being exposed to vaccine that is not fully tested (a common contributor to vaccine hesitancy, particularly among communities of color familiar with prior exploitation and abuse in the name of science).

Discriminating based on race/ethnicity alone in the spirit of achieving equity would be precedent setting for the VA and would require a strong ethical justification. The decision to prioritize for vaccine based on risk factors strives to achieve this balance of equity and utility, as it encompasses VA staff and veterans of color by way of their status as essential workers or those with comorbidities. However, it is important to address race-based access barriers and vaccine hesitancy to satisfy the equity demands. This effort is underway (eg, engaging community champions and developing tailored educational resources to reach diverse communities).

In addition, pragmatic ethics recognizes that an overly granular, complicated allocation plan would be inefficient to implement. While it might be true that some veterans who are aged < 65 years may be at higher risk from COVID-19 than some elderly veterans, achieving the goals of fairness and transparency requires establishing a vaccine prioritization plan that is both ethically defensible and feasibly implementable (ie, achieves its goal of getting “needles into arms”). For example, veterans aged ≥ 65 years may be invited to schedule their vaccination before younger veterans, but any veteran may be accepted “on-call” for vaccine appointment no-shows via first-come, first-served or by lottery. Flexibility of response is crucial. This played out in adding flexibility around the decision to vaccinate veterans aged ≥ 75 years before those aged 65 to 74 years, after revisiting how this prioritization might affect feasibility and throughput and opting to allow the opportunity to include those aged ≥ 65 years.

There will no doubt be additional modifications to the vaccine allocation plan as more data become available. Since the danger of fueling suspicion and distrust is high (ie, that certain privileged people are jumping the line, as we heard reports of in some non-VA facilities).12 There is an obvious ethical duty to explain why the chosen approach is ethically defensible. VA facility leaders should be able to answer how their approach achieves the goals of avoiding serious or fatal illness, reducing contagion, and preserving the essential workforce while ensuring a fair, respectful, evidence-based, and transparent process.

References

1. US Department of Veterans Affairs. COVID-19 vaccination plan for the Veterans Health Administration. Version 2.0, Published December 14, 2020. Accessed February 3, 2021. https://www.publichealth.va.gov/docs/n-coronavirus/VHA-COVID-Vaccine-Plan-14Dec2020.pdf

2. Hennigann WJ, Park A, Ducharme J. The U.S. fumbled its early vaccine rollout. Will the Biden Administration put America back on track? TIME. January 21, 2021. Accessed February 3, 2021. https://time.com/5932028/vaccine-rollout-joe-biden/

3. US Food and Drug Administration. FDA take key action in fight against COVID-19 by issuing emergency use authorization for first COVID-19 vaccine [press release]. Published December 11, 2020. Accessed February 3, 2021. https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19

4. US Food and Drug Administration. FDA takes additional action in fight against COVID-19 by Issuing emergency use authorization for second COVID-19 vaccine [press release]. Published December 18, 2020. Accessed February 3, 2021. https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid

5. McClung N, Chamberland M, Kinlaw K, et al. The Advisory Committee on Immunization Practices’ Ethical Principles for Allocating Initial Supplies of COVID-19 Vaccine-United States, 2020.  Am J Transplant. 2021;21(1):420-425. doi:10.1111/ajt.16437

6. National Academies of Sciences, Engineering, and Medicine. 2020. Framework for equitable allocation of COVID-19 vaccine. The National Academies Press; 2020.  doi:10.17226/25917

7 . Wood S, Schulman K. Beyond Politics - Promoting Covid-19 vaccination in the United States [published online ahead of print, 2021 Jan 6].  N Engl J Med. 2021;10.1056/NEJMms2033790. doi:10.1056/NEJMms2033790

8 . Matrajt L, Eaton J, Leung T, Brown ER. Vaccine optimization for COVID-19, who to vaccinate first? medRxiv . 2020 Aug 16. doi:10.1101/2020.08.14.20175257

9 . Makary M. Hospitals: stop playing vaccine games and show leadership. Published January 12, 2021. Accessed February 3, 2021. https://www.medpagetoday.com/blogs/marty-makary/90649

10 . Wentling N. Minority veterans to receive priority for coronavirus vaccines. Stars and Stripes. December 10, 2020. Accessed February 3, 2021. https://www.stripes.com/news/us/minority-veterans-to-receive-priority-for-coronavirus-vaccines-1.654624

11 . Kime, P. Minority veterans on VA’s priority list for COVID-19 vaccine distribution. Published December 8, 2020. Accessed February 3, 2021. https://www.military.com/daily-news/2020/12/08/minority-veterans-vas-priority-list-covid-19-vaccine-distribution.html

12 . Rosenthal, E. Yes, it matters that people are jumping the vaccine line. The New York Times . Published January 28, 2021. Accessed February 3, 2021. https://www.nytimes.com/2021/01/28/opinion/covid-vaccine-line.html

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Anita Tarzian is Deputy Executive Director of the US Department Veterans Affairs National Center for Ethics in Health Care. Cynthia Geppert is Editor-in-Chief; Chief, Consultation Psychiatry and Ethics, New Mexico VA Health Care System; and Professor and Director of Ethics Education at the University of New Mexico School of Medicine in Albuquerque. Correspondence: Cynthia Geppert ([email protected])

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Anita Tarzian is a member of the COVID-19 Vaccine Integrated Project Team.

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The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

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Author disclosures
Anita Tarzian is a member of the COVID-19 Vaccine Integrated Project Team.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

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Anita Tarzian is Deputy Executive Director of the US Department Veterans Affairs National Center for Ethics in Health Care. Cynthia Geppert is Editor-in-Chief; Chief, Consultation Psychiatry and Ethics, New Mexico VA Health Care System; and Professor and Director of Ethics Education at the University of New Mexico School of Medicine in Albuquerque. Correspondence: Cynthia Geppert ([email protected])

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Anita Tarzian is a member of the COVID-19 Vaccine Integrated Project Team.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

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The Veterans Health Administration (VHA) COVID-19 vaccine allocation plan showcases several lessons for government and health care leaders in planning for future pandemics.1 Many state governments—underresourced and overwhelmed with other COVID-19 demands—have struggled to get COVID-19 vaccines into the arms of their residents.2 In contrast, the VHA was able to mobilize early to identify vaccine allocation guidelines and proactively prepare facilities to vaccinate VHA staff and veterans as soon as vaccines were approved under Emergency Use Authorization by the US Food and Drug Administration.3,4

In August 2020, VHA formed a COVID-19 Vaccine Integrated Project Team, composed of 6 subgroups: communications, distribution, education, measurement, policy, prioritization, and vaccine safety. The National Center for Ethics in Health Care weighed in on the ethical justification for the developed vaccination risk stratification framework, which was informed by, but not identical to, that recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.5

Prioritizing who gets early access to a potentially life-saving vaccine weighs heavily on those leaders charged with making such decisions. The ethics of scarce resource allocation and triage protocols that may be necessary in a pandemic are often in tension with the patient-centered clinical ethics that health care practitioners (HCPs) encounter. HCPs require assistance in appreciating the ethical rationale for this shift in focus from the preference of the individual to the common good. The same is true for the risk stratification criteria required when there is not sufficient vaccine for all those who could benefit from immunization. Decisions must be transparent to ensure widespread acceptance and trust in the vaccination process. The ethical reasoning and values that are the basis for allocation criteria must be clearly, compassionately, and consistently communicated to the public, as outlined below. Ethical questions or concerns involve a conflict between core values: one of the central tasks of ethical analysis is to identify the available ethical options to resolve value conflicts. Several ethical frameworks for vaccine allocation are available—each balances and weighs the primary values of equity, dignity, beneficence, and utility slightly differently.6

For example, utilitarian ethics looks to produce the most good and avoid the most harm for the greatest number of people. Within this framework, there can be different notions of “good,” for example, saving the most lives, the most life years, the most quality life years, or the lives of those who have more life “innings” ahead. The approach of the US Department of Veterans Affairs (VA) focuses on saving the most lives in combination with avoiding suffering from serious illness, minimizing contagion, and preserving the essential workforce. Frameworks that give primacy to 1 notion of the good (ie, saving the most lives) may deprioritize other beneficial outcomes, such as allowing earlier return to work, school, and leisure activities that many find integral to human flourishing. Other ethical theories and principles may be used to support various allocation frameworks. For example, a pragmatic ethics approach might emphasize the importance of adapting the approach based on the evolving science and innovation surrounding COVID-19. Having more than 1 ethically defensible approach is common; the goal in ethics work is to be open to diversity of thought and reflect on the strength of one’s reasoning in resolving a core values conflict. We identify 2 central tenets of pandemic ethics that inform vaccine allocation.

 

 

1. Pandemic Ethics Requires Proactive Planning and Reevaluation of Continually Evolving Facts

There is an oft quoted saying among bioethicists: “Good ethics begins with good facts.” One obvious challenge during the COVID-19 pandemic has been the difficulty accessing up-to-date facts to inform decision making. If a main goal of a vaccination plan is to minimize the incidence of serious or fatal COVID-19 disease and contagion, myriad data points are needed to identify the best way to do this. For example, if 2 doses of the same vaccine are needed, this impacts the logistics of identifying, inviting, and scheduling eligible individuals and staffing vaccine clinics as well as ensuring that sufficient personal protective equipment and rescue equipment/medication are available to treat allergic reactions. If the adverse effects of vaccines lead to staff absenteeism or vaccine hesitancy, this needs to be factored into logistics.7 Tailored messaging is important to reduce appointment no-shows and vaccine nonadopters.8 Transportation to vaccination sites is a relevant factor: how a vaccine is stored, thawed, and reconstituted and its shelf life impacts whether it can be transported after thawing and what must be provided on site.

Consideration of the multifaceted factors influencing a successful vaccination campaign requires proactive planning and the readiness to pivot when new information is revealed. For example, vaccine appointment no-shows should be anticipated along with a fair process for allocating unused vaccine that would otherwise be wasted. This is an example of responsible stewardship of a scarce and life-saving resource. A higher than anticipated no-show rate would require revisiting a facility’s approach to ensuring that waste is avoided while the process is perceived to be fair and transparent. Ethical theories and principles cannot do all the work here; mindful attention to detail and proactive, informed planning are critical. Fortunately, the VA is well resourced in this domain, whereas many state health departments floundered in their response, causing unnecessary vaccination delays.9

2. Utility: Necessary But Insufficient

Most ethical approaches recognize to some extent that seeking good and minimizing harm is of value. However, a strictly utilitarian approach is insufficient to address the core values in conflict surrounding how best to allocate limited doses of COVID-19 vaccine. For example, some may argue that prioritizing the elderly or those in long-term care facilities like VA’s community living centers because they have the highest COVID-19 mortality rate produces less net benefit than prioritizing younger veterans with comorbidities or certain higher risk essential workers. There are 2 important points to make here.

First, the VHA vaccination plan balances utility with other ethical principles, namely, treating people with equal concern, and addressing health inequities, including a focus on justice and valuing the worth and dignity of each person. Rather than giving everyone an equal chance via lottery, the prioritization plan recognizes that some people have greater need or would stand to better mitigate viral contagion and preserve the essential workforce if they were vaccinated earlier. However, the principle of justice requires that efforts are made to treat like cases the same to avoid perceptions of bias, and to demonstrate respect for the dignity of each individual by way of promoting a fair vaccination process.

This requires transparency, consistency, and delivery of respectful and accurate communication. For example, the VA recognizes that lifetime exposure to social injustice produces health inequities that make Black, Hispanic, and Native American persons more susceptible to contracting COVID-19 and suffering serious or fatal illness. The approach to addressing this inequity is by giving priority to those with higher risk factors. Again, this is an example of blending and balancing ethical principles of utility and justice—that is, recognizing and remedying social injustice is of value both because it will help achieve better outcomes for persons of color and because it is inherently worthwhile to oppose injustice.

However, contrary to some news reports, the VHA approach does not allocate by race/ethnicity alone, as it does by age.10,11 Doing so would present logistical challenges—for example, race/ethnicity is not an objective classification as is age, and reconciling individuals’ self-reports could create confusion or chaos that is antithetical to a fair, streamlined vaccination program. Putting veterans of color at the front of the vaccination line could backfire by amplifying worries that they are being exposed to vaccine that is not fully tested (a common contributor to vaccine hesitancy, particularly among communities of color familiar with prior exploitation and abuse in the name of science).

Discriminating based on race/ethnicity alone in the spirit of achieving equity would be precedent setting for the VA and would require a strong ethical justification. The decision to prioritize for vaccine based on risk factors strives to achieve this balance of equity and utility, as it encompasses VA staff and veterans of color by way of their status as essential workers or those with comorbidities. However, it is important to address race-based access barriers and vaccine hesitancy to satisfy the equity demands. This effort is underway (eg, engaging community champions and developing tailored educational resources to reach diverse communities).

In addition, pragmatic ethics recognizes that an overly granular, complicated allocation plan would be inefficient to implement. While it might be true that some veterans who are aged < 65 years may be at higher risk from COVID-19 than some elderly veterans, achieving the goals of fairness and transparency requires establishing a vaccine prioritization plan that is both ethically defensible and feasibly implementable (ie, achieves its goal of getting “needles into arms”). For example, veterans aged ≥ 65 years may be invited to schedule their vaccination before younger veterans, but any veteran may be accepted “on-call” for vaccine appointment no-shows via first-come, first-served or by lottery. Flexibility of response is crucial. This played out in adding flexibility around the decision to vaccinate veterans aged ≥ 75 years before those aged 65 to 74 years, after revisiting how this prioritization might affect feasibility and throughput and opting to allow the opportunity to include those aged ≥ 65 years.

There will no doubt be additional modifications to the vaccine allocation plan as more data become available. Since the danger of fueling suspicion and distrust is high (ie, that certain privileged people are jumping the line, as we heard reports of in some non-VA facilities).12 There is an obvious ethical duty to explain why the chosen approach is ethically defensible. VA facility leaders should be able to answer how their approach achieves the goals of avoiding serious or fatal illness, reducing contagion, and preserving the essential workforce while ensuring a fair, respectful, evidence-based, and transparent process.

The Veterans Health Administration (VHA) COVID-19 vaccine allocation plan showcases several lessons for government and health care leaders in planning for future pandemics.1 Many state governments—underresourced and overwhelmed with other COVID-19 demands—have struggled to get COVID-19 vaccines into the arms of their residents.2 In contrast, the VHA was able to mobilize early to identify vaccine allocation guidelines and proactively prepare facilities to vaccinate VHA staff and veterans as soon as vaccines were approved under Emergency Use Authorization by the US Food and Drug Administration.3,4

In August 2020, VHA formed a COVID-19 Vaccine Integrated Project Team, composed of 6 subgroups: communications, distribution, education, measurement, policy, prioritization, and vaccine safety. The National Center for Ethics in Health Care weighed in on the ethical justification for the developed vaccination risk stratification framework, which was informed by, but not identical to, that recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.5

Prioritizing who gets early access to a potentially life-saving vaccine weighs heavily on those leaders charged with making such decisions. The ethics of scarce resource allocation and triage protocols that may be necessary in a pandemic are often in tension with the patient-centered clinical ethics that health care practitioners (HCPs) encounter. HCPs require assistance in appreciating the ethical rationale for this shift in focus from the preference of the individual to the common good. The same is true for the risk stratification criteria required when there is not sufficient vaccine for all those who could benefit from immunization. Decisions must be transparent to ensure widespread acceptance and trust in the vaccination process. The ethical reasoning and values that are the basis for allocation criteria must be clearly, compassionately, and consistently communicated to the public, as outlined below. Ethical questions or concerns involve a conflict between core values: one of the central tasks of ethical analysis is to identify the available ethical options to resolve value conflicts. Several ethical frameworks for vaccine allocation are available—each balances and weighs the primary values of equity, dignity, beneficence, and utility slightly differently.6

For example, utilitarian ethics looks to produce the most good and avoid the most harm for the greatest number of people. Within this framework, there can be different notions of “good,” for example, saving the most lives, the most life years, the most quality life years, or the lives of those who have more life “innings” ahead. The approach of the US Department of Veterans Affairs (VA) focuses on saving the most lives in combination with avoiding suffering from serious illness, minimizing contagion, and preserving the essential workforce. Frameworks that give primacy to 1 notion of the good (ie, saving the most lives) may deprioritize other beneficial outcomes, such as allowing earlier return to work, school, and leisure activities that many find integral to human flourishing. Other ethical theories and principles may be used to support various allocation frameworks. For example, a pragmatic ethics approach might emphasize the importance of adapting the approach based on the evolving science and innovation surrounding COVID-19. Having more than 1 ethically defensible approach is common; the goal in ethics work is to be open to diversity of thought and reflect on the strength of one’s reasoning in resolving a core values conflict. We identify 2 central tenets of pandemic ethics that inform vaccine allocation.

 

 

1. Pandemic Ethics Requires Proactive Planning and Reevaluation of Continually Evolving Facts

There is an oft quoted saying among bioethicists: “Good ethics begins with good facts.” One obvious challenge during the COVID-19 pandemic has been the difficulty accessing up-to-date facts to inform decision making. If a main goal of a vaccination plan is to minimize the incidence of serious or fatal COVID-19 disease and contagion, myriad data points are needed to identify the best way to do this. For example, if 2 doses of the same vaccine are needed, this impacts the logistics of identifying, inviting, and scheduling eligible individuals and staffing vaccine clinics as well as ensuring that sufficient personal protective equipment and rescue equipment/medication are available to treat allergic reactions. If the adverse effects of vaccines lead to staff absenteeism or vaccine hesitancy, this needs to be factored into logistics.7 Tailored messaging is important to reduce appointment no-shows and vaccine nonadopters.8 Transportation to vaccination sites is a relevant factor: how a vaccine is stored, thawed, and reconstituted and its shelf life impacts whether it can be transported after thawing and what must be provided on site.

Consideration of the multifaceted factors influencing a successful vaccination campaign requires proactive planning and the readiness to pivot when new information is revealed. For example, vaccine appointment no-shows should be anticipated along with a fair process for allocating unused vaccine that would otherwise be wasted. This is an example of responsible stewardship of a scarce and life-saving resource. A higher than anticipated no-show rate would require revisiting a facility’s approach to ensuring that waste is avoided while the process is perceived to be fair and transparent. Ethical theories and principles cannot do all the work here; mindful attention to detail and proactive, informed planning are critical. Fortunately, the VA is well resourced in this domain, whereas many state health departments floundered in their response, causing unnecessary vaccination delays.9

2. Utility: Necessary But Insufficient

Most ethical approaches recognize to some extent that seeking good and minimizing harm is of value. However, a strictly utilitarian approach is insufficient to address the core values in conflict surrounding how best to allocate limited doses of COVID-19 vaccine. For example, some may argue that prioritizing the elderly or those in long-term care facilities like VA’s community living centers because they have the highest COVID-19 mortality rate produces less net benefit than prioritizing younger veterans with comorbidities or certain higher risk essential workers. There are 2 important points to make here.

First, the VHA vaccination plan balances utility with other ethical principles, namely, treating people with equal concern, and addressing health inequities, including a focus on justice and valuing the worth and dignity of each person. Rather than giving everyone an equal chance via lottery, the prioritization plan recognizes that some people have greater need or would stand to better mitigate viral contagion and preserve the essential workforce if they were vaccinated earlier. However, the principle of justice requires that efforts are made to treat like cases the same to avoid perceptions of bias, and to demonstrate respect for the dignity of each individual by way of promoting a fair vaccination process.

This requires transparency, consistency, and delivery of respectful and accurate communication. For example, the VA recognizes that lifetime exposure to social injustice produces health inequities that make Black, Hispanic, and Native American persons more susceptible to contracting COVID-19 and suffering serious or fatal illness. The approach to addressing this inequity is by giving priority to those with higher risk factors. Again, this is an example of blending and balancing ethical principles of utility and justice—that is, recognizing and remedying social injustice is of value both because it will help achieve better outcomes for persons of color and because it is inherently worthwhile to oppose injustice.

However, contrary to some news reports, the VHA approach does not allocate by race/ethnicity alone, as it does by age.10,11 Doing so would present logistical challenges—for example, race/ethnicity is not an objective classification as is age, and reconciling individuals’ self-reports could create confusion or chaos that is antithetical to a fair, streamlined vaccination program. Putting veterans of color at the front of the vaccination line could backfire by amplifying worries that they are being exposed to vaccine that is not fully tested (a common contributor to vaccine hesitancy, particularly among communities of color familiar with prior exploitation and abuse in the name of science).

Discriminating based on race/ethnicity alone in the spirit of achieving equity would be precedent setting for the VA and would require a strong ethical justification. The decision to prioritize for vaccine based on risk factors strives to achieve this balance of equity and utility, as it encompasses VA staff and veterans of color by way of their status as essential workers or those with comorbidities. However, it is important to address race-based access barriers and vaccine hesitancy to satisfy the equity demands. This effort is underway (eg, engaging community champions and developing tailored educational resources to reach diverse communities).

In addition, pragmatic ethics recognizes that an overly granular, complicated allocation plan would be inefficient to implement. While it might be true that some veterans who are aged < 65 years may be at higher risk from COVID-19 than some elderly veterans, achieving the goals of fairness and transparency requires establishing a vaccine prioritization plan that is both ethically defensible and feasibly implementable (ie, achieves its goal of getting “needles into arms”). For example, veterans aged ≥ 65 years may be invited to schedule their vaccination before younger veterans, but any veteran may be accepted “on-call” for vaccine appointment no-shows via first-come, first-served or by lottery. Flexibility of response is crucial. This played out in adding flexibility around the decision to vaccinate veterans aged ≥ 75 years before those aged 65 to 74 years, after revisiting how this prioritization might affect feasibility and throughput and opting to allow the opportunity to include those aged ≥ 65 years.

There will no doubt be additional modifications to the vaccine allocation plan as more data become available. Since the danger of fueling suspicion and distrust is high (ie, that certain privileged people are jumping the line, as we heard reports of in some non-VA facilities).12 There is an obvious ethical duty to explain why the chosen approach is ethically defensible. VA facility leaders should be able to answer how their approach achieves the goals of avoiding serious or fatal illness, reducing contagion, and preserving the essential workforce while ensuring a fair, respectful, evidence-based, and transparent process.

References

1. US Department of Veterans Affairs. COVID-19 vaccination plan for the Veterans Health Administration. Version 2.0, Published December 14, 2020. Accessed February 3, 2021. https://www.publichealth.va.gov/docs/n-coronavirus/VHA-COVID-Vaccine-Plan-14Dec2020.pdf

2. Hennigann WJ, Park A, Ducharme J. The U.S. fumbled its early vaccine rollout. Will the Biden Administration put America back on track? TIME. January 21, 2021. Accessed February 3, 2021. https://time.com/5932028/vaccine-rollout-joe-biden/

3. US Food and Drug Administration. FDA take key action in fight against COVID-19 by issuing emergency use authorization for first COVID-19 vaccine [press release]. Published December 11, 2020. Accessed February 3, 2021. https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19

4. US Food and Drug Administration. FDA takes additional action in fight against COVID-19 by Issuing emergency use authorization for second COVID-19 vaccine [press release]. Published December 18, 2020. Accessed February 3, 2021. https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid

5. McClung N, Chamberland M, Kinlaw K, et al. The Advisory Committee on Immunization Practices’ Ethical Principles for Allocating Initial Supplies of COVID-19 Vaccine-United States, 2020.  Am J Transplant. 2021;21(1):420-425. doi:10.1111/ajt.16437

6. National Academies of Sciences, Engineering, and Medicine. 2020. Framework for equitable allocation of COVID-19 vaccine. The National Academies Press; 2020.  doi:10.17226/25917

7 . Wood S, Schulman K. Beyond Politics - Promoting Covid-19 vaccination in the United States [published online ahead of print, 2021 Jan 6].  N Engl J Med. 2021;10.1056/NEJMms2033790. doi:10.1056/NEJMms2033790

8 . Matrajt L, Eaton J, Leung T, Brown ER. Vaccine optimization for COVID-19, who to vaccinate first? medRxiv . 2020 Aug 16. doi:10.1101/2020.08.14.20175257

9 . Makary M. Hospitals: stop playing vaccine games and show leadership. Published January 12, 2021. Accessed February 3, 2021. https://www.medpagetoday.com/blogs/marty-makary/90649

10 . Wentling N. Minority veterans to receive priority for coronavirus vaccines. Stars and Stripes. December 10, 2020. Accessed February 3, 2021. https://www.stripes.com/news/us/minority-veterans-to-receive-priority-for-coronavirus-vaccines-1.654624

11 . Kime, P. Minority veterans on VA’s priority list for COVID-19 vaccine distribution. Published December 8, 2020. Accessed February 3, 2021. https://www.military.com/daily-news/2020/12/08/minority-veterans-vas-priority-list-covid-19-vaccine-distribution.html

12 . Rosenthal, E. Yes, it matters that people are jumping the vaccine line. The New York Times . Published January 28, 2021. Accessed February 3, 2021. https://www.nytimes.com/2021/01/28/opinion/covid-vaccine-line.html

References

1. US Department of Veterans Affairs. COVID-19 vaccination plan for the Veterans Health Administration. Version 2.0, Published December 14, 2020. Accessed February 3, 2021. https://www.publichealth.va.gov/docs/n-coronavirus/VHA-COVID-Vaccine-Plan-14Dec2020.pdf

2. Hennigann WJ, Park A, Ducharme J. The U.S. fumbled its early vaccine rollout. Will the Biden Administration put America back on track? TIME. January 21, 2021. Accessed February 3, 2021. https://time.com/5932028/vaccine-rollout-joe-biden/

3. US Food and Drug Administration. FDA take key action in fight against COVID-19 by issuing emergency use authorization for first COVID-19 vaccine [press release]. Published December 11, 2020. Accessed February 3, 2021. https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19

4. US Food and Drug Administration. FDA takes additional action in fight against COVID-19 by Issuing emergency use authorization for second COVID-19 vaccine [press release]. Published December 18, 2020. Accessed February 3, 2021. https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid

5. McClung N, Chamberland M, Kinlaw K, et al. The Advisory Committee on Immunization Practices’ Ethical Principles for Allocating Initial Supplies of COVID-19 Vaccine-United States, 2020.  Am J Transplant. 2021;21(1):420-425. doi:10.1111/ajt.16437

6. National Academies of Sciences, Engineering, and Medicine. 2020. Framework for equitable allocation of COVID-19 vaccine. The National Academies Press; 2020.  doi:10.17226/25917

7 . Wood S, Schulman K. Beyond Politics - Promoting Covid-19 vaccination in the United States [published online ahead of print, 2021 Jan 6].  N Engl J Med. 2021;10.1056/NEJMms2033790. doi:10.1056/NEJMms2033790

8 . Matrajt L, Eaton J, Leung T, Brown ER. Vaccine optimization for COVID-19, who to vaccinate first? medRxiv . 2020 Aug 16. doi:10.1101/2020.08.14.20175257

9 . Makary M. Hospitals: stop playing vaccine games and show leadership. Published January 12, 2021. Accessed February 3, 2021. https://www.medpagetoday.com/blogs/marty-makary/90649

10 . Wentling N. Minority veterans to receive priority for coronavirus vaccines. Stars and Stripes. December 10, 2020. Accessed February 3, 2021. https://www.stripes.com/news/us/minority-veterans-to-receive-priority-for-coronavirus-vaccines-1.654624

11 . Kime, P. Minority veterans on VA’s priority list for COVID-19 vaccine distribution. Published December 8, 2020. Accessed February 3, 2021. https://www.military.com/daily-news/2020/12/08/minority-veterans-vas-priority-list-covid-19-vaccine-distribution.html

12 . Rosenthal, E. Yes, it matters that people are jumping the vaccine line. The New York Times . Published January 28, 2021. Accessed February 3, 2021. https://www.nytimes.com/2021/01/28/opinion/covid-vaccine-line.html

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