COVID-19 Vaccine Allocation: Ethical Concerns, Practical Challenges

The coronavirus pandemic is continuing to wreak havoc not only on the health and economy of the US but on countries globally. In the event of a likely scarcity of vaccines, a framework must be developed to inform who should get priority. However, the decision as to who should get priority in receiving vaccination is fraught with thorny ethical and practical issues. Numerous organizations and advisory groups have proposed frameworks for equitable and effective vaccine allocation, including the World Health Organization,³ the Centers for Disease Control and Prevention (CDC),⁴ and the National Academy of Sciences, Engineering, and Medicine.²

To shed light on the ethical complexities of COVID-19 vaccine allocation, we interviewed David Marcus MD Clinical Ethicist at LIJ Medical Center in New York and former Director of the Medical Ethics Curriculum at the Zucker School of Medicine at Hofstra/Northwell. Dr Marcus is also a practicing emergency physician and internist. 

There are many currently proposed frameworks for vaccine allocation. Which do you feel to be closest to your approach?

The recently published framework of the National Academy of Sciences, Engineering, and Medicine² makes sense. Like other frameworks, it assumes that there likely will not immediately be enough vaccines for everyone and, assuming the vaccine is safe, there are certain people who should be prioritized, based on their risk of exposure.

But what is nice and novel about their statement is that they lay out “allocation phases,” which they describe as “successive deployment” and that they explicitly aim to “mitigate health inequities.” In other words, within each phase, all groups should have equal priority.

Can you please elaborate on what that means?

The CDC has a Social Vulnerability Index (SVI) and an even more specific COVID-19 Community Vulnerability Index (CCVI).

Given that people of color have been disproportionately affected by COVID-19, using these indices informs focusing on specific needs of those communities, rather than particular racial and/or ethnic groups.²

It is also important that the statement suggested that local governments, states, and tribal governments should focus on allocating vaccines, with an eye toward social justice. Regardless of the phase of distribution, social justice should always be centralized.

There are 4 values in medical practice and medical ethics: autonomy (self-determination), beneficence, nonmaleficence, and social/distributive justice. Of these 4 pillars, the last one often gets overlooked, so I am glad that this statement has focused on it.

What factors contribute to the vulnerability of these populations to excessive morbidity, mortality, and disease transmission in COVID-19?

The vulnerability to the severe impact of COVID-19 in these populations is multifactorial. According to the CDC, the disproportionate impact reflects social determinants of health, such as poverty and health care access, discrimination, and crowded housing. Additionally, more people from ethnic and racial minorities are employed in “essential” occupations in high-risk settings, such as health care facilities, farms, factories, grocery stores, and public transportation.⁵

For example, some reports⁶ suggest that early in the pandemic, the rates of COVID-19 diagnosis were higher among employees in health care settings (eg, housekeeping, maintenance, and food and nutrition services), who were not working in “patient facing” roles and therefore could not be expected to face as high a risk. There appears to be evidence that many of these infections are more attributable to social determinants of health, since they all had the same personal protective equipment.^7,8

What role do these factors play in the overall framework proposed by the National Academy of Sciences, Engineering, and Medicine?

The National Academy of Sciences, Engineering, and Medicine’s statement lays out 4 risk-based criteria in the “foundational principles” used to inform the framework. The first is the risk of contracting COVID-19, which looks specifically at settings where the virus is circulating and people could have greater exposure as a result.

The second prioritizes individuals with a higher risk of severe morbidity and mortality if they acquire the infection. The third looks at the role of an individual in the lives of others, for example, those who perform functions in which societal or family lives or livelihoods depend on them and would be endangered if they are unable to perform those functions should be given priority.

Lastly, people who have a high likelihood of transmitting the infection to others should also be prioritized.

You mentioned earlier “assuming a vaccine is safe.” What are your concerns?

One concern is the timeline for vaccine availability. There is a strong push to make a vaccine available sooner without sufficient time for phase 3 and phase 4 clinical trials. Will we be bypassing our standards under political pressure, or will the speed of getting the vaccine out genuinely offer benefit, meaning that it would be efficacious in disease prevention and also safe.

The first few years after a new vaccination may be considered a “trial,” although a much larger trial. Once the vaccine has been established as safe and effective in several thousands of people, it can be distributed to millions of people, but the first recipients are potentially subject to very rare complications that may not have been seen before general distribution.

Fortunately, the US Food and Drug Administration (FDA) is putting the breaks on too-rapid vaccine approval. A statement issued by the FDA was reassuring. “We are committed to expediting the development of COVID-19 vaccines, but not at the expense of sound science and decision making. We will not jeopardize the public’s trust in our science-based, independent review of these or any vaccines. There’s too much at stake.”⁹

Another example is that pregnant women are typically not included in trials because it is ethically hard to make a case for exposing a fetus to a potentially unsafe vaccine. So we do not know how to predict the response to the vaccine in pregnant women. Will they be protected against the virus? Will the fetus be impacted? These questions will not be answered until the vaccine has been around for much longer.

The National Academy of Sciences, Engineering, and Medicine’s statement does raise this concern, noting that pregnant women are not generally prioritized to receive new vaccines, in light of the potential for fetal harm, and have also been excluded from trials for the same reason. On the other hand, some research suggests that pregnant women are at greater risk for contracting COVID-19, or having a more serious disease course, and for giving birth to preterm babies, or babies who require neonatal intensive care.¹⁰

Beyond ethical concerns, do you see any practical challenges in bringing the vaccines to the public?

Vaccination programs only work if they are widely adopted. Once vaccination rates go down, herd immunity is lost and small local outbreaks can turn into larger outbreaks.¹¹ There are rough estimates, suggesting that the immunity rate for COVID-19 might be around 70% to 80%, but this is not clear.¹² The current skepticism of vaccination is likely one of the greatest obstacles in bringing vaccines to the public.

One of the antidotes to this is education. Once a vaccine has been shown to be safe, the risk to an individual is almost negligible, while the risk from COVID-19 is significantly higher.

I know many people who have become very ill or have died of COVID-19, not only patients but also family and friends. Similar to concerns about the MMR [measles-mumps-rubella] vaccine, where some parents are concerned that it might cause autism, based on manipulated and false data, education is needed to clarify misunderstandings. This can be done not only with one’s own patients but via social media, which is a source of a great deal of misinformation. I frequently use social media for this purpose.

References

1. Alberto Giubilini, Julian Savulescu, Dominic Wilkinson, COVID-19 vaccine: vaccinate the young to protect the old? Journal of Law and the Biosciences, Volume 7, Issue 1, January-June 2020.
2. National Academies of Sciences, Engineering, and Medicine 2020. Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press. https://doi.org/10.17226/25917.
3. World Health Organization (WHO). WHO SAGE values framework for the allocation and prioritization of COVID-19 vaccination, 14 September 2020. Available at: https://apps.who.int/iris/handle/10665/334299. Accessed: October 14, 2020.
4. Centers for Disease Control and Prevention (CDC). ACIP COVID-19 Work Group. Available at: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-08/COVID-08-Dooling.pdf. Accessed: September 24, 2020.
5. Centers for Disease Control and Prevention (CDC). Health Equity Considerations and Racial and Ethnic Minority Groups. Available at: https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/race-ethnicity.html. Accessed: September 20, 2020.
6. Boodman E. In the Covid-19 death of a hospital food worker, a microcosm of the pandemic. Stat. June 30, 2020. Available at: https://www.statnews.com/2020/06/30/covid19-death-of-hospital-food-worker-a-microcosm-of-pandemic/. Accessed: October 21, 2020.
7. Tai DBG, Shah A, Doubeni CA, Sia IG, Wieland ML. The Disproportionate Impact of COVID-19 on Racial and Ethnic Minorities in the United States. Clin Infect Dis. 2020 Jun 20:ciaa815.
8. Tyan K, Cohen PA. Investing in Our First Line of Defense: Environmental Services Workers. Ann Intern Med. 2020 Aug 18;173(4):306-307. 
9. US Food and Drug Administration (FDA). COVID-19 vaccines. Available at: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines. Accessed: October 20, 2020.
10. Allotey J, Stallings E, Bonet M, Yap M, Chatterjee S, Kew T, et al. Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus disease 2019 in pregnancy: living systematic review and meta-analysis. BMJ. 2020 Sep 1;370:m3320. 
11. Randolph HE, Barreiro LB. Herd Immunity: Understanding COVID-19. Immunity. 2020 May 19;52(5):737-741.
12. Kwok KO, Lai F, Wei WI, Wong SYS, Tang JWT. Herd immunity – estimating the level required to halt the COVID-19 epidemics in affected countries. J Infect. 2020;80(6):e32-e33.

This article originally appeared on MPR