Vaccine.

Bioethics: What Is It Good for? COVID-19 Vaccine Allocation Plans and Realities

By Carmel Shachar

Looking back at the first month of COVID-19 vaccine administration, it is clear that something was lost in the translation of vaccine allocation plans into reality.

What went wrong?

Throughout the fall and early winter, in preparation of the approval of the Pfizer and Moderna vaccines, bioethicists and health policy scholars worked with policymakers, regulators, patient advocates, and other stakeholders to articulate ethical ways to allocate a scarce medical resource to a population hungry for it.

Virtually all of these vaccine prioritization plans coalesced along similar lines: vaccinate health care workers first, followed by people who are uniquely vulnerable because of health conditions (such as age or preexisting conditions) or because of other factors (such as occupation or residence in a group living facility). The convergence of these plans suggests that these frameworks meet a certain sense of fairness and justice for most Americans. There was not a lot of controversy over the frameworks as they were announced in late 2020 and early 2021.

But, by late January 2021, it has become quite apparent that the United States is struggling to effectively administer its inventory of COVID-19 vaccines. The U.S. failed to meet Operation Warp Speed’s stated goal of administering 20 million doses by the end of 2020. Only 54% of the shots distributed by the federal government to the states have been administered by January 25, 2021, and only now, nearly one month into the new year, has the U.S. met its 2020 goal. As of writing, 22.4 million doses have been administered.

What can bioethicists learn from this experience to help guide the allocation of future scarce medical resources? And how can we get COVID-19 vaccine administration back on target?

This experience is a good reminder that meaningful bioethics does not exist in a vacuum. Articulating ethical principles that can help drive real world decisions is an important task for bioethicists. But so is placing these ethical choices in broader context. Funding for COVID-19 vaccine administration lagged way behind the money provided for the development of vaccines. Only now, with the start of the Biden Administration, are we seeing a real commitment to supporting a national vaccination program.

It is not that this failure to fund a vaccination program lies squarely at the feet of bioethicists, or that more advocacy from this field could have swayed the previous Administration into greater public health spending. But it is the responsibility of those developing the principles that should guide the fair and ethical distribution of COVID-19 vaccines to flag the impediments to achieving equity and justice. This should have included calls for significant support for frameworks to deliver the vaccine.

Similarly, understanding the cultural, social, and other factors that drive individual choices is an important imperative.

Many of these allocation frameworks were developed with racial justice issues in mind, influenced by a summer in which advocates refused to be silenced. But these allocation frameworks also needed to come with a greater understanding of the historical relationships between certain communities and providers. Black Americans have consistently polled as more vaccine hesitant than white Americans, perhaps influenced by a history that includes Tuskegee and Henrietta Lacks. Should bioethicists have focused more on encouraging translational and educational work?

The digital divide puts lower income individuals, especially those of color, at a disadvantage for vaccine appointments when those appointments are made largely through an online scheduling system. Should bioethicists have spent less time on prioritization categories and more time advocating for registration systems that would incorporate principles of equity? How can bioethicists educate themselves to the point where issues such as the digital divide would occur to them as they are asked to consider prioritization questions?

Lastly, the old adage keep it simple stupid is probably relevant. In an ideal world, we would administer the COVID-19 vaccine according to the prioritization plans smoothly. But jumping the vaccine line is not like cutting a bread line, or even like getting access to a ventilator. When I get bread I am not entitled to, only I can enjoy the benefits of eating bread. When I get vaccinated, even if I was not the “most deserving,” others benefit from the reduced spread of infection and demands on the health care system.

Over and over again, physicians, hospitals, and health centers have had to choose between violating the allocation frameworks or letting vaccines go to waste. New York State initially threatened sanctions and even considered a law that would criminalize administration of the COVID-19 vaccines that did not follow the distribution guidelines. The intentions were good — prevent the wealthy and well connected from hustling the vaccine away from those who are more vulnerable — but the execution had a chilling effect.

While the Department of Health and Human Services has urged states to relax their prioritization requirements, and many states have responded by doing so, most states are still struggling with how to get the vaccines out into the community.

There will be extensive post-mortems, academic analyses, and case studies published on why the vaccine roll out has been so challenging. Some factors would be present no matter what: the holidays were always going to delay initial uptake, for example. Hospitals and pharmacies were always going to have a learning curve in administering vaccines that require very cold temperature storage.

But perhaps it would have been more realistic to acknowledge from the start that our system is not equipped to handle such nuanced, and restrictive, prioritization plans, and instead identify the one or two groups who absolutely need early access (e.g., health care workers) and otherwise work to support the fastest and smoothest roll out that can be achieved, in hopes of controlling the pandemic as quickly as possible.

Carmel Shachar

Carmel Shachar, JD, MPH, is Assistant Clinical Professor of Law and Faculty Director of the Health Law and Policy Clinic at the Center for Health Law and Policy Innovation of Harvard Law School (CHLPI). Previously, Shachar was the Executive Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

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