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Bioethics in a Pandemic: Draft Framework for Equitable Allocation of COVID-19 Vaccine

As you know, the Draft Preliminary Framework for Equitable Allocation of COVID-19 Vaccine (the “Draft Framework”) was released earlier this week, and we are highlighting its major sections as stakeholders prepare to submit comments by Friday, September 4th.  Building on the lessons learned from past allocation frameworks, this post highlights the key provisions of the Draft Framework.

Foundational Principles

The Draft Framework centers on six foundational principles, which largely overlap with the bioethics principles we have been discussing. The foundational principles were used to inform the committee’s discussions about vaccine allocation and justify specific decisions made about criteria and phasing. The six principles are:

  1. Maximization of Benefits: The obligation to protect and promote the public’s health and its socioeconomic well-being in the short and long-term. Its primary goal is to maximize societal benefit through the reduction of morbidity and mortality caused by the transmission of the novel coronavirus. The framework seeks to reduce the risks of severe morbidity and mortality for those (a) most at risk of infection and serious outcomes, (b) in roles considered essential for societal functions, and (c) most at risk of transmitting the coronavirus to others.  This includes those whose work puts them at additional risk of infection, as well as those whose absence from societal roles or work puts others and the society at risk of loss of needed goods and services if they become infected (e.g., physicians, nurses, health care providers, first responders, workers employed in the food supply system, transportation works, teachers, etc.).
  2. Equal Regard: The obligation to consider each person of equal dignity, worth, and value.  It requires the allocation and distribution of vaccine to be nondiscriminatory in design and impact. 
  3. Mitigation of Health Inequities: The obligation to acknowledge and address disparate health outcomes in specific populations.  The committee points out that COVID-19 infections and deaths are strongly associated with race, ethnicity, occupation, and socioeconomic status.  In fact, COVID-19 has a significantly higher burden in Black, Hispanic or Latinx, and American Indian and Alaska Native populations.  Further, “There is currently no evidence that this is biologically mediated, but rather the impact of systemic racism leading to higher rates of comorbidities that increase the severity of COVID-19 infection and the socioeconomic factors that increase likelihood of acquiring the infection (front line jobs, crowded living conditions, lack of access to personal protective equipment, inability to work from home).” Mitigating these health inequities is a moral imperative of an equitable vaccination allocation system and requires developing and deploying distribution systems so that people who are allocated a vaccine actually receive it and can afford it.
  4. Fairness: Requires impartiality, uniformity and procedural fairness. This reflects the fundamental obligation to develop allocation criteria based only on relevant non-discriminatory characteristics.  Criteria should focus on individual, community, and social needs and risks, and avoid conventional practices that create and sustain discrimination. Fairness should also guide the application of the criteria.
  5. Evidence-based: Vaccine allocation and distribution must be evidenced-based to achieve the rest of the goals. The Draft Framework must be capable of adapting to new evidence as it becomes available.
  6. Transparency: Communicating with the public in an open, clear, accurate, and straightforward way that ensures community understanding. Clear and articulate explanation of the allocation criteria is key in this process – including the principles and the procedures for implementation.

Primary Goal of the Draft Framework

Using the foundational principles and drawing on the ethics literature, the committee established overarching goal to succinctly communicate the main objective of its Draft Framework:

"Maximize societal benefit by reducing morbidity and mortality caused by transmission of the novel coronavirus."

Note that this goal has two focuses: preventing morbidity/mortality and reducing transmission. The Draft Framework emphasizes prevention of morbidity and mortality in early phases of the vaccine allocation plan, with increasing focus on transmission in later phases.

Allocation Criteria

Next, the commission outlined four risk-based criteria used for assessing the vaccine priority level of various demographic and occupational groups. Each group examined by the commission received a mark of high, medium, or low depending on their perceived risk for each criterion. The criteria are:

  • Risk of Acquiring Infection: Individuals have higher priority to the extent that they have a greater probability of being in settings where COVID-19 is circulating and exposure to a sufficient dose of the virus.
  • Risk of Severe Morbidity and Mortality: Individuals have higher priority to the extent that they have a greater probability of severe disease or death if they acquire infection.
  • Risk of Negative Social Impact: Individuals have higher priority to the extent that societal function and other individuals’ lives and livelihood depend on them directly and would be imperiled if they fell ill.
  • Risk of Transmitting Disease to Others: Individuals have higher priority to the extent that there is a higher probability that they will transmit the disease to others.

Allocation Phases

The committee recommends a four-phased allocation plan to guide the distribution of an eventual coronavirus vaccine. In each population, vaccine access should be prioritized for geographic areas identified via the CDC’s Social Vulnerability Index. The phases are:

  • Phase 1
    • Phase 1a “Jumpstart Phase” – high-risk workers in health care facilities; first responders
    • Phase 1b – people of all ages with comorbid and underlying conditions that put them at significantly higher risk; older adults living in congregate or overcrowded settings
  • Phase 2
    • Critical risk workers; workers who are both essential to the functions of society and at a substantially high risk of exposure
    • Teachers and school staff
    • People of all ages with comorbid and underlying conditions that put them at moderately higher risk
    • All older adults not included in Phase 1
    • People in homeless shelters or group homes for individuals with physical or mental disabilities or in recovery
    • People in prisons, jails, detention centers, and similar facilities, and staff who work in such settings
  • Phase 3
    • Young adults
    • Children
    • Workers in industries essential to be functions of society and at increased risk of exposure not included in Phase 1 or 2
  • Phase 4
    • Everyone residing in the US who did not receive a vaccine in the previous phases

The committee expects 15% of the US population to be covered under Phase 1; 45-50% under Phase 2; 85-95% under Phase 3; and 100% of the population by Phase 4.

What’s Next?

Comments are due to the committee by the end of the day today, Friday September 4th.  In our second post today, we'll take a look at some uncertainties as to how the allocation framework might be implemented. 

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Bridgette advises health care providers, ACOs, health plans, PBMs, and laboratories on regulatory, fraud and abuse, and business planning matters, applying her experience in health system administration and ethics in health care to her health law practice.

David Friedman

Project Analyst