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

Earlier this month, the National Academies Committee on Equitable Allocation of Vaccine for the Novel Coronavirus released its Final Framework to guide US distribution and administration of a COVID-19 vaccine, once available. The nuts and bolts of the Final Framework remain largely the same as the Draft Framework we covered previously in our Bioethics Blog Series. After a quick review of the Allocation Phases here, we explore a few areas in the Final Framework the Committee expanded on and responded to stakeholder comments.

Allocation Phases: Who Should Receive the Vaccine first?

The phases set out in the Draft Framework remain the same. As a refresher, here is the order in which individuals would be recommended to receive the vaccine:

  • 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

Risk Communication and Community Engagement

Based on extensive stakeholder feedback regarding transparency and equity, the Final Framework encourages the relevant authorities to provide information on the vaccine’s safety and effectiveness as soon as possible “so that people can decide whether they want [the vaccine] for themselves and their families.” As part of this, the framework encourages general risk communications to be:

  • Consistent with existing scientific evidence,
  • Consistent with one another (avoiding conflicting communications),
  • Responsive to public needs,
  • Tested for comprehension by members of the target audience, and
  • Delivered by trusted sources through effective channels.

Community engagement, or the two-way communication between officials and the public, is another key method to increase accessible information about the vaccine, especially among diverse community groups. The Committee urges that community engagement:

  • Be a continuous process,
  • Use multiple channels to ensure all members of the public are reached,
  • Occur in a timely manner, and
  • Establish trust between officials and the public.

Achieving Acceptance of the Vaccine

Vaccine hesitancy was voiced as a paramount concern by public health stakeholders during the public comment period, so it’s no surprise that the Final Framework includes a more thorough chapter dedicated to the topic. After documenting the historic rise of vaccine hesitancy and anti-vaccine sentiments, the Committee cites the World Health Organization’s Behavioral and Social Drivers of Vaccination (BeSD) model as the guiding framework in combatting vaccine hesitancy. The BeSD model addresses root causes of vaccine hesitancy stemming from social and emotional motivations – i.e., perceived risk, worry, confidence, social norms, rumors – as well as barriers arising from practical issues – i.e., vaccine availability, convenience, costs, incentives, and intervention fatigue, among others.

The Committee stresses that any strategies to combat vaccine hesitancy must be tailored to address the specific concerns and context of the target population. The Committee notes that diverse communities will have differing motivations, barriers, and reasons for refusing vaccination; public health officials’ responses to vaccine hesitancy should reflect these differences.

There is no “one-size-fits-all” solution to vaccine hesitancy, and nuanced approaches are key to ensuring that existing health inequities are addressed and to ensuring that those who are hesitant do not turn to outright vaccine refusal.

Ensuring Global Equity

The Final Framework encourages global cooperation throughout the development and administration of a future COVID-19 vaccine. The Committee notes that vaccine nationalism, or the lack of international cooperation, can result in highly fragmented and less-than-optimal results such as cost-ineffectiveness, redundant investments, and inefficiency.

The Committee points to the COVAX Facility – a global financing, development, and distribution plan for the COVID-19 vaccine – as a key means of achieving global cooperation and reducing the harmful potential effects of vaccine nationalism. Although the United States has so far opted-out of COVAX participation, the Committee asserts that COVAX’s benefits include:

  • Insurance. In the event that a safe and effective vaccine is developed outside the United States prior to within the United States, Americans would have earlier access to a vaccine.
  • A threat anywhere is a threat everywhere. Given the United States’ global trade interests, military deployments, and citizens living abroad, American interests are at stake abroad.
  • Global health security. Investment in COVAX may better prepare the international community for future pandemics and health crises.
  • A historic and successful partnership. Investment in COVAX would continue 20 years of prior US support to GAVI (a global vaccine alliance) and “expand the influence of one of the largest U.S. development partnerships.”
  • Future domestic pandemic preparedness. Insights and tools derived from COVAX may assist in future pandemic planning.
  • National security. Investment in COVAX may move the United States closer towards its goals of biodefense preparedness and international emergency preparedness, which are paramount to national security interests.

As expected, the Final Framework did not adjust its recommended allocation phases, but the Committee considered and addressed stakeholder comments, with particular focus on community engagement both in the United States and globally. We expect there to be more activity in the coming weeks related to a potential vaccine and the ethics related to its development and distribution.

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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