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

With the release of the Draft Preliminary Framework for Equitable Allocation of COVID-19 Vaccine (the “Draft Framework”) on Tuesday and only a matter of days to provide comments, our next posts in the Bioethics in a Pandemic series will focus on the major sections of the Draft Framework.  This post will summarize the lessons learned from past vaccine allocation efforts that the committee used to develop the Draft Framework.  Subsequent posts will focus on:

  • The key provisions of the Draft Framework; and
  • The application of the Draft Framework in various scenarios.

As we discussed in past posts, the CDC and NIH sponsored an ad hoc committee of the National Academies to develop “an overarching framework for vaccine allocation to assist policy makers in…planning for equitable allocation of vaccines” for COVID-19. The committee began by analyzing the allocation and distribution methods used in the H1N1 and Ebola pandemics to identify the following key lessons learned:

  • Leverage relationships with professional medical societies and other key downstream stakeholders from the outset.
  • When cost, insurance, and other policies create barriers, consider the issue of rationing at the state, local, and practice levels.
  • Develop effective systems for tracking distribution.
  • Ensure that ancillary supply distribution is timely and appropriate.
  • “Under-promise and over-deliver” in planning and communication efforts.
  • Ensure up-to-date information on vaccine production, inventory, and projections via stronger and more formal partnerships between federal entities and vaccine producers.
  • Plan for a range of vaccine supply scenarios.
  • Continue to use the Vaccines for Children program infrastructure as a basis for emergency vaccination distribution programs; consider something similar for adults.
  • Deploy limited vaccine supplies equitably and transparently using pre-established, evidence-based criteria to prioritize allocation.
  • Promote global regulatory harmonization and standardization in vaccine development to improve speed, flexibility, and efficiency.
  • Use consistent, respectful, accurate communication to earn, secure, and maintain trust.

More notably, the committee also considered many current ethical frameworks developed for allocating scarce COVID-19 resources, including Remdesivir, ventilators, and vaccines (when available). The committee reviewed several states' frameworks for distribution of inpatient medications, as well as frameworks published in national journals and by the World Health Organization. It also considered Johns Hopkins University’s Interim Framework for COVID-19 Vaccine Allocation, which we discussed earlier this week.   

With the exception of certain state frameworks that recommend Remdesivir be allocated on a first-come, first-served basis, many of the ethical frameworks start with the principle of maximizing benefit while respecting fairness and addressing disparities. These frameworks acknowledge that COVID-19 is disproportionately impacting racial and ethnic minority communities and that allocation strategies must address these disparities.  

Many of these current frameworks for allocating COVID-19 products also stress the importance of transparency, flexibility, and promoting trust among the community.  This entails using transparent criteria for allocating treatment and vaccines (as they become available) and monitoring the effectiveness and safety of such treatments and vaccines in real time to revise recommendations. 

Building on these lessons learned, the committee developed its decision-making framework, which we will highlight in our next post.

©1994-2022 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.National Law Review, Volume X, Number 247
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About this Author

Bridgette A. Keller, health system administration LAWYER, Mintz
Associate

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

With a background in health care operations, Bridgette is able to provide clients with practical insight that includes a focus on the business implications of health care enforcement defense activities, internal investigations, regulatory compliance, and fraud and abuse...

202-434-7435
Lauren Moldawer, healthcare, health, attorney, CMS, Mintz Levin, law firm
Associate

Lauren's practice focuses on advising health care providers, PBMs, and managed care organizations on a variety of regulatory issues.*

Prior to joining the firm, Lauren* worked at the Centers for Medicare & Medicaid Services (CMS) in the Medicare-Medicaid Coordination Office. In this role, she worked with states and health plans implementing the Financial Alignment Demonstration, which is a CMS initiative that seeks to better integrate Medicare and Medicaid services for dual-eligible individuals. Prior to her tenure with CMS, she was a...

202-434-7486
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