On September 16, 2020, the Trump Administration issued, for the first time, a planning framework for allocation and distribution of an eventual COVID‑19 vaccine (the Federal Distribution Strategy). After briefly summarizing key features of the Federal Distribution Strategy, this newsletter reviews the unanswered questions and challenges that lie ahead for governments and other healthcare stakeholders with respect to vaccine distribution planning. Future newsletters will explore these considerations in greater detail.
Increased Federal Transparency Regarding Vaccine Distribution Planning
The Federal Distribution Strategy—issued jointly by the Department of Health and Human Services (HHS) and the Department of Defense (DoD)—brings new transparency to the federal government’s intentions regarding distribution efforts, which could begin before the year is out. Until now, the Administration’s “Operation Warp Speed” vaccine effort has focused primarily on issues related to vaccine development, with less attention paid to the vast administrative architecture that will be necessary to ensure that a newly approved vaccine will be equitably allocated and efficiently distributed.
The September 16 release includes a report to Congress describing the overall federal approach, a 57-page “playbook” to guide states and other jurisdictions in their vaccine planning, and a high-level infographic summary. The Administration recommends a phased approach in which the limited early batches of a vaccine are allocated to high-priority populations such as healthcare personnel or individuals with risk factors for severe sequelae after COVID‑19 infection; this approach is consistent with the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine released earlier this month by the National Academies of the Sciences, Engineering, and Medicine.
The Federal Distribution Strategy also includes recommendations regarding state preparedness planning; provider recruitment; vaccine allocation, ordering, distribution and inventory management; vaccine storage and handling; documentation and reporting; and public education and other communications.
Too Little, Too Late?
While the Federal Distribution Strategy is a welcome step, some stakeholders have criticized it as too little, too late. Consistent with the Trump Administration’s overall COVID‑19 response, the September 16 guidance consists primarily of high-level guidelines, with the intention that each state will develop its own immunization program. The Administration has set a 30-day deadline, requiring that states submit their COVID‑19 immunization plans for federal review by October 16, even as states are simultaneously launching their influenza vaccination programs. States would have had more lead time on the COVID‑19 planning front had the Administration released its vaccine distribution guidelines earlier in the summer, as did organizations like the Johns Hopkins Center for Health Security, the National Governors Association and the Center for American Progress.
Moreover, while pledging that the federal government will defray the costs of vaccines, related supplies and a new nationwide tracking system, the Federal Distribution Strategy leaves unanswered key questions as to how vaccine distribution efforts will be funded, including communication and outreach to a skeptical public. As states confront budget crises driven by plummeting revenues and swelling public benefit programs, it may be challenging for states to develop and implement sweeping public immunization programs without substantial federal support.
Many Key Questions Remain Unanswered
The guidance leaves open many issues critical to successful vaccine distributions:
- Financing. Which aspects of the nationwide immunization program will be publicly funded, whether through Medicare and Medicaid reimbursement or other federal outlays? How will costs be divided among the federal, state and local governments, as well as other stakeholders such as healthcare providers, commercial health plans and individual vaccine recipients? What existing federal funds are available for vaccine distribution efforts, including state administrative costs as well as the costs of vaccines, supplies and provider administration fees? What additional congressional appropriations may be necessary?
- Allocation. How should states approach decisions regarding the populations to prioritize for early access to a newly approved vaccine, as well as in later phases? Should vaccination be mandatory for certain groups (or for everyone)? How should states account for the likelihood of sequential approval of multiple vaccines, which may vary significantly in their safety and efficacy profiles for different populations? How should states consider vaccination for individuals where there may be little or no trial safety and efficacy data, such as pregnant women or young children?
- Distribution. What steps has the federal government taken to coordinate the manufacturing of vaccines and related supplies, such as vials and syringes? What types of immunization sites are being considered? What conditions must providers satisfy in order to participate in the immunization program? What complications arise with respect to vaccines that require multiple doses or ultracold storage, and how can stakeholders nimbly adapt to the sequential approval of multiple vaccines? How should these logistics intersect with co-occurring influenza testing and vaccination efforts?
- Communication. What are the most effective strategies for governments and other stakeholders to overcome “vaccine hesitancy”? How should education programs address issues such as moral hazard among vaccinated individuals, or potential social stigma against those who have not been vaccinated? Should governments encourage or restrict “private” immunization mandates or incentives, such as those established by employers?
- Liability and Accountability. What liability protections exist for manufacturers and providers that seek to rapidly expand capacity in response to this national emergency? What compensation may be available to individuals who suffer harm as a result of the vaccine?
In the coming weeks, Manatt Health will continue to monitor these and other issues of intense interest to stakeholders, including state governments, healthcare providers, health plans, consumer advocacy groups, pharmaceutical manufacturers and clients.