A Framework for Equitable Allocation of COVID-19 Vaccine was published on Friday by the National Academies of the Sciences, Engineering, and Medicine (NASEM) to guide ongoing vaccine planning efforts by federal, state, and local governments. This update summarizes the key features of NASEM’s Framework and contextualizes the Framework’s relationship to ongoing vaccine planning efforts. (See here for Manatt’s prior coverage of the Trump Administration’s September 16 guidance to state and local governments concerning vaccine planning.)
Background
Through Operation Warp Speed, the Administration seeks to ramp up production of promising vaccine candidates well before a vaccine actually receives authorization from the U.S. Food & Drug Administration (FDA). Even so, the initial supply of any newly approved vaccine will likely be in the millions or tens of millions, far short of the amount needed for a comprehensive nationwide immunization program (particularly if the vaccine requires two doses to be effective, as is expected for most of the current front-runners).
Typically, vaccine recommendations are developed by the Advisory Committee on Immunization Practices (ACIP), a body within the Centers for Disease Control and Prevention (CDC) that issues evidence-based guidelines about which vaccines should be administered to which populations. With respect to COVID‑19, however, CDC and the National Institutes of Health (NIH) requested input from NASEM, an independent body with no governmental affiliation. Specifically, NASEM was commissioned to “develop an overarching framework for vaccine allocation” to “inform the decisions by health authorities, including [ACIP], as they create and implement national and/or local guidelines for SARS-CoV-2 vaccine allocation.”
An ad hoc NASEM committee held public meetings over the summer, released a 114-page “discussion draft” on September 1, and has now published its 236-page final report. NASEM’s Framework may feed into existing planning efforts such as the following:
- States are currently developing vaccination plans in accordance with the Administration’s September 16 Interim Playbook for COVID‑19 vaccine planning (described by Manatt here). These plans are due to CDC by the end of next week (October 16). NASEM’s Framework is generally consistent with the Interim Playbook’s approach, including the Playbook’s direction for states to identify “critical populations” who will receive the first available vaccine doses and to develop a communication strategy aimed at “building vaccine confidence” and “dispelling vaccine misinformation.”
- ACIP has thus far declined to issue recommendations regarding COVID‑19 vaccines, citing the insufficient evidence to date regarding the safety and efficacy profiles of the leading vaccine candidates under development. When ACIP does recommend a vaccine, that recommendation will trigger mandatory coverage by certain healthcare payers, including commercial plans offered on the Marketplaces, the Vaccines for Children Program, and state Medicaid coverage for certain populations.
NASEM’s Approach and Key Recommendations
An equitable vaccine allocation framework, in NASEM’s view, should aim to maximize overall societal benefit while recognizing the government’s ethical obligations to accord equal dignity to all people and mitigate existing health inequities along lines of race and other sociodemographic traits. The framework should, moreover, be developed in a fair and transparent manner using the best available evidence. Drawing on these foundational principles, NASEM proposed four risk-based criteria to guide decisions about how to prioritize vaccine allocation across populations:
- The risk of acquiring infection (e.g., healthcare workers who come into contact with bodily fluids)
- The risk of severe morbidity and mortality (e.g., people with advanced age or comorbid conditions)
- The risk of negative societal impact (e.g., first responders, workers in critical occupations)
- The risk of transmitting infection to others (e.g., workers whose jobs involve frequent and unavoidable in-person interactions)
The report operationalizes these principles through its framework for a flexible phased approach to vaccine allocation (described below), accompanied by a discussion of various pragmatic considerations—such as ultra-cold chain requirements, out-of-pocket costs, and misinformation—that may affect vaccine distribution and uptake. In addition to outlining the phased allocation approach, NASEM offers the following recommendations for public officials (available as a standalone document):
- Leverage and expand the use of existing systems to ensure equitable allocation, distribution, administration, and oversight of a COVID-19 vaccine.
- Enhance access by offering the vaccine with no out-of-pocket costs for vaccine recipients and ensuring sufficient reimbursement for administering providers.
- Promote awareness and vaccine uptake by developing and continually refining an evidence-based strategy for COVID-19 vaccine promotion, vaccine acceptance, and community engagement (see below for additional detail).
- Support equitable global allocation of a COVID-19 vaccine by, among other things, opting into the transnational COVAX Facility coordinated by the Gavi Vaccine Alliance.
Four Phases of Vaccine Allocation
NASEM’s Framework recommends a four-phase approach to COVID-19 vaccine allocation (as summarized in this NASEM Figure):
- Phase 1 (representing an estimated 15% of total U.S. population):
- Phase 1a (the “Jumpstart Phase,” est. 5% of U.S. population): First responders and high-risk health workers involved in direct patient care and facility services (e.g., transportation or environmental services).
- Phase 1b (est. 10% of U.S. population): People with two or more health conditions that put them at significant risk of severe illness or death from COVID-19 (per CDC guidelines), as well as older adults living in nursing homes and other congregate or overcrowded settings.
- Phase 2 (est. 30–35% of U.S. population):
- K–12 teachers, school staff, and child care workers.
- Critical workers in high-risk settings who cannot avoid a high risk of exposure to COVID-19 (e.g., workers in the food supply system or public transit).
- All older adults not included in Phase 1.
- People with health conditions that put them at moderately higher risk of severe COVID‑19 consequences (per CDC guidelines).
- People in homeless shelters, group homes for individuals with physical or mental disabilities, incarcerated individuals, and detention staff (if not already included in Phase 1).
- Phase 3 (est. 40–45% of U.S. population):
- Children and young adults under age 30.
- Any essential workers at increased risk of exposure who are not covered in Phases 1 and 2.
- Phase 4 Everyone else living in the United States—individuals who may not fall into the preceding phases include adults between the ages of 30 and 65 who have neither risk-enhancing comorbid conditions nor jobs in essential occupations.
Within each phase, all populations have equal priority, although NASEM endorses the possibility of prioritizing among geographies using a vulnerability index (such as the CDC’s Social Vulnerability Index or the Surgo Foundation’s COVID-19 Community Vulnerability Index).
NASEM designed this phased structure with an eye toward local discretion with respect to elements such as the specific occupations that would be considered “critical” (in Phase 2) or “essential” (in Phase 3). Moreover, the phased structure represents a starting point for dynamic planning efforts; NASEM expects that adjustments may be necessary to account for new information regarding the risks of COVID-19 transmission or complications, as well as data on the safety and efficacy profiles of particular vaccines. If a vaccine presents significant medical risks for individuals with certain medical conditions, for example, those individuals could be excluded from Phases 1 and 2 until the approval of a second vaccine with a more favorable safety profile. Similarly, if a vaccine has not been tested in children, children could be carved out of Phase 3 pending completion of pediatric clinical trials.
Vaccine Communication Strategy
NASEM dedicates a full 25 pages of its report to issues concerning the public strategy for communicating about a vaccine, including risk communication, community engagement, and efforts to increase uptake by mitigating “vaccine hesitancy.” The Framework repeatedly emphasizes the importance of clear and consistent messaging delivered by trusted authority figures, potentially including government officials, healthcare providers, community leaders, and celebrities. Communication strategies should be evidence-based in terms of both the content (convey accurate information) and the messaging (draw on existing evidence about public health messaging, tailor messages for particular audiences, and test messages before disseminating them).
The Framework recommends that public officials initiate vaccine communication campaigns “immediately, as perceptions of COVID‑19 vaccine are already forming, in ways that might limit successful vaccination.” These communications should, moreover, promote public understanding of immunization as one COVID-19 response tool among many. Even if the first approved vaccine is highly effective at preventing COVID‑19 transmission in all populations (which is by no means guaranteed), the public’s health will be best served if widespread vaccination is accompanied, at least for a time, by ongoing protective measures such as social distancing and mask wearing.
Looking Ahead
NASEM’s Framework may prove helpful to public officials and other healthcare stakeholders as they continue to plan for an eventual COVID‑19 vaccine, which could arrive before the end of the year. As noted above, states still have time to incorporate NASEM’s insights into their preliminary vaccination plans before the October 16 deadline for submission to the CDC. To ensure the swiftest possible distribution of an approved vaccine, governments at all levels should be mindful of the need to proactively identify and engage the intended recipients of the first available doses, all while implementing the broader public health infrastructure and communications strategy that will support longer-term immunization efforts.