The administration, implementation, and evaluation of effective and equitable coronavirus disease 2019 (COVID-19) vaccination efforts is an inherently complex enterprise, given the range of constraints under which state, tribal, local, and territorial (STLT) health departments and their partners are operating. As plans for program implementation are developed in different jurisdictions, the foundational principles and criteria for determining an equitable allocation framework laid out earlier in this report need to be taken into account. Different jurisdictions may need to make adjustments to the recommended approach to accommodate the needs of their populations and resources available; however, continuing to be guided by the goal of reducing severe morbidity and mortality and negative societal impact due to the transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is essential. The ideal national program would be designed with sufficient operational simplicity to ease the burden on STLT public health entities. This requires robust coordination and clear, consistent communication within and across partner entities involved in the program. This chapter describes key coordination, cost, communication, and community engagement considerations to ensure an effective and equitable national COVID-19 vaccination program. Chapter 6 discusses risk communication and community engagement in further depth, and Chapter 7 highlights key considerations related to vaccine acceptance.
Implementing a coordinated national COVID-19 vaccination program on the ground at STLT levels will be challenging on multiple fronts, but there are lessons to be gleaned from past efforts. An analysis of key policy barriers encountered during the 2009 H1N1 pandemic response was conducted by the Centers for Disease Control and Prevention (CDC), the Association of State and Territorial Health Officials, and the National Association of County & City Health Officials (Logan Circle Policy Group, 2010). Multiple barriers to coordination were identified, including (1) inadequate coordination of state and local policies related to emergency management, public health, and education; (2) deficient communication and coordination with city- and county-level public information officers; and (3) conflicts between state- and local-level response efforts and federal-level communication and coordination practices (Logan Circle Policy Group, 2010). The latter barrier hindered the ability of STLT response efforts to provide timely information and caused STLT authorities and nonprofit partners to receive conflicting messages from the federal partners. The H1N1 vaccine campaign also illustrates challenges related to allocating vaccines in states that have more complex and diverse population needs.
Without question, coordination and administration depend on a host of laws and regulations that govern everything from transportation of vaccines, payments to institutional, business, and individual providers, licensure and scope of practice rules within and across state lines, liability exposures and insurance coverage, and treaty or other provisions specific to federally recognized tribes, among other things. The conflicts between federal and STLT authorities, and the wide variation among triggering mechanisms and powers for public health emergencies among states, makes it complex to administer vaccines according to any framework. These, and many other aspects of public health law at the national and state levels, are already being subjected to close evaluation (Burris et al., 2020). In addition, if any COVID-19 vaccine is approved through an Emergency Use Authorization (EUA), it may come with special provisions limiting off-label use (e.g., pediatric use if not labeled for such use based on the clinical trials) or with requirements for post-market studies. Such studies would need to be coordinated with existing mechanisms for reporting adverse events and the vaccine compensation entities at the federal level. Furthermore, such an approval would need to be revisited once the declared public health emergency has ended. The committee acknowledges these issues, but they are not addressed within this report.
Implementing an effective and equitable national COVID-19 vaccination program will require robust coordination across federal agencies
and with STLT partners. Traditionally, CDC leads coordination. However, CDC is not the sole entity responsible for vaccination program administration, delivery, surveillance, and evaluation. Within the U.S. Department of Health and Human Services (HHS), regional teams from the Office of the Assistant Secretary for Preparedness and Response, and other agencies such as the U.S. Food and Drug Administration (FDA), the National Institutes of Health, the Health Resources and Services Administration, and the Centers for Medicare & Medicaid Services support STLT partners. In addition, coordination with the U.S. Department of Defense will be important. To maximize efficient operations and minimize complexity, and to advance equity, guidance and communication from HHS divisions must be timely, internally consistent, and aligned with the allocation framework.
CDC’s Coordinating Role
CDC will play a key role in the national COVID-19 vaccination program by distributing COVID-19 vaccine and working with STLT authorities to assist with vaccine program implementation. This role is established in HHS’s Pandemic Influenza Plan1 and consistent with CDC’s role in the 2009 H1N1 pandemic (Rambhia et al., 2010). CDC will likely provide guidance to STLT partners on planning for different components of the COVID-19 vaccination program, including (1) defining priority groups, (2) assisting with tracking vaccine supply and administration, (3) monitoring for adverse events following immunization (in collaboration with FDA), and (4) assessing vaccine coverage and effectiveness. CDC may also develop communications and educational materials for use by stakeholders to address vaccine confidence concerns and increase vaccine demand, including strategies to reach underserved and hard-to-reach populations.
COVID-19 Vaccine Distribution
In Chapter 3, the committee suggested that, in the interest of speed and workability, federal allocation of COVID-19 vaccine to states could be made based on these jurisdictions’ population size—after which the committee’s allocation framework would be applicable. One exception to a straightforward population-based approach to allocation of vaccine would be to withhold a percentage (e.g., 10 percent) of the available vaccine supply at the federal level as a reserve for deployment by CDC for use in areas of special need (identified through a vulnerability index) or to epidemiological “hot spots.”
1 HHS’s Pandemic Influenza Plan is available from https://www.cdc.gov/flu/pandemic-resources/planning-preparedness/national-strategy-planning.html (accessed September 7, 2020).
Secure vaccine storage and transport, and safe, efficient, and equitable vaccine distribution are critical to a successful national COVID-19 vaccination program. Based on pre-pandemic plans, CDC has scaled up existing vaccine distribution programs to support the response.2 To facilitate vaccine distribution during COVID-19, CDC has expanded its existing partnership with the McKesson Corporation so that they can be the distributor of COVID-19 vaccines and ancillary supplies (HHS, 2020; McKesson, 2020). CDC had an existing contract with McKesson to support the distribution of CDC’s Vaccines for Children Program, which included an option for pandemic vaccine distribution. During the 2009 H1N1 vaccination campaign, this system was expanded to include providers of vaccinations to adults and was shown to be effective at large-scale distribution of vaccine (IOM, 2010). For the national COVID-19 vaccination program, according to CDC plans, McKesson will fill orders, with vaccines and supplies being delivered to point-of-care sites across the United States, including health departments, large health care organizations and affiliated clinics, hospitals, doctors’ offices, and pharmacies (NCIRD, 2020). The jurisdiction will be responsible for the management and approval of vaccine orders from enrolled providers within their jurisdiction, based on populations prioritized for vaccination depending on the phase of the immunization program (CDC, 2020). Other possible sites for vaccination depending on the phase of the program will include school clinics, workplaces, and mobile vaccination clinics. This possible system ensures maintenance of the cold chain, which is essential to vaccine effectiveness.
Depending on the COVID-19 vaccine product, maintenance of cold chain storage and handling could be a particular challenge because some products could require frozen (−20 degrees Celsius) or ultra-cold (−60 to −80 degrees Celsius) temperatures to retain stability. To ensure inequities are not exacerbated or created, assistance from CDC with plans for cold chain management might be required for some jurisdictions with limited resources. Another challenge to COVID-19 vaccine distribution is that a two-dose regimen separated by at least 21 or 28 days will be required for immunity for most of the vaccines currently under study. Methods to ensure that patients receive the same type of vaccine for both doses and to remind patients that their second dose is due will be needed for two-dose vaccine regimens. In addition, it is expected that some COVID-19 vaccine products might require reconstitution with diluent or adjuvant at the time of their administration (NYT, 2020). According to current plans from CDC shared with STLT partners, distribution of vaccines by jurisdictions will be allowed while maintaining the cold chain; however, CDC indicated that
2 More information about distribution, tracking, and monitoring within CDC’s Pandemic Vaccine Program is available from https://www.cdc.gov/flu/pdf/pandemic-resources/pandemic-influenza-vaccine-distribution-9p-508.pdf (accessed September 7, 2020).
jurisdictions be judicious in their redistribution and that redistribution be limited to refrigerated vaccines (NYT, 2020).
Jurisdictions must maintain an emphasis on equity in their vaccine distribution strategies, and in doing so, they should refer to the principles and allocation criteria that guided the committee’s allocation framework. Providers’ orders for vaccines will be placed via the Vaccine Tracking System (VTrckS). VTrckS is a secure web-based information technology system that integrates the vaccine supply chain, from purchasing and ordering through distribution to health departments and health care providers.3 Existing Immunization Information Systems will be used to record vaccine doses administered.
Dedicated efforts should focus on ensuring equitable distribution across tribal nations and territories. For instance, administration of the COVID-19 vaccine must include consultation and coordination with Indian country in order to fulfill the federal trust responsibility of providing health care services to American Indians and Alaska Natives.4 The Indian Health Service (IHS) is the federal program that provides health services to members of federally recognized tribes based on a special government-to-government relationship between the federal government and tribes established in 1787 based on Article I, Section 8 of the U.S. Constitution. Responsibility for these health services is spread across direct-service IHS programs, tribal programs, and urban Indian programs known as the I/T/U system of care. The I/T/U is an essential partner and holds the responsibility for the coordination and administration of vaccines for this patient population in partnership with federal agencies like CDC. For tribes that exercise their right of self-determination and self-governance through a compact with IHS to provide services for their population, vaccine administration could be coordinated through the IHS Office of Tribal Self-Governance.5 This would respect the government-to-government relationship between the U.S. and federally recognized tribes.
3 More information about distribution, tracking, and monitoring within CDC’s Pandemic Vaccine Program is available from https://www.cdc.gov/flu/pdf/pandemic-resources/pandemic-influenza-vaccine-distribution-9p-508.pdf (accessed September 7, 2020).
4 “Indian country” is a legal term with a specific definition that applies only to federally recognized tribes. U.S. Code § 1151 defines Indian country as: “Except as otherwise provided in sections 1154 and 1156 of this title, the term ‘Indian country,’ means (a) all land within the limits of any Indian reservation under the jurisdiction of the United States Government, notwithstanding the issuance of any patent, and, including rights-of-way running through the reservation, (b) all dependent Indian communities within the borders of the United States whether within the original or subsequently acquired territory thereof, and whether within or without the limits of a state, and (c) all Indian allotments, the Indian titles to which have not been extinguished, including rights-of-way running through the same” (June 25, 1948, ch. 645, 62 Stat. 757; May 24, 1949, ch. 139, § 25, 63 Stat. 94).
Leveraging Existing Systems to Support Coordination
To establish a coordinated approach for the national COVID-19 vaccination program, existing systems should be leveraged and augmented as needed. For example, public health emergency preparedness (PHEP) experts could be leveraged along with immunization program managers to help facilitate storage and cold chain management, distribution, and additional logistical needs. To conduct this work, coordinators and immunization managers will need to forge strong local partnerships with PHEP teams and other community-level partners. To facilitate vaccination programs at the local level, CDC’s National Center for Immunization and Respiratory Diseases has funded immunization program managers in 64 state, territorial, and local sites. This Center could be the coordinating point for gathering federal government input and assisting local programs. These immunization program managers will play a critical role in the implementation of a local COVID-19 vaccination program in their jurisdictions. The Association of Immunization Managers has developed guidance to support managers in preparing for a local COVID-19 vaccination program.6
It is important that, at the local level, attention is directed to using existing data aggregation and integration infrastructures for the vaccine administration effort. Many states already have immunization registries that facilitate tracking and monitoring of immunization status between public health agencies and private practitioners. Immunization registries also represent valuable systems to be leveraged. However, registries vary state by state, with some states having more well-established, highly functioning immunization registries than others. Those states who need additional support for their immunization strategies should be identified and bolstered through collaborative approaches. Given the need to identify at-risk individuals with multiple risk factors and the need to track dosing for those vaccines requiring more than one dose, this becomes especially important. The Office of the National Coordinator for Health Information Technology could work with CDC and professional medical and hospital societies to advance this work.
Monitoring and Evaluation
Within the national COVID-19 vaccination program, real-time, rapid monitoring and evaluation will be critical components that must also be robustly coordinated. Monitoring and evaluation systems are also critical for enabling the successful delivery of vaccines through appropriate ramp-
6 The guidance for immunization managers is available from https://cdn.ymaws.com/www.immunizationmanagers.org/resource/resmgr/covid-19_preparation_tips_fo.pdf (accessed September 7, 2020).
up of supplies related to administration, including both direct supplies (e.g., vaccines, needles, syringes) and indirect supplies, such as personal protective equipment for vaccinators.
A rigorous vaccine safety monitoring program will need to be in place, with an emphasis on rapid and transparent review of information on adverse events following immunization, defined as health problems or conditions that occur after vaccination that could be caused by the vaccine or purely occurring by chance, unrelated to vaccination. The system should build on existing systems, including lessons learned from the H1N1 vaccination campaign and CDC’s plans for monitoring vaccine safety in emergencies (Iskander and Broder, 2008). CDC has several systems in place to monitor the safety of vaccines in the United States, including the Vaccine Adverse Event Reporting System (co-administered by CDC and FDA), the Vaccine Safety Datalink (a collaboration among CDC’s Immunization Safety Office and nine organizations), and the Clinical Immunization Safety Assessment Project, a network of vaccine safety experts from across the country (CDC, 2020). Resources need to be made available so reporting systems can be implemented across all populations and capture race, ethnicity, and language information about different populations to ensure there is no bias in interpreting and reporting signs and symptoms being registered. The evaluation of adverse events to determine whether or not they are related to COVID-19 vaccine needs to be timely and updates on these evaluations should be shared regularly with STLT authorities, partner organizations involved in vaccination efforts, and the public. In addition to these vaccine safety reporting systems, FDA recommends that at the time of a biologics license application submission the applicants submit a Pharmacovigilance Plan. It is possible that a COVID-19 vaccine could be released under an EUA. FDA guidance states that this might be appropriate after studies have demonstrated vaccine efficacy and safety, but before the vaccine has received full approval. Under EUA requirements, monitoring and reporting of adverse events is required “to the extent practicable.” In the case of injuries related to COVID-19 vaccines, the Public Readiness and Emergency Preparedness Act “authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to certain individuals or estates of individuals who sustain a covered serious physical injury as the direct result of the administration of covered countermeasures, including vaccines” (HRSA, 2020).
Assessing COVID-19 Vaccine Coverage and Effectiveness
To promote equity, the monitoring and evaluation systems should assess the COVID-19 vaccination program’s penetrance—that is, its ability to reach key populations identified in the committee’s phases—by building
a real-time assessment program that includes community engagement and expertise. This would align with CDC’s COVID-19 Response Health Equity Strategy,7 which aims to reduce COVID-19’s disproportionate burden among populations with increased risks for infection, severe illness, and death, and to broadly address COVID-19-related health disparities and inequities through a holistic approach. The plan’s guiding principles are to (1) reduce health disparities, (2) use data-driven approaches, (3) foster meaningful engagement with community institutions and diverse leaders, (4) lead culturally responsive outreach, and (5) reduce stigma, including race- and ethnicity-associated stigma.
In this section, the committee calls attention to the key gaps in the cost and financing of COVID-19 vaccine administration. These gaps must be addressed to ensure equitable allocation. In particular, costs may be a barrier to vaccination to the extent that individuals deciding to get vaccinated are asked to share in the cost of the vaccine or its administration. Any required fee would present a greater barrier to those without sufficient financial means to pay. Given the framework’s priority on mitigating health inequities, particularly as tied to COVID-19 severe illness and deaths, addressing costs becomes a key priority given the correlation between high cost barriers and the populations experiencing health inequities. Moreover, justification for mitigating the costs borne by those choosing to be vaccinated come from their positive spillovers. The positive spillover, or externality, of a vaccine derives from the extent to which the vaccine protects others by reducing the rate of transmission of the virus. There is a history of providing services with positive spillovers for free as this can help address the provision of vaccines that can help reduce virus transmission. The goal would be to make vaccination available to all and reduce any vaccine hesitancy tied to cost thereby increasing the individual and societal benefits of having a highly vaccinated population.
Cost Implications of the Coronavirus Aid, Relief, and Economic Security Act
The 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act requires health insurance plans (group and individual) to add coverage of any CDC Advisory Committee on Immunization Practices (ACIP)-recommended COVID-19 vaccine within 15 days and offer COVID-19 vaccination without
7 More information about CDC’s COVID-19 Response Health Equity Strategy is available from https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/cdc-strategy.html (accessed September 7, 2020).
patient cost sharing (Section 3203) (Federal Register, 2015; KFF, 2020). This requirement adjusts the Patient Protection and Affordable Care Act (ACA) regulation that people with health insurance—with few exceptions—have no cost sharing for vaccines recommended by ACIP. The CARES Act ensures that COVID-19 vaccines will fall under this regulation quickly.
However, this requirement is not sufficient to support the vaccine allocation recommended by this report, for multiple reasons. For instance, it is possible that, under an EUA, the administrative fees that are covered under the ACA regulation may not apply at all, leaving patients potentially entirely at risk of cost sharing for the administration of the vaccine. The CARES Act requires coverage for the vaccine, but has not specified whether this requirement extends to the administration of the vaccine. Furthermore, this regulation does not apply to individuals without insurance. In 2018, 27.9 million non-elderly individuals were uninsured (Berchick et al., 2019). Urban Institute models project that the loss of jobs during the COVID-19 pandemic may add another 3–4 million uninsured individuals, after accounting for the millions of people who lose their jobs but who may obtain coverage through Medicaid, the ACA marketplace, or other sources (Banthin et al., 2020). Furthermore, the ACA requirements do not apply to many health insurance products, including recently promoted short-term plans, health care sharing ministry plans, grandfathered health plans, and Farm Bureau plans. Critically, for the plans where ACA requirements do apply, situations may arise in which patients receive bills where they are responsible for a share of the cost of administration. When the vaccine is administered by an out-of-network provider, the zero cost-sharing requirement is not applicable, and if a vaccine is delivered during an office visit that is not exclusively for preventive care (e.g., a patient’s medical problem is discussed), then the visit might be billed as a diagnostic visit and cost sharing would be applied to the visit.
Finally, the U.S. Supreme Court is expected to hear arguments and rule on the ACA during the period in which the vaccine is being distributed. It is possible that the ruling could affect the ACA or ACA provisions and have consequences for insured people and increase the number of uninsured people (Boumil and Curfman, 2020). This could result in severe difficulties with regard to reimbursement for and access to the vaccine for significant numbers of Americans.
Medicare and Medicaid
For those on Medicare, Part B will cover co-pay or administrative charges (Section 3713). Those on Medicare Advantage plans are similarly covered. For Medicaid, coverage depends on several factors. Most state Medicaid agencies cover at least some adult immunizations but not all offer
vaccines recommended by ACIP. Generally, Medicaid covers ACIP-recommended vaccines for all beneficiaries up to age 21 under the program’s Early and Periodic Screening, Diagnostic and Treatment program. For children under 19, the Vaccines for Children Program guarantees free vaccination to uninsured, underinsured, and Native American and Alaska Native children. Adults in a Medicaid expansion plan or an Alternative Benefit Plan also receive ACIP-recommended vaccines with no cost sharing. But for other adults who are not in states with Medicaid expansion and who are on traditional Medicaid coverage, it is up to each state to determine whether to cover vaccines. There is an incentive to do so, because states that cover ACIP-recommended vaccines and all the services recommended by the U.S. Preventive Services Task Force may be eligible for increased federal payments. However, a survey of states prior to the pandemic showed that only 22 were offering the full list of ACIP-recommended adult vaccinations under their program (Granade et al., 2020; Shen and Orenstein, 2020).
Additional resources are available to cover COVID-19 vaccines for the uninsured, including funds made available in the CARES Act through the Public Health and Social Service Emergency Fund. The federal government has also used authorities under Section 317 of the Public Health Service Act to make vaccines available to uninsured adults. As of October 1, 2012, Section 317–funded vaccines can be used to vaccinate uninsured or underinsured adults, individuals in correctional facilities and jails, and fully insured individuals seeking vaccines during public health response activities, including outbreak response, mass vaccination campaigns, or exercises for public health preparedness.
Additional Cost Barriers Related to Vaccination
Removing cost sharing for the vaccine and its administration does not eliminate all costs for people who might consider vaccination. For instance, the costs to individuals in terms of time, child care, and transportation cannot be ignored. Therefore, making the vaccine easy to access by offering vaccination clinics at schools, workplaces, and other locations in the community that people frequent can be as important as zero cost sharing in driving down cost barriers and mitigating inequities.
Even if cost sharing is zero, providers still incur costs of vaccination. The reimbursement from insurers to those delivering the vaccine may not be sufficient to cover the outlays needed to safely administer the vaccine efficiently to large numbers of recipients. Moreover, the cost of supplies and equipment needed to store and administer the vaccine may quickly exceed the revenue from insurers for all but the very largest providers. This could limit provider participation in vaccine administration and thus lead to an undersupply of critical points of access. Yet, many of these access challenges are being
addressed by HHS clarifications that a wide array of health care workers, notably pharmacists, can administer the vaccine when available, thus increasing the potential number of willing providers. Furthermore, unique cost barriers exist for Native Americans and Alaska Natives who are eligible to receive vaccinations free of charge via the IHS I/T/U system of care. The IHS I/T/U system of care is chronically underfunded and understaffed; a 2018 U.S. Government Accountability Office report found that on average, there is a 25 percent shortage of doctors, nurses, and other care providers across the I/T/U (GAO, 2018). The additional administrative and provider costs associated with COVID-19 vaccination may increase the stress on an already-struggling system unless offset with additional federal funding. Attention will need to be paid to the costs of administration for the providers.
Additional Federal Funding Needed to Eliminate Financial Barriers
To fully address these cost challenges, it is critically important for the government to pay for the vaccine to be delivered and administered, especially in the context of the well-funded vaccine development enterprise for COVID-19. As a first step, the Congressional Budget Office and other budget entities could model the net budget impact of a bill that would provide federal funds to guarantee zero out-of-pocket costs for everyone receiving a COVID-19 vaccine, particularly during the first year of vaccine administration. Additional federal funds need to be allocated both to cover the costs of vaccination for people who do not fall under the ACA regulations and to set up non-traditional modes and locations of administration to standup vaccination clinics at schools, workplaces, and other places that people frequent. Eliminating financial barriers to vaccine uptake will help promote equitable vaccine allocation which, in turn, could more rapidly ease social distancing and thus increase gross domestic product and tax revenue. The allocation framework proposed by the committee prioritizes reducing morbidity, mortality, and negative societal impacts due to the transmission of SARS-CoV-2. Therefore, federal funding to execute on these priorities would allow for a more rapid easing of social distancing than would be possible if the allocation of vaccines were restricted exclusively to states and individuals with the funds for vaccine administration.
STLT Implementation Requires Community Engagement
To ensure equity, STLT authorities will need to collaborate closely and foster community partnerships to create and develop local COVID-19
vaccination plans. Communities, especially those disproportionately impacted by COVID-19, must be effectively, authentically, and meaningfully engaged in local vaccination plans. To that end, strong partnerships need to be developed urgently with community-based organizations and other community partners in order to build effective vaccine delivery systems that are convenient for the people they are intended to reach.
Role of Community-Based Organizations in Vaccine Administration
Community-based organizations, the so-called “boots on the ground,” often have deeper insights about the people and families they serve than do many public health program managers serving in primarily administrative roles. Those insights help characterize the social inequities and community assets that make equitable allocation an imperative for program administrators. Shared authority can foster transparency and mutual accountability. It also allows deployment of limited resources to be informed by first-hand knowledge of current community needs, thereby increasing the likelihood of program effectiveness. Furthermore, partnerships with community-based organizations can improve the ability of local agencies to negotiate opportunities when they seek program flexibility so as to maximize the benefit of their service to their communities. Such partnerships can build on agencies’ experience implementing strategies to mitigate inequities through the design of programs that are available, affordable, and accessible (including strategies involving mobile services). Through collaborations, community organizations and immunization administrators can ensure that vaccination initiatives are based on the best-available evidence and that initiatives are culturally and linguistically appropriate for the people and communities who need them.
Role of Other Community Partners in Vaccine Administration
Although some jurisdictions may develop new methods to engage communities in planning for COVID-19 vaccination efforts, an extensive array of partnerships already exists in many locations. All community partners must embed ethics, equity, and cultural competence into their activities. Providers in the community can play a valuable role in reaching community members, but their own potential fragility in the context of the pandemic needs to be taken into account. Some are considered “traditional” public health partners, such as federally qualified health centers, hospitals, and pharmacies (including community pharmacies). Other entities that can serve as community partners in the vaccination campaign include community centers, schools, universities, Historically Black Colleges and Universities, Hispanic Association of Colleges and Universities, Tribal Colleges
and Universities, faith-based organizations, public safety organizations, philanthropic organizations, and employers.
Role of Workplaces, Employers, and Unions
Employers and unions must also be engaged in planning for COVID-19 vaccination efforts. The role of employers and other potentially responsible parties is likely to be particularly important in the early phases of vaccine roll-out. STLT authorities might collaborate with employers to deliver vaccination clinics. Workplace clinics may be especially critical for achieving high vaccination rates among many workers whose jobs place them in the framework’s earliest phases, such as workers in correctional and long-term care facilities, and others who perform essential roles. In addition to offering convenient access, employers may commit to covering the costs for their employees. For instance, employers could play a key role in covering immunization for those who are not insured, those who are undocumented, those who are part-time employees, and others.
Trade unions and worker centers can play an important role in encouraging and enabling workers to get vaccinated, as well as in reaching workers who are undocumented or otherwise hesitant to engage with employer or government programs. Union and worker center involvement can be especially useful in efforts to gain the trust and cooperation of their members, especially in cases in which the employer is providing the vaccines. In workplaces where the workers have union representation, employers could develop vaccination plans and programs in collaboration with the unions representing their employees. Furthermore, many workers, especially in the building trades, have health insurance coverage through joint union–management insurance plans, and some workers get their health care through clinics run by unions or joint union–management plans.
Public communication from the federal to the local level about the national COVID-19 vaccination program must be timely, consistent, and accurate in order to foster public trust, encourage participation, and manage expectations. Given the complexity of the national vaccine administration ecosystem, state and local strategies for community engagement need to entail identifying and training partners who are the best messengers for specific audiences. The chapters that follow will address national-level considerations for risk communication. Administration done well “behind the scenes,” but communicated in ways that belie public trust, may undermine public confidence that COVID-19 vaccine will be allocated equitably at the state and local levels. Governors could contribute to the quality of public
messaging by committing to the adoption of consistent communication, perhaps through the National Governors Association or through regional coalitions. Leaders may even choose to be vaccinated as a model for their community.
Vaccination programs that are culturally and linguistically appropriate can improve communication about COVID-19 vaccine and its benefits among people and their families. Improved communication may build trust in care providers and public health authorities; it also supports informed decision making and may help temper vaccine hesitancy. Because racial or ethnic concordance may increase a person’s trust in care providers, it would be beneficial for vaccine program administrators to prioritize involving diverse partners to engage communities. To help increase vaccine uptake among minority groups, vaccination planning efforts could provide resources for vaccination program implementation to members of organizations such as the National Medical Association, the National Hispanic Medical Association, the Association of American Indian Physicians, and the National Council of Asian Pacific Islander Physicians. Additionally, community health workers may help achieve successful administration by acting as health educators, navigators, and cultural brokers.
Through those roles, community health workers may also be key collaborators for surveillance, safety monitoring, and program evaluation. Those actions may be especially critical in communities that lack technology and other systems for managing data in real time, monitoring adverse events, and tracking community concerns. In addition to helping report information back to federal and STLT authorities, community health workers can maintain an ongoing dialogue with people, families, and neighborhoods in the community. Both communication and community engagement strategies should be monitored to ensure that the national COVID-19 vaccination program is responsive and adaptable to community needs. These issues are discussed further in Chapters 6 and 7.
An effective and equitable national COVID-19 vaccination program must be framed by an overarching commitment to the principles on which the committee’s allocation framework is founded: maximum benefit, equal concern, mitigation of health inequities, fairness, transparency, and evidence-based. However, the mere establishment of foundational principles does not guarantee equitable allocation: equitable allocation must be supported by equitable distribution and administration. The principles of equity should guide each program component—from its design through its administration and evaluation—and be the central tenets that guide partners responsible for implementation and monitoring.
Banthin, J., L. J. Blumberg, M. Simpson, M. Buettgens, and R. Wang. 2020. Changes in health insurance coverage due to the COVID-19 recession: Preliminary estimates using microsimulation. July 13, 2020. Washington, DC: Urban Institute. https://www.urban.org/research/publication/changes-health-insurance-coverage-due-covid-19-recession (accessed September 21, 2020).
Berchick, E. R., J. C. Barnett, and R. D. Upton. 2019. Health insurance coverage in the United States: 2018. Washington, DC: U.S. Census Bureau. https://www.census.gov/library/publications/2019/demo/p60-267.html (accessed September 21, 2020).
Boumil, M. M., and G. Curfman. 2020. The Affordable Care Act returns to the Supreme Court: Maine Community Health Options v United States. JAMA Internal Medicine. Published online September 14, 2020. doi: 10.1001/jamainternmed.2020.3549.
Burris, S. C., S. de Guia, L. Gable, D. Levin, W. E. Parmet, and N. P. Terry. 2020. Assessing legal responses to COVID-19. Boston: Public Health Law Watch, Temple University Legal Studies Research Paper No. 2020-22. https://ssrn.com/abstract=3675884 (accessed September 21, 2020).
CDC (Centers for Disease Control and Prevention). 2020. COVID-19 vaccination program interim playbook for jurisdiction operations. Atlanta, GA: CDC. https://www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination-Program-Interim_Playbook.pdf (accessed September 21, 2020).
Federal Register. 2015. Coverage of certain preventive services under the Affordable Care Act. Final rules. Federal Register 80(134):41318–41347.
GAO (U.S. Government Accountability Office). 2018. Indian Health Service: Agency faces ongoing challenges filling provider vacancies. GAO-18-580. August 15, 2018. Washington, DC: GAO. https://www.gao.gov/products/gao-18-580 (accessed September 21, 2020).
Granade, C. J., R. F. McCord, A. A. Bhatti, and M. C. Lindley. 2020. State policies on access to vaccination services for low-income adults. JAMA Network Open 3(4):e203316. doi: 10.1001/jamanetworkopen.2020.3316.
HHS (U.S. Department of Health and Human Services). 2020. Trump administration collaborates with McKesson for COVID-19 vaccine distribution. Washington, DC: HHS. https://www.hhs.gov/about/news/2020/08/14/trump-administration-collaborates-mckesson-covid-19-vaccine-distribution.html (accessed September 21, 2020).
HRSA (Health Resources and Services Administration). 2020. Frequently asked questions. Washington, DC: HRSA. https://www.hrsa.gov/cicp/faq#covid (accessed September 21, 2020).
IOM (Institute of Medicine). 2010. The 2009 H1N1 influenza vaccination campaign: Summary of a workshop series. Washington, DC: The National Academies Press.
Iskander, J., and K. Broder. 2008. Monitoring the safety of annual and pandemic influenza vaccines: Lessons from the US experience. Expert Review of Vaccines 7(1):75–82. doi: 10.1586/14760522.214.171.124.
KFF (Kaiser Family Foundation). 2020. The Coronavirus Aid, Relief, and Economic Security Act: Summary of key health provisions. https://www.kff.org/coronavirus-covid-19/issue-brief/the-coronavirus-aid-relief-and-economic-security-act-summary-of-key-health-provisions (accessed August 28, 2020).
Logan Circle Policy Group. 2010. ASTHO H1N1 policy barriers project—state meetings: Summary and analysis. Washington, DC: Logan Circle Policy Group LLC.
McKesson. 2020. McKesson to distribute future COVID-19 vaccines in support of Operation Warp Speed. https://www.mckesson.com/About-McKesson/Newsroom/Press-Releases/2020/McKesson-Distribute-Future-COVID-19-Vaccines-Operation-Warp-Speed (accessed September 21, 2020).
NCIRD (National Center for Immunization and Respiratory Diseases). 2020. Pandemic vaccine program distribution, tracking, and monitoring. Interim Pandemic Distribution Plan. Atlanta, GA: CDC. https://www.cdc.gov/flu/pdf/pandemic-resources/pandemic-influenza-vaccine-distribution-9p-508.pdf (accessed September 21, 2020).
NYT (The New York Times). 2020. COVID-19 vaccination program planning assumptions for jurisdictions. https://int.nyt.com/data/documenttools/covid-19-vax-planningassumptions-8-27-2020-final/6fc8a9ec0c3e5817/full.pdf (accessed September 21, 2020).
Rambhia, K. J., M. Watson, T. K. Sell, R. Waldhorn, and E. Toner. 2010. Mass vaccination for the 2009 H1N1 pandemic: Approaches, challenges, and recommendations. Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science 8(4):321–330. doi: 10.1089/bsp.2010.0043.
Shen, A. K., and W. Orenstein. 2020. Continued challenges with Medicaid coverage of adult vaccines and vaccination services. JAMA Network Open 3(4):e203887. doi:10.1001/jamanetworkopen.2020.3887.
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