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2 Lessons Learned from Other Allocation Efforts
Pages 59-88

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From page 59...
... vaccine, the committee's deliberations were informed by practical lessons from previous efforts to allocate vaccines for 2009 H1N1 pandemic influenza and Ebola virus disease, as well as by the goals, ethical principles, and prioritization strategies set forth in other allocation frameworks -- including several that have recently been developed to distribute scarce inpatient medications for COVID-19. The committee also reflected on the guiding principles and prioritization criteria established by concurrent efforts being led by the World Health Organization (WHO)
From page 60...
... adults aged 25–64 years BOX 2-1 Key Lessons Learned from Prior Mass Vaccination Efforts • 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.
From page 61...
... Potential Impact of Allocation Decisions on Vaccine Uptake and Risk Communications During the 2009 H1N1 vaccine campaign, decisions about how to prioritize groups for allocation impacted the rates of vaccine uptake and posed specific challenges to risk communication (IOM, 2010)
From page 62...
... Potential Impact of Distribution Strategies on Allocation Although distribution is not the focus of the committee's framework, prior vaccination campaigns can illustrate how distribution systems can make different allocation schemes more or less feasible and how the choice of distribution system can support or impede choices regarding allocation. For example, to facilitate centralized distribution of the forthcoming H1N1 vaccine in 2009, the national vaccine distribution plan leveraged the existing federal Vaccines for Children program, through which state and local health departments supplied providers with recommended pediatric vaccines.
From page 63...
... This framework provides guidance for state and local efforts to target and allocate pandemic influenza vaccine in scenarios in which vaccine demand exceeds supply (CDC, 2018)
From page 64...
... Proposed vaccination strategies included both mass vaccination in each affected nation and a ring vaccination approach.3 Important data and legal considerations included ownership, WHO donations, countries' requests for vaccines, legal liability, informed consent, authorization by national regulatory authorities for vaccine use, and data collection and sharing. In the early months of the Ebola outbreak in West Africa, lack of effective community engagement was among the barriers that delayed a rapid and effective response; it also contributed to fear and stigma around the disease and potential vaccine among community members.
From page 65...
... Frameworks for Allocating Pandemic Influenza Vaccines Many countries have developed national plans and frameworks to prepare for the allocation of limited vaccine supply during an outbreak of pandemic influenza, which are distinct from vaccination campaigns conducted outside of outbreak or pandemic scenarios in terms of goals and operationalization. These national plans are tailored to countries' own systems and resources and each influenza outbreak, as outbreaks differ in terms of specific clinical and epidemiology characteristics and the differential burden of disease across populations (Williams and Dawson, 2020)
From page 66...
... For instance, arguments based on distributive justice often called for giving priority to vulnerable groups, whereas appeals to reciprocity were used to justify priority given to health care workers. LESSONS FROM PAST CRISIS STANDARDS OF CARE GUIDANCE During the 2009 influenza pandemic, HHS asked the Institute of Medicine (IOM)
From page 67...
... . The committee identified five key elements to uphold in order to equitably allocate scarce resources under disaster conditions: •  strong ethical grounding.
From page 68...
... . LESSONS FROM GUIDANCE AND FRAMEWORKS FOR ALLOCATING SCARCE MEDICAL RESOURCES DURING THE COVID-19 PANDEMIC In addition to lessons learned from prior mass vaccination campaigns, the committee's deliberations were informed by the principles, goals, and prioritization strategies set forth in guidance and frameworks recently developed for allocating scarce resources during the COVID-19 pandemic.
From page 69...
... • Allocate scarce resources responsibly to reduce risk while providing benefit. • Provide clear and transparent criteria for prioritization strategies.
From page 70...
... • Use randomization to prioritize allocation when all other factors are equal. Ethics and COVID-19: • Use the principle of equality to allocate scarce resources • Prioritize people at greatest risk of becoming Resource Allocation and to individuals or populations expected to derive the same infected and seriously ill.
From page 71...
... • Use best available evidence to address uncertainty. Pennsylvania's Weighted • Steward scarce resources in the interest of public health.
From page 72...
... Ethics of Creating a Resource Allocation Strategy During the COVID-19 Pandemic In a July 2020 article in Pediatrics, a group of bioethicists reviewed the fundamental ethical principles that frequently underpin scarce resource allocation frameworks and interpreted those principles in the context of the COVID-19 pandemic (Laventhal et al., 2020)
From page 73...
... Broadly, the brief suggests that a fair process for allocating scarce resources should promote certain ethical values, including transparency of allocation decisions and prioritization criteria, inclusiveness of affected groups in the decision-making process, consistent treatment of all persons in the same categories, and accountability of decision makers. In making decisions about prioritization, they highlight four key ethical considerations.
From page 74...
... Ethical Frameworks for Specifically Allocating Scarce Inpatient Treatments for COVID-19 After FDA issued an Emergency Use Authorization for the use of the antiviral remdesivir for patients with severe COVID-19 in May 2020, decisions about how to allocate remdesivir have been largely delegated to state health departments. However, many hospitals are operating without clear guidance about how to ethically allocate limited supplies of the medication to eligible patients (White and Angus, 2020)
From page 75...
... Pennsylvania's Weighted Lottery System for Allocating Scarce Medications for COVID-19 The Commonwealth of Pennsylvania has endorsed a weighted lottery system for ethically allocating medications for COVID-19 to eligible patients in cases of shortage. This lottery system is part of a model hospital policy,9 developed by a multidisciplinary team at the University of Pittsburgh, which is guided by the ethical duties to steward scarce resources in the interest of public health and to mitigate the impact of social inequities on COVID-19 outcomes in disadvantaged communities.
From page 76...
... . Ethical Framework for Allocating Therapies to Hospitalized Patients with COVID-19 Another ethical framework for allocating scarce inpatient medications for COVID-19 was developed by a group at the University of California, San Francisco, in May 2020.
From page 77...
... SPECIFIC FRAMEWORKS FOR COVID-19 VACCINE ALLOCATION WITHIN AND AMONG COUNTRIES This section outlines ethical frameworks developed specifically for COVID-19 vaccine allocation within and among countries, including an interim framework developed by a group at Johns Hopkins University, forthcoming efforts from CDC, and a values framework developed by WHO. It is important to note that these frameworks were and are being developed in the context of rapidly changing goals for vaccination (e.g., as schools began to re-open in August 2020)
From page 78...
... Ethical principles falling under the broader value of treating people fairly and equitably include addressing background and emerging inequities experienced by disadvantaged and marginalized groups, giving priority to the worst-off people at greatest risk of severe illness and death, and ensuring reciprocity to protect those who provide essential services and advance the development of treatments and vaccines. The third ethical value calls for respecting the diversity of views in a pluralistic society and engaging with communities to strengthen vaccine campaigns.
From page 79...
... During ACIP's initial deliberations, proposed groups for prioritized allocation included health care workers, essential workers, adults aged ≥65 years, long-term care facility residents, and persons with high-risk medical conditions (Splete, 2020)
From page 80...
... Within-country allocation decisions remain under the authority of each individual Member State. The WHO SAGE Values Framework for the Allocation and Prioritization of COVID-19 Vaccination, published in September 2020, provides guidance both on allocating COVID-19 vaccines among countries and on prioritizing groups for vaccination within countries while the supply is limited (WHO, 2020)
From page 81...
... For the principle of human well-being, the objective of reducing COVID-19-related deaths and disease burden could translate to prioritizing populations with significantly elevated risks of severe disease or death (e.g., older adults, people with certain comorbid conditions or health states, sociodemographic groups at disproportionately higher risks) and populations with significantly elevated risks of infection (e.g., health workers, employment categories and social groups of people who are unable to physically distance, people living in dense neighborhoods and multigenerational households)
From page 82...
... the priority groups identified by the WHO SAGE values framework should inform global-level allocation decisions and (2) countries with greater financial resources should not undermine vaccine access for low- and middle-income countries.
From page 83...
... LESSONS LEARNED FROM OTHER ALLOCATION EFFORTS 83 Table 2-2 starts on next page.
From page 84...
... WHO SAGE Values WHO • Ensure that COVID-19 vaccines are Framework for SAGE a global public good that contributes the Allocation and significantly to equitably protecting and Prioritization of COVID-19 promoting human well-being for all people Vaccination worldwide.
From page 85...
... LESSONS LEARNED FROM OTHER ALLOCATION EFFORTS 85 Guiding Principles Prioritized Groups • Promote the common good Tier 1: ° Promote public health • Those most essential in sustaining the ° Promote economic and social well-being ongoing COVID-19 response • Treat people fairly and equally • Those at greatest risk of severe illness ° Address background and emerging and death, and their caregivers inequities between groups • Those most essential to maintaining ° Give priority to worst-off individuals core societal functions ° Reciprocity • Promote legitimacy, trust, and a sense of Tier 2: ownership in a pluralistic society • Those involved in broader health ° Respect the diversity of views in a provision pluralistic society • Those who face greater barriers to ° Engage community members to improve access care if they become seriously ill vaccine program design and effectiveness • Those contributing to maintenance of core societal functions • Those whose living or working conditions give them an elevated risk of infection, even if they have lesser or unknown risk of severe illness and death • Maximize benefits and minimize harms • In progress at the time of this writing • Equity • Justice • Fairness • Transparency • Human well-being • Those with elevated risks of severe • Equal respect disease or death • Global equity • Those with significantly elevated risks • National equity of being infected • Reciprocity • Groups at high risk of transmitting • Legitimacy SARS-CoV-2 • Vulnerable, disadvantaged, and persecuted groups at risk of disproportionate burdens • Those who bear significant additional risks and burdens of COVID-19 to safeguard the welfare of others (e.g., health workers and other essential workers)
From page 86...
... 2020. Fair allocation of scarce medical resources in the time of COVID-19.
From page 87...
... 2007. Prioritization strate gies for pandemic influenza vaccine in 27 countries of the European Union and the Global Health Security Action Group: A review.


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