The shared ethical framework to allocate scarce medical resources: a lesson from COVID-19.

The COVID-19 pandemic has helped to clarify the fair and equitable allocation of scarce medical resources, both within and among countries. The ethical allocation of such resources entails a three-step process: (1) elucidating the fundamental ethical values for allocation, (2) using these values to delineate priority tiers for scarce resources, and (3) implementing the prioritisation to faithfully realise the fundamental values. Myriad reports and assessments have elucidated five core substantive values for ethical allocation: maximising benefits and minimising harms, mitigating unfair disadvantage, equal moral concern, reciprocity, and instrumental value. These values are universal. None of the values are sufficient alone, and their relative weight and application will vary by context. In addition, there are procedural principles such as transparency, engagement, and evidence-responsiveness. Prioritising instrumental value and minimising harms during the COVID-19 pandemic led to widespread agreement on priority tiers to include health-care workers, first responders, people living in congregate housing, and people with an increased risk of death, such as older adults and individuals with medical conditions. However, the pandemic also revealed problems with the implementation of these values and priority tiers, such as allocation on the basis of population rather than COVID-19 burden, and passive allocation that exacerbated disparities by requiring recipients to spend time booking and travelling to appointments. This ethical framework should be the starting point for the allocation of scarce medical resources in future pandemics and other public health conditions. For instance, allocation of the new malaria vaccine among sub-Saharan African countries should be based not on reciprocity to countries that participated in research, but on maximally reducing serious illness and deaths, especially among infants and children.

Dose optimisation and scarce resource allocation: two sides of the same coin.

OBJECTIVE: A deep understanding of the relationship between a scarce drug's dose and clinical response is necessary to appropriately distribute a supply-constrained drug along these lines. SUMMARY OF KEY DATA: The vast majority of drug development and repurposing during the COVID-19 pandemic - an event that has made clear the ever-present scarcity in healthcare systems -has been ignorant of scarcity and dose optimisation's ability to help address it. CONCLUSIONS: Future pandemic clinical trials systems should obtain dose optimisation data, as these appear necessary to enable appropriate scarce resource allocation according to societal values.

Errors in Converting Principles to Protocols: Where the Bioethics of U.S. Covid-19 Vaccine Allocation Went Wrong.

For much of 2021, allocating the scarce supply of Covid-19 vaccines was the world's most pressing bioethical challenge, and similar challenges may recur for novel therapies and future vaccines. In the United States, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) identified three fundamental ethical principles to guide the process: maximize benefits, promote justice, and mitigate health inequities. We argue that critical components of the recommended protocol were internally inconsistent with these principles. Specifically, the ACIP violated its principles by recommending overly broad health care worker priority in phase 1a, using being at least seventy-five years of age as the only criterion to identify individuals at high risk of death from Covid-19 during phase 1b, failing to recommend place-based vaccine distribution, and implicitly endorsing first-come, first-served allocation. More rigorous empirical work and the development of a complete ethical framework that recognizes trade-offs between principles may have prevented these mistakes and saved lives.

Race-Specific, State-Specific COVID-19 Vaccination Rates Adjusted for Age.

The authors provide the first age-standardized race/ethnicity-specific, state-specific vaccination rates for the United States. Data encompass all states reporting race/ethnicity-specific vaccinations and reflect vaccinations through mid-October 2021, just before eligibility expanded below age 12. Using indirect age standardization, the authors compare racial/ethnic state vaccination rates with national rates. The results show that white and Black state median vaccination rates are, respectively, 89 percent and 76 percent of what would be predicted on the basis of age; Hispanic and Native rates are almost identical to what would be predicted; and Asian American/Pacific Islander rates are 110 percent of what would be predicted. The authors also find that racial/ethnic vaccination rates are associated with state politics, as proxied by 2020 Trump vote share: for each percentage point increase in Trump vote share, vaccination rates decline by 1.08 percent of what would be predicted on the basis of age. This decline is sharpest for Native American vaccinations, although these are reported for relatively few states.

Fair Allocation of Scarce Therapies for Coronavirus Disease 2019 (COVID-19).

The US Food and Drug Administration (FDA) has issued emergency use authorizations (EUAs) for monoclonal antibodies (mAbs) for nonhospitalized patients with mild or moderate coronavirus disease 2019 (COVID-19) disease and for individuals exposed to COVID-19 as postexposure prophylaxis. EUAs for oral antiviral drugs have also been issued. Due to increased demand because of the Delta variant, the federal government resumed control over the supply and asked states to ration doses. As future variants (eg, the Omicron variant) emerge, further rationing may be required. We identify relevant ethical principles (ie, benefiting people and preventing harm, equal concern, and mitigating health inequities) and priority groups for access to therapies based on an integrated approach to population health and medical factors (eg, urgently scarce healthcare workers, persons in disadvantaged communities hard hit by COVID-19). Using priority categories to allocate scarce therapies effectively operationalizes important ethical values. This strategy is preferable to the current approach of categorical exclusion or inclusion rules based on vaccination, immunocompromise status, or older age, or the ad hoc consideration of clinical risk factors.

Off-Label Prescription of COVID-19 Vaccines in Children: Clinical, Ethical, and Legal Issues.

The US Food and Drug Administration (FDA) approval of the biologics license application for the Pfizer-BioNTech coronavirus disease 2019 vaccine (Comirnaty) on August 23, 2021, opened the door to the off-label vaccination of children younger than the age range currently covered by either the biologics license application (16 years old and older) or the emergency use authorization (12 to 15 years old). Although prescribing medications at doses, for conditions, or in populations other than those approved by the FDA is generally legal and is common in pediatrics, the FDA, the Centers for Disease Control and Prevention, and the American Academy of Pediatrics have recommended against off-label prescription of the coronavirus disease 2019 vaccine. Several commentaries consider a case in which parents ask their child's pediatrician to prescribe the vaccine for their 11-year-old with special health care needs before approval or authorization in her age group. The first commentary considers the potential benefits and risks to the patient, as well as to the family, the provider, and society, emphasizing the unknown risks in younger patients and the need for adequate informed consent. The second commentary describes an algorithm and principles for evaluating off-label prescribing and argues that the current benefits of prescribing Comirnaty off label to children <12 do not outweigh the risks. The third commentary addresses ethical and legal issues, ultimately calling on federal agencies to remove legal barriers to making the vaccine available to children in age groups that currently lack authorization.

Incorporating Health Equity Into COVID-19 Reopening Plans: Policy Experimentation in California.

California has focused on health equity in the state's COVID-19 reopening plan. The Blueprint for a Safer Economy assigns each of California's 58 counties into 1 of 4 tiers based on 2 metrics: test positivity rate and adjusted case rate. To advance to the next less-restrictive tier, counties must meet that tier's test positivity and adjusted case rate thresholds. In addition, counties must have a plan for targeted investments within disadvantaged communities, and counties with more than 106 000 residents must meet an equity metric. California's explicit incorporation of health equity into its reopening plan underscores the interrelated fate of its residents during the COVID-19 pandemic and creates incentives for action. This article evaluates the benefits and challenges of this novel health equity focus, and outlines recommendations for other US states to address disparities in their reopening plans.

Tailoring Public Health Policies.

In an effort to contain the spread of COVID-19, many states and countries have adopted public health restrictions on activities previously considered commonplace: crossing state borders, eating indoors, gathering together, and even leaving one's home. These policies often focus on specific activities or groups, rather than imposing the same limits across the board. In this Article, I consider the law and ethics of these policies, which I call tailored policies.In Part II, I identify two types of tailored policies: activity-based and group-based. Activity-based restrictions respond to differences in the risks and benefits of specific activities, such as walking outdoors and dining indoors. Group-based restrictions consider differences between groups with respect to risk and benefit. Examples are policies that treat children or senior citizens differently, policies that require travelers to quarantine when traveling to a new destination, and policies that treat individuals differently based on whether they have COVID-19 symptoms, have tested positive for COVID-19, have previous COVID-19 infection, or have been vaccinated against COVID-19. In Part III, I consider the public health law grounding of tailored policies in the principles of "least restrictive means" and "well-targeting." I also examine how courts have analyzed tailored policies that have been challenged on fundamental rights or equal protection grounds. I argue that fundamental rights analyses typically favor tailored policies and that equal protection does not preclude the use of tailored policies even when imperfectly crafted. In Part IV, I consider three critiques of tailored policies, centering on the claims that they produce inequity, cause harm, or unacceptably limit liberty. I argue that we must evaluate restrictions comparatively: the question is not whether tailored policies are perfectly equitable, wholly prevent harm, or completely protect liberty, but whether they are better than untailored ones at realizing these goals in a pandemic. I also argue that evaluation must consider indirect harms and benefits as well as direct and apparent ones.

Prioritizing the Prevention of Early Deaths during Covid-19.

This letter responds to the essay "When Is Age Choosing Ageist Discrimination?," by Teneille R. Brown, Leslie P. Francis, and James Tabery, published in the January-February 2021 issue of the Hastings Center Report.

Public Perspectives on COVID-19 Vaccine Prioritization.

Importance: As COVID-19 vaccine distribution continues, policy makers are struggling to decide which groups should be prioritized for vaccination. Objective: To assess US adults' preferences regarding COVID-19 vaccine prioritization. Design, Setting, and Participants: This survey study involved 2 independent, online surveys of US adults aged 18 years and older, 1 conducted by Gallup from September 14 to 27, 2020, and the other conducted by the COVID Collaborative from September 19 to 25, 2020. Samples were weighted to reflect sociodemographic characteristics of the US population. Exposures: Respondents were asked to prioritize groups for COVID-19 vaccine and to rank their prioritization considerations. Main Outcomes and Measures: The study assessed prioritization preferences and agreement with the National Academies of Science, Engineering, and Medicine's Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. Results: A total of 4735 individuals participated, 2730 (1474 men [54.1%]; mean [SD] age, 59.2 [14.5] years) in the Gallup survey and 2005 (944 men [47.1%]; 203 participants [21.5%] aged 55-59 years) in the COVID Collaborative survey. In both the Gallup COVID-19 Panel and COVID Collaborative surveys, respondents listed health care workers (Gallup, 93.6% [95% CI, 91.2%-95.3%]; COVID Collaborative, 80.0% [95% CI, 78.0%-81.9%]) and adults of any age with serious comorbid conditions (Gallup, 78.6% [95% CI, 75.2%-81.7%]; COVID Collaborative, 72.9% [95% CI, 70.7%-74.9%]) among their 4 highest priority groups. Respondents of all political affiliations agreed with prioritizing Black, Hispanic, Native American, and other communities that have been disproportionately affected by COVID-19 (Gallup, 74.2% [95% CI, 70.6%-77.5%]; COVID Collaborative, 84.9% [95% CI, 83.1%-86.5%]), and COVID Collaborative respondents were willing to be preceded in line by teachers and childcare workers (92.5%; 95% CI, 91.2%-93.7%) and grocery workers (85.9%; 95% CI, 84.2%-87.5%). Older respondents in both surveys were significantly less likely than younger respondents to prioritize healthy adults aged 65 years and older among their 4 highest priority groups (Gallup, 23.7% vs 39.1% [χ2 = 2160.8; P < .001]; COVID Collaborative, 23.3% vs 28.8% [χ2 = 5.0198; P = .03]). COVID Collaborative respondents believed the 4 most important considerations for prioritization were preventing COVID-19 spread (78.4% [95% CI, 76.3%-80.3%]), preventing the most deaths (72.1% [95% CI, 69.9%-74.2%]), preventing long-term complications (68.9% [66.6%-71.9%]), and protecting frontline workers (63.8% [95% CI, 61.5%-66.1%]). Conclusions and Relevance: US adults broadly agreed with the National Academies of Science, Engineering, and Medicine's prioritization framework. Respondents endorsed prioritizing racial/ethnic communities that are disproportionately affected by COVID-19, and older respondents were significantly less likely than younger respondents to endorse prioritizing healthy people older than 65 years. This provides reason for caution about COVID-19 vaccine distribution plans that prioritize healthy adults older than a cutoff age without including those younger than that age with preexisting conditions, that aim solely to prevent the most deaths, or that give no priority to frontline workers or disproportionately affected communities.