The Advisory Committee on Immunization Practices' Ethical Principles for Allocating Initial Supplies of COVID-19 Vaccine — United States, 2020

United States, 2020

Nancy McClung, PhD; Mary Chamberland, MD; Kathy Kinlaw, MDiv; Dayna Bowen Matthew, JD, PhD; Megan Wallace, DrPH; Beth P. Bell, MD; Grace M. Lee, MD; H. Keipp Talbot, MD; José R. Romero, MD; Sara E. Oliver, MD; Kathleen Dooling, MD

Disclosures

Morbidity and Mortality Weekly Report. 2020;69(47):1782-1786. 

In This Article

Abstract and Introduction

Introduction

To reduce the spread of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19) and its associated impacts on health and society, COVID-19 vaccines are essential. The U.S. government is working to produce and deliver safe and effective COVID-19 vaccines for the entire U.S. population. The Advisory Committee on Immunization Practices (ACIP)* has broadly outlined its approach for developing recommendations for the use of each COVID-19 vaccine authorized or approved by the Food and Drug Administration (FDA) for Emergency Use Authorization or licensure.[1] ACIP's recommendation process includes an explicit and transparent evidence-based method for assessing a vaccine's safety and efficacy as well as consideration of other factors, including implementation.[2] Because the initial supply of vaccine will likely be limited, ACIP will also recommend which groups should receive the earliest allocations of vaccine. The ACIP COVID-19 Vaccines Work Group and consultants with expertise in ethics and health equity considered external expert committee reports and published literature and deliberated the ethical issues associated with COVID-19 vaccine allocation decisions. The purpose of this report is to describe the four ethical principles that will assist ACIP in formulating recommendations for the allocation of COVID-19 vaccine while supply is limited, in addition to scientific data and implementation feasibility: 1) maximize benefits and minimize harms; 2) promote justice; 3) mitigate health inequities; and 4) promote transparency. These principles can also aid state, tribal, local, and territorial public health authorities as they develop vaccine implementation strategies within their own communities based on ACIP recommendations.

The ACIP COVID-19 Vaccines Work Group has met several times per month (approximately 25 meetings) since its establishment in April 2020. Work Group discussions included review of the epidemiology of COVID-19 and consultation with experts in ethics and health equity to inform the development of an ethically principled decision-making process. The Work Group reviewed the relevant literature, including frameworks for pandemic influenza planning and COVID-19 vaccine allocation;[3–8] summarized this information; and presented it to ACIP. ACIP supported four fundamental ethical principles to guide COVID-19 vaccine allocation decisions in the setting of a constrained supply. Essential questions that derive from these principles can assist in vaccine allocation planning (Table 1).

Maximize Benefits and Minimize Harms

Allocation of COVID-19 vaccine should maximize the benefits of vaccination to both individual recipients and the population overall. These benefits include the reduction of SARS-CoV-2 infections and COVID-19–associated morbidity and mortality, which in turn reduces the burden on strained health care capacity and facilities; preservation of services essential to the COVID-19 response; and maintenance of overall societal functioning. Identification of groups whose receipt of the vaccine would lead to the greatest benefit should be based on scientific evidence, accounting for those at highest risk for SARS-CoV-2 infection or severe COVID-19–related disease or death, and the essential role of certain workers. The ability of essential workers, including health care workers and non–health care workers, to remain healthy has a multiplier effect (i.e., their ability to remain healthy helps to protect the health of others or to minimize societal and economic disruption). Some of these workers are at increased risk for SARS-CoV-2 infection because of their limited ability to maintain physical distance in the workplace or because they do not have consistent access to recommended personal protective equipment.

Promote Justice

Inherent in the principle of justice is an obligation to protect and advance equal opportunity for all persons to enjoy the maximal health and well-being possible. Justice rests on the belief in the fundamental value and dignity of all persons. Allocation of COVID-19 vaccine should promote justice by intentionally ensuring that all persons have equal opportunity to be vaccinated, both within the groups recommended for initial vaccination, and as vaccine becomes more widely available. This includes a commitment to removing unfair, unjust, and avoidable barriers to vaccination that disproportionately affect groups that have been economically or socially marginalized, as well as a fair and consistent implementation process. Input from a range of external entities, partners, and community representatives is particularly important in developing and assessing allocation plans.

Mitigate Health Inequities

Health equity is achieved when every person has the opportunity to attain his or her full health potential and no one is disadvantaged from achieving this potential because of social position or other socially determined circumstances. Disparities in the severity of COVID-19 and COVID-19–related death, as well as inequities in social determinants of health that are linked to COVID-19 risk, such as income or health care access and utilization, are well documented among certain racial and ethnic minority groups.[9] Vaccine allocation strategies should aim to both reduce existing disparities and to not create new disparities. Efforts should be made to identify and remove obstacles and barriers to receiving COVID-19 vaccine, including limited access to health care or residence in rural, hard-to-reach areas.

Promote Transparency

Transparency relates to the decision-making process and is essential to building and maintaining public trust during vaccine program planning and implementation. The underlying principles, decision-making processes, and plans for COVID-19 vaccine allocation must be evidence-based, clear, understandable, and publicly available. To the extent possible, considering the urgency of the COVID-19 response, public participation in the creation and review of the decision-making process should be facilitated. In addition, when feasible, tracking administration of vaccine to the groups recommended for initial vaccine allocation can contribute to transparency and trust in the process. In an ongoing public health response, the situation continually evolves as new information becomes available. Transparency includes being clear about the level of certainty in the available evidence and communicating new information that might change recommendations in a timely fashion.

For the period when the supply of COVID-19 vaccine will be limited, ACIP has considered four groups for initial vaccine allocation. These include health care personnel, other essential workers, adults with high-risk medical conditions, and adults aged ≥65 years (including residents of long-term care facilities) (Table 2). These groups were selected based on available scientific data, vaccine implementation considerations, and ethical principles. The principle of transparency is applied across the entirety of the vaccine allocation decision-making process. ACIP's meetings are open to the public, meeting minutes and archived webcasts are available online, and data (including data from vaccine clinical trials) and analytic methods used in developing ACIP recommendations are publicly available.§ Members of the public are invited to submit written comments to the Federal Register or provide oral comment during ACIP meetings. ACIP's 30 nonvoting representatives from liaison organizations facilitate engagement with professional medical and public health organizations and other stakeholders and partners.

All four groups proposed for initial allocation of COVID-19 vaccine merit strong consideration from an ethical perspective. Current planning scenarios estimate, however, that the expected number of doses during the first weeks of vaccine distribution might only be sufficient to vaccinate approximately 20 million persons. Although there is considerable overlap between groups**,[10] the initial supply will not be adequate to vaccinate the entirety of all four groups; for example, there are approximately 100 million health care personnel and essential workers (Table 2). Published frameworks for COVID-19 allocation and ACIP discussions indicate a clear consensus that the first allocation of COVID-19 vaccine supplies should be directed to health care personnel;[1,5–8] discussion of allocation to the other three groups is ongoing. As additional vaccine supplies become available, other groups may be vaccinated concurrent with health care personnel.

*The ACIP includes 15 voting members responsible for making vaccine recommendations. Fourteen of the members have expertise in vaccinology, immunology, pediatrics, internal medicine, nursing, family medicine, virology, public health, infectious diseases, and/or preventive medicine; one member is a consumer representative who provides perspectives on the social and community aspects of vaccination. In addition to the 15 voting members, ACIP includes eight ex officio members who represent other federal agencies with responsibility for immunization programs in the United States, and 30 nonvoting representatives of liaison organizations that bring related immunization expertise. https://www.cdc.gov/vaccines/acip/members/index.html.
https://www.cdc.gov/chronicdisease/healthequity/index.htm.
§ https://www.cdc.gov/vaccines/acip/index.html.
https://www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination-Program-Interim_Playbook.pdf.
**There is overlap among these four groups. For example, in one analysis, among the 3.8% of U.S. adults who work directly with patients as health care workers, 38.6% have high-risk medical conditions or are aged >65 years.

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