Advisory committee addresses principles for allocating initial COVID-19 vaccine supplies
The Advisory Committee on Immunization Practices (ACIP) 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 (EUA) or licensure.
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. 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 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; 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.
· 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 healthcare 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.
· 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 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 healthcare access and utilization, are well documented among certain racial and ethnic minority groups. Vaccine allocation strategies should aim to both reduce existing disparities and to not create new disparities.
· 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 healthcare personnel, other essential workers, adults with high-risk medical conditions, and adults aged ≥65 years (including residents of long-term care facilities). 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.
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, the initial supply will not be adequate to vaccinate the entirety of all four groups; for example, there are approximately 100 million healthcare personnel and essential workers. 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 healthcare personnel; discussion of allocation to the other three groups is ongoing. As additional vaccine supplies become available, other groups may be vaccinated concurrent with healthcare personnel.
In addition to ethical considerations, ACIP’s recommendations regarding receipt of the initial allocations of COVID-19 vaccine during the period of constrained supply will be based on science (e.g., available information about the vaccine’s characteristics such as safety and efficacy in older adults and epidemiologic risk) and feasibility of implementation (e.g., storage and handling requirements). Thus, ACIP’s allocation recommendations will be made in conjunction with specific recommendations for the use of each FDA-authorized or licensed COVID-19 vaccine. Although the ethical principles in this report are fundamental for stewardship of limited vaccine supply, they can also be applied when COVID-19 vaccines are widely available, to ensure equitable and just access for all persons.
