After three years of around-the-clock tracking of COVID-19 data from...
This primer outlines key terms and concepts related to COVID-19 vaccines and is intended for members of the general public, policy makers, educators, and key stakeholders.
The United States government invested about $10 billion dollars to develop, manufacture, and purchase Covid-19 vaccines through Operation Warp Speed. More than 40 million vaccine doses could be available by the end of 2020, enough to vaccinate more than 20 million people. If multiple vaccine manufacturers are successful, hundreds of millions of doses could be available in 2021. But, with a world population of 7.8 billion, including the United States (U.S.) population of nearly 330 million, there will not be sufficient doses for all who need or want to be vaccinated. Until enough vaccine is available for the general population, doses will need to be given to priority groups. This primer uses the framework established by the National Academies to examine who may have access to Covid-19 vaccines in the U.S.
This is not the first time the U.S. has deliberated prioritization of vaccines during a pandemic. For example, the U.S. Department of Health and Human Services developed a Pandemic Influenza Plan that included recommendations on the prioritization of influenza vaccines. The plan identified four tiers and eight sub-tiers of population groups to prioritize the order in which individuals should be vaccinated during an influenza pandemic. The first tier included health care workers, those at high risk of severe disease due to underlying conditions, pregnant women, household contacts of those at high risk, emergency response workers, government workers, and, interestingly, vaccine and antiviral drug manufacturers.
When the H1N1 influenza pandemic came in 2009, vaccine manufacturing and distribution faced challenges despite pandemic planning. Vaccine production was slow because of the need to grow influenza virus in eggs for vaccine production, a problem not faced with Covid-19 vaccines. With H1N1, by the time many vaccine doses were available, the second wave of influenza virus transmission had largely passed. In the end, only about one-quarter of the general population in the U.S. was vaccinated and one-third of those in priority groups.
The H1N1 experience has some similarities to Covid-19 vaccine allocation. The federal government purchased all of the vaccines and distributed doses to states based on population size, similar to what may happen with Covid-19 vaccines. States then decided how best to distribute vaccine doses to providers, although getting the influenza vaccine to adults was – and remains – a challenge.
Several efforts have been made to develop guiding principles and frameworks for the allocation of Covid-19 vaccines in the U.S. The first was developed by the Johns Hopkins Center for Health Security and published in August 2020, titled Interim Framework for COVID-19 Vaccine Allocation and Distribution in the United States. Subsequently, the National Academies of Science, Engineering and Medicine published the Framework for Equitable Allocation of COVID-19 Vaccine at the request of the National Institutes of Health and the Centers for Disease Control and Prevention (CDC). The National Academies were charged with developing a framework to assist policy-makers in planning for equitable allocation of Covid-19 vaccines. This framework is expected to heavily influence Covid-19 vaccine allocation and prioritization in the U.S. At the federal level, allocation decisions will be made by the CDC with input from the Advisory Committee on Immunization Practices (ACIP), although each state will have responsibility for implementing the plan. As described below, the National Academies’ Framework for Equitable Allocation of COVID-19 Vaccine lays out the goal, foundational principles, and four allocation phases.
The goal of the equitable allocation of Covid-19 vaccines is to reduce severe morbidity and mortality and negative societal impact due to the transmission of SARS-CoV-2.
Conceptualizing a framework for the equitable allocation of vaccines often begins with consideration of foundational principles that guide the decision-making process for prioritization. The Framework for Equitable Allocation of COVID-19 Vaccine lays out three ethical principles and three procedural principles that guided the allocation framework. The three ethical principles are:
1. maximum benefit to protect and promote the public’s health and socioeconomic well-being;
2. equal concern so that every person be considered and treated as having equal dignity, worth, and value; and
3. mitigation of health inequities to explicitly address the higher burden of Covid-19 in populations at high risk of exposure and compounding health inequities.
The three procedural principles are:
2. transparency; and
The Framework for Equitable Allocation of COVID-19 Vaccine proposes a phased approach to the allocation of Covid-19 vaccines. The use of the word “phases” rather than “tiers” reflects the temporal nature of the process and de-emphasizes a hierarchical allocation framework. The four phases encompass increasingly larger groups based on risk of exposure and disease severity.
Phase 1 includes high-risk health workers, first responders, people at significantly higher risk of severe disease due to underlying conditions, and older adults living in congregate or overcrowded settings. Phase 2 comprises K-12 teachers and staff, critical workers in high-risk industries, people at moderately higher risk of severe disease due to underlying conditions, people in homeless shelters or group homes, people in prisons or jails, and older adults not included in Phase 1. Phase 3 further expands Covid-19 vaccine allocation to all children, young adults, and additional workers in important industries and occupations. Finally, Phase 4 includes everyone else residing in the U.S, a phase that may be reached by the summer or fall of 2021. Although the framework does not specifically identify racial or ethnic groups, there is recognition of the disproportionate impact of Covid-19 in African-American and Latinx communities due to systemic racism that yields higher rates of underlying diseases, living conditions that contribute to disease risk, and greater employment as essential workers with increased exposure risk to SARS-CoV-2. These equity factors were considered in the framework’s development.
Federal guidelines on the allocation of Covid-19 vaccines in the U.S. will be issued by the CDC. Final allocation decisions have not been made but will be based on input from the Advisory Committee on Immunization Practices (ACIP). Shortly after the Food and Drug Administration (FDA) authorizes or approves a Covid-19 vaccine, the ACIP will hold a public meeting to review available data on vaccine safety and efficacy and will vote on whether to recommend the vaccine. If a recommendation is made, the ACIP will also provide guidance on who should receive the vaccine. These recommendations must be approved by the director of the CDC before becoming official CDC policy.
The ACIP met on November 23rd to discuss phased Covid-19 vaccine allocation and published, on the same day, ethical principles for allocating initial supplies of Covid-19 vaccines. These ethical principles include:
1. maximize benefits and minimize harms;
2. promote justice;
3. mitigate health inequities; and
4. promote transparency.
Although the ACIP did not vote on a vaccine allocation plan, they deliberated who within the U.S. would be prioritized to receive Covid-19 vaccines in Phase 1. Specifically, the ACIP discussed the proposal that Phase 1a include health care personnel and residents of long-term care facilities, Phase 1b include other non-health care essential workers (e.g., police, firefighters, and those in education, transportation, and food services), and Phase 1c include adults 65 years and older and those with high-risk medical conditions (e.g., obesity, diabetes, and chronic lung, heart, and kidney conditions). The FDA is scheduled to meet on December 10th to review Emergency Use Authorization applications for Covid-19 vaccines, and the ACIP is expected to meet and vote shortly afterward. Federal guidelines on Covid-19 vaccine allocation in the U.S. will then be issued by the CDC.
Ultimately, state, tribal, local, and territorial jurisdictions will be responsible for Covid-19 vaccine allocation and distribution, with guidance and support from the federal government, including the CDC. The federal government has asked states to submit interim draft Covid-19 vaccination plans. These plans are what will ultimately determine who receives a Covid-19 vaccine and when, and allocation plans may vary across states. These state plans will be modified based on vaccine safety and efficacy data for particular populations or risk groups as well as distribution and storage requirements as vaccines receive Emergency Use Authorization and biological licensure from the FDA. Distribution and storage requirements vary by vaccine type, with the Pfizer mRNA vaccine requiring ultracold storage temperatures, and states will need to be prepared to meet these requirements.
There are unverified rumors that Santa Claus and his elves may be among the essential workers prioritized to receive the first Covid-19 vaccine doses in mid-December, in time for the holiday season.
Interim Framework for COVID-19 Vaccine Allocation and Distribution in the United States. The Johns Hopkins Center for Health Security (August 2020): https://www.centerforhealthsecurity.org/our-work/publications/interim-framework-for-covid-19-vaccine-allocation-and-distribution-in-the-us
Framework for Equitable Allocation of COVID-19 Vaccine. National Academies of Science, Engineering and Medicine (2020): https://www.nationalacademies.org/our-work/a-framework-for-equitable-allocation-of-vaccine-for-the-novel-coronavirus
COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations. Centers for Disease Control and Prevention (October 29, 2020): https://www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination-Program-Interim_Playbook.pdf
The Advisory Committee on Immunization Practices’ Ethical Principles for Allocating Initial Supplies of COVID-19 Vaccine — United States, 2020. Centers for Disease Control and Prevention (November 23, 2020): https://www.cdc.gov/mmwr/volumes/69/wr/mm6947e3.htm