Who will get a COVID-19 vaccine first?
According to the CDC’s Advisory Committee on Immunization Practices, there are more than 200 COVID-19 vaccines under development. In the United States, two candidates have reached phase 3 trials and one phase 3 trial was put on hold.
Discussions over which groups will be prioritized to receive a vaccine when one is available have begun. At the Advisory Committee on Immunization Practices (ACIP) meeting in September, experts discussed matters of ethics and equity regarding COVID-19 vaccines.
Several groups, among them WHO, Johns Hopkins School of Public Health and the National Academies of Sciences, Engineering, and Medicine (NAM), have published varied frameworks for determining the most effective methods for vaccine distribution in the U.S., including what groups should be prioritized.
WHO, for example, did not rank groups by priority but listed all those who they believed should receive the vaccine as a priority, whereas Johns Hopkins and NAM ranked specific groups into tiers or phases, though the populations comprising their tiers varied.
According to a presentation during the ACIP meeting by Sara Oliver, MD, MSPH, an Epidemic Intelligence Service officer with CDC's Division of Viral Diseases, the committee assessed these frameworks and used them to develop its own framework for vaccine equity and allocation.
Oliver said the purpose of the framework is to “assist the ACIP in the identification of early recipients for allocation of COVID-19 vaccine in the setting of a constrained supply.”
Overall, the ACIP included four main groups as potential early COVID-19 vaccine recipients: health care personnel, other non-medical essential workers, those with high-risk medical conditions and adults aged 65 years or older.
Kathleen Dooling, MD, MPH, a medical officer in the CDC’s Division of Viral Diseases, said phase 1A of distribution would consist of health care personnel — the 17 million to 20 million people working in hospitals, long-term care facilities, outpatient care facilities, EMS and others.
Phase 1B would include non-health care essential workers, who account for roughly 40 million to 60 million people working in food and agriculture, transportation, education and law enforcement. Dooling said this group has some overlap with the next two groups: adults aged 65 years or older and people with high-risk conditions. For example, ACIP data showed that roughly 30% of essential employees are obese, 7% have diabetes and 4% have cancer; around 16% of essential workers are 65 years of age or older or live with someone who is. With such high overlap, the approximately 53 million adults aged 65 years or older and 100 million people with high-risk conditions make up the rest of phase 1B, though the ACIP acknowledged that the acceptability of and the value of a COVID-19 vaccine are unknowns among the phase 1B groups.
The ACIP said that once a vaccine is approved by the FDA, an emergency meeting will be called to vote on which populations would receive it first.
‘Need for a national policy’
In a Senate hearing, CDC Director Robert R. Redfield, MD, said he expects a “very limited supply” of COVID-19 vaccine to be available between November and December for priority groups, but that the general public would have to wait until next year to receive it.
Richard K. Zimmerman, MD, MPH, a professor at the University of Pittsburgh School of Medicine, and colleagues also discussed how to allocate limited initial doses in the U.S. in a paper published in The Journal of Infectious Diseases.
“Recent evidence of unequal risk and treatment of underrepresented citizens in multiple arenas highlights the need for a national policy that diminishes subjective decision making, represents all affected communities, and is guided by epidemiology, science, and bioethics,” they wrote.
Using the theories of egalitarianism and utilitarianism, they proposed a three- to four-tier approach. The first tier is supported by both theories: those with the critical skills needed for society during a pandemic, such as health care providers, police, firefighters, and makers of vaccines and therapeutics required for treatment of COVID-19. The second tier, which includes individuals who experience the highest medical benefit, varied by theory. According to the authors, egalitarianism supports prioritizing the medically neediest or those most likely to die from COVID-19, whereas the utilitarian approach suggests balancing medical need with likelihood of protective vaccine response in order to protect the largest number of people.
“Given that vaccines are still in development, it is unknown who among the medically needy will respond well,” the authors wrote.
The final proposed tier would be the largest group and, based on egalitarianism, would be selected by random chance.
“Lotteries for allocation of scarce COVID-19 treatments have been advocated,” the authors wrote. “Although thought to avoid overt discrimination, access to benefits from lotteries may have hidden inequalities that can even reduce the fairness of chance.”
The researchers said a fourth tier could be added and would likely consist of people critical to transmission dynamics for COVID-19, also referred to as super-spreaders. According to the study, the epidemiology of COVID-19 would need to be better understood to identify who would be included in this group.
“Our proposal is similar to those of WHO and ACIP but differs in several ways, including consideration of potential super-spreaders, use of medical benefit instead of just medical risk, use of an Area Deprivation Index-weighted lottery, and allocation of doses to each tier,” the authors wrote. “We are concerned about the historic and recent racial, socioeconomic status, ageist, and disability related injustices, calling on the need for national guidelines that are less subject to the whims of local interpretation.”
The ‘Fair Priority Model’
In a paper published in Science, Ezekiel J. Emanuel, PhD, vice provost of the University of Pennsylvania, and colleagues addressed the question of how to fairly distribute vaccines worldwide.
In an interview, Emanual cited examples of unfair or unethical distribution, including a policy based on population that has been advocated by WHO and Bill Gates.
“I don't think that's really the most ethical approach, in large part because there are some countries — New Zealand, Taiwan, South Korea — where there are almost no cases and almost no deaths, in which a vaccine is not going to make a difference,” he said. “On the other hand, places like Brazil, Mexico and India have lots of cases and a vaccine would make a much bigger difference in those countries.”
In their paper, Emanuel and colleagues presented what they called the “Fair Priority Model,” which could be used to prevent “vaccine nationalism” a country keeping a vaccine developed within its borders and unfair distribution, and reduce premature deaths.
“What are the ethical principles that should guide worldwide distribution? They should be limiting harm and benefiting people, mitigating and certainly not compounding disadvantage and having equal moral concern with basically a principle of nondiscrimination,” Emanuel said. “You don't decide who gets a vaccine on the basis of race or religion but on the basis of [if] they need it.”
He said those principles would lead to the top priority of distributing a vaccine “reducing the number of premature deaths because that is devastating, irreversible harm that you cannot compensate a person for.”
“Once we get that mortality situation under control, we move to mitigating economic harms and mitigating people thrown into the expansion of poverty, mitigating the loss of educational opportunities, and then finally we try to achieve herd immunity,” Emanuel said.