Whenever a new vaccine gets approved, health officials have to tackle the difficult question of who should be first in line to receive it. Typically health-care workers are first, and in previous outbreaks, such as the H1N1 swine flu in 2009, people whose health was most vulnerable got priority, too.
With the widely anticipated COVID-19 vaccine, there’s a new factor being considered: fairness.
On October 2, the National Academy of Medicine revealed its recommendations for COVID-19 vaccine distribution in an influential 237-page framework commissioned by the National Institutes of Health and the U.S. Centers for Disease Control and Prevention.
The report proposes distributing a vaccine in four phases as it becomes available. The first recipients are obvious picks: health-care workers, emergency responders, people with underlying conditions, and older adults living in group settings. This mirrors similar recommendations by the World Health Organization, and it is a foundational principle for the COVAX collaboration, a global effort to improve poorer countries’ access to a vaccine, which 171 nations have pledged to join. (The U.S. is not one of them, and a small group of scientists question the wisdom of putting some health-care workers at the top.)
But for the first time in history, the report also recommends that priority be given to people who score high on the CDC’s Social Vulnerability Index, which identifies factors such as poverty, lack of access to transportation, or crowded housing that are linked to poor health outcomes. The committee of virologists, epidemiologists, economists, and other health researchers who wrote the report said the goal is to rectify the pandemic’s disproportionate burden on minorities and poor people and “work toward a new commitment to promoting health equity.”
The disparities are stark: Compared with white people, African Americans, Hispanics, and Native Americans are nearly three times more likely to contract the coronavirus. Blacks are twice as likely to die.
“This approach allowed us to embrace a notion of equal regard for all people, and address the underpinnings of social inequity and factors that have landed African Americans, Hispanics, and Native Americans in situations and occupations in which they are less healthy,” committee member Jewel Mullen, associate dean for health equity at Dell Medical School at the University of Texas at Austin, tells National Geographic.
Despite the report’s nuanced guidelines, it’s not clear how they will be practiced or enforced, nor how they will play out as the country prepares for an unprecedented vaccine rollout.
Next in line
The highly contagious nature of COVID-19 is forcing officials to consider social criteria—such as protecting people living in group housing or working in conditions in which transmission is more likely—when deciding who gets the vaccine first.
The report authors are recognizing the vital roles of essential workers, such as teachers, bus drivers, and grocery stockers, on whom the rest of us depend.
The second phase of the recommended rollout would include the remaining adults older than 65, K–12 teachers, school staff, and childcare workers—as well as essential workers in industries such as meatpacking that don’t allow social distancing. Residents and staff of group homes, homeless shelters, prisons, and detention centers also fit into this category.
Children, young adults under 30, and other critical workers at increased risk are in the third group. The fourth wave includes everyone else residing in the U.S.
Now that it’s been submitted, the report will be considered by the Advisory Committee on Immunization Practices (ACIP), a nongovernmental organization that makes public policy recommendations on the use of licensed vaccines to the CDC. While ACIP’s suggestions aren’t binding, they’re usually adopted.
“These won’t be rigid recommendations. We need some flexibility,” says Jose Romero, ACIP committee chair and Secretary of Health for the state of Arkansas.
That’s because health-care regulators want to avoid some of the pitfalls encountered when they prepared for a vaccination campaign during the H1N1 flu pandemic, which killed more than 12,000 people in the U.S. At that time, counties geared up for distribution of the vaccine to the first priority group, but the shipments arrived so slowly that the threat had passed by the time they received large quantities. Historically, when supplies are limited, mass vaccination can be successfully replaced with an approach that targets those most at-risk, but the shortage wasn’t anticipated in time.
“It came in dribs and drabs, and each state got a couple thousand doses at first,” says Jennifer Nuzzo, an epidemiologist from the Johns Hopkins Center for Health Security.
Romero acknowledges that individual states or counties might have vulnerable populations, such as workers in local meatpacking plants, whom they want to focus on after receiving early vaccine shipments in a second phase.
What is fair?
Romero says that both the ACIP and the National Academy of Medicine are “aligned” in their mission to promote health equity, but that ACIP is waiting to learn which vaccines will be approved before issuing final guidelines.
“Our recommendations will probably change over time, as each version comes forward and we learn about its efficacy,” Romero says. “Maybe one doesn’t work as well in the elderly, so we would focus it on younger people.”
There’s already precedent for using fairness considerations to determine priority for other health-care resources during the COVID-19 pandemic.
When supplies of remdesivir—the experimental antiviral drug that President Donald Trump partially credits for his recent recovery—were in short supply in June, the University of Pittsburgh Medical Center implemented a weighted lottery system for patients. The hospital had enough for only about one in four patients, but those from disadvantaged backgrounds received a roughly one in three chance of being selected. So did health-care and essential workers in jobs that have a higher risk of infection.
Administrators didn’t make distinctions based on age, race, ethnicity, disability, ability to pay, or whether someone had children to care for. Rather, they used a metric called the “area deprivation index,” a database developed by the University of Wisconsin that incorporates more than a dozen census variables, including income, education, and housing.
“If you’re suffering from the disadvantages of poverty and poor access to health care and jobs that put you historically at a higher risk of dying, then we’re going to take some steps to lessen the disadvantage you’re experiencing,” explains Douglas White, director of the program on ethics and decision-making in critical care medicine at the University of Pittsburgh. He says that the model could be used for future drug shortages, such as convalescent plasma or monoclonal antibodies.
At the same time, state and county local health departments are balancing these recommendations with preparations for how to distribute whatever vaccine doses become available. Last week, Health and Human Services Secretary Alex Azar announced that the U.S. government was manufacturing six potential vaccines in 23 facilities and would have 100 million doses ready by the end of the year and enough for every American by spring.
Without thoughtful planning, logistical challenges with this huge deployment could create disparities in access to this life-saving remedy. Two frontrunner candidates—by the biotech company Moderna and the pharmaceutical giant Pfizer—require two doses spaced about a month apart and are chemically unstable at room temperature. As a consequence, those drugs must be shipped and stored frozen, and Pfizer’s version, moreover, must be kept at minus 94 degrees Fahrenheit, which is colder than standard freezers.
That’s why both the WHO and the National Academy report list vaccine storage and transport as crucial elements for equitable vaccine distribution. Vaccine shortages are already a problem for rural America due to years of hospital closures, and the mere lack of refrigerators has stymied efforts to eliminate diseases around the world for decades. To help with shipping, UPS is building two huge freezer farms in Kentucky and the Netherlands that will contain 600 deep freezers that would store 48,000 vaccine vials. Another option is a vaccine—such as Johnson & Johnson’s candidate—that can be administered in a single dose and does not require cold storage. But it’s a couple months behind in the vaccine race.
Health regulators are also trying to anticipate how many supplies, such as syringes, including adult and child sizes, to stockpile and whether they need to train additional people to administer the shots, especially for a two-dose vaccine. HHS officials have stated that the U.S. alone could require 650 million to 850 million syringes and needles, and that it could take two years to manufacture them.
“It’s not just the science of vaccine development we need to think about, but what it’s going to take to get it to the people who need it,” says Nuzzo of Johns Hopkins.
What’s also unknown is whether vaccine shipments will arrive in manageable waves so they can be distributed through the doctor’s offices and pharmacies used for seasonal flu shots—or whether officials would need to find larger spaces like stadiums.
Unlike influenza, the threat of COVID-19 won’t fade, given that nine in 10 people remain susceptible to infection. And the challenges of distributing this vaccine could be unlike any other, says medical historian Howard Markel of the University of Michigan.
“A lot of vaccination programs weren’t done in the middle of the worst pandemic of our generation,” says Markel. “It’s like we’re in the middle of a war and everyone needs a Kevlar vest.”
Many legacy vaccines were mass produced after outbreaks were over. One exception is the polio vaccine, but it required an epic effort to scale up quickly. The Eisenhower Administration licensed six different companies for polio vaccination campaigns in 1954, and then used assembly lines at high school gymnasiums, civic centers, and dance halls to produce them.
Global public health experts are also asking wealthy countries to consider COVID-19 vaccines as a “global public good” and to earmark funding and doses for another needy group: poorer countries.
Not only can unvaccinated travelers continue to spread the virus, our national interests depend on healthy foreign populations maintaining global supply chains, says Ruth Faden, bioethicist at Johns Hopkins University in Baltimore and member of the international organization’s COVID-19 vaccine working group.
“Wealthy countries are focusing primarily on securing vaccines for their own populations,” Faden says. “But it’s very short-sighted to think we can get this thing behind us if we just take care of our own.”
Yet as the world waits for a vaccine winner to hammer out the details, the emphasis on equity by health officials is meant to reassure people.
“It’s an important message to present to the public,” Mullen from the University of Texas says, “that there's a deliberate body thinking about how to advance the vaccine in a process that’s fair to all of us.”