The race to develop a COVID-19 vaccine is on, with about 35 companies and academic institutions stepping into the vaccine development ring. Of these, at least four have vaccine candidates that are already in preclinical trials. But once a vaccine is successfully developed, healthcare providers, policymakers, and public health officials will face decisions on rationing it until there is enough of a supply to vaccinate everyone in the country. The overriding question will then be: How will the vaccine be distributed, and to whom?
At the head of the pack in COVID-19 vaccine development is the National Institutes of Allergy and Infectious Diseases (NIAID), which is funding a phase 1 clinical trial that has already begun at Kaiser Permanente Washington Health Research Institute, Seattle, WA. For this open-label trial, 45 healthy adults aged 18 to 55 years will be enrolled. The first participant has already received a dose of the investigational vaccine—developed using a genetic platform, messenger RNA (mRNA). The vaccine, mRNA-1273, is being developed in collaboration with Moderna Inc., Cambridge, MA—a biotech company focused on drug discovery and development based on mRNA—and has already shown promise in animal models.
“Finding a safe and effective vaccine to prevent infection with SARS-CoV-2 is an urgent public health priority,” said NIAID Director Anthony S. Fauci, MD. “This phase 1 study, launched in record speed, is an important first step toward achieving that goal.”
Yet, despite the vast resources and research currently directed toward new vaccine development, an actual vaccine for COVID-19 is still a long way away. Typically, vaccines take 12 to 18 months to develop. And, experts say it may be even longer before a vaccine for COVID-19 is available.
A lot to consider
The ethics behind how the vaccine will be distributed and to whom—and, indeed, those underpinning the broader choices of medical resource allocation during this pandemic—are complex.
“Even when a vaccine becomes available, mass producing it to vaccinate several billion people across the globe would take a considerable [amount of] time. That means the vaccine will be limited at first,” Asal Mohamadi Johnson, PhD, MPH, assistant professor of Epidemiology, Integrative Health Science, Stetson University, DeLand, FL, told MDLinx.
“We have data to know who is more likely to be hospitalized or die of this disease. Additionally, we know an important key factor to managing a pandemic at this scale is to keep healthcare workers, who come in frequent contact with infected people, healthy. In my opinion, healthcare personnel, those with immunocompromised conditions, and the elderly should be prioritized to receive vaccinations,” added Dr. Johnson.
She also brought up several other ethical questions for consideration on a broader, worldwide scale.
“We should look at vaccine distribution from a global perspective. There are serious equity issues to be considered here. What would be the share of resource-poor countries (with much [less] medical equipment such as ventilators)? Are wealthy countries, such as Switzerland, the United States, or Saudi Arabia, going to receive more vaccines just because they are able to afford it?” she queried.
Dr. Johnson then broke it down regionally regarding population-based characteristics and demographics.
“Another consideration is disparity in geographical distribution within countries. In the United States, are urban and suburban areas going to be prioritized over rural areas? Are white people going to have a disproportionately greater share of vaccines compared to black and Hispanic populations? If there is genuine interest in equitable distribution of vaccines, decision-makers—either at global or national levels—should consider these questions and make a serious commitment to protect the most disadvantaged groups of their populations,” she said.
The optimal approach to COVID-19 vaccination within the United States, Dr. Johnson explained, would include the following:
Keeping healthcare workers healthy.
Ensuring that those who are most likely to be hospitalized or die of the disease receive the vaccine.
Ensuring fairness in vaccine distribution across countries and continents, race/ethnicity, and socioeconomic status.
The ethics of rationing
Echoing these thoughts, lead author Ezekiel J. Emanuel, MD, PhD, Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, and colleagues explore the idea of rationing supplies—including future vaccines—during the pandemic and the ensuing ethical concerns surrounding their distribution, in an article published in The New England Journal of Medicine. Like Dr. Johnson, they stressed that if and when an effective vaccine is developed, it will take time to produce, distribute, and administer.
They also recommended that healthcare workers on the front lines be given priority for all critical COVID-19 interventions, including vaccines.
“Critical COVID-19 interventions—testing, [personal protective equipment], ICU beds, ventilators, therapeutics, and vaccines—should go first to front-line health care workers and others who care for ill patients and who keep critical infrastructure operating, particularly workers who face a high risk of infection and whose training makes them difficult to replace. These workers should be given priority not because they are somehow more worthy, but because of their instrumental value: they are essential to pandemic response. If physicians and nurses are incapacitated, all patients—not just those with COVID-19—will suffer greater mortality and years of life lost.”
Dr. Emanuel and colleagues also argue that the priority for COVID-19 vaccination be given to older individuals, rather than younger ones, which may be tempered by as-yet-unknown information on viral shedding. While these recommendations are written to address distribution of COVID-19 vaccines once available, and do not reflect on distribution of care, it is interesting to note that they do directly contradict current care allocation decrees in Italy, which some have speculated may be implemented in the United States at peak. These decrees call for physicians to deprioritize care for those at highest risk of mortality to secure resources for healthier patients with a higher likelihood of recovery.
“Prioritization guidelines should differ by intervention and should respond to changing scientific evidence. For instance, younger patients should not be prioritized for COVID-19 vaccines, which prevent disease rather than cure it, or for experimental post- or pre-exposure prophylaxis. COVID-19 outcomes have been significantly worse in older persons and those with chronic conditions. Invoking the value of maximizing saving lives justifies giving older persons priority for vaccines immediately after health care workers and first responders,” they wrote.
“If the vaccine supply is insufficient for patients in the highest risk categories—those over 60 years of age or with coexisting conditions—then equality supports using random selection, such as a lottery, for vaccine allocation. Invoking instrumental value justifies prioritizing younger patients for vaccines only if epidemiologic modeling shows that this would be the best way to reduce viral spread and the risk to others,” added Dr. Emanuel and fellow authors.
They also presented an overview of considerations upon which to base the allocation of vaccines as well as other medical resources, and offered six recommendations for successfully achieving this.
“These ethical values—maximizing benefits, treating equally, promoting and rewarding instrumental value, and giving priority to the worst off—yield six specific recommendations for allocating medical resources in the COVID-19 pandemic: maximize benefits; prioritize health workers; do not allocate on a first-come, first-served basis; be responsive to evidence; recognize research participation; and apply the same principles to all COVID-19 and non–COVID-19 patients,” they concluded.
Dr. Emanuel and colleagues also stressed the need to avoid a certain type of distribution of medical resources, arguing that it would go against everything nations are trying to achieve in controlling this pandemic: “[F]irst-come, first-served medication or vaccine distribution would encourage crowding and even violence during a period when social distancing is paramount.”
Developing a vaccine for coronavirus has now become a top priority. But until one is developed and properly tested, the ethics and logistics regarding its distribution and allocation will need to be worked out globally, as well as nationally. Until then, the world--and the United States--can only wait and hope.