Stanford researchers tackle vaccine distribution’s ethical, operational challenges

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Stanford researchers are tackling the technical and ethical public health challenges that come with the distribution of the COVID-19 vaccine. Researchers say that due to supply limitations, vaccine distribution will be organized in phases, a complex ethical endeavor that involves prioritizing different groups of people for vaccine access in the fairest and most equitable way possible. 

With the Pfizer vaccine recently recommended for emergency use authorization and the Moderna vaccine currently undergoing the approval process, vaccines are expected to arrive at U.S. healthcare facilities by next week. Stanford Medicine plans to begin administering vaccines on Dec. 18, with the first doses reserved for frontline healthcare workers.

“Issues of allocation in medicine are not new; they’re actually quite ubiquitous,” said medicine and biomedical ethics professor David Magnus. 

Magnus, who is also the chair of the prioritization subcommittee for Stanford’s early phase allocation, said that as COVID-19 vaccines are being rolled out, the same ethical principles and theories of justice used to allocate organs, drugs and ventilators in the hospital during scarce conditions also need to be applied to vaccine distribution.

These broader theories of justice include utilitarianism, maximizing benefit and minimizing harm; prioritarianism, helping those who are at the bottom; and egalitarianism, the idea that everyone is treated equally. According to Magnus, these ethical frameworks help guide the resource allocation decisions that the U.S. is currently facing with vaccine distribution.  

“If you put more emphasis on one value or principle than another, you’re going to get different systems of allocation, [and] you’re going to allocate it differently to different individuals,” he added. 

These considerations are weighed back and forth among ethicists, epidemiologists, infectious disease modelers, physicians and other stakeholders, according to Magnus.

One of these decision-makers is Grace Lee, a pediatrics professor and member of the Advisory Committee on Immunization Practices (ACIP), a federal advisory committee that advises the Centers for Disease Control and Prevention (CDC) on vaccine use among the American population. 

The ACIP recently voted to include healthcare workers and residents of long-term care facilities in the first wave of vaccine distribution, otherwise known as Phase 1a. 

“Among healthcare personnel … people tend to think doctors and nurses, but we have a whole team of people that stand up the healthcare delivery system: environmental services, food service workers, nursing aides [and] front desk staff,” Lee added.

Lee and her colleagues are discussing the question of phases of allocation among healthcare providers because it is likely that there will not be enough doses in the first week to vaccinate all healthcare personnel.

Long-term care facility residents, such as those in nursing homes, were also included in the first phase because of their high risk of morbidity and mortality. They constitute 6% of COVID-19 cases in the U.S. but are responsible for 40% of the deaths nationwide, according to the CDC. 

Following Phase 1a, the populations being prioritized next are still under consideration. Last month, ACIP members supported placing essential workers next in line because of equity considerations. Essential workers, many of whom belong to communities of color and low-income communities, have been disproportionately impacted by the pandemic. They have to “go to work either to … maintain household income or because they don’t have a choice and that’s the only way they can perform their job function,” Lee said. 

Adults with high-risk medical conditions and adults aged 65 and older are likely to come after essential workers, according to Lee.

Addressing operational challenges of vaccine distribution

The ACIP and CDC make high-level recommendations on vaccine distribution, and it is the responsibility of states and counties to “adapt what’s needed from those recommendations” and “implement it in their local setting,” Lee said. 

Implementation presents unique challenges and complex logistics that need to be taken into account, such as issues with cold-chain storage. The Pfizer vaccine requires refrigeration at minus 70 degrees Celsius, which could impede vaccine distribution to smaller hospitals and rural areas, according to Yvonne Maldonado, professor of pediatrics, epidemiology and population health. Maldonado also serves as the medical school’s senior associate dean of faculty development and diversity.

Allergy and immunology professor Kari Nadeau emphasized that the vaccine’s storage conditions would impact its reach.

“If we’re talking about a vaccine that is at room temperature, that’s much easier to get to, let’s say, the far reaches of Kenya or the far reaches of Siberia,” Nadeau said. “But when we’re talking about a vaccine that requires a … freezer, that requires electricity and very specialized equipment.”

This is already an issue within the U.S. and is an even bigger problem in other countries with fewer resources to keep the vaccines cold, all the way from production facilities to the towns and villages where people live, according to Maldonado.

In addition to the ultra-cold temperatures, the vaccines are sent in thousand-dose shipments. According to Lee, this means that small, rural clinics or long-term care facilities that don’t have as many people to vaccinate may be asked to travel long distances to bigger healthcare facilities in order to access the vaccine. 

“That could potentially exacerbate inequities in access because not everybody is going to be able to come in easily,” she said. As a result, people “may not have access to the vaccine even if it’s allocated to [them] in Phase 1a.” 

Unlike the Pfizer vaccine, the Moderna vaccine only requires refrigeration at minus 20 degrees Celsius, which still poses challenges but will be easier to implement.

“We might have to pull people in [to high-volume centers] with the Pfizer vaccine and hopefully we can push out the Moderna vaccine to areas in order to ensure equitable access to the entire population,” Lee said. 

Other vaccines that are being developed, such as the ones at Johnson & Johnson and AstraZeneca, may have longer shelf-life and need much less cold storage, according to Magnus. Researchers hope that as these vaccines are rolled out, some of the operational problems will be solved along the way. 

“It’s so much work that’s been involved by so many people… just to be ready in time for Phase 1a,” Magnus added. “We’re going to have to ensure that whatever system we operationalize will hit those populations that have been hit hardest by COVID.”

As more vaccines are developed and distributed, researchers say that other challenges such as vaccine hesitancy still remain. This is true especially among members of underrepresented populations who “may not feel confidence in the vaccine or in the system, and may choose not to be vaccinated,” Maldonado said.

Stanford medical ethics researcher Ariadne Nichol said, “We need to greatly improve engagement with communities and the public at large with regard to vaccines.”

The next step is to focus on the safety parameters around the soon-to-be approved vaccines. According to Maldonado, the CDC will continue to track the vaccine long after its release to ensure safety and effectiveness.

Nadeau added, “We need to really dive deep in safety parameters … around the elderly, around people of different ethnicities and people with different comorbid conditions.”

Contact Athena Xue at axue8 ‘at’ stanford.edu.

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