Promoting Health Equity in COVID-19 Vaccine Clinical Trials

September 14, 2020 - As investigators begin recruiting patients for COVID-19 vaccine clinical trials, they must ensure traditionally marginalized populations participate in order to promote health equity.

The coronavirus has disproportionately impacted minority populations. Studies highlight that black patients are five times more likely to be hospitalized for severe COVID-19 than white patients and six times more likely to die from the disease. In fact, the Centers for Disease Control & Prevention lists race as a risk factor for the coronavirus.

And yet, early research on COVID-19 vaccine candidates was completed largely on white populations, according to William Hartman, MD, assistant professor of anesthesiology at the University of Wisconsin School of Medicine and Public Health.

“We have to make sure that this is a vaccine that is safe and effective for all populations, especially those most affected,” Hartman told PharmaNewsIntelligence.

He and colleagues at the University of Wisconsin are spearheading the Phase 3 clinical trial of AstraZeneca’s COVID-19 vaccine candidate and he noted the importance of including traditionally marginalized populations in the trial.

Note that the AstraZeneca Phase 3 clinical trial was put on hold because of participant illness after this interview took place. Only six days later, a review process confirmed the trial could resume. Nevertheless, the need for diversity in COVID-19 trials is important, regardless of the drug manufacturer.

“We want our study population to be reflective of the general population, keeping in mind that COVID-19 has disproportionately affected black and brown populations in the United States,” he continued. “We want to pay particular attention to making sure we are representative of the role folks from these populations play so we can get real, meaningful data.”

So the team at University of Wisconsin is promoting trial involvement in these populations. Having the resources of a university means they have access to a diversity division, the sole purpose of which is to work on minimizing health disparities.  

“The division tries to figure out the best ways to go about getting into minority communities to make sure that we equalize the health disparity as much as possible,” Hartman explained. “We brought this group in from the very beginning.”

Through grassroots work, Hartman and his team are working with local community leaders to discuss the vaccine trial and build trust among community members.

“We want to show them we want them to be included in this study. This is open to everybody. We want them to have every opportunity that everybody else has,” he said.

Vaccine hesitancy is already rampant among the general United States population. A recent Axios poll reported only 28 percent of black patients are willing to take the COVID-19 vaccine compared to 51 percent of white Americans and 56 percent of Hispanic Americans.

“When we have looked at different treatment options or masking or washing hands, these do make a difference, but the biggest tool in the toolbox is a vaccine,” Hartman emphasized.

The partnership with AstraZeneca gives the University the resources to investigate individual perceptions of their specific vaccine candidate as well as vaccines in general.

“We’re planning on forming a vaccine hesitancy survey to figure out what people’s views of the vaccine are. How do they feel about getting a vaccine? How do they feel about getting this COVID vaccine?” questioned Hartman.

The resources of the partnership with AstraZeneca allow the team to move quickly while maintaining a focus on scientific rigor throughout the process. 

“AstraZeneca has the resources and the money to produce a vaccine like this. They’ve got the experience and the wherewithal to be able to bring something like this into Phase 1, Phase 2, and Phase 3 trials,” Hartman continued. “This partnership is important because it’s much more difficult for a university without the same resources to be able to produce something like that. Working in partnership definitely helps.”

Despite the trial’s recent pause due to patient illness, the organization assures this a routine measure to ensuring the safety of the vaccine.

“At AstraZeneca we put science, safety, and the interests of society at the heart of our work. This temporary pause is living proof that we follow those principles while a single event at one of our trial sites is assessed by a committee of independent experts,” Chief Executive Officer of AstraZeneca, Pascal Soriot said in an earlier statement. “We will be guided by this committee as to when the trials could restart, so that we can continue our work at the earliest opportunity to provide this vaccine broadly, equitably and at no profit during this pandemic,” Chief Executive Officer of AstraZeneca Pascal Soriot said in an earlier statement.

The pharmaceutical industry has repeatedly assured patient safety and well-being will remain at the forefront of vaccine development despite repeated criticism that the process is moving too fast.  

Several factors are contributing to the speed of development, Hartman pointed out.

“The influx of money from places like AstraZeneca and governments around the world is unprecedented as is the people power that has been pushed into this,” he furthered. “There’s a singular focus on getting this vaccine done. So other things get put on hold. Yes, it’s been fast but never before has such a priority been placed on something.”

Vaccine development will not be the industry’s challenge. Building confidence in whichever vaccine is approved will be.

“Eventually there will be a vaccine, whether it’s this one or another one,” Hartman assured. “But we have to figure out the best way to communicate to all populations that this is an effective preventative measure that people can take for themselves and their neighbors to get life back to normal.”

Work will continue promoting vaccine efficacy to all populations, with Hartman’s team placing a particular emphasis on traditionally under-represented populations.

“I hope this was a lesson learned by science and medicine that people can band together. There’s success in numbers and when people are willing to work with each other,” he concluded. “I’m very optimistic that people want to get back to a normal life, so if we can prove this vaccine is safe and effective, I think we can get rid of this disease.”