By Melinda Young

The COVID-19 vaccine rollout has raised issues about trust among many Americans who are hesitant or unwilling to take the vaccine. The issue of trust is especially problematic among minority communities that have been harmed in historic medical and research incidences.

People also are skeptical of a vaccine that was developed in record time, considering most vaccines take 10-15 years to make it to market.1

Although data from the first COVID-19 vaccine research suggests there are few serious adverse reactions to the vaccines, there are no long-term data. This is not reassuring to many people who are worried about receiving a novel vaccine, says Rueben C. Warren, DDS, MPH, DrPH, MDiv, professor of bioethics and director of the National Center for Bioethics in Research and Health Care at Tuskegee University.

If researchers and IRBs want to ensure more equity and diversity in clinical trials, and gain trust among Black Americans and other minority communities, they need to listen to the people they want to engage in clinical trials — and not just when they are ready to start a research project.

“You have to build trustworthy relationships before you ask something of the community,” Warren says. “You do that first by engaging people from that community. That’s not an automatic approval, but that’s a good start.”

The context of the vaccine rollout and the research ethics breaches that preceded this once-in-a-century public health crisis are important to note when trying to understand vaccine hesitancy.

“I believe in vaccines. I believe in vaccinations. Science has made it clear that people need vaccinations, but that’s a different proposition in the context of how this vaccine has been communicated to the general public,” Warren says.

Researchers and public health officials tried to share their confidence in the first vaccines among the public.

“We want there to be a great deal of confidence in this process. We want citizens to have confidence in taking the vaccine,” said C. Buddy Creech, MD, MPH, FPIDS, member of the Infectious Diseases Society of America (IDSA), and director of the Vanderbilt Vaccine Research Program of Nashville, TN. Creech is a principal investigator for Phase III trials for the Moderna and Johnson & Johnson COVID-19 vaccines. He spoke at IDSA’s virtual COVID-19 vaccine briefing on Dec. 3, 2020.2

It is not a quick and easy task to educate people about the safety of the vaccines, especially among those with longstanding mistrust of research and the medical industry.

“We have to listen to people and their legitimate concerns, and see that hesitancy among African Americans has been earned,” says Stephen B. Thomas, PhD, founding director of the Maryland Center for Health Equity and professor of health policy and management at the University of Maryland.

Warren suggests pharmaceutical companies provide uninsured research participants with five years of access to healthcare providers in a follow-up to their participation in the COVID-19 vaccine trials. This also could be a tactic for any investigators seeking to enroll underrepresented minorities, including people who are uninsured and are low income.

“Most studies say if there’s a problem directly related to the trial then we’ll take care of it and provide appropriate care,” Warren says. “But if you ask low-income populations of people of color, who are uninsured, and ask them to take the risk, then what happens in two to five years from now if there are problems indirectly related to the vaccine, and they don’t have insurance?”

States could fix this problem by expanding Medicaid (not all states have expanded this program under the provisions of the Affordable Care Act). This would provide coverage to low-income people. But pharmaceutical companies and other research sponsors also could help by providing uninsured research participants with health coverage that can be used at federally qualified health centers (FQHCs), Warren says. This also could convince more people to take the vaccine because they would no longer have to shoulder all the possible long-term risks of receiving the COVID-19 vaccine.

“You have the vaccination, and we’ll enroll you in a FQHC for the next five to 10 years,” Warren says. “That’s not an unreasonable proposition.”

It is one way to obtain vaccine acceptance from people who have historic and well-founded distrust of the medical and research communities. “Don’t try to convince me to do something when the risk is one-sided,” Warren says. “It won’t be that expensive because FQHCs have a strong tradition of treating low-income populations at better cost and more efficiently, and they’re trusted.”

“Helicopter research,” in which investigators from wealthier areas collect data from lower-income areas and leave, does not work, he adds.

“How does the research community — both public and private — prove itself trustworthy in communities that have a history of trust problems?” Warren asks. “Health disparities are getting worse during the pandemic, so don’t blame it all on history.”

Vaccine researchers spent a lot of time thinking about how to build confidence in the vaccine among minority communities, Creech noted.

“As we recruit individuals in clinical trials, we recruit a diverse population,” he said. “We’re having multiple conversations every week to intentionally ensure diversity.”

Research organizations also are removing barriers in clinical trials that hinder acceptance of new therapies as they emerge.

“One thing you’ll see is individual states and jurisdictions thinking intentionally about how we identify those in our communities at higher risk,” Creech said. “We think hard about ensuring equitable access to those vaccines as they become available.”

REFERENCES

  1. The College of Physicians of Philadelphia. Vaccine development, testing, and regulation. Updated Jan. 17, 2018. https://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation
  2. Infectious Diseases Society of America. IDSA media briefing: COVID-19 vaccine progress report. Dec. 3, 2020. https://www.idsociety.org/multimedia/videos/idsa-media-briefing-COVID-19-Vaccine-Progress-Report/