NASHVILLE, Tenn. (WKRN) — Meharry Medical College plans to start enrolling participants for its COVID-19 vaccine trial this week.
CEO Dr. James Hildreth said they want to make sure black and brown communities are represented during the trial. He was appointed to the FDA Vaccines and Related Biological Products Advisory Committee, which will review vaccine trial data and make recommendations to the commissioner on whether a vaccine candidate should be approved.
“In essence, we want to make sure that those most vulnerable to disease and death are the ones that get the vaccine and it turns out that in this case the people who need the vaccine most are among those who are the most reluctant to accept the vaccine,” said Dr. Hildreth. “I think it’s our responsibility as medical professionals to provide enough information for people to feel comfortable participating.”
COVID-19 is having a disproportionate impact on communities of color. News 2 has reported on the long-known health disparities increasing risks for more severe infections or death.
Meharry’s goal is to enroll roughly 500 people for the vaccine trial, and Dr. Hildreth plans to be one of the first.
“There is a long-standing history of atrocities being visited upon black bodies going all the way back to 1619. Prominent among those is, of course, Tuskegee. We all know about Henrietta Lacks and having her cells used without knowledge or permission for decades for research. There’s also the fact that a lot of African Americans, especially older Americans, feel like they’re not treated with dignity and respect sometimes when they go and engage the healthcare system,” said Dr. Hildreth. “There’s well-founded reasons to be apprehensive. We have to convince our colleagues, sisters and brothers, and our colleagues in minority communities that things are different now, that this is going to be different. That’s why I myself am going to be one of the first participants in the trial here at Meharry just to demonstrate that I’m personally committed to this. I feel very comfortable doing it and I can encourage others to do the same. The person leading the vaccine studies at the NIH is a black woman. I as a scientist am involved in this. Around the country there are minority scientists involved in the vaccine study so this time is different because we’re on both sides of the equation.”
He said it’s important to have people of all backgrounds represented during the trial phase of creating a COVID-19 vaccine.
“Allergies teach us very explicitly that immune responses differ so the only way to make sure that everyone benefits from the vaccine is that we have to have all the groups represented in the studies,” said Dr. Hildreth.
He said when someone comes to enroll in the study there will be a quick medical exam along with a check of their medical history to make sure it’s safe to participate. When cleared to participate, the person is given a shot of the vaccine in their arm. Dr. Hildreth said most times there will be a booster shot 21-28 days later. The participant will then be monitored for up to two years.
“I think a lot of people are apprehensive because of the speed of this process that things are moving really fast but people need to understand that none of the steps are being omitted. Some of them are running in parallel. Some of them have been achieved through scale – just the number of people involved,” said Dr. Hildreth. “So none of the steps to evaluate the vaccine have been omitted. That’s the first thing. The other thing is that with the exception of the vaccine candidate itself, every component of the vaccine that gets injected into your arm has to be evaluated to make sure it’s safe.”
Once the trial has fully enrolled and time has elapsed to allow data to be accumulated in terms of who became infected and who didn’t become infected, the data is presented to the FDA. There’s a committee that will review the data to make a recommendation to the commissioner as to whether or not the vaccine should be approved.
CLICK HERE for more information on getting enrolled.
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