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Dr. James Hildreth, world renown immunologist and president of Meharry Medical School, sits on the FDA panel that reviews covid vaccines.
Saundra Sorenson
Published: 27 January 2021

Dr. James Hildreth is a world renowned AIDS expert and immunologist who has spent more than 40 years studying infectious diseases ranging from Hepatitis to Ebola. As president of Meharry Medical College in Nashville, Tenn., he is overseeing clinical trials for a potential additional COVID vaccine and demonstrating how to effectively engage the Black community in clinical trials and vaccination.

“Meharry’s been here in Nashville for 145 years, and we were founded as a place to make sure that people from disadvantaged communities could get healthcare. So I think we’ve just come to be, over a long period of time, a trusted institution,” Hildreth, a noted expert in racial health disparities, told The Skanner. “We also have strong connections to the church, and that’s been an important factor as well.

"But my work in HIV taught me that ‘trust the messengers’ was a really important thing.

"You may have scientifically grounded messages that are potentially impactful, but they won’t be unless the messenger delivering those messages, that information, is somebody the communities trust.”

In October, Meharry and several other historically Black colleges and universities -- including Howard University College of Medicine, Morehouse School of Medicine, Xavier University of Louisiana, Hampton University, Tuskegee University, Florida A&M University, and North Carolina A&T University -- were chosen to split a three-year, $15 million grant from the Bill & Melinda Gates Foundation to equip testing facilities and support screening for the coronavirus.

Response within these college communities was mixed. Leaders at Xavier and Dillard universities experienced a swift backlash to a joint letter they issued urging Black faculty, students, and staff to enroll in COVID vaccine clinical trials as they both had, with some commenters invoking the Tuskegee Syphilis study. Valerie Montgomery Rice, MD., dean of Morehouse School of Medicine, took the vaccine live on television in the hopes of inspiring others to do the same.

Tuskegee fullIn this 1950's photo released by the National Archives, men included in a syphilis study pose for a photo in Tuskegee, Ala. For 40 years starting in 1932, medical workers in the segregated South withheld treatment for unsuspecting men infected with a sexually transmitted disease simply so doctors could track the ravages of the horrid illness and dissect their bodies afterward. It was finally exposed in 1972. (National Archives via AP)
Black Americans show the highest rates of hesitancy about the vaccine, according to a survey by the Pew Research Center. Yet Black Americans are dying at a rate of two-and-a-half times that of White Americans.

“Communities of color need the vaccine maybe more than other communities do because they’re more likely to get sick and to die,” Hildreth told The Skanner.

henrietta lacks photo the henrietta lacks foundationHenrietta Lacks in the 1940s. (photo/The Henrietta Lacks Foundation)“On the other hand, because of Tuskegee and Henrietta Lacks and other considerations, there’s a lot of hesitancy on their part. So our approach has been to first embrace the fact that the hesitancy is well founded and real. And then to try to eliminate that distrust or hesitancy by giving people factual information they can understand, and then I think most of them would make the decision to move ahead.”

Now, White volunteers far outnumber volunteers of color in coronavirus clinical trials. In distancing the current testing climate from the many historical examples of uninformed consent and medical experimentation on Black bodies, Hildreth suggested transparency of the review process.

“The way that trials are done now that involve humans is totally different than what happened with Tuskegee,” he said. “Now we have informed consent, we have a data and safety monitoring board that’s independent. As often as once a week, they review the data to make sure the participants aren’t being harmed.”

Hildreth pointed out that he is one of two African Americans sitting on the FDA’s coronavirus review panel.

“Unlike past research, in this case, we’re involved at every level of the vaccine development process, including in the very beginning, where there’s a really brilliant young Black woman at (National Institutes of Health), Dr. (Kissmekia) Corbett, who is involved in the research on messenger RNA that makes the vaccines possible.”

He added, “Just because you have African Americans involved doesn’t necessarily confirm that this is safe, but we can speak to the process in an informed way.

"I’ve seen all the data for both Moderna and Pfizer (vaccines) for myself. And as someone who’s studied immunology and viruses for 40 years, I have a great context to evaluate that data and say that based on everything I know, we should do this. Otherwise I wouldn’t have taken it myself, and I wouldn’t have advised my family members to take it, if I had any doubt about it.”

Not the Flu

In his region of the country, Hildreth has appeared on local broadcast news stations and in press conferences to caution the public that in his decades of research, he hasn't seen anything like SARS Covi-2.

“There is nothing in the Constitution that I’m aware of that gives me the right to put your health at risk,” he said in a media briefing last June. “And that's exactly what I do when I refuse to wear a mask in the middle of a pandemic with a potentially lethal virus circulating.”

At the time, warned of the wide range of organs COVID-19 could impact -- a characteristic known as “trumpism.”

“One of the reasons for the spectrum of diseases that we see is related to the receptor, the protein the virus uses to get into our cells,” Hildreth told The Skanner. “For example, HIV only infects certain cells in our immune system -- CD4 T cells -- because only they have the receptor for the virus. And so in the case of the SARS CoV-2 virus, the virus that causes COVID-19, its receptor is on a wide range of cell types -- cells in the lungs, cells in our (gastrointestinal) tract, cells in our kidneys, cells in our brain. So the wide spectrum of symptoms and syndromes that we see is related to the fact that this virus can go into so many of our different cell types. We call it ‘trumpism.’ So the trumpism of SARS CoV-2 is very broad, whereas in other viruses it’s very narrow.”

Novavax Trials

Hildreth is leading the clinical trial of Novavax at Meharry. He has served as a temporary member of the U.S. Food & Drug Administration's Vaccines and Related Biological Products Advisory Committee to review coronavirus vaccines, where he voted in December to approve the Pfizer vaccine. With two vaccines now available in limited quantities, other pharmaceutical companies -- notably AstraZeneca, Sanofi, and Novavax -- are hoping to introduce similarly effective alternatives that will add to the available stock of vaccines.

Hildreth estimates it will take 280 million Americans being vaccinated against covid to return to a kind of “new normal.”

At this stage, it is not clear that any one of the available vaccines is superior to the others; each differs, instead, in storage logistics and how it delivers the vaccine.

“There are three fundamentally different approaches to developing the vaccine,” Hildreth said.

“They all have the same common goal, which is to induce our immune system to make antibodies to the spike protein of SARS CoV-2, which is a protein that allows the virus to go into our cells. By making antibodies -- rather large proteins that bind the virus -- to that protein, they create a shield between the virus and ourselves and they keep the virus out.”

All the vaccines are designed to do that, and none of them contain the virus itself. The Pfizer and Moderna vaccines use messenger RNA to enter cells and create the spike protein, which creates antibodies that will be present and ready to fight off the actual virus, should it ever enter the body.

Meanwhile, Hildreth said, Johnson & Johnson and AstraZeneca use a different platform, using a weakened strain of a common cold virus to deliver a gene for spike protein into the body’s cells. The adenovirus itself does not cause illness, but it does prompt the creation of messenger RNA. Pfizer and Moderna vaccines operate similarly, Hildreth said, but “skipped a step and just went directly to the messenger RNA.”

Novavax and Sanofi vaccines don’t use messenger RNA, but the actual spike protein.

“We make that into an emulsion with an antigen, and we’re injecting that directly into people,” Hildreth said. “So now the immune response can be immediate because there’s no need to read mRNA.”

These second and third platforms have the advantage of producing vaccines that can be stored in regular refrigerators, and possibly at room temperature. Because messenger RNA is relatively unstable, Hildreth said, Pfizer vaccines must be stored at or below -76 degrees Fahrenheit, while Moderna vaccines must be stored at -4 degrees or below.

Don't Call the Police for domestic disturbances

As for side effects, Hildreth said soreness at the injection site was inevitable.

“There’s some tell-tale signs that your immune system is starting to respond -- fever being one, muscle aches, fatigue,” he said. “Sometimes the nodes under your arm will swell. Because again, these are all indications that your immune system is doing what your immune system does.

“Now there is the occasional rare case where someone has a strong allergic reaction to it, and that’s not unexpected. But with every vaccine that’s been developed, I believe, there have been reports of a really few people who have a strong reaction to it. And that’s the thing -- you have to make sure that they get the vaccine in a setting where they can get epinephrine or have the response, the reaction, treated right away.”

Planning Ahead

The day after his inauguration, Pres. Biden released his National Strategy for the Covid-19 Response and Pandemic.

“I’m just so happy there is a plan,” Hildreth told The Skanner.

“They’ve made a decision to tackle this on multiple levels: the supply level, distribution, logistics, they’re focused on all of those things. I think they’re also focused on mobilizing the National Guard and other kinds of resources to make sure that we can have enough vaccination sites across the country...I’m excited about what Pres. Biden is doing, using the Defense Production Act to produce more syringes and (personal protective equipment). If this had been done a year ago, quite honestly, so many lives could be saved that were lost. But we’re going to be focused on the future.”

Asked about the administration’s public-private partnership with corporate giants that include Amazon, WalMart, and Starbucks to coordinate the logistics and distribution of vaccines, Hildreth said, “I think it’s brilliant. I mean, Amazon -- talk about an organization that knows how to do the logistics of delivery and distribution, to me that was a no-brainer to involve one of the best organizations on the planet when it comes to moving things efficiently, and distributing things efficiently.

“I think the future is much brighter than it was just a few days ago.”

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