By Sue Coons, MA
Minority populations are more likely to participate in clinical research activities when they are encouraged by trusted authority figures, such as family physicians or pastors. One such pastor and author, Bishop T.D. Jakes of The Potter’s House in Dallas, decided to use his popular YouTube channel to broadcast information about the COVID-19 vaccine to dispel myths and to encourage his followers to take the shots.
On Jan. 25, Jakes offered his webinar, “Conversations with America: Unpacking the COVID-19 vaccine,” on his YouTube channel, which has more than 1 million followers. To help with this topic, Jakes invited:
- Jill Waggoner, MD, Jakes’ personal physician, and an integrative medicine expert and author with the Methodist Health System in Dallas. Waggoner acted as co-host.
- Onyema Ogbuagu, MBBCH, FSCP, FIDSA, an infectious disease specialist and associate professor at Yale School of Medicine. Ogbuagu is the principal investigator of the Pfizer/BioNTech COVID-19 vaccine trial at Yale.
- Kizzmekia Corbett, PhD, a viral immunologist with the National Institutes of Health’s (NIH) Vaccine Research Center and the lead scientist for coronavirus research. Her team worked with Moderna on an mRNA vaccine.
- Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases at the NIH.
The first point Jakes addressed is the question of whether the vaccines were rushed through the development process. He asked Corbett to explain the vaccine development process, what precautions were taken, and why Americans should trust the vaccine.
While the vaccine was developed in nine months as America watched, Corbett said, the work that went into the vaccine development has been happening for years, since the first severe acute respiratory syndrome (SARS) coronavirus emerged more than a decade ago.
“Although it’s so-called warp speed, there have not been any particular parts of vaccine development that have been skipped along the process. We have a full portfolio of preclinical data surrounding these vaccines as well as Phase I, Phase II, and Phase III clinical trials for these vaccines’ development,” she explained.
Jakes then asked her if she felt any “angst” about the lack of long-term outcomes data from the vaccine. Is she fairly comfortable there will be no major complications from the vaccines over the long term?
“No, absolutely no angst at all,” Corbett replied. It is largely forgotten the first Phase I clinical trial actually started on March 16, she said, and the trial participants have been followed since then with no long-term adverse outcomes. “It’s very clear that long-term side effects are not something to be worried about. Dr. Fauci has said several times, over and over, that, historically, side effects happen within the first two months of vaccine development, and that’s exactly what you’re seeing here as well.”
Increasing Trust in the Vaccine
Jakes then asked Ogbuagu how to improve the level of trust people of color have in the health system overall, and with this vaccine in particular. “It’s disheartening that the group that is disproportionally impacted is not at least disproportionately interested in receiving the vaccine,” Ogbuagu said.
Historical injustices, such as the Tuskegee Syphilis Study, continue to influence Black Americans’ perception of clinical trials. They also are concerned about the accelerated pace of the clinical trials, and possible side effects. “There are a lot of circulating misconceptions and misinformation on social media overall,” he said.
Ogbuagu suggested finding trusted messengers and respected authorities to disseminate information about the vaccine. He also suggested working on what is called “vaccine literacy,” which is “finding ways to communicate in language that people understand within the appropriate cultural context to get that message out about the role that vaccines play in public health to control diseases and eradicate epidemics.” Showing trusted messengers and role models receiving their vaccines publicly helps as well, he said. “I think that has also played a great role in having people be just a little more comfortable with receiving the vaccine, and I hope that that number will continue to pick up.”
Jakes then asked Ogbuagu about whether people with pre-existing conditions or allergies should worry about taking the vaccine. It became apparent early on that individuals who experienced worse outcomes with COVID-19 had comorbidities such as obesity, diabetes, and lung conditions. “One of the reasons why we think Blacks, African-Americans especially, are having worse outcomes is because of the prevalence of these comorbidities among those populations,” Ogbuagu said. There was a good representation of individuals with medical comorbidities in the trials, he said, and the study results showed robust efficacy, even among individuals with these underlying conditions.
Ogbuagu then addressed media reports about severe allergies or life-threatening anaphylaxis some people experienced after receiving the vaccine. This tends to occur in people who have a history of these types of events, he explained, and they should be cautious about receiving the COVID-19 vaccine. Healthcare providers at vaccination sites are aware some individuals may experience an allergic reaction, and keep emergency medications on hand to mitigate the side effects.
Ogbuagu stressed this is not a common occurrence. Data he has received on the frequency of these severe and anaphylactoid reactions showed about six in 1 million doses. “It is really, really rare.”
Diversity in Vaccine Trials
Waggoner asked Ogbuagu about the racial diversity of vaccine trial participants. Ogbuagu said an alarm went out about insufficient enrollment of racial ethnic minorities midway through the Pfizer and Moderna Phase III trials.
“Let me just be clear,” he said. “Sharing my clinical trial experience, it can be challenging to involve racial ethnic minorities in clinical research. I think some of the issues that fuel vaccine hesitancy also fuels that reluctance to participate in clinical trials and clinical research.”
A lot of effort went into the clinical trials to host or optimize the enrollment of ethnic racial minorities, Ogbuagu noted. This included finding sites to reach a diverse population, community outreach programs, and adjustments to enrollment processes to help engage communities of color. In the Moderna trial, 35% of the clinical trial population (about 20% Hispanic, 10% Black, and 4.5% Asian) were racial ethnic minorities. The Pfizer trial included about 40% (about 26% Hispanic, 10% Black and 4% Asian), he explained.
Fauci noted the effort for diversity in the Moderna clinical trial. “Literally every Saturday at 10:00, we would meet with the leaders of the trial to encourage them to go the extra mile to get minorities involved.”
Investigators should ensure the vaccine is safe and effective in all the demographic groups, particularly those with a higher incidence of severe outcomes — which is racial minorities, he said. “We’ve got to get them represented, because you want to be able to look at your community of individuals in the minority demographic group and say, ‘We’ve actually tested the vaccine in you, and it is safe and it’s effective in you.’”
Fauci wished the representation of Black participants was at 13%, but distrust in the community is “understandable.” “You’ve got to address each and every one of the concerns that they have,” he said. If asked, he explains the efficacy of the vaccine is reviewed by independent groups comprised of scientists, statisticians, and immunologists who do not answer to the government or the companies that produced the vaccine. “[We tell them], the whole process was both transparent and independent, and we have to keep making that very, very clear because we have to respect the skepticism in the African-American population about federal government medical programs. You can’t walk away from that. It’s a shameful history that we have to deal with.”
Jakes also asked Fauci about vaccine distribution issues. “Can you give us any precursor information about distribution and what you have planned to make the vaccine available more readily for people, especially homeless people, oppressed communities, and neighborhoods where they don’t even have grocery stores?”
The numbers of vaccinations have not met expectation, Fauci conceded. “I believe that the reason for that is that this was a brand-new process of an unprecedented challenge of trying to vaccinate so many people. There are going be bumps in the road and hiccups.” The vaccine needs to be distributed in multiple ways, he said. Otherwise, it will exclude the people who most need it.
Jakes wondered if medical professionals could work with faith-based entities within local communities so vaccines could be administered in places such as churches or community centers. “Many of our communities are in food deserts and certain places like that where they can’t get the vaccine,” he noted.
One answer might be to find individuals who could administer an intramuscular injection, such as medical or nursing students, and set up clinics in community centers, churches, and even mobile units, Fauci said.
Fertility and Gene Distortion
Another concern long-term effects on fertility, Jakes said. Should pregnant women worry about taking the vaccine?
There have not been any considerations about long-term fertility issues, Corbett said. “Messenger RNA does not affect or alter one’s DNA, nor does it alter your fertility.”
The current recommendation is that women of childbearing age still receive the vaccines, she said. Although women were not supposed to conceive during the clinical trials, some did, and trial results have shown no complications from that small subset of women.
Fauci addressed the question of whether the mRNA vaccines interfere with or “distort” the genes of the person receiving the vaccine. “The answer to that is, absolutely not,” he said. “It’s understandable why when people hear RNA, they hear DNA, genes. They want to know if it’s going to interfere in some way or get into your genes and change your genetic makeup. Not a chance.”
Jakes then brought up the issue of side effects. “What potential side effects or adverse reactions of this vaccine do we need to worry about, or are they all minuscule?”
It appears the real-world experience is mirroring what happened in the clinical trials, Ogbuagu said. “We can say that there have been no surprises. That’s great, because the concern always is that the numbers that are exposed to a drug in clinical trials is kind of a finite number, although in Phase III we are talking about tens of thousands. When you roll it out to millions, there is always the concern that rare side effects may pop up.”
Side effects fall into two buckets: local and systemic, he said. “The term we tend to use for some of the early side effects is ‘reactive dynasty,’ which means it’s just people reacting to the vaccine.” Other than local injection site reactions, systemic side effects also occur. The vast majority are mild to moderate, occur in the first few days after vaccine receipt, and resolve quickly. Based on the at least two-month experience for these two elite vaccine candidates, the side effects definitely are tolerable, he said. “It’s something to warn people against so they know to expect that. We think the majority of these adverse events will happen very early from vaccine rather than long term. It’s heartening to see the safety profile so far.”
The muscle aches, fever, and similar effects are, paradoxically, a good sign, Fauci added. “It means your immune system is responding to the vaccine.” The muscle aches, headache, and fatigue are due to inflammatory proteins cutting loose. “It lasts no more than 24 to 36 hours, but even though it’s a little bit uncomfortable, it really is telling you that your immune system is working properly to respond to the vaccine.”
Individuals taking medication for underlying conditions also should not worry about the safety of the vaccine, Fauci said. “If you have an immunosuppressed state, the only time you have to worry in regard to safety is with a live attenuated vaccine. The mRNA vaccines and any of the others are not live attenuated,” he said. “You may not get an optimal immune response if your immune system is being suppressed medically because of an underlying condition, but that’s no reason [to skip the vaccine], because even a response that isn’t optimal is better than no response at all.”
To reach herd immunity in the United States, the country would need to vaccine 70%-85% of Americans. Communities that stay below this level still will risk contracting the virus. “If I were to predict — and I think this is the message to get out to Black and brown people — is that certain groups may achieve herd immunity and certain groups may not,” Fauci explained. “That will serve to continue to fuel this cycle. Herd immunity really has to be tied to vaccine acceptance, and I think those have to go together.”
Adapting the Message
The question returns to getting the message out and the best way to do that. Corbett said the most important thing is to listen to people first. “I try not to say anything to anyone unless I’m asked because I find that people’s inquiries around the vaccine are fairly specific to their own personal story, to their own personal community story, etc. The more that you listen, the more you can gauge what really needs to be said to a particular person around their vaccine hesitancy.”
If someone asks her about catching the virus from the vaccine, she explains it this way: “This vaccine only takes an mRNA shot of one particular protein from coronavirus. This protein does not replicate like a virus. It has no other components of the coronavirus. It is simply one specific protein, and it’s the protein that we’ve been studying at the NIAID for several years and trying to understand it in a large amount of detail. You cannot get sick from this one particular protein. It is not going to give you the virus. You can’t pass this protein on to anyone else. It basically just alerts your immune system of what the protein looks like. Your immune system essentially takes a snapshot of it, so that when it appears again to your body by way of the virus, your body says, ‘Oh, I’ve seen this protein before, let me go fight against it.’”
Fauci said they are monitoring virus mutations, and initial data do not indicate a threat to vaccine efficacy. “It’s much more likely that a mutation would block the effect of a monoclonal antibody that’s against one particular component of the spike protein. When you get vaccinated, you get multiple polyclonal antibodies against all different parts. It’s less likely that it would interfere with the effect of a vaccine than it would with the effect of an individual monoclonal antibody. Having said that, it looks good for now, but we want to make sure we keep following it very, very carefully.”