Participation Matters: Notes from a COVID Vaccine Trial VolunteerJanuary 23, 2021
A curious thing happened when I visited my primary care physician for my yearly exam. It goes without saying that this visit was different from all of the previous check-ins that I had ever had, with temperature checks, the option to wait in my car instead of the waiting room, and a questionnaire before I could even enter the office. Things once routine now seem all but and life in the pandemic era involves a new set of rituals wherever we travel. But it was the encounter with the medical assistant that caught me off-guard. While my blood pressure was being taken for the second time (more on this shortly), the topic of the emergent COVID vaccines came up. After I mentioned that I had volunteered for Moderna randomized, double-blind vaccine trial, the medical assistant recoiled and said, “uh uh, I will NOT be taking the vaccine!” I was perplexed. And so I probed, “do you mind if I ask why not?” The response stopped me in my tracks: “I don’t trust it. I don’t want it messing with my DNA.”
This encounter gave me pause for several reasons — the most important of which is that it unnerved me to hear seeds of doubt being planted from someone in a physician’s office, this sentiment was not entirely surprising. In fact, it should be expected. As Robert Drummond ‘92, MD, PhD, suggested in a recent interview, the historical context for the distrust must be acknowledged and negotiated in order to garner buy-in from communities of color. “You can’t treat if you can’t empathize,” says Drummond, citing a range of abuses of the African-American community by the medical establishment over time — including the Tuskegee syphilis experiment to the exploitation of Henrietta Lacks. To be sure, these trespasses extend beyond the borders of Blackness as well, with the most recent allegations of sterilization and other gynecological abuses being reported by immigrant detainees at ICE facilities under the Trump administration. The fact that vaccines appeared to have made their way into arms at “warp speed” driven by this same administration should not be brushed under the rug. It is incumbent on the medical community to meet people where they are and, while maintaining a contrite posture, pursue an empathetic information campaign led by trusted members of the community that it wishes to serve. This is when and where I enter.
I have long said that addressing anti-vaxx sentiment, vaccine hesitancy and distrust within the African-American community is going to be the primary responsibility of those of us who serve in the scientific and/or medical community. We must occupy the vanguard of this movement toward health equity since we are in a unique position to understand the scientific advancements that have led us to this moment and the dire consequences of having members of our community exposed to greater rates of infection. Having taken this position, it became quite obvious to me early on that I would need to take advantage of my modest platform on social media and within academia and volunteer to receive an early shot in the arm for all to see. After all, I spent the better part of a decade working in infectious disease research and molecular biology is a second language to me. It felt like nothing less than a call of duty to make plain how these vaccines were developed (and the speed by which they made it to market) and to be transparent about my experience as a volunteer.
The journey began in early September when I announced to my Men’s Health class that I had signed into the COVID vaccine trial registry and that I would track the entire process in the event that I got the call to participate. No less than a week later, the call came in and I was invited to participate in one of the first vaccine trials. I, like several of my students, was both excited and nervous. After an initial pre-screening by phone, I was called in for my first inoculation as part of a randomized, double-blind trial for one of the mRNA-based vaccines. This announcement to the class prompted a bevy of questions: Do you know what you’re getting injected with? Is it safe? Aren’t you concerned that the vaccines were rushed to market? These, among many others, were reasonable questions and I will address them here.
Messenger RNA, or mRNA, vaccines, are a relatively new type of vaccine product that can protect against viral diseases. These vaccines do not rely on a live or attenuated germ to activate an immune response within the body. Instead, they coax our cells into making a component of the virus that does not establish infection but rather allows for the production of antibodies that protect us upon exposure to the actual virus. While the technology is very new, research has been active toward this innovation for nearly a decade and the development of these types of vaccines requires readily available materials, is more easily standardized and scalable, and allows for faster vaccine development than other traditional methodologies. In addition, the financial risk associated with production of these vaccines was assumed by the federal government so that batch production could begin before the proof of efficacy was established. Luckily, this gamble paid off well as Phase II trials (smaller in scale) suggested that the vaccine was safe with little to no side effects and appeared to produce an immune response. The next step in the process, Phase III trials of which I was a volunteer, involves tens of thousands of volunteers with half receiving the actual vaccine and half receiving the placebo in efforts to prove efficacy.
At my first visit for inoculation, I was given a 40+ page informed consent document that I was allowed to read in its entirety after it was explained to me. I was given a more thorough screen by questionnaire and I was treated to a routine physical. After my blood pressure was taken, the nurse paused. She waited about five minutes and talked to me about matters mundane and then measured it again. After the second reading, she asked if I had ever been diagnosed with hypertension. I had not — although my blood pressure was elevated when I had a colonoscopy this past summer. Nonetheless, she left the screening room and brought in the physician. I was notified at the point that I had to be excluded from the study in order to protect me from any potentially adverse reactions that might occur under the experimental conditions. I present this information to you, the reader for two reasons: (1) it underscores the ethical responsibility that was taken seriously within this study to protect me as a volunteer even though my participation as an African-American male was sorely needed and (2) hypertension is called the “silent killer” for a reason because I appear to be the picture of health for someone of my age and was asymptomatic yet my blood pressure was dangerously high. At any rate, I was thanked for my willingness to serve and strongly encouraged to visit my primary care physician for treatment. It was at the time of that follow-up visit to my PCP that I encountered the aforementioned medical assistant.
Fast forward a few months after I had begun treatment for hypertension, my blood pressure was now under control and I was given the opportunity to participate in another vaccine trial. Luckily, I was allowed to move forward without incident after a similar screening and physical and received the first of two inoculations. It should be noted that I will be a participant in this trial for two years and have regularly scheduled visits to monitor my body’s response to the vaccination and to monitor my exposure to SARS-CoV2 (the virus that causes COVID). I also maintain an eDiary where my condition is monitored on a daily basis and have several swab kits on hand that will be collected in the event that I should begin to feel sick and suspect infection. But honestly, the experience has thus far been relatively uneventful — with the exception of a little injection site soreness that subsided after a day or two. On the other hand, I feel extremely grateful to have been given this opportunity to serve our community. There have been numerous friends and followers who confided that they were hesitant to get vaccinated until they considered my participation in the study. If my shot in the arm enables the protection of just one other person, it is worth any inconvenience the study might introduce. Moreover, my fear all along has been that anti-vaccine sentiment within our community would ultimately play out to our detriment and leave us on the losing end of yet another health disparity. This is playing out quite plainly in the metro District of Columbia area where a race map shows a nearly diametrically opposed distribution of COVID vaccination in the areas inhabited primarily by White residents versus hotbeds for new infections in the region more heavily populated by African-Americans. So it is clear to me that our participation in these studies MATTER. It matters to the extent that my example and that of people like me lessens the fears of the community at large.
Admittedly, this is a long blog entry but I thought it prudent to be as open with you as I could and I am more than happy to answer any questions that you may still have. My prayer is that 2021 will see us return to some semblance of normalcy. My hope is that I have done my part, however small, to move us in that direction.
Lance Shipman Young, Ph.D., is an associate professor of chemistry.