As the United States begins rolling out coronavirus vaccines, many people, especially those in the Black community, are still hesitant to participate when it becomes widely available.
Valerie Fitzhugh, MD, an associate professor and interim chair of the Departments of Pathology at Rutgers New Jersey Medical School and Rutgers Robert Wood Johnson Medical School discusses why she chose to participate in a coronavirus vaccine trial as a Black woman, wife, and mother of two children. She also talks about why she's encouraging more people, particularly minorities, to be vaccinated.
Why did you decide to participate in a coronavirus vaccine trial during the pandemic?
As a wife and a mom to two young children, I did not make this decision lightly. I wanted to be able to show my community that the vaccine is safe, that clinical trials are more inclusive and regulated, and that it is a step we can take to help curb the spread of COVID-19. I also wanted to do my part to have Black people represented in the trial to help ensure that the vaccine will be effective for all people.
As a Black woman, were you worried about participating in a clinical trial considering previous history like the Tuskegee trial?
No. I know my ancestors were experimented on and were hurt by doctors and others in the name of science, so I understand why communities of color, particularly the Black community, have a myriad of reasons not to trust medicine and not to trust this vaccine. I decided to do it anyway after doing my research.
How did you educate yourself to make the final decision?
I needed to gather as much information as possible, so I reached out to a principal investigator (PI) of a coronavirus vaccine trial. The PI was very thorough, answered all of my questions and addressed all my concerns. I was provided a copy of the informed consent to read before making a final decision.
Can you walk us through the actual process and what happened?
In early October, I arrived for the initial visit and was asked a series of questions to ensure that I would be eligible for the study. After this, the entire informed consent was reviewed with me; I signed off. After this, there was also a thorough physical examination. Based on the informed consent, I knew that I had a 50 percent chance of receiving the placebo and a 50 percent chance of receiving the vaccine, but I took those chances. It was worth it.
After the physical examination, I was required to take a urine pregnancy test as I am a woman of childbearing age. It was negative. Once that was confirmed, the study product was prepared. Of note, this is a double-blind study where the study team does not know what the patient received and the patient does not know what they received. Before my shot, blood was drawn to assess my health status baseline before the injection was administered. I was also drawn to assess my baseline health status and I was tested by nasopharyngeal swab for SARS-CoV-2. After these steps, I was given my shot. After the injection, I was required to wait for 30 minutes after to ensure there was no adverse reaction.
I had to fill out a study diary describing my symptoms on the injection day and for seven days after. The only symptom I had was a very sore arm after the injection. I didn't have a headache or swollen lymph nodes in my armpits. I never had a fever. I had to take my temperature every day, so the lack of fever was very well documented. Then it was business as usual as I resumed my normal life activities and observed all Centers for Disease Control and Prevention (CDC) recommendations in preventing the spread of COVID-19.
A month later, I went back for my second appointment, took another pregnancy test and had more blood drawn. I was again tested by nasopharyngeal swab for SARS-Co-V2. After a negative pregnancy test, I received the second injection. I waited for thirty minutes again to make sure there was no adverse reaction, then went home. The arm pain was much worse the second time and I felt like I had received a tetanus shot.
The day after the second injection, I had a terrible headache and I was exhausted. I took a nap and when I woke up, I had a fever with chills and was shivering. My temperature read 101.5F. Thankfully the fever resolved the next morning. The fatigue and headache lasted another day while the arm pain lasted for several days, but by Monday I could go to work with no issues. I have since had other follow-up visits, and so far, so good!
Why did you see the need to share your story publicly?
I did it because I believe in science and I know that the Black, indigenous and people of color (BIPOC) community was wronged. COVID-19 has ravaged these communities far more than others, and this vaccine, in addition to other public health measures, can add another layer of protection.
I took the chance so that Black people would be represented in this study. For me, that was the most important thing. And given the opportunity, I would do it again.
What do you hope people learn from your experience?
I hope people consider taking the coronavirus vaccine when it becomes publicly available. I'll encourage everyone to do their research by reading the vaccine trial study reports and speaking with their medical providers if they have any concerns. We have a chance to stop this disease with the combination of the vaccines and strict observance of all the CDC's recommended guidelines.