Without tens of thousands of volunteers around the world, the US would not currently have two vaccines to battle the coronavirus. These are those volunteers’ stories.
To say that 2020 has been rough is putting it mildly. But even amid the death, division, and chaos, people have stepped up and shown us that there is still good in the world. While some of them reject the ‘hero’ label, the sacrifices of these Americans deserve recognition for their impacts on our lives. Today, we are shining a spotlight on those who participated in COVID-19 vaccine trials.
When it came time to make the final decision, Dr. Valerie Fitzhugh wasn’t scared. She dove in head first.
The 42-year-old married mother of two knew there were risks associated with participating in an experimental COVID-19 vaccine trial. However, as the interim chair of pathology at the Rutgers New Jersey Medical School in Newark, New Jersey, and the Rutgers Robert Wood Johnson Medical School in New Brunswick, she also believes in science and understood how important the trials were.
Those weren’t the only reasons motivating her. Dr. Fitzhugh is also a Black woman who is obese and lives with high blood pressure, and her participation would be critical so that people of color and those with risk factors would be represented in these trials as well.
“I’m the kind of person they need to ensure it’s working,” she told COURIER. “Because for other people like me who have high blood pressure, who are obese—we have to know if this is going to work or not. If we’re not represented, how do we know? Representation matters.”
Dr. Fitzhugh felt it was particularly important for Black people to be represented in trials because of the disproportionately devastating impact COVID-19 has had on Black communities and the longstanding mistrust that many Black Americans have in the scientific community, owing to historical medical atrocities like the Tuskegee experiment. In that now-infamous “study,” doctors from the US Public Health Service intentionally denied treatment to Black men suffering from syphilis, even as they experienced blindness, mental impairment, passed the disease onto their spouses and children, and—in many cases—died.
“This is a generations-deep mistrust that is so incredibly well justified,” Dr. Fitzhugh said. “The things that have been done to people that look like me, there are no words. They are atrocities.”
Dr. Fitzhugh hopes her participation in the trial can play some small role in alleviating these concerns and encouraging Black people to get vaccinated in order to save lives. “I’m tired of watching people who look like me die day in and day out from this disease, and so I’m trying my best,” she said.
Volunteers “Wanted to Help the Science,” but Science Also Gave Them the Confidence to Participate
Armed with this sense of purpose, Dr. Fitzhugh signed up for and was accepted into a COVID-19 vaccine trial in early October. She declined to identify which company’s trial she participated in, but said that any lingering concerns she had were assuaged by the study’s principal investigator—the person responsible for the preparation, conduct, and administration of the trial.
“I wasn’t really scared at all because when I went through the pre-screening process, the study’s principal investigator was very thorough,” Dr. Fitzhugh said. “Everything I asked her, she addressed thoroughly in language anybody can understand. She gave me a copy of the informed consent [form]. I actually read through all 20 pages twice before my initial appointment twice just so I was comfortable, so I wasn’t really scared at all.”
Christopher Baugh, a 32-year-old resident of Los Angeles, California, who participated in Moderna’s vaccine trial, was similarly unphased by any potential risks.
“I’m young, I’m healthy—relatively speaking on both counts—so I wasn’t super worried. I didn’t think participating in this trial was going to send me to the hospital,” Baugh said. “And the results from the first two phases were really good.”
He also did his homework on how the vaccine works. Most vaccines contain a weakened or inactivated form of the virus they’re inoculating against, which then triggers an immune response against the virus. Moderna and Pfizer’s COVID-19 vaccines, however, utilize a different and newer technology. They are mRNA (messenger RNA) vaccines, which essentially give the body the virus’ blueprint, causing the body’s cells to build a spike protein that triggers an immune response and builds up a defense against COVID-19.
“It’s a much more sophisticated technology,” Baugh said.
Like Fitzhugh, Baugh participated because he knew the trials needed volunteers and wanted to try and address concerns about vaccine safety. “They needed warm bodies and especially as much hesitation as there is around this, I wanted to help the science,” he said. “We all understand how bad this sucks. No one is enjoying being in lockdown, so it’s like, ‘Cool, you need 30,000 people? I’m in. I will be one of them.’”
From Extensive Screenings to Mild Side Effects, Volunteers Felt Confidence in the Process
Olivia Browning, a 28-year-old resident of Atlanta, Georgia, participated in the Pfizer trial and rejected the notion that she was “brave” for doing so.
“I really don’t want to be sick,’ Browning told COURIER. “So my mental state is: I’d much rather have a vaccine, even if it is a little unknown, than get COVID.”
The thoroughness of the process also reassured Browning.
“The first day was really, really long. I think we were there for about six hours,” she said. “We signed a bunch of paperwork, they asked us questions, they made sure that we understood the process very clearly. They did a physical, medical background, a pregnancy test, drew blood, and then they gave us the first shot of the vaccine.”
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With Pfizer and Moderna’s vaccines now being administered across the country, rare cases of allergic reactions have drawn outsized attention and sparked concern about the safety of the COVID-19 vaccines. But the truth is, all vaccines have side effects and that is not a cause for concern. The COVID-19 vaccine is no exception. All three trial participants who spoke with COURIER were required to keep a symptom diary and report any issues on either a daily or weekly basis.
Dr. Fitzhugh documented the entire process in a lengthy twitter thread and said the only side effect she felt after her first shot was arm soreness, which is similar to what Browning experienced. Baugh experienced slightly more uncomfortable side effects.
“I was really tired and light-headed for between seven and 10 days after the first injection,” he said. “One day I decided to go hiking and I almost passed out and it’s my normal hiking route, so I was like, ‘Oh, that’s not normal.’”
One month after receiving his first injection, Baugh returned for his second dose, which hurt more. He experienced underarm swelling for more than a week following the second injection and documented one fever.
Browning experienced flu-like symptoms following her second shot, but they quickly went away. Dr. Fitzhugh, however, dealt with more significant side effects after the second dose. She once again suffered from a sore arm, but also experienced a headache and fatigue, and a 101.5 degree fever. While the arm pain lasted for another few days, her other symptoms resolved quickly and Dr. Fitzhugh hasn’t experienced any problems since.
Because of their side effects, all three participants suspect they got the vaccine, but they continue to wear masks, employ social distancing, and behave as if they didn’t.
“I don’t know which arm I was in, and again, I’m acting as though I’m in the placebo arm, because I would rather be wrong about that than be wrong about the opposite,” Baugh said.
What Happens Next for Vaccine Trial Volunteers?
All three trial participants said they hope to find out in the coming weeks whether or not they actually received the vaccine, as they’ve gotten word that there are ongoing discussions about unblinding the trials early due to the extraordinary nature of the pandemic. While the studies are supposed to last through the fall of 2022, unblinding the participants would allow volunteers who received the placebo to get the vaccine.
They also all expressed joy and relief that the Moderna and Pfizer vaccines both proved to be more than 90% effective at preventing mild and serious cases of COVID-19 infection.
“I’m super excited. I’m obviously just as ready as anyone else for all of this to be as over as it’s going to get, so I am hopeful that people will start getting it very soon,” Browning said. “I know the people running these trials were working very hard and working very long hours to do this really quickly, so I feel really good about it and I’m happy all that hard work is paying off.”
“The science worked tremendously well. I’m super happy for these people who were given an insane task of fighting an epidemic,” Baugh added.
Both are now being administered to healthcare workers as well as residents of nursing homes and other long-term care facilities. More than 600,000 Americans have received their first of two injections, according to the latest data from the Centers of Disease Control and Prevention.
That represents a remarkable feat: Scientists developed two hugely effective vaccines in less than a year, as opposed to the four or more it usually takes. That success was made possible in large part due to the volunteer efforts of people like Dr. Fitzhugh, Baugh, and Browning.
“I hope people do it because it’s important and it’s going to help a lot,” Browning said.
“What’s Most Important Is That We Address Issues of Mistrust.”
Still, there remains a long way to go. Public health experts have said that at least 70% of the population will need to be vaccinated in order to bring the pandemic to heel, and there remain issues in the nation’s vaccine distribution pipeline. One of the key issues is what convinced Dr. Fitzhugh to participate in the trial in the first place: lingering mistrust in the medical community and reluctance among some people of color to get vaccinated.
Dr. Fitzhugh acknowledged that this hesitance remains a real problem, but believes that because the racial inequities of COVID-19 have been laid bare so clearly, that those leading the distribution effort will prioritize outreach to people of color and be “very cognizant of making sure that people of color get these vaccines more quickly.”
As for her, she’s going to continue to do her part to encourage vaccination, and have conversations with people in Black and Brown communities in order to address their concerns.
“I think what’s going to be most important is that we address the issues of the mistrust in the Black and Brown communities, that we accept and talk about the prior injustices so that people who look like me understand that we’re not dismissing the mistrust,” Dr. Fitzhugh said. “I understand why people who look like me don’t want to get this thing. I get it and I understand that feeling, and I would never dismiss that. I think that’s probably the most important thing.”