What It's Like to be in a COVID-19 Vaccine Trial
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When Louis, a 45-year-old Las Vegas resident, heard that Moderna was looking for volunteers to enroll in its Covid-19 vaccine trial, he eagerly accepted.
Moderna, a Massachusetts-based biotechnology company, kicked off its Phase 3 clinical trial for its mRNA-1273 vaccine this summer. The federal government invested in Moderna as part of its “Operation Warp Speed,” an effort to make a coronavirus vaccine available as soon as possible.
The third leg of the clinical trial involves testing an experimental drug or vaccine in humans. On July 22, the Wake Research - Clinical Research Center of Nevada agreed to test the Moderna vaccine on 300 to 500 people as part of a broader push to study the effectiveness of the vaccine. Some 30,000 people are testing the Moderna vaccine in cities around the United States.
Las Vegas was selected because it’s been a hotspot for the virus, with Clark County accounting for more than 49,000 cases of the 57,000 confirmed cases in Nevada, according to The New York Times.
Louis was selected because he’s at high risk for catching the virus given his day job. He works at one of the most popular bars on the strip.
Louis, a bartender in the city, wears a mask and does his best to keep a safe distance from his customers. But despite his best efforts, he recognizes that he’s still exposed to a lot of people through work. Louis, like many other Americans in the hospitality industry, was furloughed from his job during the spring. In recent weeks, he’s been called back in for the occasional shift as things have started to pick back up.
“I know people who’ve been sick and I’m scared,” he said by phone. “I don’t see this going away unless someone can come up with something to knock it down or slow it down.”
Louis felt he should do his part because a good friend in his mid-40s spent 31 days in a coma after contracting the virus. That hit him hard, he shared, because his friend is also a bartender who works out almost every day.
“He’s fit as a fiddle,” said Louis. “He was even training for a marathon when he got sick.”
Louis declined to provide his full name for the story because he did not have permission from Moderna to do so. He also shared concerns about potential backlash from people who oppose vaccinations.
But he wanted to speak candidly about his experience because he’s growing increasingly concerned about the “disinformation campaigns” related to vaccines, which he fears could put people off from getting one if and when it’s approved.
In the U.S., according to recent polls, only half to three-quarters of people will get a vaccine if one is made available, which may hinder their effectiveness.
“I want people to see that if this guy can do it, they can do it too,” he said.
Showing Up to the Site
Louis first heard about the vaccine trial in the news. He and his girlfriend decided to sign up. Both had seen friends and co-workers get sick from the virus, so it felt personal. He promptly received an email with a phone number to call.
Louis answered a few questions about his age, medical history, and occupation. The following week, after his information was processed, he made an appointment to come in the following day.
The whole process took about five hours once he arrived at the clinical trial site. According to Louis, the first steps involved signing a 20-page consent form, with information about the study design and the various side effects. He also received routine blood-work and a Covid-19 test.
He got his first dose of the vaccine that same afternoon, Aug. 5. He didn’t experience any pain or discomfort because he was focused on a painting in the corner of the room. In about a month, he was told to return for a second dose.
Louis had some concerns about showing up to a physical site, given the risk of exposure, but he said that the 10 or so participants there that day were spaced apart and everyone wore masks. Most were in their 40s or older. He didn’t see many young people in their 20s in the room, even though the trial is open to those who are over the age of 18. About two-thirds of the people in the room were white, and the gender ratio was about 50-50, he said.
In general, clinical research trials tend to skew white, male, and higher-income. The coronavirus vaccine trials may be no different, although all of the major companies have expressed a desire to recruit a more diverse population. Louis felt that they had made an effort, at least at his research site, to bring in a more diverse group. But it can be a challenge when research studies take place on weekdays, require that participants have access to smartphones, and can be a long drive away.
“Trials are designed to cater to most privileged members of society,” said Jonathan Jackson, director at the Massachusetts General Hospital’s CARE Research Center, which works with communities to improve representation in clinical trials. “The companies behind the vaccines have said they want more diversity, but I’m concerned that there hasn’t been more enforcement or concrete targets.”
Louis left with an information packet to answer any questions he might have. He was advised to refrain from posting on social media about his involvement with the trial, but he was told that he could speak with friends and family members about it. Louis said he hasn’t told everyone in his life because he doesn’t know how they’ll react.
Since he got the first shot, he’s downloaded an app that he’ll use for seven days to log any symptoms he might experience. He’s also been told he’ll receive a phone call each week to talk about his symptoms (if he’s experiencing any) in more detail. He said it’s been fairly mild. He’s been a bit more fatigued than usual, and it’s been a bit more of a challenge for him to workout.
He’s been given numerous phone numbers that he can call in case things take a negative turn. Louis has been told he can get tested for the coronavirus anytime on site if he is experiencing symptoms or fears he’s been exposed.
“There’s a lot they go over with you,” he said. “I’ve felt really supported... it wasn’t some group of people telling us they’re going to stick us in the arm and then send us home with a ‘good luck bud.’”
Louis doesn’t know if he received the actual vaccine, or whether he got a placebo. About half of the volunteers will get a saline solution. The participants are deliberately not told which batch they’re in.
Louis has some suspicion that he received the vaccine itself, because he’s felt some side effects. But it’s plausible that it’s just general malaise or a bug.
Louis said he hasn’t changed his lifestyle much since he received the shot.
As he understands it, the overall study is designed to evaluate the safety, efficacy, and immune response in reaction to the vaccine to prevent Covid-19 for up to two years after the second dose is administered. The Phase 3 trial focuses on its effectiveness, or how well it works.
To gauge whether it’s offering protection from the virus, the trial is deliberately focusing on people who are on the front-lines or in roles that would mean they’re more likely to be exposed to Covid-19.
But he is still taking precautions as best he can.
“I’m not going to walk around without a mask on,” he said. “I don’t think I’m superman.”