What’s it like to take part in a virus vaccine trial?
Three participants from Chicago area share their experiences
David Daly was a little bit nervous earlier this month as the syringe pricked his upper arm, the first injection he received as a volunteer in a local COVID-19 vaccine clinical trial.
The 43-year-old actuary from southwest suburban Lockport knows there is always some risk involved in helping test the safety and efficacy of any new drug.
“But I think it is a pretty acceptable risk,” he said after his appointment at Rush University Medical Center, where he’s taking part in a study for a vaccine developed by the University of Oxford and the multinational pharmaceutical company AstraZeneca. “I’ve been impressed that even though it’s moved quickly, I think they’re still taking safety very seriously. They’re not shortcutting scientific protocols for the vaccine.”
Daly is among the roughly half-million Americans who have signed up to participate in various vaccine trials as scientists race to produce safe and effective immunizations to the coronavirus, which has so far killed more than 14,000 in Illinois and more than 1.5 million worldwide.
The first COVID-19 shots outside of a clinical trial could be
given in the Chicago area within days, after federal officials Friday night gave a Pfizer vaccine emergency use authorization; however, officials caution that fully vaccinating all adults will take much longer.
Even as some vaccines prepare to hit the market, researchers nationwide say there’s still a need for 1 million more clinical trial volunteers, whose bodies and experiences play a critical role in developing immunizations and bringing them to mass circulation.
More than 50 vaccines are being tested on humans in ongoing studies internationally, with about a dozen in the large-scale, later stages of development. Those trials will continue in the hopes of compiling more safety data and eventually producing enough immunizations to inoculate people around the globe. Participants will continue to be monitored long-term for health and safety data.
With most vaccines requiring two doses — an initial shotandthen abooster — that could eventually be some 14 billion doses neededworldwide.
Several local vaccine volunteers say taking part in a trial is a chance to contribute to ending the death toll and economic devastation of the pandemic.
Gregory Bowman, a registered nurse who is also taking part in the trial at Rush, plans to encourage his own patients to get vaccinated, once they are eligible.
“If I’m pushing it on my patients, I’ve got to be willing to put myself out there as well,” he said. “I see this as an act of service.”
Steve Dale, a certified animal behavior consultant and WGN radio show host, is participating in a trial at the University of Illinois at Chicago for a vaccine produced by biotechnology companyModerna. He said he’s in awe of the historical significance of aprospective new vaccine, a breakthrough for humanity.
“We’re living through history now,” he said. “I’m excited about what the future holds, for what science can bring us.”
As for Daly, he’s hopeful the Oxford-AstraZeneca vaccine and others will prove effective so theworld can return to normal.
He longs to shake hands and hug loved ones again. To travel the globe. To be at a crowded bar on a Friday night.
“A vaccine is our only way out of this,” he said. “When this does get approval and it does get rolled out, I think it will be something we can all be very confident in. It is going to be the silver bullet that takes us back to the pre-pandemic life thatwe allwant.”
Still recruiting
Like all vaccine trial participants, Daly doesn’tknow whether the immunization or a placebo was injected into the muscle of his upper arm.
For the study he’s part of, two-thirds of volunteers are given the vaccine and the other third is given a shot of saline, to control the experiment.
A randomized computer system determines who gets the vaccine versus who gets the placebo, and then alerts the pharmacist what to prepare and bring to the clinic. The study is doubleblind, which means even the researchers don’t know who has what; later in the trial, it will be officially un-blinded so researchers can analyze results.
This is designed to prevent unconscious bias, said Dr. Beverly Sha, professor of medicine at Rush UniversityMedical Center, who is leading the vaccine trial.
“If I told you that you got the vaccine and it was real, it might alter your behavior,” she said. “The risk of exposure to COVID might nowbe different among the people who know they got the vaccine versus those who knowthey didn’t.”
She added that patients or researchers could also minimize side effects unintentionally, because they reallywant the vaccine tobe successful.
Daly had his first inperson appointment at Rush on Dec. 3, after a rigorous screening process, multiple phone interviews and going over lengthy health and safety information.
The roughly 90-minute visit included a physical, a blood draw and a COVID-19 nasal swab test, as well as the first injection. The next day, he reported no side effects except minor arm soreness. He’s scheduled to receive the second shot in early January.
While Daly hopes he received the vaccine, he said he’s still taking the same precautions as he did before the trial.
“Social distance as much as possible, wearing a mask, hand-washing, good hygiene,” he said. “I don’t want to be walking around … thinking I’m immune and I really have two shots of saline inmy arm.”
At the same time, his level of possible exposure to the virus might be greater than some because he works out at a public gym four or five times a week and frequently travels domestically on airplanes forwork.
This could benefit the study, which seeks volunteers who are at a higher risk of infection, from health careworkers to those living in congregate care facilities or multigeneration al housing.
So far, more than 90 participants have been screened for the study at Rush, and most have received the first injection; to be eligible, volunteers must be over 18 and cannot have had a known COVID-19 infection, an impaired immune system, or be pregnant or breastfeeding.
Sha said the study is still recruiting, particularly older volunteers and patients with underlying health conditions, aswell as Black and Latino participants. The Oxford-AstraZeneca trial is expected to enroll some 30,000 participants at sites nationwide.
Globally, the study has had some high points — as well as some more tumultuous moments.
On Tuesday, an article in the medical journal the Lancet said the Oxford-AstraZeneca vaccine“has an acceptable safety profile and is efficacious against symptomatic COVID-19, with no hospital admissions or severe cases reported,” based on data out of the United Kingdom, Braziland South Africa.
But a recent manufacturing error raised questions and confusion about the vaccine’s dosing and efficacy, after one group of volunteers received a halfdose of the first vaccine; surprisingly, the participants given the lower dose appeared better off, with apparent 90% effectiveness compared with the group that got two full doses, where the vaccine appeared to be 62% effective.
“Of course, it’s generated a lot of questions among the patients and participants, and we don’t have all the answers, so that can be challenging,” Sha said, adding that patients at Rush were unaffected and are receiving full doses.
Earlier in the pandemic, testing was temporarily paused twice, each time after a participant developed illness; in one case, a volunteer was found to have undiagnosed multiple sclerosis, which was determined to be unrelated to the vaccine. National Institutes of Health Director Dr. Francis Collins has said theother case involved a spinal cord problem; the participant’s condition has since improved.
Neither of those volunteers was part of the study at Rush, which didn’t start until after the second pause was lifted.
Collins in September described this kind of clinical hold on a study “not at all unprecedented.”
“This certainly happens in any large-scale trial where you have tens of thousands of people invested in taking part, and some of them may get ill,” he said. “And you always have to try to figure out is that because of the vaccine or were they going to get that illness anyway?”
More options
Bowman has seen the pain and devastation of the virus firsthand.
Early in the pandemic, he worked at a coronavirus drive-thru testing site at Rush, swabbing hundreds of patients under a tent between two hospital buildings. Since July, he’s been helping prevent COVID-19 out breaks among the homeless at Chicago shelters.
“I observe a lot of human suffering as a consequence of this virus,” he said.
Bowman, 33, of the Humboldt Park neighborhood, said he decided to participate in the vaccine trial at Rush as “a service to my loved ones andmy community.”
“We need a safe and effective vaccine to bring this pandemic to a close, and that’s not going to happen unless people are willing to volunteer for these trials,” he said.
Like most people, he longs for the day when he won’t have to wear a mask everywhere and can reconnect with friends and loved ones outside his bubble. His wife is from Brazil, and the pandemic has prevented them from visiting her family; they’ve had to miss important events, like the recent birth of their niece.
Bowman received his second shot on Dec. 3.
Except for a little tenderness at the injection site after the first shot, Bowman said he’s had no side effects. Sha said some patients have reported body aches or fevers for a day or two after receiving the injection.
“But it’s definitely not two-thirds of our patients that are reporting it,” she said.
The trial is in phase 3, and the vaccine has already been given to about 10,000 patients and much data had already been compiled in earlier stages.
“I feel confident that Astra Zeneca is following the right process for formulating the vaccine,” Bowman said. “I think it is moving faster than usual but that’s because we’re trying to bring this pandemic to a close.”
Vaccine hesitancy might prove to be a major public health challenge, with just 47% of Americans reporting that they plan to get immunized against COVID-19 once a vaccine is available; 26% say they don’t plan to get vaccinated and 27% are unsure, according to a poll released Wednesday by The Associated Press-NORC Center for Public Affairs Research at the University of Chicago.
To assuage concerns, nine pharmaceutical companies issued a joint statement in September pledging a “commitment to developing and testing potential vaccines for COVID-19 with high ethical standards and sound scientific principles.”
‘Small cog in history’
Dale, who is part of the Moderna trial at the University of Illinois at Chicago, said he’s confident in the study’s safety protocols.
“I do believe that safety is paramount and the companies have made that clear,” he said. “My experience has been that they’re being incredibly careful every step of theway.”
The East Lakeview neighborhood resident has heard fromfolks who are skeptical, who say they’ll wait to get a vaccine until others get it first, or who question the speed of vaccine development. Some have called him a hero for participating in the trial, and others have called him a fool.
“And some were ready to offermy obituary,” he said.
Dale received the first injection inmid-September. He didn’t recall feeling anxious during that visit, but when his blood pressure was taken during the physical, he said it was higher than ever before.
“I didn’t really feel nervous, but there must have been some trepidation on some level,” said Dale, who oncewrote a column for the Tribune.
He got the booster shot in mid-October; he said he’s had no side effects following either injection.
“I’m very proud to be a part of this,” he said. “To be a small cog in history, to have participated in a very small way. If everybody said, ‘I’ll wait for someone else to do this,’ then no one would.”
As vaccines developed by companies like Moderna and Pfizer approach the finish line, this has raised an interesting ethical question regarding volunteers enrolled in other trials: Some have asked whether they’ll be able to get another vaccine that’s on the market once available, in case they received a placebo during the trial.
Sha said volunteers she works with can get another vaccine, but they would be encouraged to stay in the Oxford-AstraZeneca trial; researchers then would record that the participants were inoculated with another vaccine and continue collecting data.
“There is interest in knowing what happens to the antibody response in somebody who maybe did get AstraZeneca to start withandlater getsModerna or Pfizer,” she said.
Some medical experts say there are benefits to having multiple COVID-19 vaccines on the market, because some might have different advantages.
For example, while many other vaccines require deep freezer space, the one developed by Oxford and AstraZeneca only needs refrigeration, which could make it easier to store and circulate to rural areas and developing nations.
“It’s an all-hands-ondeck situation,” Bowman said. “There are just a lot of resources being thrown at this problem, more than in ordinary times, which explains why we’ve been able to find what seems like, according to preliminary data, a safe and hopefully effective vaccine so quickly.”
“I’m very proud to be a part of this. To be a small cog in history, to have participated in a very small way. If everybody said, ‘I’ll wait for someone else to do this,’ then no one would.” — Steve Dale, a certified animal behavior consultant and WGN radio show host, who is participating in a trial at the University of Illinois at Chicago for a vaccine produced by biotechnology companyModerna