AUSTIN (KXAN) — As an Air Force veteran, taking risks and helping people are in Abby Strite’s nature.
“It’s important to look outside of ourselves and see what we can do for our community,” she said.
She’s a healthy mom to two healthy kids, with no underlying conditions. She’s also currently working from home. When she heard she could sign up for Moderna’s COVID-19 vaccine trial in the Austin area, she jumped at the chance.
“For me, at least, the risk seems quite low for a really great benefit of helping science—moving this all along as fast as we can in a scientific way,” she said.
Strite did experience some side effects for around 24 hours after her second ‘booster’ shot.
“It felt like a very bad hangover,” she laughed. “It felt like I was very, very dehydrated, very tired, a little woozy.”
Since then, she’s been reporting her health status through an app and plans to check-in with the trial doctors throughout the 25-month process.
We first met Strite back in August, after she learned the timeline for one of her appointments in the trial had been rapidly pushed forward.
“It made me worry that we are rushing the trials in order to rush the results, for political purposes,” she told KXAN at the time.
Eventually, she got a response from the company. They told her they had actually moved up many scheduled appointments, in order to include more high-risk populations in the trial.
“Ultimately, their answer was a pretty good one. I wish I’d had it in the first place,” she said, hearing about Moderna’s focused efforts on diversity in the study. “That makes the results more scientific and better.”
Mark Lacy, CEO of Benchmark Research, said there are guidelines in place to ensure the speed of these trials doesn’t effect the quality of the vaccines themselves.
“Normally, you would have several Phase Three studies before you submitted to the FDA, but the studies would be much smaller—there would be maybe 6,000 patients. These studies are 30,000 patients. So, basically what they’ve done is to engineer, in the research community, a way to be able to go much faster but not sacrifice safety,” Lacy said.
He also emphasized this coronavirus, SARS-CoV-2, is similar to other coronaviruses researchers have studied in the past, so they aren’t starting from scratch.
Benchmark Research is one of the companies helping administer vaccine trials in Austin. They are working with six of the leading companies, including Moderna. Lacy said they’ve been contracted to help with nearly 20 more in the future.
Lacy noted participants do receive free health care and checks from a physician during the studies. Plus, they are compensated, sometimes as much as $2,000 or $150 a visit.
“People get side effects. You know, they may come down with a cold or they may come down with a urinary tract infection,” he said. “We have to bring then bring those people in and try to find out whether it’s definitely associated with the drug… or not associated with drug.”
According to Benchmark, they have enrolled more participants in the Moderna trial than any other clinical research company in the United States, helping the company get one step closer to widespread vaccine distribution.
Diversity in vaccine trials
Safety concerns recently prompted Johnson & Johnson and AstraZeneca, two other major pharmaceutical companies, to halt trials of experimental COVID-19 drugs, but Lacy said that’s common in the world of vaccine research.
Meanwhile, Moderna announced last week it had reached its enrollment goal of 30,000 participants for Phase 3 of the trial. Their Chief Executive Officer Stéphane Bancel called it an “important milestone.”
“We are indebted to all of the participants in the study,” Bancel said in a news release.
Moderna noted 37% of the trial participants were people of color. According to their data, more than 6,000 participants identify as Hispanic or LatinX, and more than 3,000 participants identify as Black or African American. They said 42% of study participants were medically high-risk, with more than 7,000 people over the age of 65. Plus, more than 5,000 people in the trial are under the age of 65, but have high-risk chronic diseases such as diabetes, severe obesity and cardiac disease.
In a panel last week, experts peppered the FDA with questions regarding the diversity of these trials and the speed at which they are being conducted.
The nonprofit Reagan-Udall Foundation showed some results from their ongoing survey of frontline workers and traditionally underrepresented groups. They said people of color raised concerns about being “used as guinea pigs” in trials. Others spoke out about worries that politics and money were being prioritized over safety.
“Time and time again, the U.S. has proven it is about the dollar, especially in health care,” one respondent told the Reagan-Udall Foundation.
Lacy said his team at Benchmark takes safety precautions at their site for all trial participants, but noted they are especially cautious for high-risk participants or people of color.
“They know about the Tuskegee studies,” he said. “They know that in the past they were treated with substandard care and treated as guinea pigs.”
He’s referencing a study from 1932, where researchers began tracking the progression of untreated syphilis in black men. Reports later accused the researchers of misleading the participants by not giving them all the facts required to provide informed consent and not giving them adequate treatment for their disease. Eventually, an advisory panel concluded the Tuskegee Study was “ethically unjustified.”
Officials with the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) emphasized the importance of transparency to assuage these concerns.
“You can have a fantastic vaccine, and if no one takes it, it’s not going to do much to end this pandemic,” said Dr. Hilary D. Marston, Policy Advisor for Pandemic Preparedness for NIH.
Timeline and efficacy
Lacy said companies could try to be approved for Emergency Use Authorization before Phase Three is finished, if they meet certain criteria.
They must finish a mid-point analysis. Plus, more than half of study participants must have received the full round of vaccines (several trials require a second “booster” shot) and then be studied for around more two months, for safety purposes.
By Lacy’s estimation—and if the trial continues without any interruptions—Moderna could apply by mid-December.
He said most of the major trials are also tracking and evaluating the efficacy of their vaccines. For example, he said they have to have a certain number of participants contract COVID-19. Then, 40% of those need to be the participants who received the placebo vaccine.
“The idea is: the greater the percentage that have had the vaccination and don’t come up with COVID, that points to a great efficacy rate,” he said.
Ideally, to achieve “herd immunity,” the efficacy rate would be 75 to 80%. Yet, Lacy said researchers aren’t get their hopes up.
“Even 50% would go a long way,” he said.
Still, he explained companies could begin distribution, while still tweaking their vaccine for a greater efficacy.
Abby Strite is participating in the trial through a different research firm than Benchmark, but echoed Lacy’s concern about getting the most effective vaccine to the people who need it now. That’s why she decided to participate in the first place.
“To me, it was worth it, if we ultimately have a safe and effective vaccine,” she said.