The Search for an Antidote: Research firm conducts vaccine trials

As a number of COVID-19 vaccines inch closer to release in the marketplace, one local research firm is doing its part to end the global health pandemic.

QPS Missouri Holdings LLC and its 50 study participants are in the midst of an early stage clinical research trial testing the safety and response to a COVID-19 vaccine.

“QPS as a whole is operating at full force to fight this pandemic,” said Brendon Bourg, vice president and general manager of QPS Missouri, a division of Delaware-based QPS Holdings.

Bourg would not disclose the name of the company QPS is working with due to confidentiality agreements, but he said QPS officials began reaching out in mid-March to partners they felt would try to develop vaccines or medication to combat COVID-19.

QPS Study 30620 began last month in Springfield, and it’s divided into eight groups. Each group is injected with the vaccine and remains in-house at QPS, 1820 W. Mount Vernon St., for 10 days, said Recruiting Manager Niki Powell. The study also requires six outpatient follow-ups. Bourg said some samples collected from participants are analyzed at QPS, which is among the largest contract research organizations in the United States with 240 beds.

“Whether it’s a urine collection, whether it’s a blood collection, we have to find a way to measure the antibodies to see if the vaccine is producing antibodies against the virus,” he said.

The study is expected to infuse up to $403,750 into the local economy through stipends paid to participants.

Christopher Lupfer, an assistant professor of biology at Missouri State University, said phase one clinical trials in general serve as safety tests.

“They’ll take a handful of people, maybe 50 or 100, and they’ll give them the vaccine or drug and they’ll see, does anyone die from it? Does anyone develop an allergic reaction to it? Does anything bad happen?” he said.

Meanwhile, as of press time, Moderna and Pfizer are seeking approval from the Food and Drug Administration to distribute their vaccines that have gone through three phases of clinical trials with efficacy rates upwards of 90%. And on Dec. 2, the United Kingdom became the first Western country to approve a COVID-19 vaccine, according to media reports.

Lupfer said development of the vaccine was done in “light speed.”

“For a drug or vaccine, you’re typically looking at five to 10 years, in many instances, to go from the initial discovery of the drug or the concept of the vaccine,” he said.

“There was some testing done in animals, although only briefly. The science behind this vaccine has been around for a while, so there wasn’t as much concern that it would cause allergic reactions or things like that, which is why I think they were able to jump to humans a little bit quicker.”

The apparent antidote could not come soon enough. Johns Hopkins University reports more than 64 million cases and 1.5 million deaths from COVID-19 globally, as of press time. Both Mercy Springfield Communities and CoxHealth officials are reporting record high COVID-19 caseloads, with the Springfield-Greene County Health Department tracking 228 patients hospitalized and 63 in critical care, as of press time.

Vaccine distribution
Locally, Mercy Hospital Springfield has been selected by the state as the designated distribution site for a vaccine. Brent Hubbard, president and chief operating officer of Mercy Hospital Springfield, said he expects the vaccine to arrive in the Ozarks by mid-December.

“Some of the major factors in determining those sites were the ability to store the vaccine using ultracold freezers, having the logistical expertise and capabilities to accommodate the vaccination requirements and being able to distribute,” Hubbard said in a Dec. 1 Springfield Business Journal CEO Roundtable discussion. “Our teams have been working over the last several weeks to prepare and develop really robust plans to ensure we’re ready to administer the vaccine.”

Hubbard said he expects front-line health care workers to be the first eligible for the vaccine.

The state’s Stronger Together COVID-19 vaccine information website outlines health care workers, essential workers and high-risk populations as the first recipients of Missouri’s vaccine rollout. A federal advisory panel on Dec. 1 recommended the first doses of the vaccine go to the estimated 21 million health care workers and 3 million residents and staff at long-term care facilities around the country.

Dr. Tim Jones, president of Cox Medical Group, said now the challenge is people actually getting vaccinated.

“Many polls have showed that only about 60% of people trust this vaccine and would take it right now, and that’s concerning,” he said at the SBJ roundtable discussion on COVID-19. “Those things are going to slow another potential weapon we have to control this thing. It’s another fight from a messaging standpoint that we’re already talking with our providers about.”

A Gallup poll from mid-November found 58% of Americans said they would get a COVID-19 vaccine, up from a low of 50% in September.

Recruiting participants
Pfizer’s later stage clinical trials enrolled nearly 44,000 participants, and company officials reported it is 95% effective against COVID-19. Moderna’s 30,000-person vaccine trial reported a similar 94% efficacy rate.

Locally, QPS’ Powell said recruitment went smoothly for its COVID-19 vaccine trial, adding people were ready to sign up right away.

“We had people that just wanted to hurry up and get a vaccine, and then we also had those people that just wanted to do anything they could to fight against the pandemic,” she said.

Powell said the study also is personally fulfilling for the staff.

“I got gratitude almost immediately from being involved with the development of the coronavirus vaccine,” she said. “It’s great that we are a part of something that’s not only going to help globally, but it’s also helping right here in the community. It’s putting so much money back out into the community.”

While the local trial only required certain health requirements and age restrictions, globally the trials from Pfizer and Moderna highlighted the importance of diversity within participants. In Moderna’s trial, there were 6,000 Hispanic and 3,000 African-American participants, with a near even split of gender.

Pfizer’s trial spanned six countries with 42% diverse participants, including Asian, Black, Hispanic and Native Americans.

Lupfer said that diversity in study participation is critical, as the Centers for Disease Control and Prevention finds Native American and Hispanic populations, for instance, are roughly four times as likely to be hospitalized from COVID-19 complications as compared with white people. And Black and Hispanic people are 2.8 times more likely to die from COVID-19.

“Ideally, you would want children, elderly, middle age, male, female, different ethnicities all participating,” he said. “Just because white people don’t develop an allergic reaction to the vaccine, maybe Asian people or people of African descent do.”

At QPS, the COVID-19 vaccine trial is happening amid a busy fourth quarter. Officials said more than $1 million in clinical research stipends will be paid out, with $840,000 landing in December alone. Powell said that’s another way the company is helping in the fight against the pandemic.

“For fourth quarter to be at $1 million, when usually we run in a year timeframe a stipend of $2 million total, that’s a pretty significant difference,” she said. “It comes down a lot to the coronavirus vaccine, a lot of people just wanting to help and be involved and to volunteer.

“Plus, when we were able to get our facility back and get it running safely, we were able to get as many studies going as we could locally and be able to help put (money) back out into the community.”