Editor's note: This story has been corrected. A previous version identified Marty Osbourn as a man. Osbourn is a woman and is also very understanding about our mistake.
Back in spring, Indiana State Rep. Ed Clere began recognizing the severity of the coronavirus pandemic that was taking hold throughout the United States. He said the effects of COVID-19 were already taking a “devastating toll,” and he felt a calling to help any way he could.
“And looking at projections, I knew time was of the essence,” Clere said. “And I felt like I could do something by volunteering.”
Clere and his wife, Amy, signed up for vaccine trials online. Months went by without hearing anything, but around August, a family friend told Amy about an opportunity across the Ohio River in Kentucky. Now, the Clere family, including 19-year-old daughter Hannah, are participating in trials at the Kentucky Pediatric/Adult Research (KPAR) in Bardstown.
“I trust science, and I trust scientists,” Ed Clere said.
The speed at which vaccines are being developed has raised safety concerns among the population. There also exists a partisan divide in many parts of the country regarding the severity of the virus and prevention measures. But Ed Clere, a Republican, said politics have no place in a pandemic.
“I think it's so important that we focus on the science and get past the politics that are weighing things down and have the potential to make a vaccine less effective by causing fewer people to choose to get vaccinated,” he said.
Pfizer is the manufacturer of the vaccine being tested. Marty Osbourn, chief operating officer and research director at KPAR, said phases 1, 2 and 3 of the trial involve over 44,000 participants.
“Because of the pandemic, the trial needed to move quickly to establish the safety and efficacy in record speed, which mandated conducting the phases simultaneously,” she said.
Osbourn said the pharmaceutical company provides the guidelines on how to conduct the trial. All procedures are conducted within KPAR’s office, and findings are entered into an electronic data system, allowing data to be assessed in real time.
“For this trial again, we were required to enroll a certain number of patients each day and enter the data within 24 hours of the patients visits,” Osbourn said. “Which again is not the normal and has contributed to the rapid speed of this trial.”
Participants in the Pfizer trial are ages 16 and older, and ages 12 to 15 will begin enrollment later this month. Along with certain health qualifications, preferred participants must also be active in the community to “ensure a degree of exposure to COVID-19.” Ed’s role as a legislator, Amy’s teaching position, and Hannah’s enrollment at the University of Indianapolis helped the Clere family meet those standards.
Amy Clere, a teacher at Clarksville High School, said she remembers hearing stories from her grandmothers about the 1918 flu pandemic. She has since carried with her an interest in epidemiology, even beginning her college career as a pre-med student before transitioning to journalism and foreign languages.
“I've thought if there's another pandemic, if I were a doctor, I would want to do something about it,” Amy said. “Well, I'm not a doctor, so when [the trial] came up, I thought I want to try to do something about it. Because this thing is devastating. Some people are not taking it seriously… And if I can help them in some way, yes, I want to do that. I want to be a part of the solution to this thing.”
At the beginning of the two-year trial, two injections are administered over a three-week period. Patients come in for four additional office visits, which occur one, six, 12 and 24 months after the first injection.
Blood samples are collected at each visit to monitor antibody levels and other medical information. Symptoms are also self-monitored by participants through the use of an electronic diary.
Ed Clere described his reaction as “pretty uneventful,” only noticing minor pain around the injection site on his arm. But Amy Clere did experience symptoms about 12 hours after the injection, including headache and abdominal pain. She also developed an odd taste in her mouth.
“It was pretty mild,” Amy said. “But I thought then I must have gotten a real thing, because I can't imagine that saline water would do this.”
The trial is double-blind, meaning neither doctors nor patients know which is administered.
Osbourn said figuring out when a vaccine will be approved and widely available is the “magic question.”
“The bottom line is until we have those positive cases and efficacy is proven, the vaccine can't be approved,” she said. “So there are variables we can't control, specifically the prevalence of COVID-19 circulating in the community and the reliance on the patients enrolled to report every potential symptom.”
For his part, Ed Clere said he hopes his participation in the trial can help assure his constituents and others that the vaccine development is safe, especially now that 207,000 Americans have died from COVID-19.
“I hope I can serve as an example to people in this community and give them a greater comfort level with the vaccine, because the only way we're going to slow or stop this thing and keep people from getting sick and dying and get our economy back on track is to get to a vaccine that is safe and effective.”