Behind The Scenes

The following chronicles the journey of UC Health’s role in the Moderna phase 3 COVID-19 vaccine trial, from the early days in August 2020 to present day.

9:00 a.m., Aug. 25, 2020 – Day 1 of the Vaccine Trial

It has been over five months since the new coronavirus made its way into our region. Since then, our lives have completely changed. People are wearing masks, social distancing and working remotely. Hospitals are strained responding to the needs of the community. Stadiums and movie theaters are empty. Restaurants with limited capacity. The world as we know it is no longer the same.

For the first time in a long time, however, there is hope. A vaccine study is underway at the University of Cincinnati (UC) and UC Health. Greater Cincinnati’s academic health system was recently selected as one of nearly 90 sites nationwide to host the phase 3 COVID-19 vaccine trial with Moderna, a pharmaceutical and biotechnology company based out of Cambridge, Massachusetts. Moderna is one of the organizations hoping to produce a safe, effective COVID-19 vaccine.

In partnership with UC, UC Health performs clinical trials to find new ways to treat unique diseases. Currently, UC Health’s investigational drug services team has around 275 ongoing studies. The clinical research team built the Moderna vaccine trial unit from the ground up. Once experts discovered the COVID-19 virus in Wuhan, China, UC Health’s researchers went to work, studying the disease to find potential ways to cure it. Carl J. Fichtenbaum, MD, UC Health infectious diseases physician and professor in the Division of Infectious Diseases in the Department of Internal Medicine at the UC College of Medicine, and Maggie Powers-Fletcher, PhD, assistant professor in the Division of Infectious Diseases in the Department of Internal Medicine at the UC College of Medicine, co-lead UC and UC Health’s Moderna COVID-19 vaccine study.

“It’s very exciting that Cincinnati is part of this and that our citizens can be part of this, and that they can be the heroes and heroines of the COVID-19 pandemic by helping us to try and find an effective vaccine that will prevent this disease,” Dr. Fichtenbaum says.

Many other teams, clinicians and researchers from around the organization support the trial’s efforts. One of those people is Mary Burns, PharmD, a UC Health pharmacist involved in clinical trial research. The goals at the beginning of the trial are clear: Get an inclusive, diverse population and build trust in the vaccine.

Some of UC Health’s own frontline workers are participating in the study to help build that trust for their patients and other members of the community. However, many more participants are needed to give this study the potential to be successful.

Earlier this morning, 37-year-old Jarelle Marshall, an IT professional, wrapped up his daily gym workout. After grabbing coffee, he drives over to the Holmes Building on the Clifton Campus to enroll in UC Health’s Moderna COVID-19 vaccine trial.

Jarelle decides to participate in the trial so he can set an example for his son. “I always preach to my son that what matters most are the things you do when people aren’t looking, so I decided to go ahead and do it.”

Another reason why he enrolls? COVID-19 is disproportionately affecting the African American community. As an African American male, Jarelle hopes he can make a difference.

When Jarelle arrives at the Clinical Trial Clinic, he fills out paperwork and speaks with his new research coordinator, Michelle Saemann, RN. Before receiving his first dose, he reviews and completes a lengthy consent form with Michelle, and then undergoes a physical evaluation by Laura Cho, CNP, UC Health Primary Care nurse practitioner. Today is her first day on the Vaccine Trial Research Unit.

“I have a strong inclination to be able to participate in an opportunity to serve my community and give back during the pandemic,” Laura explains. “The opportunity to not only continue to care for my patients in primary care, but to demonstrate the efforts being done for the clinical trial allow me to make a direct impact during this time of crisis.”

Many nurse practitioners throughout UC Health pull together to help with the clinical study by performing the review of histories and systems, physical exams and evaluations and decision-making in regards to illness visits for participants of the study.

After the physical exam, Michelle reviews his medical history, medications and checks his vital signs. Phlebotomist Gary Frazier draws blood and gives him a COVID-19 test swab. Meanwhile, the pharmacy team prepares doses of the vaccine or placebo. Each participant receives either the Moderna vaccine, or a placebo, a controlled substance that is different from the actual vaccine.

Participants are split up into two groups—the vaccine group or the placebo group. The pharmacist is the only person who knows which dose each participant receives for the trial. No one else is even allowed in the room during injections.

“In this case, the vaccine and placebo are completely random and takes out any possible bias,” Mary explains. The pharmacy team will also be part of the unblinding of the study, which will take place later on during the study.

Once the dose is ready, Mary delivers it and administers it to Jarelle, making him the first participant in UC Health’s Moderna phase 3 COVID-19 vaccine trial. In total, 185 participants from across the region enroll in the trial.

Jarelle will return to UC Health in 28 days to receive his second injection. Until then, he needs to continue to monitor his symptoms and check his temperature. All of this is going to be logged in his electronic diary. UC Health’s clinical trial team will follow up with all participants on a frequent basis as required by the protocol. The hope is that vaccine will be safe and effective, the top priorities of the trial.

Dec. 18, 2020 – FDA Grants Emergency Use Authorization

Moderna’s COVID-19 vaccine receives emergency use authorization (EUA) from the U.S. Food and Drug Administration. It is now the second EUA-approved COVID-19 vaccine. Soon, the vaccine will be distributed to health systems all around the country to begin vaccinating frontline caregivers.

Last month on Nov. 16, 2020, Moderna released data showing a 95% effectiveness in the 30,000 total Americans participating in the trial.

The Moderna vaccine trial is a success. Dr. Powers-Fletcher is proud of the efforts made by the community to make this achievement happen.

“A multitude of individuals at UC, UC Health and the Greater Cincinnati area came together to help our community be part of this important effort to find a solution to the COVID-19 pandemic,” she says.

8:25 a.m., Dec. 23, 2020 – Moderna’s COVID-19 Vaccines Arrive at UC Health

There is a sense of optimism on this chilly winter morning. In a few minutes, UC Health is going to receive their first shipment of the Moderna vaccine.

The pharmacy team gathers on the back dock at UC Medical Center to collect the shipment of 3,100 doses of the vaccine. Pharmacists will immediately prep the vaccines to go into the arms of UC Health’s frontline healthcare workers from UC Medical Center, West Chester Hospital, Daniel Drake Center for Post-Acute Care and UC Health’s ambulatory sites.

Mary is going to be part of vaccinating many of our employees. “This is super emotional. You never know when you are working on a clinical trial if it’s going to work or not.”

Later in the morning, healthcare workers, including doctors, nurses, technicians and other frontline support service staff, line up through a hallway in UC Medical Center to receive their vaccine. These frontline staff members take care of the sickest patients. They will now have protection against a virus that has affected the lives of millions of people around the world. After getting their vaccine, pharmacists hand them a card that verifies that they received the vaccine, and notes when they will need to return for their second dose in 28 days.

For all those involved in UC and UC Health’s phase 3 vaccine trial, this is a rewarding day. Months of research and long hours have resulted in a safe and effective vaccine that will help protect individuals from COVID-19.

7:30 a.m., Jan. 4, 2021 – Unblinding of Study Begins

With Moderna COVID-19 vaccinations underway following EUA approval, the clinical research team has scheduled appointments with participants for their unblinding. This is where patients in the blinded study have the opportunity to learn if they received the vaccine or the placebo.

“You can hear the joy either way, whether they got the vaccine or the placebo. They are just thrilled,” Laura says. “Even those who received the placebo are excited because we are providing them with the vaccine at that same appointment.”

Jarelle decides to come in for his unblinding on Jan. 12 to find out which injection he received back in August, and again in September. After both visits, his main symptom was a sore arm. Similar to his first visit in August, Michelle provides updates to consents since the EUA was approved and collects vitals. A phlebotomist draws blood and collects Jarelle's COVID-19 test swab before Laura performs another physical exam.

Jarelle finds out that not only is he the first person to enroll in UC Health’s Moderna clinical trial, he is also the first to receive the vaccine.

“It’s good to know and gives me a sense of security,” Jarelle says.

Moving forward, Jarelle will remain involved in the study. He will continue to use his electronic diary and have follow-up appointments with his coordinator. He hopes that as clinicians vaccinate more people, life will return to normal and he will be able to spend more time with his family and friends. As a lifelong Cincinnatian, he takes pride in knowing that a local health system is making such a significant impact on a greater scale during this unprecedented pandemic.

We still have a long way to go in overcoming the COVID-19 pandemic. The hard work continues for UC Health’s frontline heroes. However, there is light at the end of the tunnel. Thanks to the commitment from our researchers and clinicians, the Moderna COVID-19 vaccine is protecting our healthcare workers, patients and members of the community.

Laura feels that UC Health’s Moderna vaccine study will have an impact beyond our region. “This is something that can truly impact not only our community, but communities around the nation and the world,” she explains.

Pharmacists will play a major role in vaccinating people around the country in the coming months. Once there are enough doses, community pharmacies will be able to vaccinate around 100 million Americans each month.

Our clinical research team continues to monitor trial enrollees. Participants will be monitored for two years. Even with EUA for the Moderna vaccine, they still gather data and keep an eye on their progress to ensure the vaccine is remaining safe and effective. UC Health now has the special recognition of being a vaccine research site, accomplishing a long-standing goal of the team.

“I am very proud of UC, UC Health and our entire team. There is still much to do and more data to generate, but hopefully this signals the beginning of the end of the pandemic,” Dr. Fichtenbaum says.

Thanks to the commitment to building relationships in the community and dedication to world-class research and patient care, UC and UC Health have left a memorable mark on this once-in-a-lifetime pandemic.

“It is amazing to watch the emotions and the process, and I am definitely proud to be part of such an integral event in our history, and fortunate enough to be on the forefront representing UC and UC Health in their path of research during this pandemic,” Laura says.