While the world has paused for the COVID-19 pandemic, two of the most-asked questions about returning to regular life are “When will there be a vaccine?” and “Will it be safe?”
Thankfully, there are sites around the world, including several in South Carolina, that are conducting rigorous clinical trials to help lead the way to a safe COVID-19 vaccine.
Many people are desperate to get their lives and businesses back on track. However some are hesitant and unsure of the safety of a vaccine created so quickly, given the unprecedented scrutiny applied to the development of a vaccine for COVID-19.
No matter the speed or pressure, those that are responsible for conducting the clinical trials are doing everything they can to keep participants as safe as possible while expediting a potentially lifesaving preventive treatment.
Patrick Flume, M.D., is associate provost for research compliance and regulatory affairs and the Powers-Huggins Endowed Chair for cystic fibrosis at the Medical University of South Carolina’s College of Medicine. He also is part of a team of Lowcountry clinicians that will conduct the planned AstraZeneca Phase III trials at MUSC. He emphasized how important it was to make sure the diversity of the Lowcountry was represented in their efforts.
“When you do a study and you invite people who are going to participate in the study, you want them to be representative of the people who are likely to get this as a treatment,” Dr. Flume explained.
To participate in a trial is a straightforward but also sometimes time-consuming process. Generally, participants must be 18 years or older, relatively healthy and meet each trial’s specific conditions. Some trials aim to get as diverse of a representation of the population as possible, while others may be seeking only a certain demographic.
Patients can apply to participate by contacting the trial sites by phone or on the trial’s website. Those who meet the site’s specific criteria are scheduled to come in for an initial check-in, where clinicians will collect information such as their medical history and current medications. There is also a physical examination, as well as a blood draw. Participants receive a nasal swab and are tested for COVID-19, then given the first dose of the vaccine by injection – all in the same visit.
For the first 30 days, patients are steadily monitored for symptoms or reactions through phone calls, electronic diaries or apps on their phone. In most studies, a second injection is given 30 days after the first injection, and then clinicians follow up with patients once a month for the first six months, with less frequent check-ins for the remaining time. Overall, patients are monitored for two years, and all data pertaining to their health is recorded and shared with the trial sponsors regardless of its relevance to the COVID-19 virus. From broken wrists to common colds, it’s all documented and shared in the study.
VitaLink Research in Greenville is participating in the Phase III portion of the Moderna clinical trial. Steve Clemons, co-founder and chief executive officer of VitaLink Research, shared that the increased scrutiny in the nature of clinical trials combined with the political pressure to produce a COVID-19 vaccine will be of benefit to patient safety and the vaccine’s potential efficacy.
“Clinical trials are designed to be safe. In the pulmonary world, we do tenfold the breathing tests in clinical trials than we do in clinical practice, so days, weeks, months before someone gets sick, we tend to see it. With the vaccine space as a whole, not just the Moderna product, we see that there are many safety nets built into clinical trials that allow people to feel comfortable enough to participate in studies,” said Clemons.
Both MUSC and VitaLink Research will conduct Phase III trials of the AstraZeneca and Moderna products, respectively. Phase III of a clinical trial happens only after many hundreds of subjects have already received the vaccine in previous phases, with documented data showing that the trial’s safety profile is acceptable to continue the trial in humans.
Due to a limited outside perspective as well as media influence, many people may feel a vaccine is being developed too fast for it to be safe. However, Dr. Flume explained that while the need for a COVID-19 vaccine arose very quickly, the final product will be a result of years of scientific medical research.
“The vaccine that was brought forward is the product of a long history of the development of vaccines,” Dr. Flume said. “They develop these platforms so when you get an infection like SARS COVID-19, you can very quickly adapt that platform to try to fit that infection. So on the one hand people say ‘Boy this happened really fast!’ and the answer to that is yes, however, it happened fast because of all the work that had been done for years and years to get to this point.”
As far as determining whether the vaccine is successful or when it will be available, those decisions are made by the sponsoring companies and governing bodies that receive and review all of the data that sites such as MUSC and VitaLink Research collect and submit. As far as the expedition of a vaccine under such unprecedented pressure and time sensitivity, clinicians want to remind the public that the safety of their patients will always be of the upmost importance.
“I’ve been doing clinical research for a long time,” said Dr. Flume. “We owe a debt of gratitude to the people who do volunteer, and it’s a safe bet that everyone I talk to has taken a medicine at some time in their life, whether it’s a prescription drug or over the counter. Somebody volunteered for that. You know people have different reasons for why they participate in research, but we all owe a debt of gratitude to those who volunteer for it, so we say thank you to everybody who participates in our trials. And our job is to make sure that we try very hard to find the right therapies that we think are going to help the people that we serve, and then make sure we do the job well.”