The Medical University of South Carolina says a contract with pharmaceutical giant AstraZeneca means it will soon begin enrolling hundreds of patients in a COVID-19 vaccine trial.
Charleston will be one of the first sites in the country taking volunteers, and was chosen because the pandemic has hit the area hard.
Research leaders said it may be patients’ only shot at getting the vaccine ahead of government approval if they’re willing to take on the time commitment and limited risks.
How to enroll
To enroll in AstraZeneca’s vaccine trial in Charleston, contact one of two sites:
The Medical University of South Carolina:
Visit research.musc.edu/clinical-trials/coronavirus-clinical-trials and complete a short form.
Clinical Trials of South Carolina:
“In all likelihood, this may be the best chance to get the vaccine earlier,” Dr. Gary Headden, an emergency physician and the lead on the study at MUSC, said.
With plans to recruit 1,500 patients in eight weeks, recruitment for the trial will be the most aggressive MUSC has ever been a part of, said Dr. Patrick Flume, a pulmonary physician at MUSC who leads a group of researchers focusing on COVID-19.
A team of roughly a dozen MUSC staff will be seeing as many as 80 patients a day at the height of the work.
“It’s about doing work we feel like is important,” Flume said. “If this vaccine works, even if we can’t take it because we’re investigators in the study, you better believe we’re going to line up and get a shot once it’s approved.”
Volunteers will need to continue to follow up with MUSC for two years. Patients will be compensated for participating. They will let researchers know every time they fall ill. All of that data is recorded to generate insights into the vaccine’s efficacy and safety.
MUSC is one of two sites in the area where patients can enroll in the trial. Clinical Trials of South Carolina, which is the research arm of North Charleston-based Pain Specialists of Charleston, is also enrolling 1,500 patients.
Nathelia Roper, who is managing the trial at the North Charleston site, said pre-enrollments have brought in roughly half the needed number of volunteers already.
AstraZeneca chose Charleston because of the high infection rate seen here in the past couple of months. In order to study whether a vaccine works, participants have to come across the virus in their daily lives.
As of Tuesday afternoon, 106,574 South Carolinians had a confirmed coronavirus infection at some point since March.
Over 2,000 residents of the state had died.
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With no cure for COVID-19 available, many associate the arrival of a vaccine with the end of the coronavirus pandemic. The path to eradicating the virus won’t be that simple, however.
“Even with the vaccine, it’s not like you’re going to flip a switch and it’s going to disappear,” Headden said of the virus. He stressed the importance of continuing to wear masks and keep a distance of 6 feet from others — steps that have been shown to keep COVID-19 down in the hospital.
No vaccine is 100 percent effective, to begin with. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN in late June he would “settle” for a vaccine that is 70 to 75 percent effective.
There’s also those who would be reluctant. A recent Gallup poll found 35 percent of American adults said they would not get the vaccine if it were approved and available for free. Together, those two factors will make it hard for the U.S. to reach herd immunity, where enough people are immune that the virus can’t survive.
The vaccine to be tested in South Carolina was developed at Oxford University and licensed to AstraZeneca in April. For the trial, two-thirds of patients will receive the vaccine and one-third will get a placebo, Amy Chamberlain, a clinical research specialist at MUSC, said.
Senior Clinical Research Nurse Ajithkumar Sukumaran prepares the COVID-19 vaccine to administer to a volunteer, at a clinic in London, Wednesday, Aug. 5, 2020. File/AP
The vaccine is now in its third phase of trials, meaning the drug has already been tested for safety in two smaller rounds of volunteers. In the third phase of a clinical trial, the largest group of patients assembled so far receives the vaccine, according to the U.S. Food and Drug Administration, which will be responsible for approval of a vaccine in the United States.
AstraZeneca plans to enroll 30,000 in the trial across the country. It has committed to supply hundreds of millions of doses to the United States, European Union, Mexico, Argentina and Australia, to name a few countries on the list.
Those deals are contingent on the trial’s success, however.
Experts are moving at record speeds to get a vaccine to market. It took until 2019 for the European Union to approve an Ebola vaccine, for instance; the Ebola epidemic began in 2014. Though researchers and drug developers are under immense pressure to move quickly, Headden said the vaccines being researched are going through the standard scientific process.
“The science is actually very spot-on,” he said. “They’re not cutting corners.”
The first two phases of study at AstraZeneca showed the vaccine was safe and people mounted a “robust immune response” to COVID-19.
Reach Mary Katherine Wildeman at 843-607-4312. Follow her on Twitter @mkwildeman.