Meharry Medical College and Clinical Research Associates are working together to raise awareness about pediatric COVID vaccine clinical trials in Nashville and recruit patients as young students return to school this month.
There is currently no COVID-19 vaccine authorized for children younger than 12 years old, despite the growing need to guard against the Delta variant of COVID-19 and as cases rise among children. Severe pediatric COVID cases are increasing according to medical experts. Earlier this month, two Tennessee children died from COVID-19, and Tennessee Health Commissioner Lisa Piercy announced that children’s hospitals statewide are nearing full capacity.
Families with children under 12 who are interested in participating in pediatric COVID-19 vaccine studies can sign up with Meharry or Clinical Research Associates at COVIDnashville.com. Anyone who is generally healthy and well-managed on medications may be eligible to enroll. Patients in the trials will receive either the COVID-19 vaccine or a placebo, which is typically a saline solution used for comparison. Doctors and medical staff will routinely monitor and check in on patients to measure their health and safety. Patients who received a placebo will be given a vaccine after enough data has been collected to authorize its use.
Before a vaccine is approved or authorized, the manufacturer must first complete enrollment in its clinical trials and monitor patients for a pre-determined period. Pharmaceutical manufacturers like Pfizer and Moderna are currently working through this process with clinical trial sites like MMC and CRA to provide an authorized vaccine to children as soon as possible.
“Meharry is proud to be part of this important pediatric clinical trial process with Clinical Research Associates,” said Dr. James Hildreth, president and CEO of Meharry Medical College. “The vaccines that are in use today against COVID-19 have proven themselves more than effective for us as adults. Yet COVID-19 knows no age boundaries, and our children are the most precious things in our lives—how much more should we commit ourselves to guarding them from this pandemic as they return to school rooms across America? Clinical trials are the only way we can safely get to that point.”
The collaboration has already begun. Currently, patients in CRA’s pediatric trial receive vaccines that are mixed using MMC laboratory equipment, which has allowed additional patients to enroll in the study. Moving forward, the organizations will continue to share resources and strategies to educate and enroll clinical trial participants.
“We want to help provide a vaccine for children as soon as safely possible,” said CRA President and CEO Linda Schipani. “We hope that by combining the strengths of our two organizations, we will be able to reach a larger audience, educate our community about clinical trials, and help people feel safe taking the vaccine. Our highest priority is the health and safety of the study participants.”
About Meharry Medical College
Meharry Medical College, founded in 1876, is the nation’s largest private, independent historically Black academic health sciences center dedicated to educating minority and other health professionals. True to its heritage, it is a United Methodist Church-related institution. The College is particularly well known for its uniquely nurturing, highly effective educational programs; emerging preeminence in health disparities research; culturally sensitive, evidence-based health services, and significant contribution to the diversity of the nation’s health professions workforce. Meharry is a leading national educator of African Americans with M.D. and D.D.S. degrees and Ph.D. degrees in the biomedical sciences. Visit www.mmc.edu to learn more.
About Clinical Research Associates
Clinical Research Associates is a Nashville-based, independent, woman-owned research firm that has conducted hundreds of clinical trials during its more than 30-year history, including trials for women and men’s health, smoking cessation, migraine treatment, heartburn treatment, and influenza, shingles, Ebola, and pneumonia vaccines. In total, the firm has conducted more than 650 clinical trials and contributed to FDA approval of more than 150 medicines. CRA collaborates with experienced, board certified physicians to conduct clinical trials and its clinical study coordinators are registered nurses and/or dieticians. Each receive continuous training in their respective therapeutic areas, general care, information related to a specific study, and regulatory guidelines. These highly skilled and trained professionals care deeply about patients and science. Sign up for a clinical trial here.