Atrium Health Levine Children’s Launches COVID-19 Vaccine Clinical Trial for Children Ages 6 Months to 5 Years

05.09.2022 Atrium Health News | Levine Children's

Levine Children’s is the only site in the Charlotte area offering the trial to this age group 

CHARLOTTE, N.C., May 9, 2022 – Atrium Health Levine Children’s is the first and only site in the Charlotte area to offer the Pfizer-BioNTech COVID-19 vaccine study to healthy children ages six months old to under five years of age. The study will evaluate safety, tolerability and immune response to the vaccine among this age group. All participating children will be closely monitored by Levine Children’s highly-skilled clinical team as part of the study. Any changes to national recommendations for future Emergency Use Authorization (EUA) approvals will be incorporated into the study.

“The Pfizer-BioNTech vaccine has been shown to be very safe and effective in adults, adolescents and school-age children,” said Dr. Christine Turley, vice chair for research at Levine Children’s and principal investigator for the Charlotte trial. “We’re building on the strong safety profile that exists for adults and older children. We will be studying how well a lower dose works for young children in providing the level of protection they need. We have every reason to believe this study will show the vaccine to be a strong option to offer children protection against the COVID-19 virus.”

The vaccine being studied is the same one that has been authorized for people ages five and older, adjusted to a lower dose. Additionally, a third dose is being tested in this age group, to ensure the immune protection reaches the level that has been beneficial in older children. In adults, this vaccine has demonstrated very high protection against the COVID-19 virus and serious disease.

“Over 350 million doses of Pfizer’s COVID-19 vaccine have been given in the U.S. since the vaccine has been emergency authorized and now fully approved,” Turley said. “This gives us an enormous amount of safety information in a very rapid timeframe, because it allows us to quickly learn about rare side effects. That gives me a lot of confidence from a safety standpoint.”

“Since the beginning of the COVID-19 pandemic, a lot of people have been living with a great deal of worry,” Turley said. “Parents have been waiting very anxiously because there is currently no way to protect our youngest children. This vaccine study is a hopeful one and gives families and children the opportunity to be protected while becoming a part of history.”

With more than 20 years of personal experience, Turley is known for her work in vaccine development, advocacy and education. The wealth of experience between Turley and the research team at Levine Children’s, as well as the previous high-quality vaccine studies performed by the team, are key reasons the health system was chosen to lead this specific research in Charlotte. Atrium Health is the only health system in the region to host COVID-19 vaccine trials down to the infancy age group. 

The study is taking place around the country, and local enrollment is expected to take place quickly as there is an urgent demand for a safe, effective vaccine for this age group. Families choosing to enroll their children will be part of the pivotal three-dose, low-dose vaccine study. 

Local families interested in learning more about the study and eligibility to participate can contact the STRIVE vaccine research team at or call 704-355-4102.  Enrollment in the STRIVE COVID-19 vaccine research registry can be done online by visiting

About Atrium Health 
Atrium Healthis a nationally recognized leader in shaping health outcomes through innovative research, education and compassionate patient care. Based in Charlotte, North Carolina, Atrium Health is an integrated, nonprofit health system with more than 70,000 teammates serving patients at 40 hospitals and more than 1,400 care locations. It provides care under theAtrium Health Wake Forest Baptist name in the Winston-Salem, North Carolina, region, as well as Atrium Health NavicentandAtrium Health Floydin Georgia and Alabama. Atrium Health is renowned for its top-ranked pediatric, cancer and heart care, as well as organ transplants, burn treatments and specialized musculoskeletal programs. A recognized leader in experiential medical education and groundbreaking research, Wake Forest University School of Medicine is the academic core of the enterprise, including Wake Forest Innovations, which is advancing new medical technologies and biomedical discoveries. Atrium Health is also a leading-edge innovator in virtual care and mobile medicine, providing care close to home and in the home. Ranked nationally among U.S. News & World Report’s Best Hospitals in eight pediatric specialties and for rehabilitation, Atrium Health has also received the American Hospital Association’s Quest for Quality Prize and its 2021 Carolyn Boone Lewis Equity of Care Award, as well as the 2020 Centers for Medicare & Medicaid Services Health Equity Award for its efforts to reduce racial and ethnic disparities in care. With a commitment to every community it serves, Atrium Health seeks to improve health, elevate hope and advance healing – for all, providing more than $2 billion per year in free and uncompensated care and other community benefits.