Covid Vaccine Clinical Trial for Children Ages 6 Months to 5 Years

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.

https://atriumhealth.org/about-us/newsroom/news/2022/05/levine-childrens-launches-covid-19-vaccine-clinical-trial-for-children-ages-6-months-to-5-years