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Levine Children's Hospital launches COVID-19 vaccine trial for children aged 6 months to 5 years

Atrium Health will offer the Pfizer-BioNTech COVID-19 vaccine study to healthy children in the region.

CHARLOTTE, N.C. — A new COVID-19 vaccine clinical trial for children is now available in Charlotte. 

Atrium Health announced Monday night that Levine Children's Hospital is the first and only site in the Charlotte area to offer the Pfizer-BioNTech COVID-19 vaccine study to healthy children between the ages of 6 months and 5 years old. 

According to the health system, all participating children will be closely monitored by the hospital's clinical team as part of the study. Any changes to national recommendations for future Emergency Use Authorization (EUA) approvals will also be incorporated in the study. 

“The Pfizer-BioNTech vaccine has been shown to be very safe and effective in adults, adolescents and school-age children,” Dr. Christine Turley, vice chair for research at Levine Children’s and principal investigator for the Charlotte trial, said in a press released issued to WCNC Charlotte. “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, according to the news release. 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, Atrium Health says in the release.

Atrium Health is the only health system in the region to host COVID-19 vaccine trials down to the infancy age group.

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Local enrollment is expected to take place quickly "as there is an urgent demand for a safe, effective vaccine for this age group," Atrium Health says in the release.

Families choosing to enroll their children will be part of the three-dose, low-dose vaccine study. 

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Local families interested in learning more about the study and eligibility to participate can contact the STRIVE vaccine research team by emailing strivevaccineregistry@atriumhealth.org or by calling (704) 355-4102. 

Enrollment in the STRIVE COVID-19 vaccine research registry can be done online by visiting the health system's website.

WCNC Charlotte is part of seven major media companies and other local institutions reporting on and engaging the community around the problems and solutions as they relate to the COVID-19 pandemic. It is a project of the Charlotte Journalism Collaborative, which is supported by the Local Media Project, an initiative launched by the Solutions Journalism Network with support from the Knight Foundation to strengthen and reinvigorate local media ecosystems. See all of our reporting at charlottejournalism.org.

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