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 to under five years old. The study is evaluating safety, tolerability and immune response to the vaccine in this young population.
The vaccine being studied is the same one that has been authorized for people ages five and older, adjusted to a lower dose. The study is taking place around the country, and local enrollment has happened quickly since there is an urgent demand for a safe, effective vaccine for this age group.
“Since the beginning of the COVID-19 pandemic, a lot of people have been living with a great deal of worry. Parents have been waiting very anxiously because there is currently no way to protect our youngest children,” says Christine Turley, MD, vice chair for research at Levine Children’s and principal investigator for the Charlotte trial. “But this vaccine study is a hopeful one. It gives families and children the ability to become part of history.”
The families, who choose to enroll their children, are a part of the pivotal three-dose, low-dose vaccine study.
“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,” Dr. Turley says. “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.”
Meet Our First Patient👋
Two-year-old Arvind Jaffa of Charlotte is the first patient to participate in this vaccine trial. He’s pictured below with his parents, Rupal and Brooks Jaffa. Arvind loves Baby Shark, which was the theme of his second birthday party last month.
Arvind didn’t shed a tear when he got his blood drawn and received his first shot for the trial on May 9.
“He was so brave and calm!” says Rupal. “We could not be more excited for him to be doing this.”
His mother watched in awe and says, “I’ve been waiting so long for a vaccine to come out for somebody of Arvind’s age. The other important thing to me is contributing to scientific progress. I feel confident that this vaccine is safe, and it has the potential to protect him, our family and other people from getting COVID-19.”
Although they don’t know right now if Arvind received the vaccine or the placebo, Rupal can’t wait to tell her son one day that he made a difference thanks to this opportunity with Levine Children’s.
“I’m so grateful for Levine Children’s and everything that they do,” Rupal says. “They’ve provided Arvind excellent care throughout his two years of life. And they’re doing amazing things, like bringing this clinical trial here, so we’re very fortunate to have them in the Charlotte area.”
Local families interested in learning more about the study and eligibility to participate can contact the STRIVE vaccine research team at strivevaccineregistry@atriumhealth.org or call 704-355-4102.
Enrollment in the STRIVE COVID-19 vaccine research registry can be done online here.