Atrium Health Levine Children’s Hospital is participating in a clinical trial of COVID-19 vaccines for young children.
The Charlotte-based hospital system announced Monday it’s seeking participants for the trial, which is open to children between the ages of 6 months and 5 years old. It’s not clear whether young children who have already had COVID-19 are eligible for the study.
Each participant will receive either two doses of a low-dose Pfizer vaccine or a placebo spaced three weeks apart. They will also receive a third dose two months later. The vaccine doses for children under 5 are roughly one-tenth the strength of the adult Pfizer vaccine, according to Dr. Christine Turley, the principal investigator in the study at Atrium.
The first patient to get vaccinated as part of the study, two-year-old Arvind Jaffa, received his first dose Monday, Atrium said in a news release.
There’s currently no federally approved coronavirus vaccine for children under 5. Earlier this year, the U.S. Food and Drug Administration delayed possible authorization to wait for more data about the vaccine’s possible safety and effectiveness.
“Children under five — there’s no authorized vaccine to give them and yet they’re in the community,” Turley told reporters Tuesday. “They have to go to daycare. They are with other children … They’re learning and growing and they need to be able to socialize and do that safely.”
The study at Atrium is double-blind, meaning neither the study participants or researchers know whether a participant received the placebo or the vaccine. Turley said roughly two-thirds of participants will receive the vaccine and one-third will get the placebo. After six months, participants and researchers will be unblinded and participants who received the placebo can opt for the real vaccine.
During the study, researchers will conduct regular COVID-19 tests and blood tests to look for antibodies. Parents or guardians will also be asked to keep track of their child’s symptoms and behaviors, like fussiness or redness at the injection site, that could be connected to the vaccine.
Parents or guardians who are interested in enrolling their young children in the vaccine trial can get more information online, email strivevaccineregistry@atriumhealth.org, or call (704) 355-4102. An Atrium spokesperson said the study is hoping to enroll around 40 participants.
