Charlotte-based Atrium Health is opening a new trial for children ages 12 to 17 that will test a COVID-19 vaccine manufactured by Novavax, the hospital system announced on Friday.
Currently, there is no COVID-19 vaccine authorized in the U.S. for children under the age of 16, though Pfizer is expected to receive emergency federal approval as early as Monday for its vaccine to be administered in people ages 12 to 15.
To enroll in the Novavax trial at Atrium, children must be 12 to 17 years old, not have been previously diagnosed with COVID-19, not be receiving treatment for cancer and not have any medical condition that affects their immune system response. Children who participate in the study will be monitored for two years, during which researchers will perform blood tests and nose swabs to evaluate the vaccine’s effectiveness.
Clinical trials continue to be an important way for researchers to learn about vaccines’ effectiveness over time — even though other vaccines may become available, said Dr. Christine Turley. Turley is the vice chair of research at Atrium’s Levine Children’s and the lead physician investigator for Atrium’s coronavirus vaccine research program.
“One of the first things (people) ask after they get their first two doses (of Pfizer or Moderna) is ‘Do I need a booster?’ and “When am I gonna need a booster? Do we know?’" Turley said. “We know that we don’t have those answers yet. The only way we’re going to get them is by ongoing studies.”
Atrium has enrolled roughly 270 people since January in a separate clinical trial to test the Novavax COVID-19 vaccine in adults, Turley said. The Novavax vaccine has not yet received federal emergency approval in the U.S.
Anyone 16 and older is currently eligible for the Pfizer vaccine. Moderna’s COVID-19 vaccine is authorized for people 18 and older.
Parents or guardians who want their children to be considered for enrollment in the Novavax clinical trial can sign up through Atrium's vaccine research registry.