The vaccine is currently authorized for use under an EUA in individuals 18 years of age and older.
On Tuesday, Moderna announced that they have begun testing their COVID-19 vaccine candidate mRNA-1273 on pediatric populations as part of their kidCOVE study. The company, which specializes in mRNA technology, was a pioneer in vaccine research for the ongoing coronavirus pandemic.
The vaccine was one of the first to be approved for use against COVID-19 and has been one of the largest suppliers of doses across the globe.
The study, a phase 2/3 open label trial, is testing mRNA-1273 in pediatric populations whose ages are between 6 months and 12 years. The research is being conducted in the US and Canada in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), and the Biomedical Advanced Research and Development Authority (BARDA).
The trial is set to enroll 6,750 healthy pediatric participants and will take place in 2 parts.
For the first part of the study, a dose-escalation, age de-escalation phase, participants between the ages of 2 and 12 will receive one of two dose levels (50 μg or 100 μg) of the vaccine, and each participant aged 6 months to less than 2 years may receive one of three dose levels (25 μg, 50 μg and 100 μg).
An interim analysis will then be conducted in which investigators will determine the dose that will be used in the second part of the study, a placebo-controlled expansion portion.
The participants will be followed for a period of 12 months following their second dose, where the effectiveness of the vaccine will either be inferred through achieving a correlate of protection, if established, or through immunobridging to the young adult (ages 18-25) population.
An additional endpoint of the study will evaluate the safety and reactogenicity of mRNA-1273.
“We are pleased to begin this Phase 2/3 study of mRNA-1273 in healthy children in the U.S. and Canada and we thank NIAID and BARDA for their collaboration,” Stéphane Bancel, Chief Executive Officer of Moderna said. “It is humbling to know that 53 million doses have been administered to people in the U.S. We are encouraged by the primary analysis of the Phase 3 COVE study of mRNA-1273 in adults ages 18 and above and this pediatric study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age population.”