American drugmaker Moderna announced Tuesday that the first group of children participants have been vaccinated in its COVID-19 vaccine trial.
The Phase 2/3 study, called the KidCOVE study, will enroll approximately 6,750 pediatric participants in the United States and Canada ages 6 months to less than 12 years.
The trial will evaluate the safety, tolerability, reactogenicity and effectiveness of two doses of Moderna’s COVID-19 vaccine mRNA-1273 given 28 days apart, according to the company.
“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,” said Stephane Bancel, chief executive officer of Moderna.
In Part 1, each participant ages two years to less than 12 years may receive one of two dose levels. Also in Part 1, each participant ages six months to less than 2 years may receive one of three dose levels.
An interim analysis will be conducted to determine which dose will be used in Part 2, the placebo-controlled expansion portion of the study.
Participants will be followed through 12 months after the second vaccination. Vaccine effectiveness will either be inferred through achieving a correlate of protection, if established, or through immunobridging to the young adult population ages 18 to 25, according to Moderna.
Moderna’s COVID-19 vaccine was authorized for emergency use against COVID-19 by the U.S. Food and Drug Administration (FDA) last December, for individuals 18 years of age and older. There are three COVID-19 vaccines currently authorized for emergency use in the United States by the FDA.
Besides the one developed by Moderna, the other two are developed by American drugmaker Pfizer in partnership with German company BioNTech, and by Johnson & Johnson.
More than 110 million COVID-19 vaccine doses have been administered across the United States as of Tuesday, according to data of the U.S. Centers for Disease Control and Prevention (CDC).Over 142 million vaccine doses have been distributed across the country.
Currently, there are about 39 million Americans fully vaccinated while about 72 million have received at least one dose, CDC data show.