According to top line data from a Phase 2/3 study of Moderna’s COVID-19 vaccine among children ages 6-11, released this week, the company determined that two doses given a month apart produced a strong antibody response — stronger, even, than those seen in adults.
Conducted in collaboration with the National Institutes of Health (NIH), the KidCOVE study used mRNA-1273 shots with half the dosage used for adult versions of the vaccine. This 50 µg dose nevertheless produced as many as 1.5 times more antibodies than those seen in adults while producing light side effects — typically fatigue, headaches, fever, and injection site pain. The vaccine, deemed generally safe in testing among the more than 4,700 young participants of the trial, met its primary immunogenicity endpoints all around.
“We are encouraged by the immunogenicity and safety profile of mRNA-1273 in children aged 6 to under 12 years and are pleased that the study met its primary immunogenicity endpoints,” Stéphane Bancel, CEO of Moderna, said. “We look forward to filing with regulators globally and remain committed to doing our part to help end the COVID-19 pandemic with a vaccine for adults and children of all ages.”
As a result, Moderna announced it will soon submit this data to the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulators worldwide, as well as to a peer-reviewed publication. All participants in the trial will be monitored for 12 months after their second injection, so regulators and the company can determine longer-term protection and safety.
The KidCOVE trial is ongoing and continues to onboard children between 6 months old and 6 years old.
The new data from Moderna came the same week as a planned FDA advisory committee meeting to address a Pfizer-BioNTech request to allow their COVID-19 vaccine to be used on children between 5 to 11 years old.