CAMBRIDGE, MA –– On Monday, Moderna announced positive results in the trials currently underway for a coronavirus vaccine in kids ages 6 to 11.
According to the pharmaceutical company, children involved in the Phase 2/3 study, dubbed KidCOVE study, "showed a robust neutralizing antibody response after two doses of mRNA-1273 at the 50 µg dose level with a favorable safety profile."
The KidCOVE study has had nearly 5,000 participants between the ages of 6 to 12.
The children were given two doses of mRNA-1273 to healthy children 28-days apart.
The group was divided into three age groups:
- 6 months to <2 years
- 2 to <6 years
- 6 to <12 years
The released data only pertains to kids between 6 to 12.
The vaccine, mRNA-1273, was generally well tolerated with a safety and tolerability profile generally consistent with the Phase 3 COVE study in adolescents and adults.
The majority of adverse events were mild or moderate in severity. The most common solicited adverse events were fatigue, headache, fever, and injection site pain.
“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,” said Stéphane Bancel, Chief Executive Officer of Moderna. “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.”
The company plans to submit the data to the and Drug Administration (FDA), European Medicines Agency (EMA), and other global regulators in the near future.