Moderna has announced interim data from the Phase 2/3 KidCOVE COVID-19 vaccine study ahead of its submission to global regulatory bodies.

Approximately ​4,200 children aged 2 to <6 years and 2,500 children aged 6 months to <2 years were recruited across the U.S. and Canada ​with participants receiving 2 doses of 25 μg, 28 days apart (a lower dose compared with older age groups).

Moderna reports immunogenicity consistent with that seen in adults (18-25 years) receiving doses of 100mcg with a vaccine efficacy of 43.7% in those aged 6 months to <2 years and 37.5% in those aged 2 to <6 years.  Omicron was the predominant COVID-19 strain circulating during this trial.

Adverse events following vaccination were reported as mild or moderate and more frequently ​associated with dose two. No deaths, myocarditis, pericarditis, ​or cases of multisystem inflammatory syndrome in children (MIS-C) were reported. ​Independent safety monitoring ​will continue for 12 months following the second dose.

To read the press release in full, please click on the link below:
COVID-19 Vaccine Phase 2/3 Study in Children 6 Months to ≤ 6 Years successfully meets its primary endpoint