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