According to a press release from Moderna, two 25 μg doses of mRNA-1273 in participants 6 months to under 6 years met primary endpoint with robust neutralizing antibody titers similar to adults mRNA-1273 was generally well tolerated in this age group.
Using the Phase 3 COVE study COVID-19 definition, vaccine efficacy in children 6 months to 2 years was 43.7% and vaccine efficacy was 37.5% in the 2 to under 6 years age group. In this case, statistically significant is defined as a lower bound on the 95% confidence interval which is greater than 0. The majority of cases were mild, and no severe COVID-19 disease was observed in either age group. The absence of any severe disease, hospitalization or death in the study precludes the assessment of vaccine efficacy against these endpoints.
Moderna is moving forward with global regulatory submissions for mRNA-1273 for primary vaccination of children 6 months to under 6 years of age. Additionally, Moderna has initiated a submission to the FDA for emergency use authorization (EUA) of mRNA-1273 in children 6 to under 12 years of age; mRNA-1273 is approved for use in this age group in Europe, Canada and Australia.
Moderna, announced positive interim data from the Phase 2/3 KidCOVE study of the Moderna COVID-19 vaccine (mRNA-1273) in children 6 months to under 2 years and 2 years to under 6 years of age. This interim analysis showed a robust neutralizing antibody response in both age groups after a 25 µg two-dose primary series of mRNA-1273 along with a favorable safety profile.
Based on these data, Moderna will submit a request for authorization of a 25 μg two-dose primary series of mRNA-1273 for children 6 months to under 6 years of age to the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other global regulators in the coming weeks.
KidCOVE is a randomized, observer-blind, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of two doses of mRNA-1273 given to healthy children 28 days apart. The study population is divided into three age groups (6 to <12 years, 2 to <6 years, and 6 months to <2 years). In the study, efficacy could be evaluated if enough cases accrued. Overall, the Company has enrolled approximately 11,700 pediatric participants in the U.S. and Canada into the trial including approximately 4,200 children ages 2 to under 6 years and approximately 2,500 children ages 6 months to under 2 years.
In both age groups, two doses of 25 µg provided similar immunogenicity to the 100 µg two-dose primary series in adults ages 18 to 25 years, meeting the non-inferiority criteria and immunobridging, and indicating that the benefit of mRNA-1273 conferred to adults ages 18 to 25 are also conferred to children and infants as young as 6 months. SARS-Cov-2-neutralizing antibody geometric mean ratio (GMR) comparing the response in children 6 months to under 2 years to the response in young adults from the Phase 3 COVE study was 1.3 and was 1.0 for the 2 to under 6 years age group. This also predicts protection from COVID-19 and severe COVID-19 disease down to 6 months of age.
The Omicron SARS-CoV-2 variant predominated in the U.S. during the KidCOVE study in these younger age groups. The secondary endpoint of vaccine efficacy confirms statistically significant, but lower efficacy against COVID-19 infection as expected during the Omicron wave and consistent with adult observational data.
Similar to adults, Moderna is preparing to evaluate the potential of a booster dose for all pediatric populations, including those age 6 months to under 6 years, 6 to under 12 years, and adolescents. The Company is evaluating booster doses of mRNA-1273 and its bivalent booster candidate (mRNA-1273.214), which includes Omicron variant booster and mRNA-1273.
