COVID 19 vaccine phase II/III KidCOVE trial in children 6 months to under 6 years has successfully met its endpoint.- Moderna

This interim analysis showed a robust neutralizing antibody response in both age groups after a 25 ug 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 ug two-dose primary series of mRNA-1273 for children 6 months to under 6 years of age to the 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.></2></6></12>

Moderna is reporting on the 6 months to under 2 years and 2 years to under 6 years age groups. . Approximately 6,700 participants 6 months to under 6 years of age were enrolled into this age cohort. In both age groups, the tolerability profile was generally consistent with that observed in children age 6 to under 12, in adolescents age 12 to 17, and in adults.

The majority of adverse events were mild or moderate and were more frequently reported after dose two. Rates of fever greater than 38°C among vaccine recipients were consistent with other commonly used and recommended pediatric vaccines and were 17.0% and 14.6% in the 6 months to under two years and the two to under six years age groups, compared to 23.9% in the six to under 12 years age group, which received a 50 ug two-dose primary series. Fever greater than 40°C was seen in only a few children (0.2% in each age group). No study pause rules were met, and no new safety concerns were identified in either age group. No deaths, no myocarditis or pericarditis, and no multisystem inflammatory syndrome in children (MIS-C) were reported.

In both age groups, two doses of 25 ug provided similar immunogenicity to the 100 ug 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 III COVE study was 1.3 (95% Cl: 1.1, 1.5) and was 1.0 (95% Cl: 0.9, 1.2) 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. Using the Phase III 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. 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.

Safety data continue to accrue , and the study continues to be monitored by an independent safety monitoring committee. All participants will be monitored for 12 months after their second injection to assess long-term protection and safety. These data are subject to change based on ongoing data collection. The Company plans to submit these data to a peer-reviewed publication.