Moderna trial for young children

[M_T]

Moderna has announced their results of their trial on young children.

Moderna Announces its COVID-19 Vaccine Phase 2/3 Study in Children 6 Months to Under 6 Years Has Successfully Met Its Primary Endpoint 

• 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
  
• Although not a primary endpoint, statistically significant vaccine efficacy was observed during the Omicron wave that was consistent with the lower two-dose effectiveness against Omicron seen in adults
  
• 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 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
  

In both age groups [6 months to 2 years; 2 years to 6 years], 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[1], 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 (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 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.