Moderna Files for FDA EUA for its COVID-19 Vaccine for Children 6 Months to Under 6 Years

The company announced this morning it had filed for a request for an Emergency Use Authorization (EUA) with the Food and Drug Administration (FDA) for two 25 μg doses of the primary series of their mRNA-1273 vaccine for children 6 months to under 2 years and 2 years to under 6 years of age.

The company said it had reached its met primary endpoint with robust neutralizing antibody titers similar to adults in their phase 2/3 KidCOVE study.

"We are proud to share that we have initiated our EUA submission for authorization for our COVID-19 vaccine for young children," Moderna CEO Stéphane Bancel, said in a statement. "We believe mRNA-1273 will be able to safely protect these children against SARS-CoV-2, which is so important in our continued fight against COVID-19 and will be especially welcomed by parents and caregivers."

Data from the KidCOVE Study

A few weeks ago, Moderna announced its topline data for the KidCOVE phase 2/3 study. The trial had been ongoing for several months, and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA).

Moderna reported that the Omicron variant was the predominant strain in the United States during this study in the 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. 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.

When the analysis was limited only to cases confirmed positive for SARS-CoV-2 by central lab RT-PCR vaccine efficacy remained significant at 51% (95% CI: 21-69) for 6 months to <2 years and 37% (95% CI: 13-54) for 2 to <6 years. These efficacy estimates are similar to vaccine efficacy estimates in adults against Omicron after two doses of mRNA-1273.

The company said its EUA submission will be complete next week, and that they are studying booster doses for all pediatric cohorts.