Moderna’s COVID-19 Vaccine Mets Primary Endpoint in Phase 2/3 Trial in Children 6 Months to Under Six Years
Along with reporting positive data in the youngest pediatric population, the company is working with the Food and Drug Administration (FDA) for emergency use authorization of its vaccine in children 6 years to under 11 years as well as the 12-17 age groups.
Moderna announced today that 2 doses of their mRNA-1273 COVID-19 vaccine in children at 6 months and under 6 years of age demonstrated robust neutralizing antibody titers, meeting the study's primary endpoint. The dosing was at 25 μg, which is half the antigen amount of the adult population being utilized for vaccination, yet had a similar amount of titers according to the company’s statement.
These results come from the company’s KidCOVE phase 2/3 study.
"We believe these latest results from the KidCOVE study are good news for parents of children under 6 years of age. We now have clinical data on the performance of our vaccine from infants six months of age through older adults," Moderna CEO Stéphane Bancel, said. "Given the need for a vaccine against COVID-19 in infants and young children we are working with the US FDA and regulators globally to submit these data as soon as possible."
KidCOVE Study Specifics
The trial has 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 reports that the Omicron variant was the predominant strain in the Unite 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.
Moderna is also submitting data to modify their current vaccine in older children and teens.
“After consultation with the U.S. FDA we have initiated a submission for emergency use authorization of our COVID-19 vaccine in children ages 6 to under 12 years old and are updating our submission to the FDA for emergency use authorization of mRNA-1273 in adolescents ages 12 to 17 years with additional follow-up data,” Bancel said.
For children between 6 years to under 12 years, the company’s EUA submission is for a 50 μg two-dose primary vaccine series.