The manufacturer, Moderna, Inc., announced that it completed its submission for a request for EUA to the FDA for its COVID-19 vaccine (mRNA-1273) in pediatric patients aged 6 months to younger than age 2 years and patients aged 2 years to younger age 6 years. The company said comparable requests are underway with international regulatory authorities. The requests are based on a 25-mcg, two-dose primary series of mRNA-1273.
Positive interim results from the phase II/III KidCOVE study announced on March 23, 2022, demonstrated a robust neutralizing antibody response in the age 6 months to younger than age 6 years group after a two-dose primary series of mRNA-1273, along with a favorable safety profile.
The antibody titers in the prespecified age 6 months to 23 months and age 2 years to younger than age 6 years subgroups met the statistical criteria for similarity to the adults in the COVE study, which satisfied the primary objective of the trial. The previously announced results included a supportive preliminary efficacy analysis of cases largely collected during the Omicron wave, including home testing for COVID-19.
When the analysis is limited only to cases confirmed positive for SARS-CoV-2 by central laboratory RT-PCR, vaccine efficacy remained significant at 51% (95% CI: 21-69) for patients aged 6 months to younger than age 2 years and 37% (95% CI: 13-54) for patients aged 2 years to younger than age 6 years. These efficacy estimates are comparable with vaccine efficacy estimates in adults against Omicron after two doses of mRNA-1273.
Moderna is also currently studying booster doses for all pediatric cohorts. The KidCOVE study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
In a press release, Stéphane Bancel, CEO of Moderna, stated, "We are proud to share that we have initiated our EUA submission for authorization for our COVID-19 vaccine for young children. 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."
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