Moderna files for authorization of its Covid-19 vaccine in young children six months to six years

Submission to regulators globally is based on phase 2/3 studies of mRNA-1273 in young children

Moderna announced that it has submitted a request for emergency use authorization (EUA) for its Covid-19 vaccine in children 6 months to under 2 years and 2 years to under 6 years of age to the U.S. Food and Drug Administration and that similar requests are underway with international regulatory authorities. The requests are based on a 25 μg two-dose primary series of mRNA-1273.

"We are proud to share that we have initiated our EUA submission for authorization for our Covid-19 vaccine for young children," said Stéphane Bancel, Chief Executive Officer of Moderna. "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."

Positive interim results from the Phase 2/3 KidCOVE study, announced on March 23, 2022, showed a robust neutralizing antibody response in the 6 months to under 6 years of age group after a two-dose primary series of mRNA-1273, along with a favourable safety profile. The antibody titers in the pre-specified 6 month to 23 month and 2 years to under 6 years age sub-groups met the statistical criteria for similarity to the adults in the COVE study, which satisfied the primary objective of the study. The previously announced results included a supportive preliminary efficacy analysis on cases mostly 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 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 EUA submission for children ages 6 months to under 6 years will be complete next week. Moderna is also currently studying booster doses for all pediatric cohorts.