Moderna announced on Thursday that it had submitted to the US Food and Drug Administration (FDA) a request for emergency use authorization (EUA) for its COVID-19 vaccine (mRNA-1273) in children aged 6 months to under 2 years and 2 years to under 6 years of age, making it the first manufacturer to do so.
Similar requests are underway with international regulatory authorities, the biotechnology company said in a press release. The requests are based on a 25 µg 2-dose primary series of mRNA-1273.
On March 23, 2022, Moderna announced that interim results from the phase 2/3 KidCOVE study showed a “robust” neutralizing antibody response in participants aged 6 months to <6 years after a 2-dose primary series of mRNA-1273, as well as a favorable safety profile. The antibody titers in the prespecified 6-month to 23-month and 2-years to <6-years age subgroups met the statistical criteria for similarity to the adults in the COVE study, which satisfied the primary objective of the study.
These previous interim findings included a supportive preliminary efficacy analysis on COVID-19 cases that were mostly collected during the Omicron wave, including home testing. 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% confidence interval [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,” noted the company in the press release.
Moderna said the EUA submission for children aged 6 months to <6 years will be completed by next week. The company is also currently studying booster doses for all pediatric cohorts.
At this time, mRNA-1273 is only indicated for persons aged ≥18 years.