Moderna announced it is seeking emergency use authorization for its Covid-19 vaccine for children five and under.

The company announced April 28 it wants authorization from the US Food and Drug Administration for its Covid-19 vaccine for children six months through five years old. According to a news release from Moderna:

Positive interim results from the Phase 2/3 KidCOVE study, announced on March 23, 2022, showed a robust neutralizing antibody response in the 6 month to under 6 years of age group after a two-dose primary series of mRNA-1273, along with a favorable 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.

BARDA, part of ASPR within the U.S. HHS is supporting the continued research and development of the Company’s COVID-19 vaccine development efforts with federal funding under contract no. 75A50120C00034. BARDA is reimbursing Moderna for 100 percent of the allowable costs incurred by the Company for conducting the program described in the BARDA contract.

Moderna

To view the release in its entirety, click here.