On Apr. 28, 2022, Moderna announced that it had submitted a request for emergency use authorization (EUA) for its COVID-19 vaccine (mRNA-1273) 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 were underway with international regulatory authorities. The requests were based on a 25 ﾵg two-dose primary series of mRNA-1273.

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 prole. The antibody titers in the pre-specied 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 satised the primary objective of the study.

The previously announced results included a supportive preliminary ecacy analysis on cases mostly collected during the Omicron wave, including home testing for COVID-19. When the analysis is limited only to cases conrmed positive for SARS-CoV-2 by central lab RT-PCR vaccineecacy remained signicant at 51% (95% CI: 21-69) for 6 months to <2 years and 37% (95% CI: 13-54) for 2 to <6years. These ecacy estimates are similar to vaccine ecacy estimates in adults against Omicron after two doses ofmRNA-1273.

A 50 ﾵg booster dose of mRNA-1273.211 demonstrated superiority against Beta, Delta and Omicron variants of concern one month after administration. Superiority continued six months after administration for Beta and Omicron variants of concern as well. A 50 ﾵg booster dose of mRNA-1273.211 was generally well tolerated with a reactogenicity profile comparable to a booster dose of mRNA-1273 at the 50 ﾵg dose level. The manuscript was available as a preprint through Research Square.

The EUA submission for children ages 6 months to under 6 years will be complete next week. Moderna is alsocurrently studying booster doses for all pediatric cohorts.