On Apr. 29, 2022, Moderna announced that it had submitted for a variation to the conditional marketing authorization (CMA) with the European Medicines Agency (EMA) for the evaluation of a 25 ﾵg two-dose series of Spikevax, the Company’s vaccine against COVID-19, in children six months to under six years of age. Similar requests are underway with international regulatory authorities and are based on a 25 ﾵg two-dose primary series of mRNA-1273.

Positive interim results from the Phase 2/3 KidCOVE study showed a robust neutralizing antibody response in the six months to under six 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 six months to 23 months and two years to under six 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.