On Oct. 19, 2022, Moderna announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending a variation to the marketing authorization (CMA) to include a 25 ﾵg two-dose series of Spikevax (mRNA-1273) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in children 6 months to 5 years.

Following the CHMP’s positive opinion, the European Commission made an authorization decision on the use of Spikevax in children ages 6 months to 5 years.