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.

Positive interim results from the Phase 2/3 KidCOVE study showed a robust neutralizing antibody response in the 6-month to 5 years of age group after a two-dose primary series of mRNA-1273 and a favorable safety prole. The antibody titers in the pre-specfied 6 months to 23 months and 2 years to 5 years of age sub-groups met the statistical criteria for similarity to the adults in the COVE study, which satisfied the primary objective of the study. Preliminary efficacy analysis on PCR-confirmed cases collected during the Omicron wave showed similar efficacy estimates against Omicron in the 6-month to 5 years of age group to those in adults after two doses of mRNA-1273.

The KidCOVE study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. mRNA-1273 has been authorized for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6 months to 5 years in a number of countries worldwide, including Australia, Canada, and the US. In addition, Spikevax bivalent Original/Omicron BA.1 mRNA-1273.214), a bivalent vaccine candidate that contains mRNA-1273 and a vaccine candidate targeting the Omicron variant of concern (BA.1), is approved as a booster dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older, who have previously received at least a primary vaccination course against COVID- 19.