Committee for Medicinal Products for Human Use recommends authorization for the use of Spikevax (mRNA-1273) in children 6 months - 5 years in the European Union
Moderna, Inc.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 conditional marketing authorization (CMA) to include a 25 µg 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 will make an authorization decision on the use of Spikevax in children ages 6 months to 5 years.
Positive interim results from the Phase II/III 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 profile. The antibody titers in the pre-specified 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.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.