Moderna files to expand conditional marketing authorization for its COVID-19 vaccine
Moderna, Inc. announced that it has submitted for a variation to the conditional marketing authorization (CMA) with the European Medicines Agency (EMA) for the evaluation of a 25 ug 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 ug two-dose primary series of mRNA-1273.
Positive interim results from the Phase II/III 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.
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