16.12.2022 14:12:57

Moderna: CHMP Recommends Approval Of Bivalent COVID-19 Booster In Children

(RTTNews) - Moderna, Inc. (MRNA) announced the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending a variation to the marketing authorization to include a booster dose of Spikevax bivalent Original/Omicron BA.1, or mRNA-1273.214, at the dose level for children, 6-11 years, of 12.5mcg/12.5mcg at least three months after the last prior dose of a COVID-19 vaccine.

Moderna's bivalent Omicron-targeting COVID-19 vaccines, mRNA.1273.214 (BA.1) and mRNA.1273.222, are approved for use in individuals 12 years of age and older in the European Union.

The company noted that a Phase 2/3 trial evaluating mRNA-1273.214 as booster and primary series in children 6 months through 5 years of age is currently underway, with initial results expected in early 2023.

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