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Moderna Files With EU to Expand CMA for Covid-19 Vaccine

Dow Jones2022-04-29

By Stephen Nakrosis

Biotechnology company Moderna Inc. on Friday said it filed with the European Medicines Agency to request its Spikevax Covid-19 vaccine be authorized for children aged six months to under six years old.

Moderna said similar requests are underway with international regulatory authorities, based on a two-dose primary series of mRNA-1273, the research name used for Spikevax.

The company said its filing follows a Feb. 24 decision by the EMA's Committee for Medicinal Products for Human Use "to adopt a positive opinion recommending marketing authorization for Moderna's Covid-19 vaccine to include children six years of age and older."

According to Moderna, positive interim results from a Phase 2/3 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."

Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

$(END)$ Dow Jones Newswires

April 29, 2022 11:53 ET (15:53 GMT)

Copyright (c) 2022 Dow Jones & Company, Inc.

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aaronh
·2022-04-30
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