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)
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