Moderna on Tuesday applied for approval of its coronavirus vaccine in Europe for children aged 6 to 11, the company said in a statement.
The American biotech said it had submitted the dossier for a course of two doses of its mRNA vaccine for children to the European Medicines Agency. The dose of 50 micrograms per injection is half that given to adults.
“This is our first submission for the use of our vaccine in this age group”, said Stéphane Bancel, CEO of Moderna.
“The current assessment schedule foresees an opinion in about two months, unless additional information or analysis is required”, Amsterdam-based EMA, for its part, said in a statement.
“This is a shortened schedule compared to similar types of examinations outside of a pandemic”, adds the same source.
Last month, Moderna reported that the vaccine elicited a strong antibody response in children aged 6 to 11, similar to that seen in young adults. The filing comes shortly after the company’s booster vaccine was also cleared for use in the EU on October 25.
Biotechnology said the study of the vaccine in children as young as six months is underway. The Moderna vaccine is currently approved for people 12 years of age and older in Europe.
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