(Reuters) – Europe’s drug regulator said on Tuesday it expects to give a verdict on the use of Moderna Inc’s COVID-19 vaccine in 12- to 17-year olds next month, following an application by the drugmaker.
A European Medicines Agency (EMA) committee would speed up assessment of data submitted with the application, the regulator said, adding that a delay would happen if the EMA required any additional information. (bit.ly/3g1Vrn6)
The two-dose vaccine is already being used in the European Union (EU) for people over 18 years of age, and in the United States and Canada. The company has also sought approval in Canada for use in adolescents and plans for a U.S. application.
If approved, Moderna’s vaccine would become the second shot okayed for use in teenagers in the EU after Pfizer and BioNTech’s vaccine was given the greenlight last month.
Vaccinating children has been considered important for reaching herd immunity against the novel coronavirus, and Moderna last month said its vaccine was found safe and effective in teens.
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