(Reuters) – The European Union’s drug regulator expects to decide in about two months on whether to allow the use of Moderna’s COVID-19 vaccine in children aged six to 11 years, it said on Wednesday, after the U.S. drugmaker sought approval.
“The current timeline for evaluation foresees an opinion in approximately 2 months, unless supplementary information or analysis is needed,” the European Medicines Agency (EMA) said in a statement.
Moderna said on Tuesday it had applied for European authorization for use of a 50 micrograms dose of its shot in the 6-11 years age group, weeks after it delayed a similar filing with U.S. regulators.
The company had in October said its vaccine generated a strong immune response in children in that age group.
The European Union had in July authorised the vaccine for use in teens aged 12 to 17 years, but several countries including Sweden have paused its use for people 30 or younger due to rare heart-related side-effects.
(Reporting by Pushkala Aripaka in Bengaluru; Editing by Shailesh Kuber)
