Moderna said on Tuesday it has submitted for a variation to the conditional marketing authorisation with the European Medicines Agency for the evaluation of its Covid-19 vaccine's use in children in the age-group of six to 11 years.
The vaccine was authorised for use in teens aged 12 to 17 years by the European Union in July, but several countries including Sweden have paused its use for people aged 30 and younger due to rare heart-related side-effects.
The drugmaker sought US authorisation of its vaccine for use in teens in June and is awaiting a decision by the US Food and Drug Administration.
"This marks our first submission for the use of our vaccine in this age group," said Stephane Bancel, chief executive of Moderna, adding the company will submit the data to other regulatory agencies around the world. – Reuters