Moderna seeks EU authorization for Covid-19 vaccine in young kids
Moderna Inc on Tuesday sought conditional marketing authorization with the European Medicines Agency for use of its Covid-19 vaccine in children in the age-group of 6-11 years.
The vaccine was authorized 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 authorization 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 Stéphane Bancel, Chief Executive of Moderna, adding the company will submit the data to other regulatory agencies around the world.
[Reuters]
