Pfizer/BioNTech seek green light on Covid vaccine for 12 year olds

Submission to EMA comes on back of data from clinical trial

Children as young as 12 could be in line for Covid vaccination after Pfizer and its partner, BioNTech, said on Friday that they had applied to the European Medicines Agency to extend the marketing authorisation for their coronavirus vaccine for use in adolescents.

The companies filed a similar request in the United States earlier this month for use of the vaccine in people aged 12-15. It is already authorised for use in people from 16 years of age in both the US and the European Union.

The submissions are based on positive data from a late-stage clinical trial that enrolled 2,260 participants aged 12-15, the companies said.

In the US the director of the Centers for Disease Control and Prevention, Rochelle Walensky, told ABC News earlier this month that she expected the vaccine to be authorised for those aged 12-15 by mid-May. – Reuters