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The European drugs regulator has approved an application to extend the use of the Pfizer–BioNTech COVID-19 vaccine to children aged 12 to 15, it said on Friday.
The European Medicines Agency (EMA) said its human-medicines committee has recommended the vaccine, which has already been authorized for use in adults and young people over 16, be extended to include 12-to-15-year-olds.
It said the effects of the vaccine, developed by German biotech BioNTech
BNTX,
and U.S. drug company Pfizer
PFE,
were investigated in 2,260 children aged 12 to 15. The trial showed the immune response was comparable to that of people in the 16-to-25 age range, the EMA said.
Germany will start offering COVID-19 vaccines to children as young as 12 from June 7, Chancellor Angela Merkel said on Thursday, pending authorization by the EMA.
The U.S. Food and Drug Administration authorized the Pfizer–BioNTech vaccine for 12-to-15 year-olds on May 10.
