The EU’s drug watchdog on Friday approved the Pfizer/BioNTech coronavirus jab for 12- to 15-year-olds, the first vaccine to get the green light for children in the bloc.
The vaccine was “well tolerated” in children and there were no “major concerns” in terms of side effects, the Amsterdam-based European Medicines Agency said.
Germany has said it will start vaccinating children over the age of 12 from June 7 following the authorisation by the EMA.
The United States and Canada have both already authorised the vaccine for children of the same age.
“As anticipated, the EMA’s Committee for Human Medicines has today approved the use of the vaccine from Pfizer/BioNTech in adolescents from 12 to 15 years,” Marco Cavaleri, the EMA’s head of vaccine strategy, told journalists.
Data from clinical trials “is really showing that the vaccine is highly preventative” for young people, he added.
“The vaccine was well tolerated” among children for side effects, and they were “not raising major concerns at this time”.
Until now the shot made by US pharmaceutical giant Pfizer and German research firm BioNTech had only been authorised by the EU for people aged 16 and older across the 27-nation bloc.
Pfizer and its partner BioNTech said in March that their two-dose vaccine regimen was shown to be safe and highly effective in a trial of 2,260 12- to 15-year-olds.
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