The EU’s medicines agency (EMA)on May 28 approved the Pfizer/BioNTech coronavirus vaccine for 12- to 15-year-olds, the first vaccine to get the green light for children in the bloc.
The announcement came as the World Health Organization (WHO) said Europe needed to speed up its vaccine rollout.
The US and Canada have already authorized 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”.
“From a safety perspective, the vaccine was well tolerated and the side effects in this age group were very much similar to what we have seen in young adults and not raising major concerns at this point in time,” he added.
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.