The Hague:
The European Union’s drug watchdog on Friday authorized the Pfizer/BioNTech coronavirus jab for 12 to 15-year-olds, the initial vaccine to get the green light for children in the bloc.
The vaccine was “well tolerated” in adolescents and there had been no “major concerns” in terms of side effects, the Amsterdam-based European Medicines Agency mentioned.
The move will be a additional enhance for Europe’s vaccination programme, with Germany saying it will commence providing the jab to children more than the age of 12 from next month.
The United States and Canada have currently authorised Pfizer for adolescents.
“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 tactic, told a news conference.
Until now the shot made by US pharmaceutical giant Pfizer and German analysis firm BioNTech had only been authorised by the EU for folks aged 16 and older.
‘Parents’ decision’
EU Health Commissioner Stella Kyriakides hailed it as “one step closer to ending the pandemic”, but mentioned folks would nevertheless have the option about no matter whether their children should really get the jab.
“Beyond the decisions of governments, this is ultimately a decision to be made by parents for their children,” she mentioned on Twitter.
With EU nations attempting to expand their vaccination coverage, EMA chief Emer Cooke has mentioned the regulator speedy-tracked the approval, which was initially anticipated in June.
The watchdog insisted that it had taken the required methods to make certain it was secure.
Trials showed the Pfizer vaccine was “highly preventative” for Covid-19 in children, the EMA’s Cavaleri mentioned.
None of the 1,005 children who received the vaccine in a trial created Covid-19, compared to 16 children out of the 978 who received a placebo injection.
“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,” Cavaleri mentioned.
The EMA confirmed it was searching into “very rare” situations of heart inflammation in folks aged below 30 who had been provided the Pfizer vaccine.
“Currently there is no indication that these cases are due to the vaccine and EMA is closely monitoring this issue,” it mentioned in a statement.
‘Critical milestone’
US authorities have also reported a modest quantity of reports of heart inflammation amongst some younger folks who Pfizer and Moderna, which makes use of the similar Messenger RNA technologies.
The EMA mentioned it was “working closely” with its US counterparts.
BioNTech CEO and co-founder Ugur Sahin hailed Friday’s choice as “another critical milestone in our collective effort to broaden vaccination programmes to as many people as possible”.
Pfizer CEO Albert Bourla mentioned that creating vaccines offered to adolescents “will help re-open schools and support the return to a normal day-to-day life”.
The approval of Pfizer for adolescents fires the beginning gun for Germany to start vaccinating children more than 12, as Chancellor Angela Merkel announced on Thursday.
But Merkel stressed that vaccination would not be compulsory and would have no bearing on no matter whether children can attend college or go on vacation.
Austria’s vaccination committee announced late Friday that it would stick to suit.
Moderna has mentioned it expects to seek authorisation from EU and US authorities in early June, soon after trials showed it was “highly effective” in adolescents.
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