The European Medicines Agency (EMA) approved, Friday, May 28, the vaccination of adolescents aged 12 to 15 with the anti-Covid vaccine from Pfizer and BioNTech.

It will be the first vaccine to be authorized for adolescents in the 27 countries of the European Union. 

"As expected, the EMA Committee for Medicinal Products for Human Use today approved the use of Pfizer-BioNTech's vaccine for adolescents 12 to 15 years old," Marco Cavaleri told a press conference , responsible for the vaccine strategy of the EMA, according to whom the vaccine is "well tolerated" by young people and there are "no major concerns" about possible side effects. Comirnaty, the commercial name of the vaccine developed by the American laboratory Pfizer and the German BioNTech, was so far only authorized from the age of 16 in the EU and the three other vaccines validated by the European Agency for drugs those of AstraZeneca, Janssen, a subsidiary of Johnson & Johnson, and Moderna, are at thecurrently reserved for adults, and even only for certain older categories.

Accelerated assessment 

The Amsterdam-based EMA launched at the beginning of May an accelerated assessment of the data transmitted by vaccine developers for its authorization to 12-15 year olds, after the authorization request filed at the end of April by the American pharmaceutical giant Pfizer and the laboratory. German BioNTech for this age group in the EU.

The two companies had based their request on data from a phase 3 clinical study, published at the end of March, showing "100% effectiveness" of the vaccine in this age group, which was also "well tolerated in general" .

US biotech company Moderna also announced this week that its vaccine, using the same RNA technology as Pfizer / BioNTec, was "highly effective" in adolescents aged 12 to 17, according to comprehensive clinical trial results. 

The boss of Moderna, Stéphane Bancel, announced in the Journal du dimanche that his company would file "early June" an application for marketing authorization in the European Union.

Adolescents soon to be vaccinated?

In France, the president of the orientation council on the vaccination strategy, Alain Fischer, had called last week to start "in June" the vaccination of adolescents aged 16 to 18 years, then that of 12-15 years to the Back to School.

"There is work that is currently being carried out within the government," French government spokesman Gabriel Attal commented on Franceinfo on Friday, specifying that announcements could be made soon.

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Germany announced on Thursday its intention to open vaccination to minors over 12 years old on June 7, subject to the authorization of the European regulator.

Japan has also given the green light for the use of the Pfizer / BioNTech vaccine for people aged 12 and older, a health ministry official said on Friday.

In the United States, American regulators have already authorized the use of the vaccine from Pfizer and BioNTech in children from 12 years old in early May.

Very rare cases of myocarditis, inflammation of the heart muscle, in adolescents or young adults vaccinated were reported last week by US health authorities, without the link with the vaccination has been established for the moment.

With Reuters and AFP

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