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European regulator approves Pfizer vaccine for 12-15 year olds – RT en français

Adolescents aged 12-15 in the European Union will be able to receive Pfizer’s vaccine after the green light given by the European Medicines Agency. Germany is already planning to vaccinate people over 12 years old from June 7.

The European Medicines Agency (EMA) approved on May 28 the use of the Pfizer / BioNTech vaccine for 12-15 year olds. It becomes the first vaccine to be authorized for adolescents in the 27 countries of the European Union.

The vaccine is “well tolerated” by young people and there are “no major concerns” about possible side effects, said Marco Cavaleri, head of the vaccine strategy at a press conference. EMA.

This authorization marks a new step forward in the European vaccination strategy. Germany announced on May 27 its intention to open the vaccination against Covid-19 to minors over 12 years of age on June 7. The vaccine is already widely used for this age group in the United States and Canada.

“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,” said Marco Cavaleri.

European Health Commissioner Stella Kyriakides greeted the EMA’s green light on Twitter, while stressing that vaccination remained a choice that had to be made “by parents for their children”.

Moderna will also ask for permission for 12-17 year olds

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 Pfizer / BioNTech study involved 2,260 adolescents, and found that none of the 1,005 young people who received the vaccine developed Covid-19, while 16 of the 978 children who received a placebo injection caught the virus, the EMA said.

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

Moderna boss Stéphane Bancel told the French weekly Sunday newspaper that his company was going to file in early June an application for marketing authorization in the European Union for its anti-Covid vaccine for 12-17 year olds.

Very rare cases of heart problems in adolescents or young adults vaccinated were reported last week by US health authorities, without the link to the vaccination being established at this time.

There have been reports of myocarditis, an inflammation of the heart muscle, in people who have received a messenger RNA vaccine, noted the Centers for Disease Prevention and Control, the country’s main federal public health agency.

When asked, the European regulator said it was “examining” the problem but that so far “nothing indicates” that the problem is linked to the vaccine.

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