The EU drug regulator approves the Pfizer vaccine for children aged 12-15

The EU drug watchdog Friday approved the Pfizer / BioNTech coronavirus shot for 12 to 15-year-olds, the first vaccine to get the green light for children on the block.

The vaccine was “well-tolerated” by 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 EMA approval.

The United States and Canada have both already approved the vaccine for children of the same age.

“As expected, the EMA’s Committee for Medicinal Products for Human Use today approved the use of the Pfizer / BioNTech vaccine in adolescents aged 12 to 15,” Marco Cavaleri, EMA’s head of vaccine strategy, told journalists. .

Data from clinical trials “really shows that the vaccine is very preventive” for young people, he added.

“The vaccine was well tolerated” by children because of its side effects, and they “were not very concerned at this time.”

Until now, the shot made by the American pharmaceutical giant Pfizer and the German research firm BioNTech had only been approved by the EU for people 16 and older in the 27-country bloc.

Pfizer and its partner BioNTech said in March that their two-dose vaccination regimen was found to be safe and highly effective in a study of 2,260 12 to 15-year-olds.

Fast approval

EMA chief Emer Cooke had said the Amsterdam-based watchdog sped up adoption for young people, which was originally expected in June.

She told European newspapers on May 11 that the regulator had received Pfizer-BioNTech data and “have been promised data from clinical trials and the study being conducted in Canada within the next two weeks, and we are going to speed up our evaluation.”

Chancellor Angela Merkel announced on Thursday that Germany is proceeding with a plan to vaccinate children over the age of 12, pending the EMA’s announcement.

But she stressed that vaccination is not mandatory and does not affect whether children can go to school or go on vacation.

Moderna, which also uses the same Messenger RNA technology as Pfizer, said earlier this month that its vaccine was 96 percent effective in people ages 12 to 17, according to initial clinical trial results.

US health authorities have said they were investigating a small number of reports of heart inflammation in some younger people receiving mRNA vaccines, such as Pfizer and Moderna.

There were “relatively few reports of myocarditis,” mainly in adolescents and young adults, according to the US Centers for Disease Control and Prevention (CDC).

“Most cases appear to be mild, and follow-up of the cases is ongoing,” the CDC said, adding that reports were more frequent of men who received their second dose.


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