German laboratory BioNTech is about to apply to the EU for permission to use its COVID-19 vaccine in children between the ages of 12 and 15, which will make it possible for approval as early as June.
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“In Europe, we are in the final stages of submitting clinical trial data to the European Medicines Agency (EMA), and the review should take four to six weeks,” said co-founder and director Ugur Sahin. German magazine Spiegel.
This vaccine is currently only approved for people aged 16 and over.
In the United States, BioNTech and its partner Pfizer already filed a request in early April for an extension of the urgent vaccine authorization for adolescents aged 12 to 15.
The requests for approval are based on data from a Phase 3 clinical trial in this age group, published in late March, which labs said were “100% effective” in preventing disease.
The vaccine was also “well tolerated, with side effects broadly in line with those seen” in people aged 16 to 25, Pfizer and BioNTech added on Friday.
For children aged 5 to 12, Mr. Sahin continues to rely on the results of the clinical trial conducted in July and remains “on track” to obtain approval by early September.
The results of a study on children, even young children, may be available from September.
“The check takes four to six weeks,” Sahin said.
On Wednesday, the co-founder of the Mainz laboratory with his wife considered “herd immunity” possible in Europe “in July, no later than August” and reiterated his “confidence” in the effectiveness of the vaccine against the virus. the Indian variant speaks of the coronavirus.