A girl holds a small bottle labeled with a “Coronavirus COVID-19 Vaccine” sticker and a medical syringe in entrance of a Pfizer brand. (REUTERS/Dado Ruvic/File Photo)
If accredited it will likely be the primary vaccine to get the inexperienced mild for younger individuals within the 27-nation European Union. Pfizer is at present authorised for individuals aged 16 and older.
- AFP The Hague
- Last Updated:May 26, 2021, 15:55 IST
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The European Medicines Agency will announce on Friday whether or not it has accredited the Pfizer/BioNTech coronavirus jab for 12- to 15-year-olds, the regulator mentioned. If accredited it will likely be the primary vaccine to get the inexperienced mild for younger individuals within the 27-nation European Union. Pfizer is at present authorised for individuals aged 16 and older.
The EMA will give a briefing on Friday to “cowl the result of the extraordinary assembly of EMA’s human drugs committee… to talk about the paediatric indication for Comirnaty”, it said in an email on Wednesday.
Comirnaty is the brand name for the vaccine developed by US pharmaceutical giant Pfizer and the German research firm BioNTech.
The US Food and Drug Administration has already authorised Pfizer for 12- to 15-year-olds.
EMA chief Emer Cooke said earlier this month that the Amsterdam-based watchdog was fast-tracking the approval 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 “we’ve been promised data from clinical trials and the study carried out in Canada within the next two weeks, and we are going to speed up our evaluation”.
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