Sunday, August 1, 2021

EU watchdog to rule Friday on Pfizer for youths – ET HealthWorld


The European Medicines Agency will announce on Friday whether it has approved the Pfizer/BioNTech coronavirus jab for 12- to 15-year-olds, the regulator said.

If approved it will be the first vaccine to get the green light for young people in the 27-nation European Union. Pfizer is currently authorised for people aged 16 and older.

The EMA will give a briefing on Friday to “cover the outcome of the extraordinary meeting of EMA’s human medicine committee… to discuss 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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