EMA decision on Pfizer vaccine in young people due Friday

By TPN/Lusa, in News, COVID-19 · 26-05-2021 15:34:00 · 0 Comments

The European Medicines Agency (EMA) will announce on Friday, 28 May, the decision of experts on the administration of the Pfizer/BioNTech Covid-19 vaccine in young people aged between 12 and 15 years.

The European regulator responsible for the evaluation and supervision of medicinal products in the European Union (EU) announced that the decision will be made at Friday's extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP).

"This extraordinary meeting is organised as part of the assessment of an application to extend the use of the vaccine Comirnaty [trade name of the drug] in children aged 12 to 15 years," the EMA said, advancing that the aim "is to conclude the assessment, if possible".

The CHMP is responsible for preparing the EU agency's technical opinions on all matters relating to medicines for human use.

Comirnaty, a messenger RNA vaccine developed by US drugmaker Pfizer and German laboratory BioNTech, is authorised by the EMA for people aged 16 years and older and received conditional marketing authorisation across the EU on 21 December 2020.

On 25 May, the president of the European Commission said she expected EMA authorisation this month to start immunising 12- to 15-year-olds with PfizerBioNtech's Covid-19 vaccine.

"We expect authorisation from the EMA by the end of the month to start administering PfizerBioNtech's vaccine to young people between 12 and 15 years old," said Ursula von der Leyen, adding that this is the only laboratory that has submitted a request for authorisation to this end.



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