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Pfizer/BioNTech vaccine applies for EU approval of use in adolescents aged 12-15

30 April 2021 18:56 (UTC +04:00)

Pfizer and BioNTech submitted an application to the European Medicines Agency (EMA) on Friday to expand emergency use authorization of their vaccine among minors aged from 12-15, APA reports citing Sputnik.

"Pfizer Inc. and BioNTech SE today announced they have submitted a variation to the Conditional Marketing Authorization in the European Union to the European Medicines Agency for the Pfizer-BioNTech vaccine COMIRNATY® to request an extension of the indication for use in adolescents 12 to 15 years of age," BioNTech said in a press release.

If the EU regulator approves the variation, the vaccine will be scheduled for use in this age group in all 27 member states.

The US-German pharmaceutical duo submitted a similar application to the US Food and Drug Administration, with plans to request additional amendments with other regulatory authorities across the world.

In late March, Pfizer and BioNTech announced that their vaccine demonstrated nearly 100% efficacy during trials in adolescents aged from 12-15, with robust immune responses exceeding results of earlier trials of participants aged from 16-25.