EU's medicines regulator approves Pfizer/BioNTech vaccine

By Busra Nur Bilgic Cakmak

ANKARA (AA) - The European Medicine Agency (EMA) on Monday approved the COVID-19 vaccine developed by BioNTech and Pfizer to be used in the European Union.

“I'm delighted to be here and to announce that that EMA Scientific Committee met today and recommended a conditional marketing authorization in the EU for the vaccine developed by BioNTech and Pfizer,” Emer Cooke, the EMA executive director, said in a news conference.

Cooke said the clinical trials showed the vaccine was effective at preventing COVID-19 in people from 16 years of age and the EMA’s scientific opinion paves the way for the first marketing authorization of a COVID-19 vaccine in the EU, "with the corresponding safeguards, controls, and obligations.”

“It will be valid in all 27 member states at the same time, and it provides them with a firm scientific foundation for the rollout of their vaccination programs, and a continuing framework for control and supervision of the vaccines,” she added.