The European Medicines Agency (EMA), Europe’s drug regulator on Monday greenlighted the COVID-19 vaccine candidate developed by US drugmaker Pfizer and its German partner BioNTech, which now awaits for the Commission’s formal approval.
“I am pleased to announce that the Scientific Committee of the EMA met today and recommended a conditional market authorisation in the EU for the vaccine developed by BioNTech and Pfizer,” said Emer Cook, EMA’s Executive Director.
“Our scientific opinion paves the way for the first market authorisation for a Covid-19 vaccine in the EU,” Cook added.
The evaluation meeting was brought forward a week, following increased pressure by Germany, whose Health Minister, Jens Spahn called for a market authorisation before Christmas. The approval allows for countries to kickstart the vaccination marathon before the end of the year.
As the vaccine got the green light, the European Commission is now required to formally approve it within 48 hours. The procedure is considered a formality, as the chief of the EU Executive last week said she was hoping for a positive assessment by EMA.
In what Ursula von der Leyen called “Europe’s moment,” COVID-19 vaccinations across Europe are set to begin on December 27, in a bid to “put an end” to the Coronavirus pandemic.
EMA is also set to decide in early January on the COVID-19 vaccine candidate developed by the US-based Moderna. The Amsterdam-based European Medicines Agency had originally been due to decide on the vaccine on 12 January, however, the regulator said that Moderna had submitted ahead of time the last outstanding data package needed for the assessment of the application.
