EU gives conditional approval to vaccine

THE European Medicines Agency has recommended conditional approval for a coronavirus vaccine developed by BioNTech and Pfizer to be used across the European Union.

Following a closed-doors expert meeting, the EU drug regulator said it was recommending the shot be licensed for use in people over 16 years of age, with some exceptions.

The pharmaceutical companies will need to submit follow-up data on their vaccine for the next year.

“This is really a historic scientific achievement,” said Emer Cooke, the head of the agency.

“It is a significant step forward in our fight against the pandemic.”

The approval needs to be rubberstamped by the EU’s executive branch, a move its chief said was likely to happen last night.

European Commission president Ursula von der Leyen tweeted that the EMA’s approval was “a decisive moment in our efforts to deliver safe and effective Europeans!”

She added: “Now we will act fast. I expect a @EU-Commission decision by this evening.”

The EU’s executive arm had been expected to require two or three days to approve the EMA’s decision.

Authorities in Germany and several other European countries have vaccines to said they hope to begin vaccinating people on December 27.

“Today is a particularly personal and emotional day for us at BioNTech,” said Ugur Sahin, the company’s chief executive and co-founder.

“Being in the heart of the EU, we are thrilled to be one step closer to potentially delivering the first vaccine in Europe to help combat this devastating pandemic. We are standing by ready to start the delivery of initial vaccine doses across the EU as soon as we get the green light.”

The European regulator came under heavy pressure last week from countries calling for the vaccine to be granted approval for use as quickly as possible.

The EMA originally set December 29 as the date for its evaluation of the vaccine made by Germanybased BioNTech, but moved the meeting to yesterday after calls from the German government and other countries for the agency to move more quickly.

The vaccine has already been given some form of regulatory authorisation in at least 15 countries. Britain, Canada and the US authorised the vaccine to be used according to emergency provisions, meaning the shot is an unlicensed product whose temporary use is justified by the pandemic that has killed almost 1.7 million people.