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Coronavirus

21st Dec 2020

Pfizer/BioNTech Covid-19 vaccine approved for use across the EU

Alan Loughnane

Some positive news on this bleak Monday

The European Medicines Agency said today that it had approved the Pfizer-BioNTech coronavirus vaccine, paving the way for inoculations to start across the EU within days.

The decision was announced by the European Medicines Agency (EMA) at a press conference this afternoon.

In a statement, the EMA said its human medicines committee (CHMP) has completed its rigorous evaluation of Pfizer/BioNTech vaccine, concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available to recommend a formal conditional marketing authorisation.

“Today’s positive news is an important step forward in our fight against this pandemic, which has caused suffering and hardship for so many,” said Emer Cooke, Executive Director of EMA. “We have achieved this milestone thanks to the dedication of scientists, doctors, developers and trial volunteers as well as many experts from all EU Member States.

“Our thorough evaluation means that we can confidently assure EU citizens of the safety and efficacy of this vaccine and that it meets necessary quality standards. However, our work does not stop here. We will continue to collect and analyse data on the safety and effectiveness of this vaccine to protect people taking the vaccine in the EU.”

The EMA also said there is no evidence to suggest the vaccine won’t be effective against the new strain of Covid-19 identified in the UK, and which has led to UK citizens being banned from travelling to EU countries for at least 48 hours.