The EMA's approval paves the way for the roll out of the Pfizer vaccine throughout EU countries.
The final authorisation was granted later on Monday by the EU Commission.
The approval also clears the vaccine for use in Norway and Iceland, which are signed up to the EU's procurement scheme.
“Today we add an important chapter to a European success story, by making available the 1st #COVID19 vaccine for Europeans,” said Commission chief Ursula von der Leyen.
“More vaccines will come soon. Doses of the vaccine approved today will be available for all EU countries, at the same time, on the same conditions.
“The upcoming European vaccination days will also be a great moment of unity. This is a good way to end this difficult year, and to start turning the page on this pandemic. We are all in this together.”
Today we add an important chapter to a European success story, by making available the 1st #COVID19 vaccine for Europeans.
More will come.
— Ursula von der Leyen (@vonderleyen) December 21, 2020
In a statement the EMA said: “EMA’s scientific opinion paves the way for the first marketing authorisation of a COVID-19 vaccine in the EU by the European Commission, with all the safeguards, controls and obligations this entails.”
— EU Medicines Agency (@EMA_News) December 21, 2020
“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 (pictured), 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.”
Commission President Ursula von der Leyen said the approval is a “decisive moment in our efforts to deliver safe and effective vaccines to Europeans”.
The vaccine has already been approved in the UK, US and Canada.
In recent weeks EU countries have been preparing to roll out the vaccine. To read more on the vaccination programme in certain countries you can click on the links below: