The European Medicines Agency (EMA) has approved 'conditional authorisation' for a coronavirus vaccine for the European Union.
The announcement was made at the agency's headquarters in Amsterdam this afternoon.
This gives the potential green light to the Pfizer/Biontech drug, which will be valid in all EU member states at the same time.
The executive director of the EMA, Irish woman Emer Cooke, said she was "delighted" to announce the "historic scientific" achievement.
Health Minister Stephen Donnelly also welcomed the news, which will now go to the European Commission for approval tomorrow.
— Stephen Donnelly (@DonnellyStephen) December 21, 2020
The EMA has recommended granting a conditional marketing authorisation for the vaccine in people from 16 years of age.
The EMA's human medicines committee - CHMP - has completed a rigorous evaluation of the drug, and concluded that "sufficiently robust data on the quality, safety and efficacy of the vaccine" are available to recommend a formal conditional marketing authorisation.
However no timeframe has been set out by the EMA.
Ms Cooke said: "Today’s positive news is an important step forward in our fight against this pandemic, which has caused suffering and hardship for so many.
"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."