The European Medicines Agency said it has approved 'conditional authorisation'
The announcement was made at the agency's headquarters on Monday afternoon in Amsterdam.
The executive director of the EMA, Irish woman Emer Cooke, said she was "delighted" to announce the "historic scientific" achievement.
This gives the green light to the Pfizer/Biontech drug, which will be valid in all EU member states at the same time.
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.
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".
