The European Medicines Agency said on Monday that it had approved the Pfizer-BioNTech coronavirus vaccine, paving the way for inoculations to start across the EU within days.
The Amsterdam-based regulator dramatically moved the decision on the jab ahead from December 29, following pressure to accelerate the process from Germany and other EU states.
"I am delighted to announce that the EMA scientific committee met today and recommended a conditional marketing authorisation in the EU for the vaccine developed by Pfizer and BioNTech," EMA chief Emer Cooke told an online press conference.
"Our scientific opinion paves the way for the first marketing authorisation in the EU," she said, adding that it would cover all 27 countries.
"It is a significant step forward in the fight against this pandemic that is causing suffering and hardship," she said.
"This is really a historic scientific achievement, within less than a year a vaccine will have been developed and authorised against this disease."
The clamour for action grew as Britain and the United States have already started giving their citizens the vaccine developed by US giant Pfizer and German firm BioNTech under emergency national rules.
Cooke added that it appeared the Pfizer-BioNTech vaccine would protect against a new strain of the coronavirus found mainly in Britain.
"At this moment there is no evidence to suggest this vaccine will not work against the new variant," she added.