The European Medicines Agency has recommended conditional approval for the jab to be used on people over 16 years of age - with some exceptions.
However, the approval needs to be rubber-stamped by the EU’s executive branch, a move its chief said is likely to happen on Monday evening.
The pharmaceutical companies will need to submit follow-up data on their vaccine for the next year.
“This is really a historic scientific achievement,” said Emer Cooke, the head of the agency.
“It is a significant step forward in our fight against the pandemic.”
It’s a decisive moment in our efforts to deliver safe & effective vaccines to Europeans!
The @EMA_News just issued a positive scientific opinion on the #BioNTech / @pfizer vaccine.
Now we will act fast. I expect a @EU_Commission decision by this evening.
— Ursula von der Leyen (@vonderleyen) December 21, 2020
European Commission president Ursula von der Leyen tweeted that the EMA’s approval was “a decisive moment in our efforts to deliver safe & effective vaccines to Europeans!”
“Now we will act fast. I expect a @EU_Commission decision by this evening,” she said.
The EU’s executive arm had been expected to require two or three days to approve the EMA’s decision.
Authorities in Germany and several other European countries have said they hope to begin vaccinating people on December 27.
The European regulator came under heavy pressure last week from countries calling for the vaccine to be granted approval for use as quickly as possible.
The EMA originally set December 29 as the date for its evaluation of the vaccine made by Germany-based BioNTech, but moved the meeting to Monday after calls from the German government and other countries for the agency to move more quickly.
The vaccine has already been given some form of regulatory authorisation in at least 15 countries.
Britain, Canada and the US authorised the vaccine to be used according to emergency provisions, meaning the shot is an unlicensed product whose temporary use is justified by the pandemic that has killed almost 1.7 million people worldwide to date, according to a tally by Johns Hopkins University.
Switzerland on Saturday became the first country to authorise the Pfizer/BioNTech vaccine according to the normal licensing procedure.
EMA approval also follows the regular process, only on an accelerated schedule and under the condition that the pharmaceutical companies submit follow-up data on their vaccine for the next year.