The 27-member European Union will start vaccinating citizens with the BioNTech-Pfizer coronavirus vaccine shortly after Christmas.
On Tuesday morning (Australian time), the EU gave official approval for the vaccine to be put onto the market.
Deliveries are expected to start on Saturday.
The European Commission granted market authorisation of the BioNTech-Pfizer vaccine under conditional approval, meaning a scientific assessment showed its overall benefits outweighed the risks.
Its President Ursula von der Leyen announced the commission had decided to make the continent’s first COVID vaccine available to European citizens.
People across Europe will be able to get inoculated against the coronavirus as early as December 27.
It comes as countries around the world close their doors to Britain because of fears about a new COVID-19 strain in London and south-east England, which British Health Secretary Matt Hancock said was “out of control”.
BioNTech and Pfizer offered the EU 400 million doses of the vaccine, but the bloc’s leaders chose to buy only 200 million doses, with an option for 100 million more.
The European Commission’s announcement came just hours after the European Medicines Agency said the shot met safety and quality standards.
The EMA approval is largely similar to the normal licensing procedure that would be granted to any new vaccine, but on an accelerated schedule.
During a closed-door discussion, EMA scientists responsible for assessing the vaccine presented their analysis to other experts and scrutinised data from companies.
EMA had originally set December 29 as the date for its evaluation of the vaccine but moved the meeting forward after calls from Berlin and others to move quicker.
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 vaccine has already been given some form of regulatory OK in more than a dozen countries.
Britain, Canada and the US authorised the vaccine to be used according to emergency provisions.
The US Centres for Disease Control and Prevention said it had so far seen six cases of severe allergic reaction out of more than 250,000 shots of the BioNTech-Pfizer vaccine given, including in one person with a history of vaccination reactions.
Vaccine to be rolled out in Singapore
On Tuesday morning, Singapore became the first Asian nation to receive a batch of the Pfizer vaccine, ahead of a rollout in the city-state that health officials have said could be just two weeks away.
Singapore Airlines, which carried the vaccines on board a freighter from Belgium, did not specify the size of the batch.
Singapore announced last week that it had approved the companies’ vaccine.
Prime Minister Lee Hsien Loong, 68, has said he will be among the early recipients of the vaccine in the nation of 5.7 million people. Singapore has one of the world’s lowest coronavirus fatality rates.
The government plans to first administer the vaccine to healthcare workers and the elderly.
Meanwhile, Malaysia’s National Pharmaceutical Regulatory Agency could take up to four months to decide if the Pfizer vaccine can be administered there.
“We may take around 90 to 120 days to scrutinise everything and make sure it is safe to use. That is the first step,” Health Ministry Director-General Noor Hisham Adbullah said.
Mr Hisham said Malaysia’s NPRA received an official application to register the jab on December 15.
“We expect to officially engage with the company around the end of this month,” he said.
Malaysia’s government has already ordered 12.8 million doses of the Pfizer-BioNTech vaccine.