The European Medicines Agency (EMA) said AstraZeneca and Oxford University have submitted an application seeking emergency use approval (EUA) for their Covid-19 vaccine.
In a statement on Tuesday, the EU regulator said it has received a request for the vaccine to be green-lighted under an expedited process and that it could be approved by January 29 during an EMA meeting, “provided that the data submitted on the quality, safety and efficacy of the vaccine are sufficiently robust and complete”.
The EMA has already approved two other coronavirus vaccines, one made by American drug-maker Pfizer and Germany's BioNTech and another by Moderna.
Britain gave its approval to the Oxford-AstraZeneca vaccine last month and has been using it. India approved it earlier this month.
The Oxford-AstraZeneca vaccine is expected to be a game changer for many countries because of its low cost, availability and ease of use. It can be kept in refrigerators rather than the ultra-cold storage that the Pfizer vaccine requires. The company has said it will sell it for $2.50 a dose and plans to make up to 3 billion doses by the end of 2021.
Researchers claim the Oxford-AstraZeneca vaccine protected 62 percent volunteers who were administered two full doses and protected 90 percent of those initially given a half dose because of a manufacturing error. However, the second group included only 2,741 people -- too few to be conclusive.
Questions also remain about how well the vaccine protects older people. Only 12% of study participants were over 55 and they were enrolled later, so there hasn't been enough time to see whether they develop infections at a lower rate than those not given the vaccine.