LONDON (AP) – The European Medicines Agency said on Tuesday that AstraZeneca and the University of Oxford have applied for their COVID-19 vaccine for licensing across the European Union.
The EU regulator said it had received a request for the vaccine to be covered in an accelerated process and that it could be approved by 29 January “provided that the data provided on the quality, safety and efficacy of the vaccine are sufficiently reliable and complete. ”
The EMA, the drug agency for the 27-nation EU, has already approved two other coronavirus vaccines, one from US drug maker Pfizer and Germany̵
The UK approved the Oxford-AstraZeneca vaccine last month and is using it. India approved it this month.
As part of its strategy to get as many different COVID-19 vaccines as possible for Europeans, the EU said it had concluded early talks with French biotechnology company Valneva to provide up to 60 million doses of vaccine.
Earlier, Valneva signed a deal with Britain to provide tens of millions of doses of the shot, which was developed using technology similar to that used to make flu vaccines. The EU has signed six vaccine contracts for up to 2 billion doses, far more than is needed to cover its population of around 450 million.
The Oxford-AstraZeneca vaccine is expected to be a key vaccine for many countries due to its low cost, availability and ease of use. It can be stored in refrigerators instead of the ultra-cold storage that the Pfizer vaccine requires. The company said it would sell it for $ 2.50 per dose and plans to make up to 3 billion doses by the end of 2021.
The researchers claimed that the Oxford-AstraZeneca vaccine was protected against the disease in 62% of those who received two full doses and in 90% of those who initially received half the dose due to a manufacturing error. However, the second group includes only 2,741 people – too few to be convincing.
Questions remain about how well the vaccine protects the elderly. Only 12% of the study participants were over 55 years of age and were enrolled later, so there was not enough time to see if they developed infections with a lower frequency than those not given the vaccine.
The US Food and Drug Administration has said it will not consider approving the Oxford-AstraZeneca vaccine until data from the latest government studies testing the shot in about 30,000 people are available.
The World Health Organization is also considering a request from AstraZeneca and Oxford for an emergency use list for its vaccine.
The UN Health Agency does not license or regulate vaccines themselves, but usually evaluates vaccines once they have been approved by an agency such as the UK regulator or the European Medicines Agency. WHO experts conduct their own assessment of whether the risks of the vaccine outweigh its benefits and then recommend that the photos be “pre-qualified” so that they can be purchased by donors for developing countries.
Lorne Cook in Brussels and Jamey Keaten in Geneva contributed to this report.
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