LONDON (AP) – The European Medicines Agency said on Tuesday that AstraZeneca and Oxford University had applied for their COVID-19 vaccine to be licensed across the European Union.
The EU regulator said it had received an application for the vaccine to be approved in an accelerated process and could be approved by 29 January “provided that the data provided on the quality, safety and efficacy of the vaccine is available. robust enough and complete. ”
EMA, the EU’s 27-nation drug agency, has already approved two more coronavirus vaccines, one manufactured by US doctor Pfizer and German company BioNTech and another by US biotechnology company Moderna. Switzerland approved the Moderna vaccine on Tuesday and intends to immunize about 4% of its population using it and the Pfizer-BioNTech shot.
The UK approved the Oxford-AstraZeneca vaccine last month and is using it. India approved it this month.
As part of its strategy to obtain 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.
Valneva has previously signed an agreement with the United Kingdom to provide tens of millions of doses of its vaccine, which is being developed using technology similar to that used to make flu vaccines. The EU has concluded six vaccination 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 rather than in the ultra-cold storage required by the Pfizer vaccine. The company said it will sell it for $ 2.50 per dose and plans to make up to 3 billion doses by the end of 2021.
The researchers say that the Oxford-AstraZeneca vaccine is protected against the disease in 62% of those who received two full doses and in 90% of those who were initially given half a dose due to a manufacturing error. However, the second group included only 2,741 people – too few to be conclusive.
There are also questions about how well the vaccine protects the elderly. Only 12% of study participants were over 55 years old and enrolled later, so there was not enough time to see if they developed infections at a lower rate than those who were not given the vaccine.
The US Food and Drug Administration says it will not consider approving the Oxford-AstraZeneca vaccine until data from the latest state research testing the shot on about 30,000 people are available.
The World Health Organization is also examining a request from AstraZeneca and Oxford for an emergency use list for its vaccine.
The UN Health Agency does not authorize or regulate vaccines per se, but usually evaluates vaccines after they have been approved by an agency such as the UK regulatory authority or the European Medicines Agency. WHO experts conduct their own assessment of whether or not the risks of a vaccine outweigh its benefits and then recommend that vaccines be “pre-qualified” so that they can be purchased by donors for developing countries.
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Lorne Cook in Brussels and Jamey Keaten in Geneva contributed to this report.
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