LONDON (AP) – The European Medicines Agency said on Tuesday that AstraZeneca and the University of Oxford have submitted an application for their COVID-19 vaccine to be licensed across the European Union.
The EU regulator said that he had received a request for the vaccine to be given the green light under an accelerated process and that it could be approved until January 29 “provided that the data presented on the quality, safety and efficacy of the vaccine are sufficiently robust and complete . “
EMA, the drug agency for the 27 EU countries, has already approved two other vaccines against coronavirus, one made by the American pharmaceutical company Pfizer and the German one BioNTech and the other made by the American biotechnology company Modern. Switzerland approved the Modern vaccine on Tuesday and plans to immunize about 4% of its population using this and the Pfizer-BioNTech vaccine.
Britain approved the Oxford-AstraZeneca vaccine last month and is using it. India approved 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 its first negotiations with the French biotechnology company Valneva to guarantee up to 60 million doses of the vaccine.
Valneva previously signed an agreement with Britain to provide tens of millions of doses of its vaccine, which is developed using technology similar to that used to make flu vaccines. The EU has sealed six vaccine contracts for up to 2 billion doses, far more than necessary to cover its population of approximately 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 kept in refrigerators instead of the ultra-cool storage that the Pfizer vaccine requires. The company said it would sell it for $ 2.50 a dose and plans to make up to 3 billion doses by the end of 2021.
The researchers say that the Oxford-AstraZeneca vaccine protected against disease in 62% of those who received two full doses and in 90% of those who received half a dose initially because of a manufacturing error. However, the second group included only 2,741 people – too few to be conclusive.
Doubts also remain about how well the vaccine protects the elderly. Only 12% of study participants were over 55 and were enrolled later, so there was not enough time to see if they developed infections at a lower rate than those who did not receive 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 is testing the vaccine on about 30,000 people.
The World Health Organization is also examining a request from AstraZeneca and Oxford for a list of emergency use for their vaccine.
The UN health agency does not license or regulate vaccines on its own, but usually evaluates vaccines as soon as they are approved by an agency such as the UK regulator or the European Medicines Agency. WHO experts carry out their own assessment of whether a vaccine’s risks outweigh its benefits and then recommend that vaccines be “prequalified” 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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