LONDON (AP) – The European Medicines Agency said on Tuesday that AstraZeneca and the University of Oxford had submitted an application for their COVID-19 vaccine to be licensed across the European Union.
The EU regulator said it had received a request to release the vaccine under a speedy process and that it could be approved on January 29, provided that the data submitted on the quality, safety and efficacy of the vaccine were sufficient. robust and complete. ”
The EMA, the 27-country EU medicine agency, has already approved two other coronavirus vaccines, one made by US drugmaker Pfizer and German BioNTech, and one made by US biotechnology company Moderna. Switzerland approved the Moderna vaccine on Tuesday and plans to immunize about 4% of the population using the Pfizer BioNTech shot.
Britain last month approved and used the Oxford-AstraZeneca vaccine. India approved it this month.
As part of its strategy to obtain as many COVID-19 vaccines as possible for Europeans, the EU said it had concluded early talks with French biotechnology company Valneva to secure up to 60 million doses of vaccine.
Valneva had earlier entered into an agreement with Britain to supply tens of millions of doses of his shot, developed using technology similar to that used to make flu vaccines. The EU has concluded six vaccine contracts for up to 2 billion doses, far more than is needed to cover the population of around 450 million.
The Oxford-AstraZeneca vaccine is expected to be a major vaccine for many countries due to its low cost, availability and ease of use. It can be kept in refrigerators, rather than in the ultra-cold storage space required by the Pfizer vaccine. 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.
Researchers claim that the Oxford-AstraZeneca vaccine is protected against disease in 62% of those who receive two full doses, and in 90% of those who initially receive half the dose due to a manufacturing defect. However, the second group included only 2,741 people – too few to be conclusive.
There are also questions about how well the vaccine protects older people. Only 12% of the study participants were older than 55 and they were enrolled later, so there was not enough time to see if they developed lower infections than those who did not receive the vaccine.
The U.S. Food and Drug Administration says it will not consider approving the Oxford-AstraZeneca vaccine until information is available from late investigations that tested the shot in about 30,000 people.
The World Health Organization is also investigating a request from AstraZeneca and Oxford for a list of emergency uses for the vaccine.
The UN Health Agency does not license or regulate vaccinations itself, but usually evaluates vaccinations once they have been approved by an agency such as the UK regulator or the European Medicines Agency. WHO experts do their own evaluation of whether or not the risks of a vaccine outweigh its benefits, and then make a recommendation that the shots be ‘pre-qualified’ so that they can be purchased by developing country donors.
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Lorne Cook in Brussels and Jamey Keaten in Geneva contributed to this report.
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