LONDON (AP) – The European Medicines Agency said Tuesday that AstraZeneca and Oxford University have filed for authorization of their COVID-19 vaccine across the European Union.
The EU regulator said it had received a request for the vaccine to be greened through an accelerated process and that it could be approved on January 29, “provided that the data submitted on the quality, safety and efficacy of the vaccine is sufficiently robust. and be complete. “
The EMA, the drug agency for the EU with 27 countries, has already approved two other coronavirus vaccines, one made by the American drug manufacturer Pfizer and Germany’s BioNTech and another made by the American biotechnology company Moderna. Switzerland approved the Moderna vaccine on Tuesday and plans to immunize about 4% of the population using that and the Pfizer-BioNTech shot.
Britain approved the Oxford-AstraZeneca vaccine last month and is now using it. India approved it this month.
As part of its strategy to obtain as many different COVID-19 vaccines for Europeans as possible, the EU said it had completed early talks with French biotech company Valneva to secure up to 60 million doses of vaccine.
Valneva previously struck a deal with Britain to provide tens of millions of doses of its injection, which has been developed using similar technology to that used to make flu vaccines. The EU has signed six vaccine contracts for up to 2 billion doses, far more than is necessary to cover the population of about 450 million.
The Oxford AstraZeneca vaccine is expected to be an important vaccine for many countries due to its low cost, availability and ease of use. It can be kept in refrigerators instead of the ultra-cold storage that the Pfizer vaccine requires. The company has said it will 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 protects against disease in 62% of those who received two full doses and in 90% of those who initially received a half dose due to a manufacturing defect. However, the second group included only 2,741 people – too few to be definitive.
Questions also remain about how well the vaccine protects the elderly. Only 12% of the study participants were over 55 and enrolled later, so there was not enough time to see if they develop infections less often 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 data is available from a late state study that tested the injection in about 30,000 people.
The World Health Organization is also investigating a request from AstraZeneca and Oxford for an emergency use list for its vaccine.
The UN health agency itself does not license or regulate vaccines, but usually evaluates vaccines after they have been approved by an agency such as the UK regulator or the European Medicines Agency. WHO experts themselves assess whether or not a vaccine’s risks outweigh its benefits, then recommend that the injections 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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