LONDON (AP) – The European Medicines Agency said on Tuesday that AstraZeneca and Oxford University have applied for a COVID-19 vaccine license across the European Union.
The EU regulator said it had received a request for the vaccine to be revealed in an accelerated process and that it could be approved on January 29, provided the data presented on the quality, safety and efficacy of the vaccine be sufficiently solid and complete. ”
The EMA, the EU drug agency in 27 countries, has already approved two other coronavirus vaccines, one manufactured by US manufacturer Pfizer and Germany’s BioNTech and another manufactured by US biotechnology company Modern. Switzerland approved the Modern vaccine on Tuesday and plans to vaccinate about 4% of its population using this vaccine and the Pfizer-BioNTech trait.
Britain last month approved the Oxford-AstraZeneca vaccine and has used it. India has approved it this month.
As part of its strategy to get as many COVID-19 vaccines as possible for Europeans, the EU said it had concluded initial talks with French biotechnology company Valneva to get up to 60 million vaccine doses.
Valneva previously signed an agreement with Britain 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 sealed six vaccine contracts for up to 2 billion doses, many more than needed to cover its population of about 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 has said it will sell it for $ 2.50 a dose and plans to make up to 3 billion doses by the end of 2021.
The researchers say the Oxford-AstraZeneca vaccine is protected against the disease in 62% of those who received two full doses and in 90% of those who received half a dose initially due to a manufacturing error. However, the second group included only 2,741 people, too few to be conclusive.
There are also questions about vaccine protection for the elderly. Only 12% of study participants were over 55 years old and enrolled later, so there has not been enough time to see if they develop infections at a slower rate than those who have not been given the vaccine.
The U.S. Food and Drug Administration says it will not consider approving the Oxford-AstraZeneca vaccine until data are available from the late state investigation proving the shooting in approximately 30,000 people.
The World Health Organization is also examining an application from AstraZeneca and Oxford to obtain an emergency use list for their vaccine.
The United Nations health agency does not license or regulate vaccines per se, but usually evaluates vaccines once they have been approved by an agency such as the UK regulator or the European Medicines Agency. WHO experts make their own assessment of whether or not the risks of a vaccine outweigh its benefits and then make a recommendation that the shots be “prequalified” so that donors can buy them in developing countries.
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Lorne Cook in Brussels and Jamey Keaten in Geneva contributed to this report.
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