World news – The EU regulator is considering a vaccine against Oxford-AstraZeneca


The Associated Press

Head Nurse Sam Foster is holding a vial containing the Oxford University / AstraZeneca COVID-19 vaccine on January 4, 2021 at Churchill Hospital in Oxford, England. (Steve Parsons / pool photo via AP)

The European Medicines Agency announced on Tuesday that AstraZeneca and Oxford University had filed an application for their COVID-19 vaccine across the European Union.

The EU regulator said it had received an accelerated green light application for the vaccine and that it could be approved by January 29, provided the data submitted on the quality, safety and effectiveness of the vaccine are robust enough and be complete. «  »

The EMA, the drug agency for the EU with 27 countries, has already approved two further coronavirus vaccines, one from the American drug manufacturer Pfizer and the German BioNTech, and one from the US biotechnology company Moderna. Switzerland approved the Moderna vaccine on Tuesday and plans to use it and the Pfizer BioNTech shot to immunize around 4% of its population.

The UK approved and is using the Oxford-AstraZeneca vaccine last month. India approved it this month.

As part of its strategy of getting as many different COVID-19 vaccines as possible for Europeans, the EU concluded early talks with the French biotech company Valneva in order to receive up to 60 million vaccine doses.

Valneva had previously signed a contract with the UK to provide tens of millions of doses of his shot, which was developed using technology similar to that used to make flu vaccines. The EU has six vaccination contracts for up to 2 billion doses, much more than it takes 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 kept in refrigerators rather than the ultra-cold storage required for the Pfizer vaccine. The company has announced it will sell for $ 2.50 per dose and plans to produce up to 3 billion doses by the end of 2021.

Researchers claim that the Oxford-AstraZeneca vaccine was protected against disease due to a manufacturing defect in 62 percent of patients who were given two full doses and 90 percent of those who were originally given a half dose. However, the second group only comprised 2,741 people – too few to be conclusive.

The question also remains how well the vaccine protects the elderly. Only 12% of the study participants were over 55 years old and enrolled later. As a result, there was not enough time to determine if they were developing infections at a lower rate than those who were not given the vaccine.

The U.S. Food and Drug Administration says it won’t consider approving the Oxford-AstraZeneca vaccine until it has data from late state research that tested the shot in about 30,000 people.

The World Health Organization is also considering an application from AstraZeneca and Oxford for an emergency listing for their vaccine.

The United States Health Agency does not license or regulate vaccines itself, but it typically assesses vaccines once they have been approved by a government agency such as the UK Regulatory Agency or the European Medicines Agency. WHO experts themselves assess whether or not the risks of a vaccine outweigh the benefits, and then recommend that vaccinations be « pre-qualified » so that donors can buy them for developing countries.

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