LONDON (AP)-The European Medicines Agency said on Tuesday that AstraZeneca and Oxford University have submitted applications for their COVID-19 vaccine, which will be licensed throughout the European Union.
The EU regulator said it has received a request to expedite the vaccine approval process. If the data provided on vaccine quality, safety and effectiveness are sufficiently robust and complete, it can be approved before January 29. “
The European Union (EMA), a pharmaceutical agent in the 27 EU countries, has approved two other coronavirus vaccines. One is produced by the US drug maker Pfizer and Germany̵
The UK approved the Oxford-AstraZeneca vaccine last month and has been using it. India approved it this month.
The EU stated that it is part of a strategy for Europeans to obtain as many different COVID-19 vaccines as possible. The EU has concluded early negotiations with the French biotech company Valneva to obtain up to 60 million doses of vaccine.
Valneva previously signed an agreement with the United Kingdom to provide tens of millions of injection needles, which were developed using technology similar to that used to make flu vaccines. The EU has signed six vaccine contracts, involving up to 2 billion doses of vaccine, far exceeding the number needed to cover about 450 million people.
The Oxford-AstraZeneca vaccine is expected to become a key vaccine in many countries due to its low cost, high availability and ease of use. It can be stored in the refrigerator instead of the ultra-cold storage required by Pfizer vaccine. The company said it will sell it at a price of US$2.50 per dose and plans to produce as many as 3 billion doses by the end of 2021.
Researchers said that 62% of people were given two full doses of the vaccine due to a manufacturing error in the Oxford AstraZeneca vaccine, while 90% of people were given half-dose vaccine to prevent disease. However, the second group only includes 2,741 people, which is too small to be determined.
There are still questions about the degree of protection of the vaccine for the elderly. Only 12% of study participants were over 55 years old and were enrolled later, so there was not enough time to see if they were infected at a lower rate than unvaccinated people.
The U.S. Food and Drug Administration said it would not consider approving the Oxford-AstraZeneca vaccine until data from a later national study can test the injection volume of about 30,000 people.
The World Health Organization is also reviewing the requirements of AstraZeneca and Oxford University on their emergency vaccine lists.
The United Nations health agency itself does not license or regulate vaccines, but they usually evaluate vaccines after obtaining approval from agencies such as the UK regulatory agency or the European Medicines Agency. WHO experts have conducted their own assessments of whether the risks of the vaccine outweigh its benefits, and then put forward recommendations for “prequalification” of the vaccine so that it can be purchased by donors in developing countries.
Lorne Cook in Brussels and Jamey Keaten in Geneva contributed to this report.
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