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On December 21, the EVA approved the use of the Pfizer and BioNTech COVID-19 vaccine to oversee the approval of vaccines in the unit. The Agency is due to make a decision on the Moderna vaccine on January 6.
However, an EU decision on AstraZeneca and the Oxford University vaccine will take time.
“Conditional Marketing Authorization (CMA) … is considered to require additional scientific information on the quality, safety and efficacy of the vaccine, and the company has been asked to do so,” the EEA said in a statement. “More information on ongoing clinical trials is also expected from January.”
Amsterdam-based EVA previously told AFP news agency that it had not yet received the formal request necessary to come up with the agency’s recommendation to use the vaccine, and that the agency had not set a time limit for approval of the AstraZeneca vaccine.
On Tuesday, EVA Deputy Executive Director Noel Wathion told Belgian newspaper Het Nieuwsblad that approval of the AstraZeneca vaccine in January was unlikely.
AstraZeneca and the University of Oxford are currently in the process of evaluating the vaccine’s safety and efficacy in light of new data, although the manufacturer has not yet submitted a formal application. This evaluation process will allow the CMA to be issued more quickly once the application is received.
On Wednesday, the EEA said it was “aware that the UK MHRA (Medicines and Healthcare Agency) has granted a temporary emergency distribution of this vaccine, which is different from the marketing authorization.”
An AstraZeneca spokesperson told AFP that the company “provided the European Medicines Agency with a complete data package in support of its CMA request …”.
The representative added: “AstraZeneca provides regular data and will continue to work closely with the EEA in launching a formal CMA application process.”
Britain is the first in the world to approve a vaccine from AstraZeneca and the University of Oxford that is cheaper to manufacture and easier to store and transport than Pfizer and BioNTech vaccines.
In the European Union, following the recommendation of the EEA, the final authorization of the vaccine is granted by the European Commission in Brussels. Pfizer and BioNTech launched last weekend in a 27-nation bloc.
AstraZeneca was the first pharmaceutical company to sign a contract with the European Commission for 300 million. COVID-19 vaccine dose with the possibility of selling another 100 million units to the unit. dose.
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