The European Medicines Agency (EMA) indicated on Tuesday that AstraZeneca and the University of Oxford have requested permission for the emergency use of the coronavirus vaccine in the European Union. (European Union), decision could arrive by January 29.
The Amsterdam-based European Organization said in a statement: “The European Medicines Agency has received an application for a conditional marketing authorization for the Covid-19 vaccine developed by AstraZeneca and the University of Oxford.”
If approved, the injection will be the third available in the European Union’s 27 countries, which are seeking to speed up the deployment of vaccination campaigns, after their approval. Pfizer-BioNTech and Moderna.
The authority indicated that it would accelerate the evaluation of the new vaccine, and that the opinion regarding the license may arrive by January 29. “Provided that the data provided on quality, safety and efficacy (…) are sufficiently strong and complete“.
President of the European Commission, Ursula von der Leyen, Celebrated the “good news” which means that “AstraZeneca has requested that its vaccine be allowed to be used in the European Union” and confirmed that “once the drug has obtained scientific approval (from the EMA)”, Brussels will act “at full speed to allow use in Europe”.
The possibility of assessing the application for a license in such a short time is due to the fact that EMA scientists, together with a group of European experts that the agency has formed to strengthen its team during the pandemic, They analyzed all clinical and laboratory data in real time for several months That the pharmaceutical company shared with them.
In recent weeks, the EMA has been evaluating the data regarding the Overall production process, ingredients and vaccine qualityPlus some evidence of its safety and efficacy comes from a joint analysis of interim clinical data from four ongoing trials in the UK, Brazil and South Africa.
AstraZeneca and Oxford recently released a new data package containing answers to human medicine experts’ questions about the vaccine’s efficacy and safety, which will be analyzed over the next three weeks before confirming to the panel whether it is. It is safe to allow the drug to be used in the COVID-19 vaccination campaigns in European countriesWhich today can only be used by Pfizer and Moderna.
If you get the green light, and like the other two vaccines already authorized in the European Union, AstraZeneca will get Conditional license, not finalTherefore, you will have to commit to monitoring the vaccination campaigns and continue to investigate volunteers in your clinical studies for at least two years to detect any problems of efficacy or side effect not yet noticed in the studies that have been conducted.
With information from EFE and AFP
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