AstraZeneca and Oxford ask European Union for authorization of their coronavirus vaccine

Pharmaceutical AstraZeneca and the University of Oxford They asked the European Medicines Agency (EMA) on Tuesday for a possible conditional license for the use of the vaccine against the coronavirus in the European Union, which the EMA can evaluate before January 29.

As confirmed by the agency, its experts in medicines for human use (CHMP) will analyze the entire data package available in a “as short as possible” and they could publish their findings on the possibility of the European Commission granting the conditional license to AstraZeneca later this month.

To gain the approval of European scientists, Oxford vaccine reportedly third against covid-19 to receive green light in EU, after Pfizer / BioNTech and Moderna.

The President of the European Commission, Úrsula von der Leyen, celebrated the “good news” which implies that “AstraZeneca has requested that the use of its vaccine be authorized in the EU” and assured that “once the drug will have received scientific approval (from the EMA) ”, Brussels will work“ at full speed to authorize its use in Europe ”.

The EMA stressed on Tuesday that it will only support this drug in this period of time if the data presented on “the quality, safety and efficacy of the vaccine are the sufficiently solid and complete, and that any information necessary to complete the assessment be sent immediately ”by AstraZeneca.

The possibility of evaluating the license application in such a short timeframe is due to the fact that scientists from the EMA, as well as a group of European experts formed by the agency to strengthen their team during the pandemic, they have been analyzing all clinical data in real time for months and laboratory that the pharmacist shared with them.

In recent weeks, the EMA has assessed data on the production process, ingredients and quality of the vaccine in general, as well as some evidence on its safety and effectiveness from a joint analysis of interim clinical data. of four ongoing trials. in the UK, Brazil and South Africa.

AstraZeneca and Oxford recently delivered a new data pack containing answers to CHMP questions on the efficacy and safety of the vaccine, which will be analyzed by European experts over the next three weeks, before confirming to the Commission. it is safe to allow the use of the vaccine. drug for covid-19 vaccination campaigns in European countries, which today can only use the drug from Pfizer and Moderna.

To get the green light, and like the two other vaccines already authorized in the EU, AstraZeneca would be granted a conditional, not final, license you will therefore have to commit to monitoring the vaccination campaigns and continue to investigate the volunteers of your clinical studies for at least two years to detect possible problems of efficacy or a side effect not observed so far in the studies carried out. .

With information from EFE.

JPE