Thursday, January 28, 2021

AstraZeneca/Oxford apply for EU approval of COVID vaccine

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British-Swedish pharmaceutical firm together with the Oxford University have utilized for a market approval of their COVID-19 vaccine within the EU, the European Medicines Agency (EMA) mentioned in an announcement on Tuesday. 
“EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by AstraZeneca and Oxford University,” reads the assertion by the Amsterdam-based firm, which added that the evaluation of the vaccine will proceed “under an accelerated timeline.”
EMA justified its upcoming move by saying that the fast-track analysis is feasible because it has “already reviewed some data on the vaccine” throughout a assembly of its scientific committee for human medicines (CHMP), provided that the situation that the information submitted by AstraZeneca/Oxford “are sufficiently robust and complete.”
An opinion on a conditional advertising and marketing authorisation may very well be issued by January 29, EMA added. 
The Commission’s chief, Ursula von der Leyen has welcomed the event, labelling it as “good news.”
“Once the vaccine receives a positive scientific opinion, we will work full speed to authorize its use in Europe,” von der Leyen wrote in a Twitter submit. 

Good information! @AstraZeneca has utilized to @EMA_News to have its vaccine authorised within the EU. @EMA_News will assess the vaccine’s security & efficacy.
Once the vaccine receives a constructive scientific opinion, we are going to work full pace to authorise its use in Europe.
— Ursula von der Leyen (@vonderleyen) January 12, 2021

Should the AstraZeneca/Oxford vaccine get the greenlight by EMA after which the Commission’s formal approval, it should turn out to be the third vaccine towards Coronavirus accessible within the EU, after the shot developed by BioNTech/Pfizer and Moderna. 

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