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HomeWorld‘Good News,’ says EC President, as AstraZeneca files for EU approval of its Covid-19 vaccine

‘Good News,’ says EC President, as AstraZeneca files for EU approval of its Covid-19 vaccine

‘Good News,’ says EC President, as AstraZeneca files for EU approval of its Covid-19 vaccine

The European Medicines Agency has received an application from pharmaceutical giant AstraZeneca for the conditional marketing authorization of their Covid-19 jab.

On Tuesday, the European Medicines Agency (EMA) confirmed that AstraZeneca had applied for its vaccine to be approved for use across the EU.

European Commission President Ursula von der Leyen took to Twitter, describing the announcement as “good news.” 

Good news! @AstraZeneca has applied to @EMA_News to have its vaccine authorised in the EU. @EMA_News will assess the vaccine’s safety & efficacy.

Once the vaccine receives a positive scientific opinion, we will work full speed to authorise its use in Europe.

— Ursula von der Leyen (@vonderleyen) January 12, 2021

The EMA could make a decision on the UK-developed jab by January 29, the organization said on its website.

“Such a short timeframe for evaluation is only possible because EMA has already reviewed some data on the vaccine during a rolling review,” the EMA said.

Any recommendation by the EMA would then have to be approved by the EU before it can be used in any of the 27 nations of the European bloc. 

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The jab could become the third vaccine to be given the green light after the EU granted market access to Pfizer/BioNTech and Moderna.

AstraZeneca has previously been criticized for a lack of clarity concerning trial data. Using two different dosing regimens, initial large-scale trial data showed the vaccine to be 70-percent effective in preventing Covid-19.

The UK began rollout of the vaccine last week; it is reportedly much easier to transport, store and administer as it does not need to be kept at sub-zero temperatures, unlike the vaccines produced by Pfizer and Moderna. 

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