THE EUROPEAN MEDICINES Agency (EMA) has received an application for approval of the Oxford/AstraZeneca Covid-19 vaccine.
A decision on the conditional marketing authorisation of the vaccine could be issued by 29 January, the EMA said.
The assessment of the vaccine will proceed under an accelerated timeline. If approved, it would be the third Covid-19 vaccine given the green light in the EU after Pfizer/BioNTech and Moderna.
A conditional marketing authorisation results in a fast-tracked approval during public health emergencies valid throughout all EU member states.
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.
— Ursula von der Leyen (@vonderleyen) January 12, 2021
Once the vaccine receives a positive scientific opinion, we will work full speed to authorise its use in Europe.
European Commission President Ursula von der Leyen described this as “good news” on Twitter.
“Once the vaccine receives a positive scientific opinion, we will work full speed to authorise its use in Europe,” she said.
The Oxford/AstraZeneca vaccine was approved for use in the UK late last month.
This speedy evaluation process is possible because the EMA has already reviewed some data on the vaccine during a rolling review.
To embed this post, copy the code below on your site
have your say